WorldWideScience

Sample records for bacterial vaccine safety

  1. Vaccine Safety

    Science.gov (United States)

    ... the safety of Tdap, Meningococcal, and HPV vaccines Human Papillomavirus (HPV) Vaccine is Very Safe Read about the safety of ... Hepatitis A Vaccine Safety Hepatitis B Vaccine Safety Human Papillomavirus (HPV) Vaccine Safety FAQs about HPV Safety Influenza (Flu) Vaccine ...

  2. Vaccine Safety Datalink

    Science.gov (United States)

    The Vaccine Safety Datalink is part of the National Immunization Program within the Centers for Disease Control and Prevention and was started in recognition of gaps in the scientific knowledge of rare vaccine side effects.

  3. A stable live bacterial vaccine.

    Science.gov (United States)

    Kunda, Nitesh K; Wafula, Denis; Tram, Meilinn; Wu, Terry H; Muttil, Pavan

    2016-06-01

    Formulating vaccines into a dry form enhances its thermal stability. This is critical to prevent administering damaged and ineffective vaccines, and to reduce its final cost. A number of vaccines in the market as well as those being evaluated in the clinical setting are in a dry solid state; yet none of these vaccines have achieved long-term stability at high temperatures. We used spray-drying to formulate a recombinant live attenuated Listeria monocytogenes (Lm; expressing Francisella tularensis immune protective antigen pathogenicity island protein IglC) bacterial vaccine into a thermostable dry powder using various sugars and an amino acid. Lm powder vaccine showed minimal loss in viability when stored for more than a year at ambient room temperature (∼23°C) or for 180days at 40°C. High temperature viability was achieved by maintaining an inert atmosphere in the storage container and removing oxygen free radicals that damage bacterial membranes. Further, in vitro antigenicity was confirmed by infecting a dendritic cell line with cultures derived from spray dried Lm and detection of an intracellularly expressed protective antigen. A combination of stabilizing excipients, a cost effective one-step drying process, and appropriate storage conditions could provide a viable option for producing, storing and transporting heat-sensitive vaccines, especially in regions of the world that require them the most. PMID:27020530

  4. Vaccination against salmonid bacterial kidney disease

    Science.gov (United States)

    Bacterial kidney disease (BKD) of salmonid fishes, caused by Renibacterium salmoninarum, has presented challenges for development of effective vaccines, despite several decades of research. The only vaccine against BKD that is commercially licensed is an injectable preparation containing live cells ...

  5. DNA vaccines and bacterial DNA in immunity

    OpenAIRE

    Bandholtz, Lisa Charlotta

    2002-01-01

    This thesis describes DNA-based vaccination and the importance of bacterial DNA in different immunological perspectives. Intranasal (i.n.) DNA vaccination utilizing a plasmid encoding the chlamydial heat shock protein 60 (p-hsp-60) generated lower bacterial burden and reduced pathology in the lungs of mice after subsequent infection with C. pneumoniae. This DNA vaccine- induced protection was dependent on T cells and induction of IFN-gamma. Co-administration of a plasmid...

  6. Vaccination against bacterial kidney disease: Chapter 22

    Science.gov (United States)

    Elliott, Diane G.; Wiens, Gregory D.; Hammell, K. Larry; Rhodes, Linda D.

    2014-01-01

    Bacterial kidney disease (BKD) of salmonid fishes, caused by Renibacterium salmoninarum, has been recognized as a serious disease in salmonid fishes since the 1930s. This chapter discusses the occurrence and significance, etiology, and pathogenesis of BKD. It then describes the different vaccination procedures and the effects and side-effects of vaccination. Despite years of research, however, only a single vaccine has been licensed for prevention of BKD, and has demonstrated variable efficacy. Therefore, in addition to a presentation of the current status of BKD vaccination, a discussion of potential future directions for BKD vaccine development is included in the chapter. This discussion is focused on the unique characteristics of R. salmoninarum and its biology, as well as aspects of the salmonid immune system that might be explored specifically to develop more effective vaccines for BKD prevention.

  7. Meningococcal Disease (Bacterial Meningitis) Vaccine and Pregnancy

    Science.gov (United States)

    Meningococcal Disease (Bacterial meningitis) Vaccine and Pregnancy In every pregnancy, a woman starts out with a 3-5% chance of having a baby ... advice from your health care provider. What is meningitis? Meningitis is an infection of the lining that ...

  8. A global perspective on vaccine safety and public health: the Global Advisory Committee on Vaccine Safety

    OpenAIRE

    Folb, Peter I; Bernatowska, Ewa; Chen, Robert; Clemens, John; Dodoo, Alex N O; Ellenberg, Susan S.; Farrington, C Patrick; John, T. Jacob; Lambert, Paul Henri; MacDonald, Noni E; Miller, Elizabeth; Salisbury, David; Schmitt, Heinz-J; Siegrist, Claire-Anne; Wimalaratne, Omala

    2004-01-01

    Established in 1999, the Global Advisory Committee on Vaccine Safety advises the World Health Organization (WHO) on vaccine-related safety issues and enables WHO to respond promptly, efficiently, and with scientific rigor to issues of vaccine safety with potential global importance. The committee also assesses the implications of vaccine safety for practice worldwide and for WHO policies. We describe the principles on which the committee was established, its modus operandi, and the scope of t...

  9. [Vaccination safety and media publicity strategy].

    Science.gov (United States)

    Tan, J B; Guo, X M; Li, K L; Zhang, X M

    2016-03-10

    Due to the over negative report of adverse event following immunization (AEFI) by media, some people began to question the safety of vaccination. Date published since 2005 were collected by literature retrieval, mainly including relative AEFI date, current status of media report of AEFI, public awareness about AEFI. Public concern about the vaccination safety mainly focused on the serious diseases which might be caused, influence on immune system. Media' s over negative reactions to AEFI and lack of related knowledge in general public have led to the public' s concern about vaccination safety. Vaccination is the most economical and effective measure for the prevention of diseases and AEFI incidence rate is very low. Therefore, it is necessary for media to give more positive report about vaccination safety. PMID:27005553

  10. Safety and efficacy of DNA vaccines: Plasmids vs. minicircles

    OpenAIRE

    Stenler, Sofia; Blomberg, Pontus; Smith, Ci Edvard

    2014-01-01

    While DNA vaccination using plasmid vectors is highly attractive, there is a need for further vector optimization regarding safety, stability, and efficiency. In this commentary, we review the minicircle vector (MC), which is an entity devoid of plasmid bacterial sequences, as an alternative to the traditional plasmid construct. The commentary highlights the recent discovery by Stenler et al. (2014) that the small size of an MC enables improved resistance to the shearing forces associated wit...

  11. Bacterial Artificial Chromosome Clones of Viruses Comprising the Towne Cytomegalovirus Vaccine

    OpenAIRE

    Xiaohong Cui; Adler, Stuart P.; Davison, Andrew J.; Larry Smith; EL-Sayed E. Habib; McVoy, Michael A.

    2012-01-01

    Bacterial artificial chromosome (BAC) clones have proven invaluable for genetic manipulation of herpesvirus genomes. BAC cloning can also be useful for capturing representative genomes that comprise a viral stock or mixture. The Towne live attenuated cytomegalovirus vaccine was developed in the 1970s by serial passage in cultured fibroblasts. Although its safety, immunogenicity, and efficacy have been evaluated in nearly a thousand human subjects, the vaccine itself has been little studied. I...

  12. Preclinical and clinical safety studies on DNA vaccines.

    OpenAIRE

    Schalk, Johanna A C; Mooi, Frits R.; Berbers, Guy A M; Aerts, Leon A G J M van; Ovelgönne, Hans; Kimman, Tjeerd G.

    2007-01-01

    DNA vaccines are based on the transfer of genetic material, encoding an antigen, to the cells of the vaccine recipient. Despite high expectations of DNA vaccines as a result of promising preclinical data their clinical utility remains unproven. However, much data is gathered in preclinical and clinical studies about the safety of DNA vaccines. Here we review current knowledge about the safety of DNA vaccines. Safety concerns of DNA vaccines relate to genetic, immunologic, toxic, and environme...

  13. 9 CFR 113.64 - General requirements for live bacterial vaccines.

    Science.gov (United States)

    2010-01-01

    ... bacterial vaccines. 113.64 Section 113.64 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION... STANDARD REQUIREMENTS Live Bacterial Vaccines § 113.64 General requirements for live bacterial vaccines... bacterial vaccine shall meet the requirements in this section. (a) Purity test. Final container samples...

  14. HPV Vaccine Safety PSA (:30)

    Centers for Disease Control (CDC) Podcasts

    2014-01-15

    In this 30 second public service announcement, a mother talks about the importance of protecting 11-12 year-old boys and girls with HPV vaccination. (Una madre habla sobre la importancia de proteger a los niños y las niñas de 11 a 12 años con la vacuna contra el VPH.).  Created: 1/15/2014 by National Center for Immunizations and Respiratory Diseases (NCIRD).   Date Released: 1/15/2014.

  15. Development of a vaccine for bacterial kidney disease in salmon

    International Nuclear Information System (INIS)

    This document is the executive summary and background review for the final report of ''Development of a Vaccine for Bacterial Kidney Disease in Salmon''. A description of the disease is provided, with microbiological characterization of the infective agent. A brief discussion of attempts to eradicate the disease is included. Recent progress in vaccine development and attempts to control the disease through pharmacological means are described, along with potential ways to break the cycle of infection. 80 refs

  16. Monitoring vaccine safety using the Vaccine Safety Datalink: utilizing immunization registries for pandemic influenza.

    Science.gov (United States)

    McCarthy, Natalie L; Gee, Julianne; Weintraub, Eric; Donahue, James G; Nordin, James D; Daley, Matthew F; Naleway, Allison; Henninger, Michelle; Baxter, Roger; Crane, Bradley; Aukes, Laurie; Wagner, Nicole; Fisher, Sarah; Jacobsen, Steven J; Sy, Lina; Baggs, James

    2011-07-12

    Mass vaccination campaigns during which new vaccines may be administered to many millions of people in a short period of time call for timely and accurate post-licensure surveillance to monitor vaccine safety. To address the need for timely H1N1 influenza vaccine safety information during the 2009-2010 H1N1 influenza pandemic, the Vaccine Safety Datalink (VSD) project assessed the feasibility and potential mechanisms for utilizing data from state and local immunization registries to capture vaccinations that would not otherwise be captured by the data systems of the participating VSD managed care organizations (MCOs). Three of the eight VSD sites were able to capture H1N1 immunization data electronically from the state and local registries, and one site was able to capture the immunizations through a paper-based system; however, the remaining four sites encountered various obstacles that prevented capture of such data. Additional work will be required at these sites to overcome the barriers, which included privacy and confidentiality laws, time constraints brought on by the pandemic, as well as data quality concerns. PMID:21596088

  17. Vaccination for the control of childhood bacterial pneumonia - Haemophilus influenzae type b and pneumococcal vaccines

    Directory of Open Access Journals (Sweden)

    Diana C Otczyk

    2013-01-01

    Full Text Available Pneumonia in childhood is endemic in large parts of the world and in particular, in developing countries, as well as in many indigenous communities within developed nations. Haemophilus influenzae type b and Streptococcus pneumoniae conjugate vaccines are currently available against the leading bacterial causes of pneumonia.  The use of the vaccines in both industrialised and developing countries have shown a dramatic reduction in the burden of pneumonia and invasive disease in children.  However, the greatest threat facing pneumococcal conjugate vaccine effectiveness is serotype replacement.  The current vaccines provide serotype-specific, antibody–mediated protection against only a few of the 90+ capsule serotypes.  Therefore, there has been a focus in recent years to rapidly advance technologies that will result in broader disease coverage and more affordable vaccines that can be used in developing countries.  The next generation of pneumococcal vaccines have advanced to clinical trials.

  18. Live bacterial delivery systems for development of mucosal vaccines

    NARCIS (Netherlands)

    Thole, J.E.R.; Dalen, P.J. van; Havenith, C.E.G.; Pouwels, P.H.; Seegers, J.F.M.L.; Tielen, F.D.; Zee, M.D. van der; Zegers, N.D.; Shaw, M.

    2000-01-01

    By expression of foreign antigens in attenuated strains derived from bacterial pathogens and in non-pathogenic commensal bacteria, recombinant vaccines are being developed that aim to stimulate mucosal immunity. Recent advances in the pathogenesis and molecular biology of these bacteria have allowed

  19. Bacterial Outer Membrane Vesicles and Vaccine Applications

    OpenAIRE

    Acevedo, Reinaldo; Fernández, Sonsire; Zayas, Caridad; Acosta, Armando; Sarmiento, Maria Elena; Valerie A. Ferro; Rosenqvist, Einar; Campa, Concepcion; Cardoso, Daniel; Garcia, Luis; Perez, Jose Luis

    2014-01-01

    Vaccines based on outer membrane vesicles (OMV) were developed more than 20 years ago against Neisseria meningitidis serogroup B. These nano-sized structures exhibit remarkable potential for immunomodulation of immune responses and delivery of meningococcal antigens or unrelated antigens incorporated into the vesicle structure. This paper reviews different applications in OMV Research and Development (R&D) and provides examples of OMV developed and evaluated at the Finlay Institute in Cuba. A...

  20. BACTERIAL OUTER MEMBRANE VESICLES AND VACCINE APPLICATIONS

    OpenAIRE

    Reinaldo eAcevedo; Sonsire eFernandez; Caridad eZayas; Armando eAcosta; Maria Elena Sarmiento; Valerie A. Ferro; Einar eRosenqvist; Concepcion eCampa; Daniel eCardoso; Luis eGarcia; Jose Luis Perez

    2014-01-01

    Vaccines based on outer membrane vesicles (OMV) were developed more than 20 years ago against Neisseria meningitidis serogroup B. These nano-sized structures exhibit remarkable potential for immunomodulation of immune responses and delivery of self meningococcal antigens or unrelated antigens incorporated into the vesicle structure. This paper reviews different applications in OMV Research and Development (R&D) and provides examples of OMV developed and evaluated at the Finlay Institute in Cu...

  1. Bacterial outer membrane vesicles and vaccine applications.

    Science.gov (United States)

    Acevedo, Reinaldo; Fernández, Sonsire; Zayas, Caridad; Acosta, Armando; Sarmiento, Maria Elena; Ferro, Valerie A; Rosenqvist, Einar; Campa, Concepcion; Cardoso, Daniel; Garcia, Luis; Perez, Jose Luis

    2014-01-01

    Vaccines based on outer membrane vesicles (OMV) were developed more than 20 years ago against Neisseria meningitidis serogroup B. These nano-sized structures exhibit remarkable potential for immunomodulation of immune responses and delivery of meningococcal antigens or unrelated antigens incorporated into the vesicle structure. This paper reviews different applications in OMV Research and Development (R&D) and provides examples of OMV developed and evaluated at the Finlay Institute in Cuba. A Good Manufacturing Practice (GMP) process was developed at the Finlay Institute to produce OMV from N. meningitidis serogroup B (dOMVB) using detergent extraction. Subsequently, OMV from N. meningitidis, serogroup A (dOMVA), serogroup W (dOMVW), and serogroup X (dOMVX) were obtained using this process. More recently, the extraction process has also been applied effectively for obtaining OMV on a research scale from Vibrio cholerae (dOMVC), Bordetella pertussis (dOMVBP), Mycobacterium smegmatis (dOMVSM), and BCG (dOMVBCG). The immunogenicity of the OMV has been evaluated for specific antibody induction, and together with functional bactericidal and challenge assays in mice has shown their protective potential. dOMVB has been evaluated with non-neisserial antigens, including with a herpes virus type 2 glycoprotein, ovalbumin, and allergens. In conclusion, OMV are proving to be more versatile than first conceived and remain an important technology for development of vaccine candidates. PMID:24715891

  2. BACTERIAL OUTER MEMBRANE VESICLES AND VACCINE APPLICATIONS

    Directory of Open Access Journals (Sweden)

    Reinaldo eAcevedo

    2014-03-01

    Full Text Available Vaccines based on outer membrane vesicles (OMV were developed more than 20 years ago against Neisseria meningitidis serogroup B. These nano-sized structures exhibit remarkable potential for immunomodulation of immune responses and delivery of self meningococcal antigens or unrelated antigens incorporated into the vesicle structure. This paper reviews different applications in OMV Research and Development (R&D and provides examples of OMV developed and evaluated at the Finlay Institute in Cuba. A Good Manufacturing Practice (GMP process was developed at the Finlay Institute to produce OMV from N. meningitidis serogroup B (dOMVB using detergent extraction. Subsequently, OMV from N. meningitidis, serogroup A (dOMVA, serogroup W (dOMVW and serogroup X (dOMVX were obtained using this process. More recently, the extraction process has also been applied effectively for obtaining OMV on a research scale from Vibrio cholerae (dOMVC, Bordetella pertussis (dOMVBP, Mycobacterium smegmatis (dOMVSM and BCG (dOMVBCG. The immunogenicity of the OMV have been evaluated for specific antibody induction, and together with functional bactericidal and challenge assays in mice have shown their protective potential. dOMVB has been evaluated with non-self neisserial antigens, including with a herpes virus type 2 glycoprotein, ovalbumin and allergens. In conclusion, OMV are proving to be more versatile than first conceived and remain an important technology for development of vaccine candidates.

  3. Near Real-Time Surveillance for Influenza Vaccine Safety: Proof-of-Concept in the Vaccine Safety Datalink Project

    OpenAIRE

    Greene, Sharon K.; Kulldorff, Martin; Lewis, Edwin M.; Li, Rong; Yin, Ruihua; Weintraub, Eric S.; Fireman, Bruce H.; Lieu, Tracy A.; Nordin, James D.; Jason M Glanz; Baxter, Roger; Jacobsen, Steven J.; Broder, Karen R.; Grace M Lee

    2009-01-01

    The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent ...

  4. Contagious bovine pleuropneumonia (CBPP) in the Maasai ecosystem of south-western Kenya: Evaluation of seroprevalence, risk factors and vaccine safety and efficacy.

    OpenAIRE

    Mtui-Malamsha, Niwael Jesse

    2009-01-01

    Contagious bovine pleuropneumonia (CBPP) is a bovine bacterial disease of major economic importance in sub-Saharan Africa. Vaccination has been recommended to control the disease in endemic areas such as the Maasai ecosystems of Kenya and Tanzania; however, the currently used live attenuated vaccine has been reported to have poor vaccine safety and efficacy. To compare standard (current) and an improved (buffered) version of the live CBPP-vaccine, several epidemiological studie...

  5. The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy.

    Science.gov (United States)

    Ahmed, S Sohail; Montomoli, Emanuele; Pasini, Franco Laghi; Steinman, Lawrence

    2016-01-01

    Despite the very high benefit-to-risk ratio of vaccines, the fear of negative side effects has discouraged many people from getting vaccinated, resulting in the reemergence of previously controlled diseases such as measles, pertussis and diphtheria. This fear has been amplified more recently by multiple epidemiologic studies that confirmed the link of an AS03-adjuvanted pandemic influenza vaccine (Pandemrix, GlaxoSmithKline Biologicals, Germany) used in Europe during the 2009 H1N1 influenza pandemic [A(H1N1) pdm09] with the development of narcolepsy, a chronic sleep disorder, in children and adolescents. However, public misperceptions of what adjuvants are and why they are used in vaccines has created in some individuals a closed "black box" attitude towards all vaccines. The focus of this review article is to revisit this "black box" using the example of narcolepsy associated with the European AS03-adjuvanted pandemic influenza vaccine. PMID:27228647

  6. Quadrivalent HPV vaccine safety review and safety monitoring plans for nine-valent HPV vaccine in the United States.

    Science.gov (United States)

    Gee, Julianne; Weinbaum, Cindy; Sukumaran, Lakshmi; Markowitz, Lauri E

    2016-06-01

    Quadrivalent human papillomavirus (4vHPV) vaccine was licensed for use in the United States in 2006 and through 2015 was the predominate HPV vaccine used. With the exception of syncope, a known preventable adverse event after any injected vaccination, both pre-licensure and post-licensure 4vHPV safety data have been reassuring with no confirmed safety signals identified. Nine-valent HPV vaccine (9vHPV) was licensed in 2014. This review includes post-licensure 4vHPV safety findings published to date that have informed the US vaccination program; these data will inform US safety monitoring and evaluation for 9vHPV. PMID:27029786

  7. Safety experience with heptavalent pneumococcal CRM197-conjugate vaccine (Prevenar) since vaccine introduction.

    Science.gov (United States)

    Center, Kimberly J; Strauss, Ann

    2009-05-26

    Documentation of the safety of any vaccine is of paramount importance given the nature and scale of vaccination as a public health intervention. Prevenar was first approved for use in 2000, and includes seven pneumococcal serotypes conjugated to CRM(197), a carrier protein that has been used safely in multiple conjugate vaccines for more than 20 years. The safety profile of Prevenar was established prior to licensure in 5 clinical trials involving more than 18,000 infants and children. The largest postmarketing study of the safety of Prevenar given concomitantly with other recommended vaccines was conducted in the United States, and included more than 162,000 subjects. This analysis did not suggest any new safety consideration that would alter the risk-benefit balance of the vaccine, and demonstrated the favorable safety profile of Prevenar. To date, global surveillance of spontaneously reported adverse events to the manufacturer after more than 198 million doses distributed has confirmed these findings. The WHO has recommended the priority inclusion of this vaccine in national childhood immunization programs based on both its documented efficacy and safety. We will discuss the importance of monitoring vaccine safety and the methodologies by which this may be done, using Prevenar as an illustrative example. PMID:19200818

  8. Sequential Generalized Likelihood Ratio Tests for Vaccine Safety Evaluation

    OpenAIRE

    Shih, Mei-Chiung; Lai, Tze Leung; Heyse, Joseph F; Chen, Jie

    2010-01-01

    The evaluation of vaccine safety involves pre-clinical animal studies, pre-licensure randomized clinical trials and post-licensure safety studies. Sequential design and analysis are of particular interest because they allow early termination of the trial or quick detection that the vaccine exceeds a prescribed bound on the adverse event rate. After a review of recent developments in this area, we propose a new class of sequential generalized likelihood ratio tests for evaluating adverse event...

  9. Pneumococcal Vaccines

    OpenAIRE

    Chen-Fang Ho; Tzou-Yien Lin

    2005-01-01

    Streptococcus pneumoniae is the leading bacterial pathogen of infectious diseases inchildren and adolescents. The 23-valent pneumococcal polysaccharide vaccine could preventinvasive pneumococcal infection with broader serotype coverage but still has some limitations.On the other hand, 7-valent pneumococcal conjugate vaccine has been shown todecrease cases of nasopharyngeal acquired S. pneumoniae vaccine serotypes and provedherd immunity. The safety and efficacy against vaccine serotype pneumo...

  10. Current developments in avian influenza vaccines, including safety of vaccinated birds as food.

    Science.gov (United States)

    Swayne, D E; Suarez, D L

    2007-01-01

    Until recently, most vaccines against avian influenza were based on oil-emulsified inactivated low- or high-pathogenicity viruses. Now, recombinant fowl pox and avian paramyxovirus type 1 vaccines with avian influenza H5 gene inserts (+ or - N1 gene insert) are available and licensed. New technologies might overcome existing limitations to make available vaccines that can be grown in tissue culture systems for more rapid production; provide optimized protection, as a result of closer genetic relations to field viruses; allow mass administration by aerosol, in drinking-water or in ovo; and allow easier strategies for identifying infected birds within vaccinated populations (DIVA). The technologies include avian influenza viruses with partial gene deletions, avian influenza-Newcastle disease virus chimeras, vectored vaccines such as adenoviruses and Marek's disease virus, and subunit vaccines. These new methods should be licensed only after their purity, safety, efficacy and potency against avian influenza viruses have been demonstrated, and, for live vectored vaccines, restriction of viral transmission to unvaccinated birds. Use of vaccines in countries affected by highly pathogenic avian influenza will not only protect poultry but will provide additional safety for consumers. Experimental studies have shown that birds vaccinated against avian influenza have no virus in meat and minimal amounts in eggs after HPAI virus challenge, and that replication and shedding from their respiratory and alimentary tracts is greatly reduced. PMID:18411943

  11. Seasonal Flu Vaccine Safety and Pregnant Women

    Science.gov (United States)

    ... breastfeeding women get a flu vaccine? Why should pregnant women get a flu shot? Flu is more ... Pregnant Women & Influenza (Flu) . Is it safe for pregnant women and their developing babies to get a ...

  12. Bacterial vaccines for fish--an update of the current situation worldwide.

    Science.gov (United States)

    Håstein, T; Gudding, R; Evensen, O

    2005-01-01

    During the last few years, the use of vaccines for disease prevention in aquaculture has expanded both with regard to the number of fish species and number of microbial diseases. According to the responses to a questionnaire received from 41 countries, vaccination is used in the commercial aquaculture of species like Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), sea bass (Dicentrarchus labrax), sea bream (Sparus aurata), barramundi (Lates calcarifer), tilapia (Tilapia spp), turbot (Scophthalmus maximus L.), yellowtail (Seriola quinqueradiata), purplish and gold-striped amberjack (Seriola dumereli), striped jack (Pseudocaranx dentex) and channel catfish (Ictalurus punctatus). The range of bacterial infections for which vaccines are commercially available now comprises classical vibriosis (Listonella anguillarum, Vibrio ordalii), furunculosis (Aeromonas salmonicida subsp. salmonicida), cold-water vibriosis (Vibrio salmonicida), yersiniosis (Yersinia ruckeri), pasteurellosis (Photobacterium damselae supsp. piscicida), edwardsiellosis (Edwardsiella ictaluri), winter ulcer (Moritella viscosa), and streptococcosis/lactococcosis (Streptococcus iniae, Lactococcus garviae). Furthermore, experimental vaccines are used against diseases such as infection with Vibrio harveyi and Photobacterium damsela subsp. damsela in barramundi, piscirickettsiosis and bacterial kidney disease in salmonids, as well as infection with Flexibacter maritimus (now: Tenacibaculum maritimum) in turbot. There was good agreement between the information received from different sources in the same country. Most vaccines are licensed products, but some non-licensed vaccines are also used in commercial fish farms. Most bacterial vaccines are inactivated products and recombinant vaccine technology has so far been used to a very limited extent. Salmonid fish are usually immunised with multivalent vaccines by intraperitoneal injection. In marine fish species vaccination is generally

  13. Efficacy of cellular vaccines and genetic adjuvants against bacterial kidney disease in chinook salmon (Oncorhynchus tshawytscha).

    Science.gov (United States)

    Rhodes, Linda D; Rathbone, Cindra K; Corbett, Stephen C; Harrell, Lee W; Strom, Mark S

    2004-04-01

    DNA adjuvants and whole bacterial cell vaccines against bacterial kidney disease (BKD) were tested in juvenile chinook salmon. Whole cell vaccines of either a nonpathogenic Arthrobacter spp. or an attenuated Renibacterium salmoninarum strain provided limited prophylactic protection against acute intraperitoneal challenge with virulent R. salmoninarum, and the addition of either synthetic oligodeoxynucleotides or purified R. salmoninarum genomic DNA as adjuvants did not increase protection. However, a combination of both whole cell vaccines significantly increased survival among fish naturally infected with R. salmoninarum, and the surviving fish treated with the combination vaccine exhibited reduced levels of bacterial antigens in the kidney. This is the first demonstration of a potential therapeutic effect of a whole cell vaccine against BKD. PMID:15123289

  14. Assessment of safety and interferon gamma responses of Mycobacterium bovis BCG vaccine in goat kids and milking goats.

    Science.gov (United States)

    Pérez de Val, Bernat; Vidal, Enric; López-Soria, Sergio; Marco, Alberto; Cervera, Zoraida; Martín, Maite; Mercader, Irene; Singh, Mahavir; Raeber, Alex; Domingo, Mariano

    2016-02-10

    Vaccination of domestic animals has emerged as an alternative long-term strategy for the control of tuberculosis (TB). A trial under field conditions was conducted in a TB-free goat herd to assess the safety of the Mycobacterium bovis BCG vaccine. Eleven kids and 10 milking goats were vaccinated with BCG. Bacterial shedding and interferon gamma (IFN-γ) responses were monitored throughout the study. Comprehensive pathological examination and mycobacterial culture of target tissues were performed. BCG vaccine strain was only isolated from the draining lymph node of the injection site of a kid euthanized at week 8 post-vaccination. The remaining animals were euthanized at week 24. Six out of 20 showed small granulomas at the injection site. BCG shedding was not detected in either faeces or in milk throughout the study. All vaccinated kids showed BCG-induced IFN-γ responses at week 8 post-vaccination. BCG vaccination of goats showed no lack of biological safety for the animals, environment and public health, and local adverse reactions were negligible. PMID:26795364

  15. 21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Inactivated influenza vaccine, general safety test. 610.11a Section 610.11a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety...

  16. Bacterially produced recombinant influenza vaccines based on virus-like particles.

    Directory of Open Access Journals (Sweden)

    Andrea Jegerlehner

    Full Text Available Although current influenza vaccines are effective in general, there is an urgent need for the development of new technologies to improve vaccine production timelines, capacities and immunogenicity. Herein, we describe the development of an influenza vaccine technology which enables recombinant production of highly efficient influenza vaccines in bacterial expression systems. The globular head domain of influenza hemagglutinin, comprising most of the protein's neutralizing epitopes, was expressed in E. coli and covalently conjugated to bacteriophage-derived virus-like particles produced independently in E.coli. Conjugate influenza vaccines produced this way were used to immunize mice and found to elicit immune sera with high antibody titers specific for the native influenza hemagglutinin protein and high hemagglutination-inhibition titers. Moreover vaccination with these vaccines induced full protection against lethal challenges with homologous and highly drifted influenza strains.

  17. HPV Vaccine Safety PSA (:30) (No Tag)

    Centers for Disease Control (CDC) Podcasts

    2014-01-15

    In this 30 second public service announcement, a mother talks about the importance of protecting 11-12 year-old boys and girls with HPV vaccination. No CDC tag at the end. (Una madre habla sobre la importancia de proteger a los niños y las niñas de 11 a 12 años con la vacuna contra el VPH.).  Created: 1/15/2014 by National Center for Immunizations and Respiratory Diseases (NCIRD).   Date Released: 1/15/2014.

  18. Historical aspects of immunization and vaccine safety communication.

    Science.gov (United States)

    Helfert, Stephanie M

    2015-01-01

    It has been a long journey starting from the beginnings of variolation [3] leading up to the greatest success in the history of immunization: the eradication of smallpox [39]. Today, vaccines are an acknowledged important medical advance [40]. Nevertheless, immunization has been the subject of public controversy on several occasions [15, 24, 31]. This article shall provide a short overview of some aspects of the early stages of immunization in Western countries, including some examples of vaccine safety controversies in the past. PMID:25859668

  19. Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

    OpenAIRE

    Maro, Judith C.; Fryback, Dennis G.; Lieu, Tracy A; Lee, Grace M.; David B Martin

    2014-01-01

    Background: Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system. Methods: We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental...

  20. Genetically Engineered Poxviruses for Recombinant Gene Expression, Vaccination, and Safety

    Science.gov (United States)

    Moss, Bernard

    1996-10-01

    Vaccinia virus, no longer required for immunization against smallpox, now serves as a unique vector for expressing genes within the cytoplasm of mammalian cells. As a research tool, recombinant vaccinia viruses are used to synthesize and analyze the structure--function relationships of proteins, determine the targets of humoral and cell-mediated immunity, and investigate the types of immune response needed for protection against specific infectious diseases and cancer. The vaccine potential of recombinant vaccinia virus has been realized in the form of an effective oral wild-life rabies vaccine, although no product for humans has been licensed. A genetically altered vaccinia virus that is unable to replicate in mammalian cells and produces diminished cytopathic effects retains the capacity for high-level gene expression and immunogenicity while promising exceptional safety for laboratory workers and potential vaccine recipients.

  1. DNA vaccination for rabies: Evaluation of preclinical safety and toxicology

    Directory of Open Access Journals (Sweden)

    Rajni Garg

    2014-01-01

    Full Text Available The worldwide incidence of rabies and high rates of therapy failure, despite availability of effective vaccines indicate the need for timely and improved prophylactic approaches. DNA vaccination based on optimized formulation of lysosome-targeted glycoprotein of the rabies virus provides potential platform for preventing and controlling rabies. As per the pre-clinical requirements, listed in guidelines of Schedule Y, FDA and that of The European Agency for evaluation of Medicinal Products; we evaluated the acute (single dose – 14 days using three dosing levels, that is, the therapeutic (1×, average (5× and high dose (10× intramuscular toxicity in the rodent model Swiss Albino mice. Furthermore, the chronic intramuscular toxicity (repeated dose – 43 days with another 14 days for satellite groups was investigated using broad dosing levels ranging from low (7×, mid (14× to high (28× in Wistar rats. A range of parameters including physical, physiological, clinical, immunological, hematological along with histopathology profiles of target organs was monitored to assess the impact of vaccination. There were no observational adverse effects despite high dose administration of the DNA vaccine formulation. Thus, this study indicates the safety of next generation of vaccines as well as highlights their potential application.

  2. The effects of vaccination and immunity on bacterial infection dynamics in vivo.

    Directory of Open Access Journals (Sweden)

    Chris Coward

    2014-09-01

    Full Text Available Salmonella enterica infections are a significant global health issue, and development of vaccines against these bacteria requires an improved understanding of how vaccination affects the growth and spread of the bacteria within the host. We have combined in vivo tracking of molecularly tagged bacterial subpopulations with mathematical modelling to gain a novel insight into how different classes of vaccines and branches of the immune response protect against secondary Salmonella enterica infections of the mouse. We have found that a live Salmonella vaccine significantly reduced bacteraemia during a secondary challenge and restrained inter-organ spread of the bacteria in the systemic organs. Further, fitting mechanistic models to the data indicated that live vaccine immunisation enhanced both the bacterial killing in the very early stages of the infection and bacteriostatic control over the first day post-challenge. T-cell immunity induced by this vaccine is not necessary for the enhanced bacteriostasis but is required for subsequent bactericidal clearance of Salmonella in the blood and tissues. Conversely, a non-living vaccine while able to enhance initial blood clearance and killing of virulent secondary challenge bacteria, was unable to alter the subsequent bacterial growth rate in the systemic organs, did not prevent the resurgence of extensive bacteraemia and failed to control the spread of the bacteria in the body.

  3. Safety and Immunogenicity of Boosting BCG Vaccinated Subjects with BCG: Comparison with Boosting with a New TB Vaccine, MVA85A

    OpenAIRE

    Whelan, KT; Pathan, AA; Sander, CR; Fletcher, HA; Poulton, I; Alder, NC; Hill, AV; Mcshane, H.

    2009-01-01

    OBJECTIVES To investigate the safety and immunogenicity of a booster BCG vaccination delivered intradermally in healthy, BCG vaccinated subjects and to compare with a previous clinical trial where BCG vaccinated subjects were boosted with a new TB vaccine, MVA85A. DESIGN Phase I open label observational trial, in the UK. Healthy, HIV-negative, BCG vaccinated adults were recruited and vaccinated with BCG. The primary outcome was safety; the secondary outcome was cellular immune responses ...

  4. Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015.

    Science.gov (United States)

    Pillsbury, Alexis; Cashman, Patrick; Leeb, Alan; Regan, Annette; Westphal, Darren; Snelling, Tom; Blyth, Christopher; Crawford, Nigel; Wood, Nicholas; Macartney, Kristine

    2015-01-01

    Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination. PMID:26536867

  5. Establishment of a new quality control and vaccine safety test for influenza vaccines and adjuvants using gene expression profiling.

    Directory of Open Access Journals (Sweden)

    Haruka Momose

    Full Text Available We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine.

  6. Responding to vaccine safety signals during pandemic influenza: a modeling study.

    Directory of Open Access Journals (Sweden)

    Judith C Maro

    Full Text Available Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system.We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1 expected vaccination benefit from averted influenza; 2 expected vaccination risk from vaccine-associated febrile seizures; 3 expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4 expected change in vaccine-seeking behavior in future influenza seasons.Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3:1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior.The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior.

  7. A novel multi-stage subunit vaccine against paratuberculosis induces significant immunity and reduces bacterial burden in tissues (P4304)

    DEFF Research Database (Denmark)

    Thakur, Aneesh; Aagaard, Claus; Riber, Ulla;

    2013-01-01

    Effective control of paratuberculosis is hindered by lack of a vaccine preventing infection, transmission and without diagnostic interference with tuberculosis. We have developed a novel multi-stage recombinant subunit vaccine in which a fusion of four early expressed MAP antigens is combined with...... characterized by a significant containment of bacterial burden in gut tissues compared to non-vaccinated animals. There was no cross-reaction with bovine tuberculosis in vaccinated animals. This novel multi-stage vaccine has the potential to become a marker vaccine for paratuberculosis....

  8. Secretome, surfome and immunome: emerging approaches for the discovery of new vaccine candidates against bacterial infections.

    Science.gov (United States)

    Dwivedi, Pratistha; Alam, Syed Imteyaz; Tomar, Rajesh Singh

    2016-09-01

    Functional genomics has made possible advanced structure-to-function investigation of pathogens and helped characterize virulence mechanisms. Proteomics has been become a tool for large-scale identification of proteins involved during invasion and infection by the pathogens. Bacterial surface and secreted proteins play key role in the interaction between the bacterial cell and the host environment. Thus exoproteome and surface proteome of a microorganism are hypothesized to contain components of effective vaccines. Surfome and exoproteome analysis strategy facilitates identification of novel vaccine antigen and overall helps in progress of discovery of vaccine. The study of the antibody response can advance how proteomics is used, because it investigates antibody-antigen interactions and also unravel the relationship of antibody responses to pathogen and host characteristics. System immunology integrating with proteome i.e. immunoproteomics is applicable to those infections that are having tendency of diverse antibody target recognition and thus accurately reflects progression of the infection. PMID:27465855

  9. Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study

    OpenAIRE

    Kusnandi Rusmil; Eddy Fadlyana; Novilia Sjafri Bachtiar; Hadyana

    2013-01-01

    Background The World Health Organization (WHO) has recommended the introduction of hepatitis B (HB) and Haemophilus influenza type b (Hib) vaccines into routine childhood vaccination programs. A new diptheria/tetanus/pertussis (DTP)/hepatitis B/Hib pentavalent combination vaccine has been developed. Objective To evaluate the safety and immunogenicity of a new combination DTP/HB/Hib liquid vaccine in infants. Methods An open-label, uncontrolled, prospective intervention phase I study w...

  10. A New Method for the Evaluation of Vaccine Safety Based on Comprehensive Gene Expression Analysis

    Directory of Open Access Journals (Sweden)

    Haruka Momose

    2010-01-01

    Full Text Available For the past 50 years, quality control and safety tests have been used to evaluate vaccine safety. However, conventional animal safety tests need to be improved in several aspects. For example, the number of test animals used needs to be reduced and the test period shortened. It is, therefore, necessary to develop a new vaccine evaluation system. In this review, we show that gene expression patterns are well correlated to biological responses in vaccinated rats. Our findings and methods using experimental biology and genome science provide an important means of assessment for vaccine toxicity.

  11. A novel multi-stage subunit vaccine against paratuberculosis induces significant immunity and reduces bacterial burden in tissues (P4304)

    DEFF Research Database (Denmark)

    Thakur, Aneesh; Aagaard, Claus; Riber, Ulla; Skovgaard, Kerstin; Andersen, Peter; Jungersen, Gregers

    Effective control of paratuberculosis is hindered by lack of a vaccine preventing infection, transmission and without diagnostic interference with tuberculosis. We have developed a novel multi-stage recombinant subunit vaccine in which a fusion of four early expressed MAP antigens is combined with...... followed for a year. The FET11 vaccine induced a significant T cell response against constituent vaccine proteins characterized by a high percentage of CD4+ T cells and participation of polyfunctional CD4+ T cells. Of the two different age groups, late FET11 vaccination conferred protective immunity...... characterized by a significant containment of bacterial burden in gut tissues compared to non-vaccinated animals. There was no cross-reaction with bovine tuberculosis in vaccinated animals. This novel multi-stage vaccine has the potential to become a marker vaccine for paratuberculosis....

  12. Production of a Recombinant Vaccine Candidate against Burkholderia pseudomallei Exploiting the Bacterial N-Glycosylation Machinery

    Directory of Open Access Journals (Sweden)

    MarioFeldman

    2014-07-01

    Full Text Available Vaccines developing immune responses towards surface carbohydrates conjugated to proteins are effective in preventing infection and death by bacterial pathogens. Traditional production of these vaccines utilizes complex synthetic chemistry to acquire and conjugate the glycan to a protein. However, glycoproteins produced by bacterial protein glycosylation systems are significantly easier to produce, and could possible be used as vaccine candidates. In this work we functionally expressed the B. pseudomallei O polysaccharide (OPS II, the C. jejuni oligosaccharyltransferase (OTase, and a suitable glycoprotein (AcrA in a designer E. coli strain with a higher efficiency for production of glycoconjugates. We were able to produce and purify the OPS II-AcrA glycoconjugate, and MS analysis confirmed correct glycan was produced and attached. We observed the attachment of the O-acetylated deoxyhexose directly to the acceptor protein, which expands the range of substrates utilized by the OTase PglB. Injection of the glycoprotein into mice generated an IgG immune response against B. pseudomallei, and this response was partially protective against an intranasal challenge. Our experiments show that bacterial engineered glycoconjugates can be utilized as vaccine candidates against B. pseudomallei. Additionally, our new E. coli strain SDB1 is more efficient in glycoprotein production, and could have additional applications in the future.

  13. Microbiological food safety issues in Brazil: bacterial pathogens.

    Science.gov (United States)

    Gomes, Bruna Carrer; Franco, Bernadette Dora Gombossy de Melo; De Martinis, Elaine Cristina Pereira

    2013-03-01

    The globalization of food supply impacts patterns of foodborne disease outbreaks worldwide, and consumers are having increased concern about microbiological food safety. In this sense, the assessment of epidemiological data of foodborne diseases in different countries has not only local impact, but it can also be of general interest, especially in the case of major global producers and exporters of several agricultural food products, such as Brazil. In this review, the most common agents of foodborne illnesses registered in Brazil will be presented, compiled mainly from official databases made available to the public. In addition, some representative examples of studies on foodborne bacterial pathogens commonly found in Brazilian foods are provided. PMID:23489044

  14. Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

    OpenAIRE

    Haruka Momose; Takuo Mizukami; Madoka Kuramitsu; Kazuya Takizawa; Atsuko Masumi; Kumiko Araki; Keiko Furuhata; Kazunari Yamaguchi; Isao Hamaguchi

    2015-01-01

    We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in th...

  15. Bacterial Protein Characterization of Streptococcus agalactiae by SDS-page Method for Subclinical Mastitis Irradiated Vaccine Materials in Dairy Cattle

    OpenAIRE

    B.J. Tuasikal; I.W.T. Wibawan2; F.H. Pasaribu2; S. Estuningsih2

    2012-01-01

    A study have been conducted to isolate and characterize bacterial protein S. agalactiae, which is antigenic and can be used to test immunogenicity of vaccine in order to manufacture irradiated mastitis (inflammation of the udder) vaccine in ruminant. The study aims to determine the Molecular Weight (MW) bacterial protein S. agalactiae irradiation, which can be used to test the nature of its antigenic caharacteristic. The character of S. agalactiae antigenic stimulates antibody induction of th...

  16. Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008–2011

    Science.gov (United States)

    Naleway, Allison L.; Crane, Brad; Smith, Ning; Daley, Matthew F.; Donahue, James; Gee, Julianne; Greene, Sharon K.; Harrington, Theresa; Jackson, Lisa A.; Klein, Nicola P.; Tseng, Hung Fu; Vellozzi, Claudia; Weintraub, Eric S.

    2016-01-01

    Background To investigate concerns about a potential association between quadrivalent human papillomavirus vaccination (HPV4) and venous thromboembolism (VTE), we conducted a self-controlled case series study in adolescents and young adults 9–26 years of age in the Vaccine Safety Datalink. Methods We identified potential VTE cases diagnosed in 2008 through 2011 who had also received at least one HPV4 dose during that period. We confirmed each presumptive diagnosis by medical record review. We calculated incidence rate ratios (IRRs) and 95% confidence intervals (CI) to estimate the risk in the 1–60 day period following HPV4 exposure and in subsets of that period. IRRs were stratified by age, gender, hormonal contraceptive use, and recent surgery or trauma. Results We identified 313 potential cases of VTE among HPV4 vaccinees, and 291 (93%) had sufficient medical records for review. Of these, we confirmed 156 (54%) cases. VTE was uncommon among males (n = 3) and 9–12 year olds (n = 4). Nearly all confirmed cases (97%) had at least one known risk factor for VTE, including hormonal contraceptive use, obesity, and hypercoagulability. Sixteen (10%) confirmed cases occurred in the 1–60 days following HPV4 exposure. The risk of VTE varied from 1.47 (95% CI: 0.47–4.64) in the 1–7 days following HPV4 exposure to 0.92 (95% CI: 0.54–1.57) in the 1–60 days following vaccination. It was not possible to calculate a stratified IRR for males due to small sample size; the other risk factors evaluated did not significantly affect the risk of VTE after HPV4 exposure. Conclusion The risk of developing VTE among 9- to 26-year-olds was not elevated following HPV4 exposure. Sample size limited our ability to rigorously evaluate potential effect modifiers, such as gender, through stratified analysis. PMID:26549361

  17. Safety, immunogenicity and duration of immunity elicited by an inactivated bovine ephemeral fever vaccine.

    Directory of Open Access Journals (Sweden)

    Orly Aziz-Boaron

    Full Text Available Bovine ephemeral fever (BEF is an economically important viral vector-borne cattle disease. Several live-attenuated, inactivated and recombinant vaccines have been tested, demonstrating varying efficacy. However, to the best of our knowledge, duration of immunity conferred by an inactivated vaccine has never been reported. In the last decade, Israel has faced an increasing number of BEF outbreaks. The need for an effective vaccine compatible with strains circulating in the Middle East region led to the development of a MONTANIDE™ ISA 206 VG (water-in-oil-in-water, inactivated vaccine based on a local strain. We tested the safety, immunogenicity and duration of immunity conferred by this vaccine. The induced neutralizing antibody (NA response was followed for 493 days in 40 cows vaccinated by different protocols. The vaccine did not cause adverse reactions or a decrease in milk production. All cows [except 2 (6.7% which did not respond to vaccination] showed a significant rise in NA titer of up to 1:256 following the second, third or fourth booster vaccination. Neutralizing antibody levels declined gradually to 1:16 up to 120 days post vaccination. This decline continued in cows vaccinated only twice, whereas cows vaccinated 3 or 4 times showed stable titers of approximately 1:16 for up to 267 days post vaccination. At least three vaccinations with the inactivated BEF vaccine were needed to confer long-lasting immunity. These results may have significant implications for the choice of vaccination protocol with inactivated BEF vaccines. Complementary challenge data should however be added to the above results in order to determine what is the minimal NA response conferring protection from clinical disease.

  18. Safety of the novel influenza viral vector Brucella abortus vaccine in pregnant heifers

    OpenAIRE

    Kaissar Tabynov; Sholpan Ryskeldinova; Zhailaubay Kydyrbayev; Abylai Sansyzbay

    2016-01-01

    ABSTRACT: The present study provides the first information about the safety of a new influenza viral vector vaccine expressing the Brucella ribosomal protein L7/L12 or Omp16 containing the adjuvant Montanide Gel01 in pregnant heifers. Immunization of pregnant heifers was conducted via the conjunctival (n=10) or subcutaneous (n=10) route using cross prime and booster vaccination schedules at an interval of 28 days. The vector vaccine was evaluated in comparison with positive control groups vac...

  19. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

    OpenAIRE

    Reinaldo de Menezes Martins; Gilberta Bensabath; Luiz Claudio Arraes; Maria de Lourdes Aguiar Oliveira; Juliana Custódio Miguel; Glayse Glayde Barbosa; Luiz Antonio Bastos Camacho

    2004-01-01

    The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang®) were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70%) met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the ...

  20. Recombinant plants provide a new approach to the production of bacterial polysaccharide for vaccines.

    Directory of Open Access Journals (Sweden)

    Claire M Smith

    Full Text Available Bacterial polysaccharides have numerous clinical or industrial uses. Recombinant plants could offer the possibility of producing bacterial polysaccharides on a large scale and free of contaminating bacterial toxins and antigens. We investigated the feasibility of this proposal by cloning and expressing the gene for the type 3 synthase (cps3S of Streptococcus pneumoniae in Nicotinia tabacum, using the pCambia2301 vector and Agrobacterium tumefaciens-mediated gene transfer. In planta the recombinant synthase polymerised plant-derived UDP-glucose and UDP-glucuronic acid to form type 3 polysaccharide. Expression of the cps3S gene was detected by RT-PCR and production of the pneumococcal polysaccharide was detected in tobacco leaf extracts by double immunodiffusion, Western blotting and high-voltage paper electrophoresis. Because it is used a component of anti-pneumococcal vaccines, the immunogenicity of the plant-derived type 3 polysaccharide was tested. Mice immunised with extracts from recombinant plants were protected from challenge with a lethal dose of pneumococci in a model of pneumonia and the immunised mice had significantly elevated levels of serum anti-pneumococcal polysaccharide antibodies. This study provides the proof of the principle that bacterial polysaccharide can be successfully synthesised in plants and that these recombinant polysaccharides could be used as vaccines to protect against life-threatening infections.

  1. Reproductive and safety assessment of vaccination with Gavac against the cattle tick (Boophilus microplus).

    Science.gov (United States)

    Boué, O; Redondo, M; Montero, C; Rodríguez, M; de la Fuente, J

    1999-06-01

    Recent developments in cattle tick control have incorporated the use of recombinant Bm86 vaccines against this ectoparasite. The vaccine developed by our group (Gavac) contains an antigen expressed in Pichia pastoris, and has been successfully employed for the control of tick infestations and transmission of tick-borne diseases. Here, we examined the safety and effect of the Gavac vaccine on reproductive parameters in cattle. Toxicity tests in mice and guinea pigs demonstrated the safety of Gavac. To study the adverse effects of vaccination on reproduction, a field trial involving 9,500 animals in Cuba was conducted. The cattle at 3 farms were vaccinated while those on a fourth farm were left unvaccinated and served as the control. Following vaccination, the control of tick infestation and the transmission of babesiosis were used to demonstrate the efficacy of the vaccine. No adverse effects were observed in any of the reproductive parameters studied when comparing the data before and after vaccination with Gavac and between the vaccinated farms and the control farm. These results demonstrate that under the conditions of our study vaccination with Gavac is safe for use on cattle. PMID:10729081

  2. Identification of the serotypes of bacterial meningitis agents; implication for vaccine usage.

    Directory of Open Access Journals (Sweden)

    Mohammad Mehdi Attarpour-Yazdi

    2014-08-01

    Full Text Available Bacterial meningitis is one of the most serious infections and should be treated as emergency. As it has significant morbidity and mortality throughout the world, every country should have precise information regarding the etiological agents of disease and populations at risk to design public health prevention strategy. In the present study in addition of evaluation of common etiological agents (Haemophilus influenzae, Neisseria meningitidis, and Streptococcus pneumoniae in bacterial meningitis cases, we sero-grouped or serotyped the obtained agents in order to predict the usefulness of existing vaccines against bacterial meningitis.Cerebrospinal fluid of 182 suspected meningitis patients were collected, from which 114 cases were approved by biochemical, microbiological and molecular tests as bacterial meningitis. The isolated bacteria were serogrouped or serotyped to determine the dominant serotypes.Streptococcus pneumoniae accounted for 36%, Haemophilus influenza for 26% and Neisseria meningitidis for 14% of cases. From 13 serogroups of N. meningitides the most frequent serogroups, were meningococcus group B (51%, C(24% A (18%, Z(2%, W135 (1% and 3% was not identified. In H. influenzae group only serotype b (100% have been identified and in pneumococcal meningitis the most common serotype among our cases were 18C (44% followed by14 (17%, 19A (13%, 6A (9%, 7F (4%, 4(3%, 3 (3%, 9V (2%, 8 (2%, 23f (2%, 5 (1%.Since there is no nationwide mass immunization program for common agents of bacterial meningitis in Iran, the result of this study can be used to improve the existing vaccines to cover the detected serotypes and consequently reduce the incidence of bacterial meningitis.

  3. Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination

    DEFF Research Database (Denmark)

    Theander, Thor Grundtvig; Lusingu, John Peter Andrea

    2014-01-01

    BACKGROUND: A malaria vaccine could be an important addition to current control strategies. We report the safety and vaccine efficacy (VE) of the RTS,S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria transmission. METHODS AND FINDINGS: 6,537 infants aged 6......-12 wk and 8,923 children aged 5-17 mo were randomized to receive three doses of RTS,S/AS01 or comparator vaccine. VE against clinical malaria in children during the 18 mo after vaccine dose 3 (per protocol) was 46% (95% CI 42% to 50%) (range 40% to 77%; VE, p<0.01 across all sites). VE during the 20 mo...... after vaccine dose 1 (intention to treat [ITT]) was 45% (95% CI 41% to 49%). VE against severe malaria, malaria hospitalization, and all-cause hospitalization was 34% (95% CI 15% to 48%), 41% (95% CI 30% to 50%), and 19% (95% CI 11% to 27%), respectively (ITT). VE against clinical malaria in infants was...

  4. Bacterial antigen expression is an important component in inducing an immune response to orally administered Salmonella-delivered DNA vaccines.

    Directory of Open Access Journals (Sweden)

    Michelle E Gahan

    Full Text Available BACKGROUND: The use of Salmonella to deliver heterologous antigens from DNA vaccines is a well-accepted extension of the success of oral Salmonella vaccines in animal models. Attenuated S. typhimurium and S. typhi strains are safe and efficacious, and their use to deliver DNA vaccines combines the advantages of both vaccine approaches, while complementing the limitations of each technology. An important aspect of the basic biology of the Salmonella/DNA vaccine platform is the relative contributions of prokaryotic and eukaryotic expression in production of the vaccine antigen. Gene expression in DNA vaccines is commonly under the control of the eukaryotic cytomegalovirus (CMV promoter. The aim of this study was to identify and disable putative bacterial promoters within the CMV promoter and evaluate the immunogenicity of the resulting DNA vaccine delivered orally by S. typhimurium. METHODOLOGY/PRINCIPAL FINDINGS: The results reported here clearly demonstrate the presence of bacterial promoters within the CMV promoter. These promoters have homology to the bacterial consensus sequence and functional activity. To disable prokaryotic expression from the CMV promoter a series of genetic manipulations were performed to remove the two major bacterial promoters and add a bacteria transcription terminator downstream of the CMV promoter. S. typhimurium was used to immunise BALB/c mice orally with a DNA vaccine encoding the C-fragment of tetanus toxin (TT under control of the original or the modified CMV promoter. Although both promoters functioned equally well in eukaryotic cells, as indicated by equivalent immune responses following intramuscular delivery, only the original CMV promoter was able to induce an anti-TT specific response following oral delivery by S. typhimurium. CONCLUSIONS: These findings suggest that prokaryotic expression of the antigen and co-delivery of this protein by Salmonella are at least partially responsible for the successful

  5. Vaccines for viral and bacterial pathogens causing acute gastroenteritis: Part II: Vaccines for Shigella, Salmonella, enterotoxigenic E. coli (ETEC) enterohemorragic E. coli (EHEC) and Campylobacter jejuni.

    Science.gov (United States)

    O'Ryan, Miguel; Vidal, Roberto; del Canto, Felipe; Carlos Salazar, Juan; Montero, David

    2015-01-01

    In Part II we discuss the following bacterial pathogens: Shigella, Salmonella (non-typhoidal), diarrheogenic E. coli (enterotoxigenic and enterohemorragic) and Campylobacter jejuni. In contrast to the enteric viruses and Vibrio cholerae discussed in Part I of this series, for the bacterial pathogens described here there is only one licensed vaccine, developed primarily for Vibrio cholerae and which provides moderate protection against enterotoxigenic E. coli (ETEC) (Dukoral(®)), as well as a few additional candidates in advanced stages of development for ETEC and one candidate for Shigella spp. Numerous vaccine candidates in earlier stages of development are discussed. PMID:25715096

  6. Live attenuated S. Typhimurium vaccine with improved safety in immuno-compromised mice.

    Directory of Open Access Journals (Sweden)

    Balamurugan Periaswamy

    Full Text Available Live attenuated vaccines are of great value for preventing infectious diseases. They represent a delicate compromise between sufficient colonization-mediated adaptive immunity and minimizing the risk for infection by the vaccine strain itself. Immune defects can predispose to vaccine strain infections. It has remained unclear whether vaccine safety could be improved via mutations attenuating a vaccine in immune-deficient individuals without compromising the vaccine's performance in the normal host. We have addressed this hypothesis using a mouse model for Salmonella diarrhea and a live attenuated Salmonella Typhimurium strain (ssaV. Vaccination with this strain elicited protective immunity in wild type mice, but a fatal systemic infection in immune-deficient cybb(-/-nos2(-/- animals lacking NADPH oxidase and inducible NO synthase. In cybb(-/-nos2(-/- mice, we analyzed the attenuation of 35 ssaV strains carrying one additional mutation each. One strain, Z234 (ssaV SL1344_3093, was >1000-fold attenuated in cybb(-/-nos2(-/- mice and ≈100 fold attenuated in tnfr1(-/- animals. However, in wt mice, Z234 was as efficient as ssaV with respect to host colonization and the elicitation of a protective, O-antigen specific mucosal secretory IgA (sIgA response. These data suggest that it is possible to engineer live attenuated vaccines which are specifically attenuated in immuno-compromised hosts. This might help to improve vaccine safety.

  7. An update on safety studies on the attenuated ?RIEMSER? Schweinepestoralvakzine? for vaccination of wild boar against classical swine fever

    OpenAIRE

    Kaden, Volker; Lange, Elke; Küster, Heike; Müller, Thomas; Lange, Bodo

    2009-01-01

    Abstract The RIEMSER? Schweinepestoralvakzine is an attenuated vaccine for oral vaccination of wild boar against classical swine fever (CSF). The safety of this licensed bait vaccine which is based on the CSF virus (CSFV) strain ?C? was investigated in 8 animal species, e.g. weaner pigs (n=111), wild boar (n=11), ruminants (cattle, goats and sheep, n=11), foxes (n=5), rabbits (n=12), and mice (n=10). Animals were vaccinated either with a single vaccine dose containing at least 104....

  8. Methods to Evaluate the Preclinical Safety and Immunogenicity of Genetically Modified Live-Attenuated Leishmania Parasite Vaccines.

    Science.gov (United States)

    Gannavaram, Sreenivas; Bhattacharya, Parna; Dey, Ranadhir; Ismail, Nevien; Avishek, Kumar; Salotra, Poonam; Selvapandiyan, Angamuthu; Satoskar, Abhay; Nakhasi, Hira L

    2016-01-01

    Live-attenuated parasite vaccines are being explored as potential vaccine candidates since other approaches of vaccination have not produced an effective vaccine so far. In order for live-attenuated parasite vaccines to be tested in preclinical studies and possibly in clinical studies, the safety and immunogenicity of these organisms must be rigorously evaluated. Here we describe methods to test persistence in the immunized host and immunogenicity, and to identify biomarkers of vaccine safety and efficacy with particular reference to genetically attenuated Leishmania parasites. PMID:27076157

  9. Subdominant antigens in bacterial vaccines: Am779 is subdominant in the anaplasma marginale outer membrane vaccine but does not associate with protective immunity

    Science.gov (United States)

    Identification of specific antigens responsible for the ability of complex immunogens to induce protection is a major goal in development of bacterial vaccines. Much of the investigation has focused on highly abundant and highly immunodominant outer membrane proteins. Recently however, genomic and p...

  10. Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.

    Science.gov (United States)

    Alicino, Cristiano; Merlano, Caterina; Zappettini, Simona; Schiaffino, Sergio; Della Luna, Giovanni; Accardo, Cristina; Gasparini, Roberto; Durando, Paolo; Icardi, Giancarlo

    2015-01-01

    Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate. PMID:25483520

  11. Aromatic-dependent salmonella as anti-bacterial vaccines and as presenters of heterologous antigens or of DNA encoding them.

    Science.gov (United States)

    Stocker, B A

    2000-09-29

    The development of live bacterial vaccines is reviewed, in particular aromatic-dependent Salmonella, either for protection against the corresponding infections (including typhoid fever) or as carrier-presenter of antigens of unrelated pathogens or of DNA specifying them. Aromatic-dependent Salmonella live vaccines are also compared with BCG and Ty21a and the recent records of exceptional situations are discussed in which aroA (deletion) strains of Salmonella typhimurium cause progressive disease in mice. PMID:11000459

  12. Live-Attenuated Bacterial Vectors: Tools for Vaccine and Therapeutic Agent Delivery

    Directory of Open Access Journals (Sweden)

    Ivan Y. C. Lin

    2015-11-01

    Full Text Available Genetically attenuated microorganisms, including pathogenic and commensal bacteria, can be engineered to carry and deliver heterologous antigens to elicit host immunity against both the vector as well as the pathogen from which the donor gene is derived. These live attenuated bacterial vectors have been given much attention due to their capacity to induce a broad range of immune responses including localized mucosal, as well as systemic humoral and/or cell-mediated immunity. In addition, the unique tumor-homing characteristics of these bacterial vectors has also been exploited for alternative anti-tumor vaccines and therapies. In such approach, tumor-associated antigen, immunostimulatory molecules, anti-tumor drugs, or nucleotides (DNA or RNA are delivered. Different potential vectors are appropriate for specific applications, depending on their pathogenic routes. In this review, we survey and summarize the main features of the different types of live bacterial vectors and discussed the clinical applications in the field of vaccinology. In addition, different approaches for using live attenuated bacterial vectors for anti-cancer therapy is discussed, and some promising pre-clinical and clinical studies in this field are outlined.

  13. Rethinking the antivaccine movement concept: A case study of public criticism of the swine flu vaccine's safety in France.

    Science.gov (United States)

    Ward, Jeremy K

    2016-06-01

    In this article I discuss the definition of "the Antivaccine Movement" using the case of the French controversy over the safety of the 2009 pandemic flu vaccine. I show that the group of main actors who criticized the vaccine's safety is heterogeneous. This heterogeneity can be found in the type of arguments mobilized to question the vaccine's safety and in these actors' likelihood of being involved in any vaccine-related controversies. I show that only a minority of these actors rejected vaccination in general and mobilized against all vaccination campaigns. Most of these actors only occasionally mobilized against a given vaccine or vaccination campaign and they did so to promote a political or cultural agenda that went beyond the vaccine itself. Using these results, I argue that in order to better understand how vaccine-related controversies emerge and why some activists devote time and resources to spread vaccine-critical arguments, social scientists should use three distinct concepts to refer to vaccine criticism: The Antivaccine Movement, the Marginally Antivaccine Movements and the Occasionally Vaccine Critical Movements. To do so would enable social scientists and public health experts to better understand the different ways in which vaccination can become politicized and the evolution of this politicization. PMID:27173740

  14. Bacterial Meningitis in Brazil: Baseline Epidemiologic Assessment of the Decade Prior to the Introduction of Pneumococcal and Meningococcal Vaccines.

    Directory of Open Access Journals (Sweden)

    Luciano Cesar Pontes Azevedo

    Full Text Available Bacterial meningitis is associated with significant burden in Brazil. In 2010, both 10-valent pneumococcal conjugate vaccine and meningococcal capsular group C conjugate vaccine were introduced into the routine vaccination schedule. Haemophilus influenzae type b vaccine was previously introduced in 1999. This study presents trends in demographics, microbiological characteristics and seasonality patterns of bacterial meningitis cases in Brazil from 2000 to 2010.All meningitis cases confirmed by clinical and/or laboratory criteria notified to the national information system for notifiable diseases between 2000 and 2010 were analyzed. Proportions of bacterial meningitis cases by demographic characteristics, criteria used for confirmation and etiology were calculated. We estimated disease rates per 100,000 population and trends for the study period, with emphasis on H. influenzae, N. meningitidis and S. pneumoniae cases. In the decade, 341,805 cases of meningitis were notified in Brazil. Of the 251,853 cases with defined etiology, 110,264 (43.8% were due to bacterial meningitis (excluding tuberculosis. Of these, 34,997 (31.7% were due to meningococcal disease. The incidence of bacterial meningitis significantly decreased from 3.1/100,000 population in 2000-2002 to 2.14/100,000 in 2009-2010 (p<0.01. Among cases of meningococcal disease, the proportion of those associated with group C increased from 41% in 2007 to 61.7% in 2010, while the proportion of group B disease progressively declined. Throughout the study period, an increased number of cases occurred during winter.Despite the reduction in bacterial meningitis incidence during the last decade, it remains a significant healthcare issue in Brazil. Meningococcal disease is responsible for the majority of the cases with group C the most common capsular type. Our study demonstrates the appropriateness of introduction of meningococcal vaccination in Brazil. Furthermore, this study provides a baseline

  15. Safety and efficacy of hepatitis A vaccine in children with chronic liver disease

    Institute of Scientific and Technical Information of China (English)

    Hanaa Mostafa El-Karaksy; Manal Ismail El-Hawary; Nehal Mohammad El-Koofy; Rokaya El-Sayed; Mona Al-Saeed El-Raziky; Samah Asaad Mansour; Gamal Mohammad Taha; Fatma El-Mougy

    2006-01-01

    AIM: To study the safety and efficacy of hepatitis A vaccine (HAV) in children with chronic liver disease of various etiologies.METHODS: Eleven children with chronic liver disease and thirteen age- and sex-matched controls negative for HAV antibodies were vaccinated against hepatitis A after they gave their informed consent. Children with uncontrolled coagulopathy or signs of hepatic decompensation were excluded. The vaccine (Havrix:720 ELISA units in 0.5 mL, from GlaxoSmithKline Biologicals) was given intramuscularly in the deltoid in 2 doses 6 mo apart. Children were tested for HAV antibodies one and six months after the 1st dose and one month after the 2nd dose. Total serum bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were determined immediately before and after one month of the 1st dose of the vaccine.RESULTS: Only 7 out of the 11 patients were positive for HAV antibodies after the 1st dose of the vaccine,as compared to 100% of the controls. One month after the 2nd dose, all patients tested were positive for HAV antibodies. No deterioration in liver functions of patients was noted after vaccination. No adverse events,immediate or late, were reported by the mothers after each dose of the vaccine.CONCLUSION: Hepatitis A vaccine is both safe and effective in this small studied group of children with chronic liver disease. Given the high seroconversion rate, post-vaccination testing for HAV antibodies is not needed.

  16. Artificial bacterial biomimetic nanoparticles synergize pathogen-associated molecular patterns for vaccine efficacy.

    Science.gov (United States)

    Siefert, Alyssa L; Caplan, Michael J; Fahmy, Tarek M

    2016-08-01

    Antigen-presenting cells (APCs) sense microorganisms via pathogen-associated molecular patterns (PAMPs) by both extra- and intracellular Toll-like Receptors (TLRs), initiating immune responses against invading pathogens. Bacterial PAMPs include extracellular lipopolysaccharides and intracellular unmethylated CpG-rich oligodeoxynucleotides (CpG). We hypothesized that a biomimetic approach involving antigen-loaded nanoparticles (NP) displaying Monophosphoryl Lipid A (MPLA) and encapsulating CpG may function as an effective "artificial bacterial" biomimetic vaccine platform. This hypothesis was tested in vitro and in vivo using NP assembled from biodegradable poly(lactic-co-glycolic acid) (PLGA) polymer, surface-modified with MPLA, and loaded with CpG and model antigen Ovalbumin (OVA). First, CpG potency, characterized by cytokine profiles, titers, and antigen-specific T cell responses, was enhanced when CpG was encapsulated in NP compared to equivalent concentrations of surface-presented CpG, highlighting the importance of biomimetic presentation of PAMPs. Second, NP synergized surface-bound MPLA with encapsulated CpG in vitro and in vivo, inducing greater pro-inflammatory, antigen-specific T helper 1 (Th1)-skewed cellular and antibody-mediated responses compared to single PAMPs or soluble PAMP combinations. Importantly, NP co-presentation of CpG and MPLA was critical for CD8(+) T cell responses, as vaccination with a mixture of NP presenting either CpG or MPLA failed to induce cellular immunity. This work demonstrates a rational methodology for combining TLR ligands in a context-dependent manner for synergistic nanoparticulate vaccines. PMID:27162077

  17. DNA vaccination for rabies: Evaluation of preclinical safety and toxicology

    OpenAIRE

    Rajni Garg; Manpreet Kaur; Ankur Saxena; Rakesh Bhatnagar

    2014-01-01

    The worldwide incidence of rabies and high rates of therapy failure, despite availability of effective vaccines indicate the need for timely and improved prophylactic approaches. DNA vaccination based on optimized formulation of lysosome-targeted glycoprotein of the rabies virus provides potential platform for preventing and controlling rabies. As per the pre-clinical requirements, listed in guidelines of Schedule Y, FDA and that of The European Agency for evaluation of Medicinal Products; we...

  18. Multicenter Safety and Immunogenicity Trial of an Attenuated Measles Vaccine for NHP.

    Science.gov (United States)

    Yee, Joann L; McChesney, Michael B; Christe, Kari L

    2015-10-01

    Measles is a highly contagious viral disease in NHP. The infection can range from asymptomatic to rapidly fatal, resulting in significant morbidity and mortality in captive populations. In addition to appropriate quarantine practices, restricted access, the immunization of all personnel in contact with NHP, and the wearing of protective clothing including face masks, measles immunization further reduces the infection risk. Commercially available measles vaccines are effective for use in NHP, but interruptions in their availability have prevented the implementation of ongoing, consistent vaccination programs. This need for a readily available vaccine led us to perform a broad, multicenter safety and immunogenicity study of another candidate vaccine, MVac (Serum Institute of India), a monovalent measles vaccine derived from live Edmonston-Zagreb strain virus that had been attenuated after 22 passages on human diploid cells. PMID:26473350

  19. Safety of West Nile Virus vaccines in sandhill crane chicks

    Science.gov (United States)

    Olsen, G.H.; Miller, K.J.; Docherty, D.E.; Bochsler, V.S.

    2008-01-01

    West Nile virus arrived in North America in 1999 and has spread across the continent in the ensuing years. The virus has proven deadly to a variety of native avian species including sandhill cranes (Grus canadensis). In order to provide safe and efficacious protection for captive and released populations of whooping cranes (G. americana), we have conducted a series of four research projects. The last of these was a study of the effects of two different West Nile virus vaccines on young Florida sandhill crane (G. c. pratensis) chicks and subsequent challenge with the virus. We found that vaccinating crane chicks as early as day 7 post-hatch caused no adverse reactions or noticeable morbidity. We tested both a commercial equine vaccine West Nile - Innovator (Fort Dodge Laboratories, Fort Dodge, Iowa) and a new recombinant DNA vaccine (Centers for Disease Control). We had a 33% mortality in control chicks (n =6) from West Nile virus infection, versus 0% mortality in two groups of vaccinated chicks (n = 12), indicating the two vaccines tested were not only safe but effective in preventing West Nile virus.

  20. Biotechnology and DNA vaccines for aquatic animals

    Science.gov (United States)

    Kurath, G.

    2008-01-01

    Biotechnology has been used extensively in the development of vaccines for aquaculture. Modern molecular methods such as polymerase chain reaction (PCR), cloning and microarray analysis have facilitated antigen discovery, construction of novel candidate vaccines, and assessments of vaccine efficacy, mode of action, and host response. This review focuses on DNA vaccines for finfish to illustrate biotechnology applications in this field. Although DNA vaccines for fish rhabdoviruses continue to show the highest efficacy, DNA vaccines for several other viral and bacterial fish pathogens have now been proven to provide significant protection against pathogen challenge. Studies of the fish rhabdovirus DNA vaccines have elucidated factors that affect DNA vaccine efficacy as well as the nature of the fish innate and adaptive immune responses to DNA vaccines. As tools for managing aquatic animal disease emergencies, DNA vaccines have advantages in speed, flexibility, and safety, and one fish DNA vaccine has been licensed.

  1. Communicating vaccine safety in the context of immunization programs in low resource settings.

    Science.gov (United States)

    Arwanire, Edison M; Mbabazi, William; Mugyenyi, Possy

    2015-01-01

    Vaccines are effective in preventing infectious diseases and their complications, hence reducing morbidity and infectious disease mortaity. Successful immunization programs, however, depend on high vaccine acceptance and coverage rates. In recent years there has been an increased level of public concern towards real or perceived adverse events associated with immunizations, leading to many people in high- as well as low-resource settings to refuse vaccines. Health care workers therefore must be able to provide parents and guardians of children with the most current and accurate information about the benefits and risks of vaccination. Communicating vaccine safety using appropriate channels plays a crucial role in maintaining public trust and confidence in vaccination programs. Several factors render this endeavor especially challenging in low-resource settings where literacy rates are low and access to information is often limited. Many languages are spoken in most countries in low-resource settings, making the provision of appropriate information difficult. Poor infrastructure often results in inadequate logistics. Recently, some concerned consumer groups have been able to propagate misinformation and rumors. To successfully communicate vaccine safety in a resource limited setting it is crucial to use a mix of communication channels that are both culturally acceptable and effective. Social mobilization through cultural, administrative and political leaders, the media or text messages (SMS) as well as the adoption of the Village Health Team (VHT) strategy whereby trained community members (Community Health Workers (CHWs)) are providing primary healthcare, can all be effective in increasing the demand for immunization. PMID:25859678

  2. Controlled viral glycoprotein expression as a safety feature in a bivalent rabies-ebola vaccine.

    Science.gov (United States)

    Papaneri, Amy B; Bernbaum, John G; Blaney, Joseph E; Jahrling, Peter B; Schnell, Matthias J; Johnson, Reed F

    2015-02-01

    Using a recombinant rabies (RABV) vaccine platform, we have developed several safe and effective vaccines. Most recently, we have developed a RABV-based ebolavirus (EBOV) vaccine that is efficacious in nonhuman primates. One safety feature of this vaccine is the utilization of a live but replication-deficient RABV construct. In this construct, the RABV glycoprotein (G) has been deleted from the genome, requiring G trans complementation in order for new infectious viruses to be released from the initial infected cell. Here we analyze this safety feature of the bivalent RABV-based EBOV vaccine comprised of the G-deleted RABV backbone expressing EBOV glycoprotein (GP). We found that, while the level of RABV genome in infected cells is equivalent regardless of G supplementation, the production of infectious virus is indeed restricted by the lack of G, and most importantly, that the presence of EBOV GP does not substitute for G. These findings further support the safety profile of this replication-deficient RABV-EBOV bivalent vaccine. PMID:25481284

  3. Patterns of pneumococcal vaccination and revaccination in elderly and non-elderly adults: a Vaccine Safety Datalink study

    Directory of Open Access Journals (Sweden)

    Belongia Edward A

    2009-03-01

    Full Text Available Abstract Background Pneumococcal polysaccharide vaccine (PPV is recommended for all adults 65 years of age and older and for younger adults with high-risk conditions. While data from national surveys provide information on the proportion of adults 65 years of age and older reporting ever receipt of PPV they do not collect more detailed information, such as age at vaccination or the total number of vaccinations received. In addition, there is relatively little information available on PPV coverage in younger adults with chronic conditions. To assess contemporary patterns of pneumococcal vaccination and revaccination of adults, we conducted a cross-sectional study of adults enrolled in medical care organizations (MCOs participating in the Vaccine Safety Datalink project. Methods The study population included 1.5 million adults 25 years of age and older enrolled in the four participating MCOs on December 1, 2006. PPVs administered to members of the study population prior to that date were identified from computerized immunization registries maintained by the MCOs. Results Among the general population of adults 25 through 64 years of age, vaccine coverage increased from 2% in the 25–29 year old age-group to 26% in the 60–64 year old age-group. In all age-groups, coverage was substantially higher in persons defined as having a chronic high risk condition. This was particularly true for diabetes mellitus, with vaccine coverage of over 50% in the lower age-groups and 75% in those 60–64 years of age. Among adults 65 years of age and older, 82% had received at least one PPV and 18% had received two or more PPVs. Conclusion We found higher levels of PPV coverage among adults 65 years of age and older and among younger adults with diabetes mellitus than reported by national surveys and for those groups PPV coverage approached the Healthy People 2010 national objectives. These results suggest that achieving those objectives for PPV is possible and

  4. [Analysis of the evidence on the efficacy and safety of CYD-TDV dengue vaccine and its potential licensing and implementation through Mexico's Universal Vaccination Program].

    Science.gov (United States)

    Hernández-Ávila, Mauricio; Lazcano-Ponce, Eduardo; Hernández-Ávila, Juan Eugenio; Alpuche-Aranda, Celia M; Rodríguez-López, Mario Henry; García-García, Lourdes; Madrid-Marina, Vicente; López Gatell-Ramírez, Hugo; Lanz-Mendoza, Humberto; Martínez-Barnetche, Jesús; Díaz-Ortega, José Luis; Ángeles-Llerenas, Angélica; Barrientos-Gutiérrez, Tonatiuh; Bautista-Arredondo, Sergio; Santos-Preciado, José Ignacio

    2016-02-01

    Dengue is a major global public health problem affecting Latin America and Mexico Prevention and control measures, focusing on epidemiological surveillance and vector control, have been partially effective and costly, thus, the development of a vaccine against dengue has created great expectations among health authorities and scientific communities worldwide. The CYD-TDV dengue vaccine produced by Sanofi-Pasteur is the only dengue vaccine evaluated in phase 3 controlled clinical trials. Notwithstanding the significant contribution to the development of a vaccine against dengue, the three phase 3 clinical studies of CYD-TDV and the meta-analysis of the long-term follow up of those studies, have provided evidence that this vaccine exhibited partial vaccine efficacy to protect against virologically confirmed dengue and lead to four considerations: a) adequate vaccine efficacy against dengue virus (DENV) infections 3 and 4, less vaccine efficacy against DENV 1 and no protection against infection by DENV 2; b) decreased vaccine efficacy in dengue seronegative individuals at the beginning of the vaccination; c) 83% and 90% protection against hospitalizations and severe forms of dengue, respectively, at 25 months follow-up; and d) increased hospitalization for dengue in the vaccinated group, in children under nine years of age at the time of vaccination, detected since the third year of follow-up. The benefit of the CYD-TDV vaccine can be summarized in the protection against infection by DENV 3 and 4, as well as protection for hospitalizations and severe cases in people over nine years, who have had previous dengue infection, working mainly as a booster. In this review we identified elements on efficacy and safety of this vaccine that must be taken into account in the licensing process and potential inclusion in the national vaccination program of Mexico. The available scientific evidence on the CYD-TDV vaccine shows merits, but also leads to relevant questions that

  5. Safety and Immunogenicity of Cuban Antipneumococcal Conjugate Vaccine PCV7-TT in Healthy Adults.

    Science.gov (United States)

    González, Nadezhda; Paredes, Beatriz; Pérez, Sonia; Mirabal, Mayelín; Rivero, Ivonne; González, Carlos A; Díaz, Alina; García, Dagmar; Rodríguez, Laura; Pérez, Amarilis; Soroa, Yamilka; Santana, Darielis; Alvarez, Alina; Valdés, Yury; Vérez, Vicente

    2015-10-01

    INTRODUCTION Pneumococcal infections are a major cause of morbidity and mortality and are associated with considerable economic burden on health systems. To prevent pneumococcal infections, 7-valent conjugate vaccines have been available for over a decade; more recently, 10- and 13-valent conjugate vaccines have been formulated, which are more immunogenic than vaccines with capsular polysaccharides only. In Cuba, a new vaccine candidate has been developed, PCV7-TT, a conjugate of tetanus toxoid with antigens of seven of the serotypes of Streptococcus pneumoniae with highest circulation in Cuba and in the world: 1, 5, 6B, 14, 18C, 19F and 23F. OBJECTIVE Assess the safety of the vaccine candidate PCV7-TT in healthy adults and conduct a preliminary assessment of its immunogenicity. METHODS A phase I, double-blind clinical trial was performed at the National Toxicology Center in Havana, Cuba. Healthy male volunteers aged 18-35 years were randomly assigned to two groups: 20 received the vaccine candidate PCV7-TT and 20 the polyvalent antipneumococcal vaccine PNEUMO-23 used as control, each in a single intramuscular dose. To assess safety, the occurrence of adverse events was monitored for 30 days following inoculation. To explore immunogenicity, concentrations of serotype-specific antibodies was quantified before and 30 days after inoculation, as well titers of opsonophagocytic antibodies. (National Clinical Trial Registry RPCEC00000133) RESULTS Local adverse events were pain, redness, induration, increased sensitivity to touch, and warmth in the injection area. Pain was registered in 70% of individuals who received PCV7-TT and in 75% of those vaccinated with PNEUMO-23. Reported systemic adverse events were general malaise, headache and drowsiness. All adverse events appeared in the first 72 hours post inoculation and lasted no longer than 3 days. One event was reported that was classified as severe in intensity and serious in consequences, but it was unrelated to

  6. Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study

    Directory of Open Access Journals (Sweden)

    Kusnandi Rusmil

    2013-11-01

    Full Text Available Background The World Health Organization (WHO has recommended the introduction of hepatitis B (HB and Haemophilus influenza type b (Hib vaccines into routine childhood vaccination programs. A new diptheria/tetanus/pertussis (DTP/hepatitis B/Hib pentavalent combination vaccine has been developed. Objective To evaluate the safety and immunogenicity of a new combination DTP/HB/Hib liquid vaccine in infants. Methods An open-label, uncontrolled, prospective intervention phase I study was conducted on 30 healthy infants aged 6−11 weeks. Each subject received 3 doses of DTP/HB/Hib vaccine, formulated by Bio Farma, 0.5 mL intramuscularly at the left anterolateral thigh region using a 25-gauge needle of 25 mm length. Subjects were followed for 1 month after administration of each vaccine dose to evaluate its safety, while serum anti-diphteria, tetanus, HBb, Hib, and pertussis antibodies were measured prior to the 1st dose and 1 month after the 3rd dose. Results Among 30 vaccinated subjects, 18 infants had fever within 24 hours after the first vaccination. Most cases of fever were mild in intensity and resolved within 24 hours. No other systemic or local reactions, or serious adverse events were observed in our subjects during the study. The immunogenicity results after 3rd vaccine dose showed that the geometric mean titer of the anti-polyribosylribitol phosphate (PRP antibody levels increased significantly from 0.0041μg/mL to 4.37 μg/mL after vaccination, and most infants had a fourfold or greater rise in antibody levels over their pre-injection levels. All subjects who received DTP/HB/Hib liquid vaccine had seroprotective antibodies against tetanus, diphtheria,a and hepatitis B, while 29/30 infants had seroprotective antibodies against pertussis. Conclusion This new diphtheria/tetanus/pertusis/hepatitis B/Hib combination vaccine has excellent safety profile and antibody responses in infants. These results encourage further clinical evaluation in

  7. Priming Effect of Dengue and Yellow Fever Vaccination on the Immunogenicity, Infectivity, and Safety of a Tetravalent Dengue Vaccine in Humans

    OpenAIRE

    Qiao, Ming; Shaw, David; Forrat, Remi; Wartel-Tram, Anh; Lang, Jean

    2011-01-01

    A dengue vaccine effective against all four serotypes is urgently needed. However, safety and immunogenicity could be affected by prior exposure to flaviviruses. This open, controlled, phase IIa study was conducted in 35 healthy adults who had received monovalent, live attenuated Vero cell-derived dengue vaccine against dengue virus 1 (VDV1) or 2 (VDV2) or yellow fever (YF) vaccine 1 year before or who were flavivirus-naïve. All participants received one subcutaneous injection of tetravalent ...

  8. Host response to secondary bacterial infection associated with antecedent influenza virus infection in pigs – exacerbation associated with vaccination

    Science.gov (United States)

    The increasing number of annual influenza (IAV) cases, coupled with the recent IAV pandemic, has amplified concerns about its impact on human and animal health. It is appreciated that Flu is complicated by bacterial pneumonia. Vaccine-associated enhanced respiratory disease (VAERD) can occur followi...

  9. An Overview of Quadrivalent Human Papillomavirus Vaccine Safety

    DEFF Research Database (Denmark)

    Vichnin, Michelle; Bonanni, Paolo; Klein, Nicola P;

    2015-01-01

    BACKGROUND: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types...

  10. Safety and tolerability of intradermal influenza vaccination in patients with cardiovascular disease

    Institute of Scientific and Technical Information of China (English)

    Arintaya Phrommintikul; Wanwarang Wongcharoen; Srun Kuanprasert; Narawudt Prasertwitayakij; Rungsrit Kanjanavanit; Siriluck Gunaparn; Apichard Sukonthasarn

    2014-01-01

    Background It is well-established that influenza vaccination reduces adverse cardiovascular outcomes in patients with cardiovascular diseases (CVD), however, the vaccine coverage rate in most countries remains low. The concern about the local adverse effects of intramus-cular injection, particularly in CVD patients receiving antithrombotic therapy, is one of the important impediments. This study was con-ducted to assess the safety, side effects and tolerability of intradermal influenza vaccine in CVD patients. Methods This was an observa-tional study in adult CVD patients who had undergone vaccination against seasonal influenza by intradermal vaccination between May 16th and May 30th, 2012 at Maharaj Nakorn Chiang Mai Hospital. The medical history, patients’ acceptability and adverse effects were collected using a written questionnaire completed by the patient immediately following vaccination and by a telephone survey eight days later. Results Among 169 patients, 52.1%were women and the mean age was 63 ± 12 years. Coronary artery disease, valvular heart disease and dilated cardiomyopathy were present in 121 (71.6%), 40 (23.7%) and 8 (4.7%), respectively. Antithrombotics were used in 89.3%. After vaccination, the pain score was 0, 1 or 2 (out of 10) in 44.4%, 15.1%, and 27.6%of the patients, respectively. Eight days after vaccination, the common adverse reactions were itching 19 (11.9%), swelling 9 (5.7%) and fatigue (4.7%). No hematoma or bruising was reported. Conclusions The intradermal influenza vaccination is safe and well tolerates with high rates of satisfaction in CVD patients. This technique should be useful in expanding influenza vaccine coverage.

  11. Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1987 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Kaattari, Stephen

    1988-06-01

    Bacterial kidney disease (BKD) has been and remains a chronic contributory problem limiting the productivity of salmon in the Columbia River Basin. Control of this disease will not come easily, but it would lead to a tremendous increase in the health and numbers of salmon populations. Vaccination of salmon to Renibacterium salmoninarum (KDB) is a potentially successful method of controlling this disease. To date, however, no successful vaccine has been developed for general use. A possible solution to this problem, and thus the goal of this research, is to isolate the antigenic components of KDB and enhance their ability to activate the host defenses. This will be accomplished by the chemical modification of these antigens with potent immunomodulatory substances. These modified antigens will then be tested for their effectiveness in inducing immunity to BKD and thereby preventing the disease. The goal of the project's fourth year was to test the immunogenicity and prophylactic value in coho salmon (Oncorhynchus kisutch) of various--chemical conjugates of Renibacterium salmoninarum cell and major antigens. This was accomplished by assessing the serum antibody response, the cellular immune response (chemiluminescence), and the kinetics of mortality after lethal injections of the bacteria. The studies completed this year have: (1) identified immunization procedures which enhance the induction of high levels of antibody; (2) identified functionally distinct serum antibodies which may possess different abilities to protect salmon against BKD; (3) begun the isolation and characterization of anti-R. salmoninarum antibodies which may correlate with varying degrees of protection; (4) identified chemiluminescence as a potential method for assessing cellular immunity to bacterial kidney disease; and (5) characterized two monoclonal antibodies to R. salmoninarum which will be of benefit in the diagnosis of this disease.

  12. Vaccinations

    Science.gov (United States)

    ... vaccinated? For many years, a set of annual vaccinations was considered normal and necessary for dogs and ... to protect for a full year. Consequently, one vaccination schedule will not work well for all pets. ...

  13. Efficacy and safety of a combined Porcine Circovirus and Mycoplasma hyopneumoniae vaccine in finishing pigs

    Directory of Open Access Journals (Sweden)

    Maarten Witvliet

    2015-01-01

    Full Text Available The safety and protective efficacy of a new one dose combination vaccine containing Porcine Circovirus type 2 (PCV2 and M. hyopneumoniae antigens – Porcilis® PCV M Hyo - was evaluated in laboratory studies and under field conditions. Vaccination resulted in a moderate temperature increase on the day of vaccination and mild systemic and local reactions were found in only a low percentage of the vaccinated pigs. The local reactions observed were small (max. 2 cm and transient (max. 1 day. In short term (onset of immunity and long term (duration of immunity challenge studies with the individual pathogens, the vaccine significantly reduced the PCV2 load in lymphoid tissue and lungs and M. hyopneumoniae-induced lung lesions. In a placebo-controlled field trial on a farm where both PCV2 and M. hyopneumoniae were present, vaccination of piglets at 3 weeks of age resulted in a reduction of PCV2 viremia and shedding and lower lung lesion scores at slaughter. In addition, a positive effect on the average daily weight gain (+ 34 g/day in the finishing phase was observed. It can therefore be concluded that this new ready to use combination vaccine is safe and efficacious against PCV2 and M. hyopneumoniae single and combined infections.

  14. Safety and immunogenicity of a live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) in children.

    Science.gov (United States)

    Chokephaibulkit, K; Houillon, G; Feroldi, E; Bouckenooghe, A

    2016-02-01

    JE-CV (IMOJEV®, Sanofi Pasteur, France) is a live attenuated virus vaccine constructed by inserting coding sequences of the prM and E structural proteins of the Japanese encephalitis SA14-14-2 virus into the genome of yellow fever 17D virus. Primary immunization with JE-CV requires a single dose of the vaccine. This article reviews clinical trials of JE-CV in children aged up to 6 years conducted in countries across South-East Asia. Strong and persistent antibody responses were observed after single primary and booster doses, with 97% of children seroprotected up to five years after booster vaccination. Models of long-term antibody persistence predict a median duration of protection of approximately 30 years after a booster dose. The safety and reactogenicity profiles of JE-CV primary and booster doses are comparable to other widely used childhood vaccines. PMID:26588242

  15. How vaccine safety can become political--the example of polio in Nigeria.

    Science.gov (United States)

    Clements, Christopher J; Greenough, Paul; Shull, Diana

    2006-01-01

    Vaccine safety is increasingly a major aspect of immunization programmes. Parents are becoming more aware of safety issues relating to vaccines their babies might receive. As a consequence, public health initiatives have had to take note of pressures brought to bear by individual parents and groups. Now we document a new phase in vaccine safety where it has been used to achieve political objectives. In 1988, the World Health Assembly declared its intention to eradicate poliomyelitis from the globe by the year 2000. This goal had to be postponed to 2005 for a number of reasons. Although the progress has been spectacular in achieving eradication in almost all nations and areas, the goal has been tantalizingly elusive. But arguably the most difficult country from which to eradicate the virus has been Nigeria. Over the past two years, tension has arisen in the north against immunizing against polio using the oral polio vaccine (OPV). Although this vaccine has been used in every other country in the world including other Muslim states, some religious leaders in the north found reason in August 2003 to advise their followers not to have their children vaccinated with OPV. Subsequent to this boycott, which the Kano governor had endorsed for a year and then ended in July 2004, cases of polio occurred in African nations previously free of the virus, and the DNA finger-print of the virus indicated it had come from Nigeria. In other words, Nigeria became a net exporter of polio virus to its African neighbours and beyond. Now the disease has spread to a dozen formerly polio-free countries, including Sudan and Indonesia. We show that, while the outward manifestations of the northern Nigerian intransigence were that of distrust of vaccine, the underlying problem was actually part of a longstanding dispute about political and religious power vis a vis Abuja. It is unlikely that polio transmission will be interrupted by 2005 if this dispute is allowed to run its course. PMID

  16. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

  17. Immunogenicity and safety of the human papillomavirus vaccine in patients with autoimmune diseases: A systematic review.

    Science.gov (United States)

    Pellegrino, Paolo; Radice, Sonia; Clementi, Emilio

    2015-07-01

    Whereas safety and efficacy of HPV vaccines in healthy women have been shown in several randomised controlled clinical trials and in post marketing analyses, only few data exist in patients affected by autoimmune diseases. These issues are significant as autoimmune conditions are recognised as a risk factor for the persistence of HPV infection. Herein we review and systematise the existing literature to assess immunogenicity and safety of HPV vaccination in patients with autoimmune diseases, including systemic lupus erythematosus and juvenile idiopathic arthritis. The results of our literature revision suggest that the HPV vaccines are efficacious and safe in most of the patients affected by autoimmune diseases. Yet, some points of concern remain to be tackled, including the effects of concomitant therapies, the risk of disease exacerbation and the cost-effectiveness of such immunisation programmes in these populations. PMID:26036945

  18. A UMLS-based spell checker for natural language processing in vaccine safety

    OpenAIRE

    Liu Fang; Tong Wesley; Law Barbara; Walop Wikke; Matters Michael D; Tolentino Herman D; Fontelo Paul; Kohl Katrin; Payne Daniel C

    2007-01-01

    Abstract Background The Institute of Medicine has identified patient safety as a key goal for health care in the United States. Detecting vaccine adverse events is an important public health activity that contributes to patient safety. Reports about adverse events following immunization (AEFI) from surveillance systems contain free-text components that can be analyzed using natural language processing. To extract Unified Medical Language System (UMLS) concepts from free text and classify AEFI...

  19. Hepatitis B vaccine safety monitoring in the chimpanzee: interpretation of results.

    Science.gov (United States)

    Berthelot, P; Courouce, A M; Eyquem, A; Feldmann, G; Jacob, J; Ravisse, P; Vacher, B; Moor-Jankowski, J; Muchmore, E; Prince, A

    1984-01-01

    In September, 1983, a group of French and American experts met at the French National Health Laboratory to discuss their experience in monitoring for the safety of a hepatitis B vaccine in 42 chimpanzees. The observations made, conclusions reached, and recommendations for future studies are presented. PMID:6239039

  20. Genetically engineered poxviruses for recombinant gene expression, vaccination, and safety.

    OpenAIRE

    B. Moss

    1996-01-01

    Vaccinia virus, no longer required for immunization against smallpox, now serves as a unique vector for expressing genes within the cytoplasm of mammalian cells. As a research tool, recombinant vaccinia viruses are used to synthesize and analyze the structure-function relationships of proteins, determine the targets of humoral and cell-mediated immunity, and investigate the types of immune response needed for protection against specific infectious diseases and cancer. The vaccine potential of...

  1. SIV Infection-Mediated Changes in Gastrointestinal Bacterial Microbiome and Virome Are Associated with Immunodeficiency and Prevented by Vaccination.

    Science.gov (United States)

    Handley, Scott A; Desai, Chandni; Zhao, Guoyan; Droit, Lindsay; Monaco, Cynthia L; Schroeder, Andrew C; Nkolola, Joseph P; Norman, Megan E; Miller, Andrew D; Wang, David; Barouch, Dan H; Virgin, Herbert W

    2016-03-01

    AIDS caused by simian immunodeficiency virus (SIV) infection is associated with gastrointestinal disease, systemic immune activation, and, in cross-sectional studies, changes in the enteric virome. Here we performed a longitudinal study of a vaccine cohort to define the natural history of changes in the fecal metagenome in SIV-infected monkeys. Matched rhesus macaques were either uninfected or intrarectally challenged with SIV, with a subset receiving the Ad26 vaccine, an adenovirus vector expressing the viral Env/Gag/Pol antigens. Progression of SIV infection to AIDS was associated with increased detection of potentially pathogenic viruses and bacterial enteropathogens. Specifically, adenoviruses were associated with an increased incidence of gastrointestinal disease and AIDS-related mortality. Viral and bacterial enteropathogens were largely absent from animals protected by the vaccine. These data suggest that the SIV-associated gastrointestinal disease is associated with the presence of both viral and bacterial enteropathogens and that protection against SIV infection by vaccination prevents enteropathogen emergence. PMID:26962943

  2. Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1988 Final Report.

    Energy Technology Data Exchange (ETDEWEB)

    Kaattari, Stephen L.

    1989-08-01

    Bacterial kidney disease of salmonids is a very complex disease which appears to exploit a variety of pathogenic mechanisms. An understanding of these mechanisms is essential to the development of efficacious vaccines. It has become well established from the studies published .in this report and those of others that soluble antigens which are secreted by Renibacterium salmoninarum have toxigenic potential. If they are found to be responsible for mortality, the development of toxoid(s) could be paramount to the production of a vaccine. One must, however, be circumspect in producing a vaccine. A thorough knowledge, not only of the pathogen, but also of the immune system of the host is an absolute requirement. This becomes of particular importance when dealing with fish diseases, since the field of fish immunology is still within its infancy. This lack of knowledge is particularly felt when the induction of a prophylactic immune response concomitantly leads to pathological side effects which may be as destructive as the original infection. Indeed, it appears that some aspects of BKD may be due to the induction of hypersensitivity reactions. If such immunopathologies are expressed, it is prudent to thoroughly evaluate the nature of the immunoprophylaxis to insure that these harmful sequelae do not occur. Evaluation of a variety of antigens, adjuvants, immune responses, and survival data leads us to recommend that attempts at prophylaxis against BKD should center upon the elicitation of cellular immunity utilizing preparations of Mycobacterium chelonii. The choice of this species of mycobacteria was made because of its effectiveness, ease of maintenance and production, and the lack of need for its propagation within containment facilities. These assets are important to consider if large scale vaccine production is to be profitable. As can be seen from the data provided, M. chelonii alone is capable of producing prophylaxis to BKD, however, this is likely due to the

  3. Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.

    Science.gov (United States)

    McNicholas, Anne; Galloway, Yvonne; Stehr-Green, Paul; Reid, Stewart; Radke, Sarah; Sexton, Kerry; Kieft, Charlotte; Macdonald, Claire; Neutze, Jocelyn; Drake, Ross; Isaac, Dorothy; O'Donnell, Mary; Tatley, Michael; Oster, Philipp; O'Hallahan, Jane

    2007-01-01

    New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety. PMID:17660718

  4. Effect of Bacterial Flora on Postimmunization Gastritis following Oral Vaccination of Mice with Helicobacter pylori Heat Shock Protein 60

    OpenAIRE

    Yamaguchi, Hiroyuki; Osaki, Takako; Taguchi, Haruhiko; Sato, Noriko; Toyoda, Atushi; Takahashi, Motomichi; Kai, Masanori; Nakata, Noboru; Komatsu, Akio; Atomi, Yutaka; Kamiya, Shigeru

    2003-01-01

    In order to assess the efficacy of oral Helicobacter pylori heat shock protein 60 (HSP60) as a vaccine, protection against H. pylori infection in specific-pathogen-free (SPF) C57BL/6 and germfree (GF) IQI mice was examined. Prophylactic oral vaccination of these two strains of mice with either H. pylori HSP60 or Escherichia coli GroEL inhibited H. pylori colonization by 90 to 95% at 3 weeks postinfection (p.i.). However, these mice were only partially protected because bacterial loads increas...

  5. Extended Preclinical Safety, Efficacy and Stability Testing of a Live-attenuated Chikungunya Vaccine Candidate.

    Directory of Open Access Journals (Sweden)

    Kenneth S Plante

    Full Text Available We recently described a new, live-attenuated vaccine candidate for chikungunya (CHIK fever, CHIKV/IRES. This vaccine was shown to be well attenuated, immunogenic and efficacious in protecting against CHIK virus (CHIKV challenge of mice and nonhuman primates. To further evaluate its preclinical safety, we compared CHIKV/IRES distribution and viral loads in interferon-α/β receptor-incompetent A129 mice to another CHIK vaccine candidate, 181/clone25, which proved highly immunogenic but mildly reactive in human Phase I/II clinical trials. Compared to wild-type CHIK virus, (wt-CHIKV, both vaccines generated lower viral loads in a wide variety of tissues and organs, including the brain and leg muscle, but CHIKV/IRES exhibited marked restrictions in dissemination and viral loads compared to 181/clone25, and was never found outside the blood, spleen and muscle. Unlike wt-CHIKV, which caused disrupted splenic architecture and hepatic lesions, histopathological lesions were not observed in animals infected with either vaccine strain. To examine the stability of attenuation, both vaccines were passaged 5 times intracranially in infant A129 mice, then assessed for changes in virulence by comparing parental and passaged viruses for footpad swelling, weight stability and survival after subcutaneous infection. Whereas strain 181/clone25 p5 underwent a significant increase in virulence as measured by weight loss (from 30% and mortality (from 0 to 100%, CHIKV/IRES underwent no detectible change in any measure of virulence (no significant weight loss and no mortality. These data indicate greater nonclinical safety of the CHIKV/IRES vaccine candidate compared to 181/clone25, further supporting its eligibility for human testing.

  6. Assessing safety and immunogenicity of post-exposure prophylaxis following interchangeability of rabies vaccines in humans.

    Science.gov (United States)

    Ravish, Hardanahalli S; Sudarshan, Mysore K; Madhusudana, Shampur N; Annadani, Rachana R; Narayana, Doddabele H Ashwath; Belludi, Ashwin Y; Anandaiah, Gangaboraiah; Vijayashankar, Veena

    2014-01-01

    Rabies post exposure prophylaxis with cell culture vaccines by either intramuscular route or intradermal route spans over a period of one month. World Health Organization recommends completing post exposure prophylaxis against rabies with the same cell culture or embryonated egg rabies vaccine and with same route of administration and any deviation from this shall be an exception. In the present study, the safety and immunogenicity of rabies post-exposure prophylaxis was studied prospectively in 90 animal bite cases that had interchangeability of rabies vaccines either by route of administration or brand/type and such changes had occurred due to logistical/financial problems. Among them, 47 had change in route of administration from intramuscular to intradermal or vice versa and 43 had change in the brand/type of cell culture rabies vaccine. All of them had category III rabies exposure and received equine rabies immunoglobulin along with the rabies vaccine. None of the study subjects had any adverse reactions. The rabies virus neutralizing antibody titers was assessed by rapid fluorescent focus inhibition test and all the vaccinees had titers ≥0.5 IU per mL on day 14 which is considered as adequate for protection against rabies. Thus, the present study showed that, rabies post-exposure prophylaxis was safe and immunogenic despite changes in the route of administration and brand/type of rabies vaccine. PMID:24584134

  7. The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil.

    Science.gov (United States)

    Haupt, Richard M; Sings, Heather L

    2011-11-01

    Human papillomavirus (HPV) infection causes cervical cancer, a significant portion of anal, genital, and oropharyngeal cancers, genital warts, and recurrent respiratory papillomatosis. In June 2006, a quadrivalent HPV-6/11/16/18 vaccine (Gardasil/Silgard) was licensed in the United States, and subsequently in the European Union (September 2006). It has since been approved in 121 countries, with >74 million doses distributed globally as of March 2011. As the incidence of HPV infection peaks 5-10 years after the onset of sexual activity, preadolescents and adolescents represent an appropriate target group to implement HPV vaccination programs so as to achieve the maximal public health benefit. In this article, we provide an overview of the prophylactic efficacy of the vaccine in young women who were found to be negative to at least one of the four vaccine HPV types, thus approximating sexually naive adolescents. Because adolescents are also at high risk for other infections which are preventable by currently available vaccines, the development of concurrent immunization strategies may lead to better compliance, thereby contributing to the overall goal of protection against preventable diseases. We also summarize concomitant administration studies with meningococcal, diphtheria, tetanus, and pertussis vaccines, which were conducted in adolescents aged 9-15 years. Prophylactic efficacy in other populations (males aged 16-26 years) is also summarized along with long-term safety and efficacy studies. PMID:22018560

  8. A postmarket safety comparison of 2 vaccination strategies for measles, mumps, rubella and varicella in Italy.

    Science.gov (United States)

    Cocchio, Silvia; Zanoni, Giovanna; Opri, Roberta; Russo, Francesca; Baldo, Vincenzo

    2016-03-01

    It is strategically important to monitor the safety profile of vaccination schedules in order to achieve and maintain high levels of coverage. We analyzed the cohort of individuals actively invited for measles, mumps, rubella and varicella (MMRV) vaccination in the Veneto region (north-east Italy) from 8/1/2013 to 7/31/2014, assessing the onset of adverse events (AE) relating to 2 different vaccination strategies for MMRV (MMR+V vs MMRV). During the vaccination session at 14 months old, parents were given a form for recording local and systemic reactions to vaccinations for 4 weeks afterwards. Overall, 12,288 forms were returned, and 84.6% of them were included in this analysis (5,130 relating to MMR+V and 5,265 to MMRV); 37.3% of the sample reported no AEs, with no difference between the 2 groups. Local reactions were more common in the MMR+V group (9.6% vs 2.9%; RR 3.33; 95% CI 2.79-3.98), while there was no difference in general reactions between the 2 groups (50% MMR+V vs 52% MMRV). The events most often reported were "fever perception of the AEs occurring in response to their child's vaccination. PMID:26528829

  9. Safety of a Live Attenuated Infectious Bovine Rhinotracheitis Vaccine IBRV LNM Strain

    Institute of Scientific and Technical Information of China (English)

    Guo; Li; Wang; Wei; Zhang; Shuqin; Cheng; Shipeng; Wu; Hua

    2014-01-01

    The paper was to evaluate the vaccine safety,and to prevent public health risk due to virus spread,the approach vaccination of was adopted in this research; and neck intramuscular injection of IBRV LNM attenuated vaccine strain was carried out. Blind passage for three generations in animal has tested the reversion risk to virulence. A total of 14 healthy and weaning cows at 6- 8 month old were divided into three groups. The 1st reversion of virulence trials used 105. 0TCID50/mL neck intramuscular injection of IBRV LNM attenuated vaccine strain. Then,the nose swab samples were collected for continuous 14 days. After passed through 0. 45 μm filter membrane,nasal swabs mixture was prepared as the virulence test inoculum for next generation. The body temperature was detected and clinical observation was carried out for continuous 14 days after inoculation. The inoculation dose was 1ml / cattle. Blood was collected on the 0 and 14 thdays of animal vaccination. After serum isolation,it was used for the antibody detection of serum. Research results showed that no virus was isolated from the nasal swabs from the F2 generation; vaccinated animals did not show any clinical signs of IBR; serological testing of IBRV antibody was negative,which indicated that the strain-inoculated animals did had reversion of virulence in all three generations.

  10. Safety of the novel influenza viral vector Brucella abortus vaccine in pregnant heifers

    Directory of Open Access Journals (Sweden)

    Kaissar Tabynov

    2016-01-01

    Full Text Available ABSTRACT: The present study provides the first information about the safety of a new influenza viral vector vaccine expressing the Brucella ribosomal protein L7/L12 or Omp16 containing the adjuvant Montanide Gel01 in pregnant heifers. Immunization of pregnant heifers was conducted via the conjunctival (n=10 or subcutaneous (n=10 route using cross prime and booster vaccination schedules at an interval of 28 days. The vector vaccine was evaluated in comparison with positive control groups vaccinated with B. abortus S19 (n=10 or B. abortus RB51 (n=10 and a negative (PBS+Montanide Gel01; n=10 control group. Clinical studies, thermometry, assessment of local reactogenicity and observation of abortion showed that the vector vaccine via the conjunctival or subcutaneous route was completely safe for pregnant heifers compared to the commercial vaccines B. abortus S19 or B. abortus RB51. The only single adverse event was the formation of infiltration at the site of subcutaneous injection; this reaction was not observed for the conjunctival route.

  11. Safety of classical swine fever virus vaccine strain LOM in pregnant sows and their offspring.

    Science.gov (United States)

    Lim, Seong-In; Song, Jae-Young; Kim, Jaejo; Hyun, Bang-Hun; Kim, Ha-Young; Cho, In-Soo; Kim, Byounghan; Woo, Gye-Hyeong; Lee, Jung-Bok; An, Dong-Jun

    2016-04-12

    The present study aimed to evaluate the safety of the classical swine fever virus (CSFV) vaccine strain LOM in pregnant sows. Pregnant sows with free CSFV antibody were inoculated with a commercial LOM vaccine during early pregnancy (day 38; n=3) or mid-pregnancy (days 49-59; n=11). In pregnant sows vaccinated during the early stages of gestation, abortion (day 109) was observed in one case, with two stillbirths and seven mummified fetuses. The viability of live-born piglets was 34.9% in sows vaccinated during mid-pregnancy compared with 81.8% in the control group. Post-mortem examination of the organs of the sows and piglets did not reveal any pathological lesions caused by CSFV; however, CSFV RNA was detected in the organs of several vaccinated sows and their litters. The LOM strain was transmitted from sows with free CSFV antibody to their fetus, but did not appear to induce immune tolerance in the offspring from vaccinated pregnant sows. Side effects were not observed in pregnant sows with antibody to the LOM strain: transmission from sow to their litters and stillbirth or mummified fetuses. The LOM strain may induce sterile immunity and provide rapid, long-lasting, and complete protection against CSFV; however, it should be contraindicated in pregnant sows due to potential adverse effects in pregnant sows with free CSFV antibody. PMID:26947495

  12. Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Recurrent protracted bacterial bronchitis (PBB), chronic suppurative lung disease (CSLD) and bronchiectasis are characterised by a chronic wet cough and are important causes of childhood respiratory morbidity globally. Haemophilus influenzae and Streptococcus pneumoniae are the most commonly associated pathogens. As respiratory exacerbations impair quality of life and may be associated with disease progression, we will determine if the novel 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) reduces exacerbations in these children. Methods A multi-centre, parallel group, double-blind, randomised controlled trial in tertiary paediatric centres from three Australian cities is planned. Two hundred six children aged 18 months to 14 years with recurrent PBB, CSLD or bronchiectasis will be randomised to receive either two doses of PHiD-CV or control meningococcal (ACYW135) conjugate vaccine 2 months apart and followed for 12 months after the second vaccine dose. Randomisation will be stratified by site, age (, nasopharyngeal and saliva swabs, and serum will be collected at baseline and at 2, 3, 8 and 14 months post-enrolment. Local and systemic reactions will be recorded on daily diaries for 7 and 30 days, respectively, following each vaccine dose and serious adverse events monitored throughout the trial. Fortnightly, parental contact will help record respiratory exacerbations. The primary outcome is the incidence of respiratory exacerbations in the 12 months following the second vaccine dose. Secondary outcomes include: nasopharyngeal carriage of H. influenzae and S. pneumoniae vaccine and vaccine- related serotypes; systemic and mucosal immune responses to H. influenzae proteins and S. pneumoniae vaccine and vaccine-related serotypes; impact upon lung function in children aged ≥6 years; and vaccine safety. Discussion As H. influenzae is the most common bacterial pathogen associated with these chronic respiratory diseases in

  13. Long-term safety assessment of live attenuated tetravalent dengue vaccines: deliberations from a WHO technical consultation.

    Science.gov (United States)

    Bentsi-Enchill, Adwoa D; Schmitz, Julia; Edelman, Robert; Durbin, Anna; Roehrig, John T; Smith, Peter G; Hombach, Joachim; Farrar, Jeremy

    2013-05-28

    Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use. PMID:23570986

  14. Safety and efficacy of a turkey herpesvirus vector laryngotracheitis vaccine for chickens.

    Science.gov (United States)

    Esaki, Motoyuki; Noland, Lauren; Eddins, Tim; Godoy, Alecia; Saeki, Sakiko; Saitoh, Shuji; Yasuda, Atsushi; Dorsey, Kristi Moore

    2013-06-01

    Turkey herpesvirus vector laryngotracheitis vaccine (HVT/LT) expressing the glycoprotein B gene of laryngotracheitis virus (LTV) has been developed. In vitro growth kinetics of HVT/LT were similar to those of parental turkey herpesvirus (HVT), FC-126 strain. Genetic and phenotypic stabilities of HVT/LT after in vitro (in cell culture) or in vivo (in chickens) passage were confirmed by various assays, including Southern blot analysis, western blot analysis, and an indirect immunofluorescence assay. Safety of HVT/LT was assessed by an overdose study as well as by a backpassage study in specific-pathogen-free (SPF) chickens. The overdose study indicated that HVT/LT did not cause any adverse effects in chickens. The backpassage study confirmed that HVT/LT does not revert to virulence after five passages in chickens. The vaccine did not transmit laterally from vaccinated chickens to commingled nonvaccinated chickens. Efficacy of HVT/LT was evaluated in SPF layer chickens after vaccination by the subcutaneous route at 1 day of age. The majority of the vaccinated chickens (92%-100%) were protected against challenge with virulent LTV at 7 wk of age. Efficacy of HVT/LT was further evaluated in broiler chickens from a commercial source after in ovo vaccination to embryos at 18 days of incubation. After challenge with virulent LTV at 21 and 35 days of age, 67% and 87% of HVT/LT-vaccinated chickens did not develop LT clinical signs, respectively, while 100% (21 days of age) and 73% (35 days of age) of the challenge control chickens showed clinical signs of LT. These results suggest that HVT/LT is a safe and efficacious vaccine for control of laryngotracheitis (LT). PMID:24689173

  15. Dose site reactions and related findings after vaccine administration in safety studies.

    Science.gov (United States)

    Baldrick, Paul

    2016-08-01

    Potential new human vaccines undergo toxicology testing to evaluate local reactogenicity and systemic toxicity. A review of 30 recently published and in-house repeat dose toxicity studies with a variety of vaccines was performed. Species tested were generally rat or rabbit, usually by intramuscular (although occasionally subcutaneous) injection. Results showed no unexpected findings indicating vaccine toxicity, but classic signs of enhanced acute and/or chronic inflammation at the dose site compared with that seen in injected control animals, often accompanied by changes in draining lymph nodes and the spleen (lymphoid hyperplasia and/or increased weight). Other associated signs of a response to vaccine dosing were altered clinical pathology parameters (commonly raised blood neutrophil count and altered globulin level). No obvious difference in dose site or systemic reaction was seen across vaccine, species or the dose route used. A non-dose recovery period of 2 to 4 weeks was sufficient to show evidence of reversibility of dose site effects. Injection site, lymphoid tissue and clinical pathological changes can be interpreted as related to an expected reaction after vaccine dosing, with generation of an immune response largely as a result of the presence of adjuvant, although direct vaccine antigen involvement was also occasionally demonstrated by the presence of a slightly increased inflammatory response seen over adjuvant treatment only. Overall, the need for toxicity testing of vaccines is in line with current regulatory guideline requirements and has proven to be a valuable part of the safety evaluation process prior to human use. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26968331

  16. Factors Associated with Intention to Receive Influenza and Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccines during Pregnancy: A Focus on Vaccine Hesitancy and Perceptions of Disease Severity and Vaccine Safety

    OpenAIRE

    Chamberlain, Allison T.; Seib, Katherine; Ault, Kevin A.; Orenstein, Walter A.; Frew, Paula M.; Malik, Fauzia; Cortés, Marielysse; Cota, Pat; Whitney, Ellen A.S.; Flowers, Lisa C.; Berkelman, Ruth L.; Omer, Saad B

    2015-01-01

    BACKGROUND: Improving influenza and tetanus, diphtheria and acellular pertussis (Tdap) vaccine coverage among pregnant women is needed. PURPOSE: To assess factors associated with intention to receive influenza and/or Tdap vaccinations during pregnancy with a focus on perceptions of influenza and pertussis disease severity and influenza vaccine safety. METHODS: Participants were 325 pregnant women in Georgia recruited from December 2012 – April 2013 who had not yet received a 2012/2013 influen...

  17. A Live Salmonella Gallinarum Vaccine Candidate Secreting an Adjuvant Protein Confers Enhanced Safety and Protection Against Fowl Typhoid.

    Science.gov (United States)

    Shafiq, Muhammad Hassan; Kamble, Nitin M; Kim, Tae Hoon; Choi, Yoonyoung; Lee, John Hwa

    2015-12-01

    Live attenuated vaccines are used for effective protection against fowl typhoid (FT) in domestic poultry. In this study, a lon/cpxR/asd deletion mutant of Salmonella Gallinarum expressing the B subunit of a heat labile toxin (LTB) from Escherichia coli, a known adjuvant, was cloned in a recombinant p15A ori plasmid, JOL1355, and evaluated as a vaccine candidate in chickens. The plasmid was shown to be stable inside the attenuated Salmonella Gallinarum cell after three successive generations. Moreover, from an environmental safety point of view, apart from day 1 the JOL1355 strain was not detected in feces through day 21 postinoculation. For the efficacy of JOL1355, a total of 100 chickens were equally divided into two groups. Group A (control) chickens were intramuscularly inoculated with phosphate-buffered saline at 4 and 8 wk of age. Group B chickens were primed and boosted via the intramuscular route with 200 μL of a bacterial suspension of JOL1355 containing 1 × 10(8) colony forming units. All the chickens in Group A and B were challenged at 3 wk postbooster by oral inoculation with a wild-type Salmonella Gallinarum strain, JOL420. The JOL1355-immunized group showed significant protection and survival against the virulent challenge compared to the nonimmunized group. In addition, Group B exhibited a significantly higher humoral immune response, and the chickens remained healthy without any symptoms of anorexia, diarrhea, or depression. Group B also exhibited a significantly lower mortality rate of 4% compared to the 46% of the control group, which can be attributed to higher immunogenicity and better protection. The Group B chickens had significantly lower lesion scores for affected organs, such as the liver and spleen, compared to those of the control chickens (P < 0.01). These findings suggest that JOL1355 is a promising candidate for a safe and highly immunogenic vaccine against FT. PMID:26629629

  18. Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study

    Directory of Open Access Journals (Sweden)

    Naleway Allison

    2009-10-01

    Full Text Available Abstract Background Local reactions are the most commonly reported adverse events following tetanus and diphtheria toxoid (Td vaccine and the risk of local reactions may increase with number of prior Td vaccinations. Methods To estimate the risk of medically attended local reactions following Td vaccination in adolescents and young adults we conducted a six-year retrospective cohort study assessing 436,828 Td vaccinations given to persons 9 through 25 years of age in the Vaccine Safety Datalink population from 1999 through 2004. Results Overall, the estimated risk of a medically attended local reaction was 3.6 events per 10,000 Td vaccinations. The lowest risk (2.8 events per 10,000 vaccinations was found in the 11 to 15 year old age group. In comparison with that group, the event risks were significantly higher in both the 9 to 10 and 21 to 25 year old age groups. The risk of a local reaction was significantly higher in persons who had received another tetanus and diphtheria toxoid containing vaccine (TDCV in the previous five years (incidence rate ratio, 2.9; 95% confidence interval, 1.2 to 7.2. Twenty-eight percent of persons with a local reaction to Td vaccine were prescribed antibiotics. Conclusion Medically attended local reactions were uncommon following Td vaccination. The risk of those reactions varied by age and by prior receipt of TDCVs. These findings provide a point of reference for future evaluations of the safety profile of newer vaccines containing tetanus or diphtheria toxoid.

  19. Cell-penetrating peptides mediated protein cross-membrane delivery and its use in bacterial vector vaccine.

    Science.gov (United States)

    Ma, Jimei; Xu, Jinmei; Guan, Lingyu; Hu, Tianjian; Liu, Qin; Xiao, Jingfan; Zhang, Yuanxing

    2014-07-01

    It is an attractive strategy to develop a recombinant bacterial vector vaccine by expressing exogenous protective antigen to induce the immune response, and the main concern is how to enhance the cellular internalization of antigen produced by bacterial vector. Cell-penetrating peptides (CPPs) are short cationic/amphipathic peptides which facilitate cellular uptake of various molecular cargoes and therefore have great potentials in vector vaccine design. In this work, eleven different CPPs were fused to the C-terminus of EGFP respectively, and the resultant EGFP-CPP fusion proteins were expressed and purified to assay their cross-membrane transport in macrophage J774 A.1 cells. Among the tested CPPs, TAT showed an excellent capability to deliver the cargo protein EGFP into cytoplasm. In order to establish an efficient antigen delivery system in Escherichia coli, the EGFP-TAT synthesis circuit was combined with an in vivo inducible lysis circuit PviuA-E in E. coli to form an integrated antigen delivery system, the resultant E. coli was proved to be able to lyse upon the induction of a mimic in vivo signal and thus release intracellular EGFP-TAT intensively, which were assumed to undergo a more efficient intracellular delivery by CPP to evoke protective immune responses. Based on the established antigen delivery system, the protective antigen gene flgD from an invasive intracellular fish pathogen Edwardsiella tarda EIB202, was applied to establish an E. coli recombinant vector vaccine. This E. coli vector vaccine presented superior immune protection (RPS = 63%) under the challenge with E. tarda EIB202, suggesting that the novel antigen delivery system had great potential in bacterial vector vaccine applications. PMID:24746937

  20. Efficacy and safety of lomefloxacin on bacterial extraocular disease in the horse.

    Science.gov (United States)

    Hidaka, Shuhei; Kobayashi, Mitsutoshi; Ando, Kunihide; Fujii, Yoshikazu

    2015-07-01

    Lomefloxacin is a broad-spectrum fluoroquinolone antibiotic used for the treatment of bacterial extraocular disease. This study investigated the efficacy and safety of lomefloxacin eye drops for bacterial extraocular disease in horses. Lomefloxacin ophthalmic solution (0.3%) was instilled three times daily for 2-5 days in 65 horses diagnosed with bacterial extraocular disease based on clinical findings. Clinical observations and bacteriological examinations were performed at the start of treatment, 2 and 5 days after the start of treatment, and at the discontinuation or termination of treatment. Of the 65 horses, 64 were positive for bacteria, and 22 bacterial genera and 47 bacterial species were identified. The efficacy of lomefloxacin was evaluated in 63 horses; one horse with a negative culture and another with suspected bacterial contamination were excluded. Lomefloxacin was considered to be clinically effective in 54 horses. The major bacterial species identified were Staphylococcus aureus, Streptococcus equi subsp. zooepidemicus, Acinetobacter lwoffii, Staphylococcus xylosus, Staphylococcus vitulinus, Enterobacter agglomerans, Flavimonas oryzihabitans and Staphylococcus sciuri, with a cumulative disappearance rate of 80% or more at the termination of instillation. Excluding one horse that did not undergo a bacteriological examination, the remaining 62 horses were assessed for bacteriological outcome. Full or partial bacterial clearance was detected in 95% or more of the 62 horses. One of the 65 horses reported adverse events that had no causal relation with the eye drops. Our results showed that lomefloxacin is safe and effective for the treatment of bacterial extraocular disease in horses. PMID:25787926

  1. Comparison of the Immunogenicity and Safety of the Conventional Subunit, MF59-Adjuvanted, and Intradermal Influenza Vaccines in the Elderly

    OpenAIRE

    Seo, Yu Bin; Choi, Won Suk; Lee, Jacob; Song, Joon Young; Cheong, Hee Jin; Kim, Woo Joo

    2014-01-01

    The influenza vaccination is known as the most effective method for preventing influenza infection and its complications in the elderly. Conventional subunit (Agrippal S1; Novartis), MF59-adjuvanted (Fluad; Novartis), and intradermal (IDflu15; Sanofi Pasteur) influenza vaccines are widely used throughout South Korea. However, few comparative studies evaluating the safety and immunogenicity of these vaccines are available. Prior to the beginning of the 2011-2012 influenza season, 335 healthy e...

  2. An update on safety studies on the attenuated "RIEMSER Schweinepestoralvakzine" for vaccination of wild boar against classical swine fever.

    Science.gov (United States)

    Kaden, Volker; Lange, Elke; Küster, Heike; Müller, Thomas; Lange, Bodo

    2010-07-14

    The RIEMSER Schweinepestoralvakzine is an attenuated vaccine for oral vaccination of wild boar against classical swine fever (CSF). The safety of this licensed bait vaccine which is based on the CSF virus (CSFV) strain "C" was investigated in eight animal species, e.g. weaner pigs (n=111), wild boar (n=11), ruminants (cattle, goats and sheep, n=11), foxes (n=5), rabbits (n=12), and mice (n=10). Animals were vaccinated either with a single vaccine dose containing at least 10(4.5) TCID(50), or with overdoses, i.e. the 10-fold dose, or they were subjected to repeated application schemes. During the entire observation period none of the animals which were given the vaccine virus showed clinical signs, with the exception of rabbits. These reacted to the vaccination with fever. Orally vaccinated pigs did not transmit vaccine virus to susceptible contact animals (sentinels). In none of the species examined neither vaccine virus nor viral RNA could be detected in blood after vaccination. In one wild boar viral RNA could be established in the tonsil 21 days post-vaccination (dpv); all other organ samples tested virologically negative. Up to 77.5% of the pigs and wild boar developed virus neutralising antibodies (VNA) already 14 dpv. The mean VNA titres observed in the vaccination groups seemed to depend rather on individual factors than on the administered virus dose (virus titre per dose) or the vaccination scheme. These results are comparable with findings obtained during oral vaccination campaigns in wild boar and after parenteral vaccination with this C-strain virus. From the results presented here it can be concluded that RIEMSER Schweinepestoralvakzine is safe for target and non-target species. PMID:20022716

  3. Safety of pandemic (H1N1 2009 monovalent vaccines in taiwan: a self-controlled case series study.

    Directory of Open Access Journals (Sweden)

    Wan-Ting Huang

    Full Text Available In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of special interest (AESIs in a large-linked safety database, and used the self-controlled case series (SCCS method to examine the risk of each AESI in the 0-42 days after H1N1 vaccination. Of the 3.5 million doses of H1N1 vaccines administered and captured in the linked database, the SCCS analysis of Guillain-Barré syndrome (GBS found an incidence rate ratio of 3.81 (95% confidence interval 0.43-33.85 within 0-42 days after nonadjuvanted H1N1 vaccination and no cases after MF59®-adjuvanted H1N1 vaccination. The risks of other AESIs were, in general, not increased in any of the predefined postvaccination risk periods and age groups. The databases and infrastructure created for H1N1 vaccine safety evaluation may serve as a model for safety, effectiveness and coverage studies of licensed vaccines in Taiwan.

  4. The safety of measles vaccination%麻疹疫苗接种安全性

    Institute of Scientific and Technical Information of China (English)

    戴智勤

    2012-01-01

    Measles remains one of the major causes of death among young children. Measles vaccination is one of the best measures to prevent measles,The safety surveillance of measles vaccination is a key factor to ensure immunization program implementation. This paper reviews the safety of measles vaccination,the surveillance of and response strategies for adverse reactions following measles vaccination.%麻疹仍是造成幼儿死亡的主要原因之一,麻疹疫苗接种是预防麻疹最有效的施措之一,对麻疹疫苗接种的安全性监测是保证免疫计划实施的关键因素.此文阐述了麻疹疫苗接种的安全性、对麻疹疫苗接种不良反应的监测以及应对接种不良反应的策略.

  5. Immunogenicity and safety of the 9-valent HPV vaccine in men

    DEFF Research Database (Denmark)

    Castellsagué, X; Giuliano, A R; Goldstone, S;

    2015-01-01

    OBJECTIVES: This study was designed to evaluate the immunogenicity and tolerability of a prophylactic 9-valent HPV (types 6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine in young men 16-26 years of age in comparison to young women 16-26 years of age (the population that was used to establish 9vHPV...... vaccine efficacy). Safety and immunogenicity data from this study will be used to bridge 9vHPV vaccine efficacy findings in 16-26 year old women to 16-26 year old men. METHODS: This study enrolled 1106 heterosexual men (HM) and 1101 women who had not yet received HPV vaccination. In addition, 313 men...... having sex with men (MSM) were enrolled and were evaluated separately for immunogenicity because previous results showed that antibody responses to quadrivalent HPV (types 6/11/16/18) VLP (qHPV) vaccine were lower in MSM than in HM. All subjects were administered a 3-dose regimen (Day 1, Month 2, Month 6...

  6. Immunogenicity and safety of liposome-vaccine encapsulating hepatitis B surface antigen and phosphodiester CpG oligodeoxynucleotides

    Institute of Scientific and Technical Information of China (English)

    CHUN YAN HE; QING LIANG LIU

    2006-01-01

    CpG oligodeoxynucleotides (CpG ODN) as adjuvant have been extensively studied in recent years. Phosphodiester CpG ODN (PO CpG ODN) can perfectly mimic bacterial DNA in enhancing immune response but are vulnerable to nucleases in vivo. This study aimed to evaluate the immunostimu latory potential and safety of phosphodiester CpG ODN encapsulated in nonphospholipid liposomes.BALB/c mice were immunized intramuscularly with different formulations of liposomes, CpG ODN and hepatitis B surface antigen (HBsAg). The results demonstrated that the encapsulated PO CpG ODN were protected against rapid degradation in vivo and retained their adjuvant activity. PO CpG ODN encapsulated with HBsAg in liposomes induced strong Th1-biased or Th1/Th2 mixed humoral immune response in mice with the magnitude similar to their phosphothioate equivalent in the same formulation.High IFN-gamma production induced by this formulation confirmed the generation of strong cellular immune response. Additionally, co-delivery of HBsAg and PO CpG ODN improved the immune response over that obtained with separate delivery. Safety experiment showed that liposome-encapsulaed PO CpG ODN and HBsAg caused mild systemic and moderate local adverse reaction. In conclusion, our data shows that PO CpG ODN encapsulated in liposomes fully exhibit their Th1-type adjuvant activity and act as a potential adjuvant for vaccines.

  7. Comparative evaluation for safety & potency of inactivated Cell Culture Rabies Vaccines from four Indian manufacturers

    OpenAIRE

    Chand, Subhash; Bindra, Gurminder; Vaishnav, Saurabh; Pandey, Anupama; Karol, Ayush; Sheikh, Faraz; Meena, Jaipal; Tewari, Shalini; Kiran, Manjula; Malik, Neeraj; Yadav, Shikha; Soni, G. R.; Singh, Surinder

    2016-01-01

    Rabies is a fatal but preventable disease. Various cell culture rabies vaccines (CCRV) are recommended by World Health Organization (WHO) for pre- exposure prophylaxis and post-exposure therapeutic application. In the present study, we have evaluated seventy batches of inactivated CCRV, for safety and potency by test for Virus Inactivation and National Institute of Health (NIH) potency test respectively in Swiss albino mice, produced by four manufacturers of India, using different cell substr...

  8. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    OpenAIRE

    Thomas, Roger

    2015-01-01

    Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects); MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Dat...

  9. Safety of Pandemic (H1N1) 2009 Monovalent Vaccines in Taiwan: A Self-Controlled Case Series Study

    OpenAIRE

    Wan-Ting Huang; Hsu-Wen Yang; Tzu-Lin Liao; Wan-Jen Wu; Shu-Er Yang; Yi-Chien Chih; Jen-Hsiang Chuang

    2013-01-01

    In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of special interest (AESIs) in a large-linked safety database, and used the self-controlled case series (SCCS) method to examine the risk of each AESI in the 0-42 days after H1N1 vaccination. Of the 3.5 m...

  10. A cohabitation challenge to compare the efficacies of vaccines for bacterial kidney disease (BKD) in chinook salmon Oncorhynchus tshawytscha

    Science.gov (United States)

    Alcorn, S.; Murray, A.L.; Pascho, R.J.; Varney, J.

    2005-01-01

    The relative efficacies of 1 commercial and 5 experimental vaccines for bacterial kidney disease (BKD) were compared through a cohabitation waterborne challenge. Groups of juvenile chinook salmon Oncorhynchus tshawytscha were vaccinated with one of the following: (1) killed Renibacterium salmoninarum ATCC 33209 (Rs 33209) cells; (2) killed Rs 33209 cells which had been heated to 37??C for 48 h, a process that destroys the p57 protein; (3) killed R. salmoninarum MT239 (Rs MT239) cells; (4) heated Rs MT239 cells; (5) a recombinant version of the p57 protein (r-p57) emulsified in Freund's incomplete adjuvant (FIA); (6) the commercial BKD vaccine Renogen; (7) phosphate-buffered saline (PBS) emulsified with an equal volume of FIA; or (8) PBS alone. Following injection, each fish was marked with a subcutaneous fluorescent latex tag denoting its treatment group and the vaccinated fish were combined into sham and disease challenge tanks. Two weeks after these fish were vaccinated, separate groups of fish were injected with either PBS or live R. salmoninarum GL64 and were placed inside coated-wire mesh cylinders (liveboxes) in the sham and disease challenge tanks, respectively. Mortalities in both tanks were recorded for 285 d. Any mortalities among the livebox fish were replaced with an appropriate cohort (infected with R. salmoninarum or healthy) fish. None of the bacterins evaluated in this study induced protective immunity against the R. salmoninarum shed from the infected livebox fish. The percentage survival within the test groups in the R. salmoninarum challenge tank ranged from 59% (heated Rs MT239 bacterin) to 81 % (PBS emulsified with FIA). There were no differences in the percentage survival among the PBS-, PBS/FIA-, r-p57-and Renogen-injected groups. There also were no differences in survival among the bacterin groups, regardless of whether the bacterial cells had been heated or left untreated prior to injection. ?? Inter-Research 2005.

  11. A cohabitation challenge to compare the efficacies of vaccines for bacterial kidney disease (BKD) in chinook salmon Oncorhynchus tshawytscha.

    Science.gov (United States)

    Alcorn, Stewart; Murray, Anthony L; Pascho, Ronald J; Varney, Jed

    2005-02-28

    The relative efficacies of 1 commercial and 5 experimental vaccines for bacterial kidney disease (BKD) were compared through a cohabitation waterborne challenge. Groups of juvenile chinook salmon Oncorhynchus tshawytscha were vaccinated with one of the following: (1) killed Renibacterium salmoninarum ATCC 33209 (Rs 33209) cells; (2) killed Rs 33209 cells which had been heated to 37 degrees C for 48 h, a process that destroys the p57 protein; (3) killed R. salmoninarum MT239 (Rs MT239) cells; (4) heated Rs MT239 cells; (5) a recombinant version of the p57 protein (r-p57) emulsified in Freund's incomplete adjuvant (FIA); (6) the commercial BKD vaccine Renogen; (7) phosphate-buffered saline (PBS) emulsified with an equal volume of FIA; or (8) PBS alone. Following injection, each fish was marked with a subcutaneous fluorescent latex tag denoting its treatment group and the vaccinated fish were combined into sham and disease challenge tanks. Two weeks after these fish were vaccinated, separate groups of fish were injected with either PBS or live R. salmoninarum GL64 and were placed inside coated-wire mesh cylinders (liveboxes) in the sham and disease challenge tanks, respectively. Mortalities in both tanks were recorded for 285 d. Any mortalities among the livebox fish were replaced with an appropriate cohort (infected with R. salmoninarum or healthy) fish. None of the bacterins evaluated in this study induced protective immunity against the R. salmoninarum shed from the infected livebox fish. The percentage survival within the test groups in the R. salmoninarum challenge tank ranged from 59% (heated Rs MT239 bacterin) to 81% (PBS emulsified with FIA). There were no differences in the percentage survival among the PBS-, PBS/FIA-, r-p57- and Renogen-injected groups. There also were no differences in survival among the bacterin groups, regardless of whether the bacterial cells had been heated or left untreated prior to injection. PMID:15819430

  12. Safety and immunogenicity of multi-antigen AMA1-based vaccines formulated with CoVaccine HT™ and Montanide ISA 51 in rhesus macaques

    Directory of Open Access Journals (Sweden)

    Walraven Vanessa

    2011-07-01

    Full Text Available Abstract Background Increasing the breadth of the functional antibody response through immunization with Plasmodium falciparum apical membrane antigen 1 (PfAMA1 multi-allele vaccine formulations has been demonstrated in several rodent and rabbit studies. This study assesses the safety and immunogenicity of three PfAMA1 Diversity-Covering (DiCo vaccine candidates formulated as an equimolar mixture (DiCo mix in CoVaccine HT™ or Montanide ISA 51, as well as that of a PfAMA1-MSP119 fusion protein formulated in Montanide ISA 51. Methods Vaccine safety in rhesus macaques was monitored by animal behaviour observation and assessment of organ and systemic functions through clinical chemistry and haematology measurements. The immunogenicity of vaccine formulations was assessed by enzyme-linked immunosorbent assays and in vitro parasite growth inhibition assays with three culture-adapted P. falciparum strains. Results These data show that both adjuvants were well tolerated with only transient changes in a few of the chemical and haematological parameters measured. DiCo mix formulated in CoVaccine HT™ proved immunologically and functionally superior to the same candidate formulated in Montanide ISA 51. Immunological data from the fusion protein candidate was however difficult to interpret as four out of six immunized animals were non-responsive for unknown reasons. Conclusions The study highlights the safety and immunological benefits of DiCo mix as a potential human vaccine against blood stage malaria, especially when formulated in CoVaccine HT™, and adds to the accumulating data on the specificity broadening effects of DiCo mix.

  13. EFFICACY AND SAFETY OF 23-VALENT PNEUMOCOCCAL POLYSACCHARIDE VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    M. S. Naumtseva

    2015-01-01

    Full Text Available Objective: to study the clinical efficacy, immunogenicity, and safety of a 23-valent pneumococcal vaccine in patients with rheumatoid arthritis (RA. Subjects and methods. The investigation enrolled 70 patients (55 women and 15 men aged 23–70 years, including 40 patients with RA and 30 people without systemic inflammatory rheumatic diseases (a control group who had a recent history of 2 and more cases of lower respiratory tract infections (bronchitis, pneumonia. When included, all the patients received anti-inflammatory therapy with methotrexate (MT (n = 24, leflunomide (LEF (n = 6, or MT + tumor necrosis factor-α (TNF-α inhibitors (n = 10. A single 0.5-ml dose of the 23-valent pneumococcal vaccine Pneumo-23 (Sanofi Pasteur was administered subcutaneously or intramuscularly during continuous MT or LEF therapy for the underlying disease or 3–4 weeks before the use of a TNF-α inhibitor. During control visits (1 and 3 months and 1 year after administration of the vaccine, the patients underwent physical examination and routine clinical and laboratory studies. Results. No clinical and radiological symptoms of pneumonia were recorded in any case during a 12-month follow-up. The RA and control groups showed a more than 2-fold increase in anti-pneumococcal antibody levels 1 year after vaccination. The vaccine was well tolerated by 50 patients. Sixteen patients were observed to have pain, cutaneous swelling and hyperemia and 4 had subfebrility. There were neither episodes of RA exacerbation nor new autoimmune disorders during the follow-up. Conclusion. The findings suggest that 23-valent pneumococcal vaccine shows a good clinical efficacy, adequate immunogenicity, and good tolerability in the patients with RA. 

  14. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

    Directory of Open Access Journals (Sweden)

    Reinaldo Menezes Martins

    2004-12-01

    Full Text Available The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang® were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70% met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566, children 1 to 10 years old (484, adolescents from 11 to 19 years (740, adults from 20 to 30 years (568, and adults from 31 to 40 years (396. Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults or 0, 1, and 7 months (children. Vaccine dose was intramuscular 10 µg (infants, children, and adolescents or 20 µg (adults. Percent seroprotection (assumed when anti-HBs titers were > 10mIU/ml and geometric mean titer (mIU/ml were: newborn infants, 93.7% and 351.1 (Butang® and 97.5% and 1530.6 (Engerix B®; children, 100% and 3600.0 (Butang® and 97.7% and 2753.1 (Engerix B®; adolescents, 95.1% and 746.3 (Butang® and 96% and 1284.3 (Engerix B®; adults 20-30 years old, 91.8% and 453.5 (Butang® and 95.5% and 1369.0 (Engerix B®; and adults 31-40 years old, 79.8% and 122.7 (Butang® and 92.4% and 686.2 (Engerix B®. There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults.

  15. Technical Note: FIELD STUDY OF SAFETY AND ANTIBODY PRODUCTION FURTHER TO A COMBINED MYXOMATOSIS AND VIRAL HAEMORRHAGIC DISEASE (VHD) VACCINATION IN DWARF RABBITS BY INTRADERMAL ROUTE.

    OpenAIRE

    Lemière, S.; Alaphilippe, A.; Boucher, S; Bertagnoli, S.

    2003-01-01

    A study of safety of combined vaccination against myxomatosis and VHD was performed using a duly reconstituted vaccine made of a live homologous myxomatosis component SG33 strain and of an inactivated VHD component in adjuvant AG88 strain. The vaccine was administered intradermally to a representative sample of pet rabbits. A local reaction at the vaccine administration area was frequently observed from 2 to 3 days after vaccination in young animals. These local reactions were less frequently...

  16. Bacterial Protein Characterization of Streptococcus agalactiae by SDS-page Method for Subclinical Mastitis Irradiated Vaccine Materials in Dairy Cattle

    Directory of Open Access Journals (Sweden)

    B.J. Tuasikal

    2012-08-01

    Full Text Available A study have been conducted to isolate and characterize bacterial protein S. agalactiae, which is antigenic and can be used to test immunogenicity of vaccine in order to manufacture irradiated mastitis (inflammation of the udder vaccine in ruminant. The study aims to determine the Molecular Weight (MW bacterial protein S. agalactiae irradiation, which can be used to test the nature of its antigenic caharacteristic. The character of S. agalactiae antigenic stimulates antibody induction of the immune system, in which case is the body's defense system against mastitis disease in cattle. In this study, irradiation of gamma ray is used to attenuate the pathogenicity of bacteria by reducing S. agalactiae antigenic caharacteristic. Previous research, in irradiation dose orientation before antigenic protein isolation of S. agalactiae, indicated that irradiation lethal dose to 50% (LD50 is 17 Gy. The characterization of S. agalactiae bacteria isolate using SDS-page method results in no significance different between irradiated and non-irradiated group, which indicated by MW range 75 – 100 kDa base on marker standard which used, or 99 kDa by the linier equation of Y = 11,60 – 0.05X (where Y = bands distance; X = MW standard protein; r2 = 0.99. In conclusion, 17 Gy irradiation dose does not impair antigenic property of S. agalactiae and therefore, can be applied to produce base material of irradiated vaccine for mastitis

  17. Control of tick infestations in cattle vaccinated with bacterial membranes containing surface-exposed tick protective antigens.

    Science.gov (United States)

    Almazán, Consuelo; Moreno-Cantú, Orlando; Moreno-Cid, Juan A; Galindo, Ruth C; Canales, Mario; Villar, Margarita; de la Fuente, José

    2012-01-01

    Vaccines containing the Rhipicephalus (Boophilus) microplus BM86 and BM95 antigens protect cattle against tick infestations. Tick subolesin (SUB), elongation factor 1a (EF1a) and ubiquitin (UBQ) are new candidate protective antigens for the control of cattle tick infestations. Previous studies showed that R. microplus BM95 immunogenic peptides fused to the Anaplasma marginale major surface protein (MSP) 1a N-terminal region (BM95-MSP1a) for presentation on the Escherichia coli membrane were protective against R. microplus infestations in rabbits. In this study, we extended these results by expressing SUB-MSP1a, EF1a-MSP1a and UBQ-MSP1a fusion proteins on the E. coli membrane using this system and demonstrating that bacterial membranes containing the chimeric proteins BM95-MSP1a and SUB-MSP1a were protective (>60% vaccine efficacy) against experimental R. microplus and Rhipicephalus annulatus infestations in cattle. This system provides a novel, simple and cost-effective approach for the production of tick protective antigens by surface display of antigenic protein chimera on the E. coli membrane and demonstrates the possibility of using recombinant bacterial membrane fractions in vaccine preparations to protect cattle against tick infestations. PMID:22085549

  18. Bacterial Protein Characterization of Streptococcus agalactiae by SDS-page Method for Subclinical Mastitis Irradiated Vaccine Materials in Dairy Cattle

    International Nuclear Information System (INIS)

    A study have been conducted to isolate and characterize bacterial protein S. agalactiae, which is antigenic and can be used to test immunogenicity of vaccine in order to manufacture irradiated mastitis (inflammation of the udder) vaccine in ruminant. The study aims to determine the Molecular Weight (MW) bacterial protein S. agalactiae irradiation, which can be used to test the nature of its antigenic caharacteristic. The character of S. agalactiae antigenic stimulates antibody induction of the immune system, in which case is the body's defense system against mastitis disease in cattle. In this study, irradiation of gamma ray is used to attenuate the pathogenicity of bacteria by reducing S. agalactiae antigenic characteristic. Previous research, in irradiation dose orientation before antigenic protein isolation of S. agalactiae, indicated that irradiation lethal dose to 50% (LD50) is 17 Gy. The characterization of S. agalactiae bacteria isolate using SDS-page method results in no significance different between irradiated and non-irradiated group, which indicated by MW range 75 - 100 kDa base on marker standard which used, or 99 kDa by the linier equation of Y = 11,60 - 0.05X (where Y = bands distance; X = MW standard protein); r2 = 0.99. In conclusion, 17 Gy irradiation dose does not impair antigenic property of S. agalactiae and therefore, can be applied to produce base material of irradiated vaccine for mastitis. (author)

  19. Improving the Immunogenicity of the Mycobacterium bovis BCG Vaccine by Non-Genetic Bacterial Surface Decoration Using the Avidin-Biotin System.

    Directory of Open Access Journals (Sweden)

    Ting-Yu Angela Liao

    Full Text Available Current strategies to improve the current BCG vaccine attempt to over-express genes encoding specific M. tuberculosis (Mtb antigens and/or regulators of antigen presentation function, which indeed have the potential to reshape BCG in many ways. However, these approaches often face serious difficulties, in particular the efficiency and stability of gene expression via nucleic acid complementation and safety concerns associated with the introduction of exogenous DNA. As an alternative, we developed a novel non-genetic approach for rapid and efficient display of exogenous proteins on bacterial cell surface. The technology involves expression of proteins of interest in fusion with a mutant version of monomeric avidin that has the feature of reversible binding to biotin. Fusion proteins are then used to decorate the surface of biotinylated BCG. Surface coating of BCG with recombinant proteins was highly reproducible and stable. It also resisted to the freeze-drying shock routinely used in manufacturing conventional BCG. Modifications of BCG surface did not affect its growth in culture media neither its survival within the host cell. Macrophages phagocytized coated BCG bacteria, which efficiently delivered their surface cargo of avidin fusion proteins to MHC class I and class II antigen presentation compartments. Thereafter, chimeric proteins corresponding to a surrogate antigen derived from ovalbumin and the Mtb specific ESAT6 antigen were generated and tested for immunogenicity in vaccinated mice. We found that BCG displaying ovalbumin antigen induces an immune response with a magnitude similar to that induced by BCG genetically expressing the same surrogate antigen. We also found that BCG decorated with Mtb specific antigen ESAT6 successfully induces the expansion of specific T cell responses. This novel technology, therefore, represents a practical and effective alternative to DNA-based gene expression for upgrading the current BCG vaccine.

  20. Improving the Immunogenicity of the Mycobacterium bovis BCG Vaccine by Non-Genetic Bacterial Surface Decoration Using the Avidin-Biotin System.

    Science.gov (United States)

    Liao, Ting-Yu Angela; Lau, Alice; Joseph, Sunil; Hytönen, Vesa; Hmama, Zakaria

    2015-01-01

    Current strategies to improve the current BCG vaccine attempt to over-express genes encoding specific M. tuberculosis (Mtb) antigens and/or regulators of antigen presentation function, which indeed have the potential to reshape BCG in many ways. However, these approaches often face serious difficulties, in particular the efficiency and stability of gene expression via nucleic acid complementation and safety concerns associated with the introduction of exogenous DNA. As an alternative, we developed a novel non-genetic approach for rapid and efficient display of exogenous proteins on bacterial cell surface. The technology involves expression of proteins of interest in fusion with a mutant version of monomeric avidin that has the feature of reversible binding to biotin. Fusion proteins are then used to decorate the surface of biotinylated BCG. Surface coating of BCG with recombinant proteins was highly reproducible and stable. It also resisted to the freeze-drying shock routinely used in manufacturing conventional BCG. Modifications of BCG surface did not affect its growth in culture media neither its survival within the host cell. Macrophages phagocytized coated BCG bacteria, which efficiently delivered their surface cargo of avidin fusion proteins to MHC class I and class II antigen presentation compartments. Thereafter, chimeric proteins corresponding to a surrogate antigen derived from ovalbumin and the Mtb specific ESAT6 antigen were generated and tested for immunogenicity in vaccinated mice. We found that BCG displaying ovalbumin antigen induces an immune response with a magnitude similar to that induced by BCG genetically expressing the same surrogate antigen. We also found that BCG decorated with Mtb specific antigen ESAT6 successfully induces the expansion of specific T cell responses. This novel technology, therefore, represents a practical and effective alternative to DNA-based gene expression for upgrading the current BCG vaccine. PMID:26716832

  1. Bacterial quality and safety of packaged fresh leafy vegetables at the retail level in Finland.

    Science.gov (United States)

    Nousiainen, L-L; Joutsen, S; Lunden, J; Hänninen, M-L; Fredriksson-Ahomaa, M

    2016-09-01

    Consumption of packaged fresh leafy vegetables, which are convenient ready-to-eat products, has increased during the last decade. The number of foodborne outbreaks associated with these products has concurrently increased. In our study, (1) label information, (2) O2/CO2 composition, (3) bacterial quality and (4) safety of 100 fresh leafy vegetables at the retail level were studied in Finland during 2013. Bacterial quality was studied using aerobic bacteria (AB) and coliform bacteria (CB) counts, and searching for the presence of Escherichia coli, Listeria and Yersinia. The safety was studied by the presence of Salmonella, ail-positive Yersinia, stx-positive E. coli (STEC) and Listeria monocytogenes using PCR and culturing. Important label information was unavailable on several packages originating from different companies. The packaging date was missing on all packages and the date of durability on 83% of the packages. Storage temperature was declared on 62% of the packages and 73% of the packages contained information about prewashing. The batch/lot number was missing on 29% of the packages. Very low oxygen (O2) (companies varied widely. High AB and CB counts and pathogenic bacteria were detected in ready-to-eat products not needing washing before use. Our study shows that the bacterial quality and safety of packaged fresh leafy vegetables is poor and label information on the packages is inadequate. More studies are needed concerning the impact of a protective atmosphere on bacterial growth, and the impact of washing for removing bacteria. PMID:27257744

  2. Safety evaluation in mice of the childhood immunization vaccines from two south-eastern states of Nigeria

    Institute of Scientific and Technical Information of China (English)

    Oli; Angus; Nnamdi; Agu; Remigus; Uchenna; Oli; Ugochukwu; Chinedum; Nwoye; Charles; Ugochukwu; Ejiofor; Obiora; Shedrack; Esimone; Charles; Okechukwu

    2015-01-01

    Objective:To check the effects of the vaccines on the hematopoietic system and weight of mice after immunization.Methods:The study was done with the Expanded Programme on Immunization vaccines donated by the Ministries of Health of Abia and Imo States of Nigeria.The vaccines were collected from the cold-chain stores and transported in vaccine carriers to the cold-chain facility in Nnamdi Azikiwe University Teaching Hospital within 3 hours of collection.They were used to immunize a total of 160 mice.The Ethics Committee of Nnamdi Azikiwe University Teaching Hospital,Nnewi of Anambra State,Nigeria approved the protocol.Results:Mice body weight changes test showed that the mice all had increased body weight at Days 3 and 7 post-immunization and none died during the 7 d post-immunization observation.The percentage weight gains of the mice compared with the control were 69%.70%,64%.63%,65%and 68%for oral polio vaccine,diphtheria-pertussis-tetanus.bacillus CalmetteGuerin,measles,yellow fever and hepatitis B vaccines respectively collected from Imo State.The mice immunized with oral polio vaccine,pentavalent.bacillus Calmette-Guerin.measles,yellow fever and hepatitis B vaccines collected from Abia State had 123%.114%,121%.116%,142%and 119%weight gain respectively compared with the control.Leukocytosis promoting toxicity test showed that none of the vaccines was able to induce proliferation of leukocytes up to ten folds.Leukopenic toxicity test showed that all the vaccines had an leukopenic toxicity test value higher than 80%of the control(physiological saline).Conclusions:The vaccine samples tested were safe and did not affect the hematopoietic system adversely.The storage conditions of the vaccines in the States’ cold-chain stores had not compromised the safety of the vaccines.

  3. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002.

    Science.gov (United States)

    Begier, Elizabeth M; Burwen, Dale R; Haber, Penina; Ball, Robert

    2004-03-15

    Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis. PMID:14999618

  4. Bacterial superglue enables easy development of efficient virus-like particle based vaccines

    DEFF Research Database (Denmark)

    Thrane, Susan; Janitzek, Christoph M; Matondo, Sungwa;

    2016-01-01

    responses as well as to efficiently break B cell self-tolerance. The spy-VLP-system may serve as a generic tool for the cost-effective development of effective VLP-vaccines against both infectious- and non-communicable diseases and could facilitate rapid and unbiased screening of vaccine candidate antigens....

  5. Vaccines and Thimerosal

    Science.gov (United States)

    ... Preparedness Vaccine Safety Partners About ISO Thimerosal in Vaccines Recommend on Facebook Tweet Share Compartir Thimerosal is ... harm. Thimerosal prevents the growth of bacteria in vaccines. Thimerosal is added to vials of vaccine that ...

  6. Safety and Immunogenicity of a Fully Liquid Vaccine Containing Five-Component Pertussis-Diphtheria-Tetanus-Inactivated Poliomyelitis-Haemophilus influenzae Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age

    Directory of Open Access Journals (Sweden)

    Ronald Gold

    2007-01-01

    Full Text Available OBJECTIVE: The safety, immunogenicity and lot consistency of a fully liquid, five-component acellular pertussis combination vaccine, comprised of diphteria, tetanus and acellular pertussis, inactivated polio vaccine, Haemophilus influenzae type b (DTaP-IPV-Hib [Pediacel, sanofi pasteur, Canada] were assessed and compared with that of Hib vaccine reconstituted with the five-component acellular pertussis combination vaccine (DTaP-IPV//Hib, Pentacel [sanofi pasteur, Canada].

  7. Safety and Immunogenicity of a Fully Liquid Vaccine Containing Five-Component Pertussis-Diphtheria-Tetanus-Inactivated Poliomyelitis-Haemophilus influenzae Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age

    OpenAIRE

    Ronald Gold; Luis Barreto; Santiago Ferro; John Thippawong; Roland Guasparini; William Meekison; Margaret Russell; Elaine Mills; Dana Harrison; Pierre Lavigne

    2007-01-01

    OBJECTIVE: The safety, immunogenicity and lot consistency of a fully liquid, five-component acellular pertussis combination vaccine, comprised of diphteria, tetanus and acellular pertussis, inactivated polio vaccine, Haemophilus influenzae type b (DTaP-IPV-Hib [Pediacel, sanofi pasteur, Canada]) were assessed and compared with that of Hib vaccine reconstituted with the five-component acellular pertussis combination vaccine (DTaP-IPV//Hib, Pentacel [sanofi pasteur, Canada]).METHODS: Infants we...

  8. In a safety net population HPV4 vaccine adherence worsens as BMI increases.

    Directory of Open Access Journals (Sweden)

    Diane M Harper

    Full Text Available Obesity adversely inhibits antibody response to vaccination. Three doses of HPV4 may or may not provide adequate long term protection against HPV 16/18 in obese females. The aim of this study was to determine whether adherence to HPV4 vaccination in a safety net population was reduced with increasing body mass index (BMI.We designed a historical prospective study evaluating the number and dates of HPV4 dosing that occurred from July 1, 2006 through October 1, 2009 by the demographic characteristics of the 10-26 year old recipient females. The defined dosing intervals were adapted from the literature and obesity categories were defined by the WHO.1240 females with BMI measurements received at least one dose of HPV4; 38% were obese (class I, II and III and 25% were overweight. Females with normal BMI received on-time triplet dosing significantly more often than did the obese class II and III females (30% vs. 18%, p<0.001. Obese class II/III females have a significant 45% less chance of completing the on-time triplet HPV4 series than normal women (OR = 0.55, 95% CI: 0.37, 0.83. Pregnancy history has a significant influence on BMI and HPV4 dosing compliance in this safety net population where 71% had been gravid. Hispanic females were less likely to complete HPV4 dosing regardless of BMI (aOR = 0.39, 95% CI: 0.16, 0.95.Obesity, as well as gravidity and Hispanic race, are risk factors for lack of HPV4 vaccine adherence among young females in a safety net population.

  9. Biomarkers of safety and immune protection for genetically modified live attenuated Leishmania vaccines against visceral leishmaniasis-Discovery and implications

    Directory of Open Access Journals (Sweden)

    Sreenivas eGannavaram

    2014-05-01

    Full Text Available Despite intense efforts there is no safe and efficacious vaccine against visceral leishmaniasis, which is fatal and endemic in many tropical countries. A major shortcoming in the vaccine development against blood borne parasitic agents such as Leishmania is the inadequate predictive power of the early immune responses mounted in the host against the experimental vaccines. Often immune correlates derived from in-bred animal models do not yield immune markers of protection that can be readily extrapolated to humans. The limited efficacy of vaccines based on DNA, sub-unit, heat killed parasites has led to the realization that acquisition of durable immunity against the protozoan parasites requires a controlled infection with a live attenuated organism. Recent success of irradiated malaria parasites as a vaccine candidate further strengthens this approach to vaccination. We developed several gene deletion mutants in L. donovani as potential live attenuated vaccines and reported extensively on the immunogenicity of LdCentrin1 deleted mutant in mice, hamsters and dogs. Additional limited studies using genetically modified live attenuated Leishmania parasites as vaccine candidates have been reported. However, for the live attenuated parasite vaccines, the primary barrier against widespread use remains the absence of clear biomarkers associated with protection and safety. Recent studies in evaluation of vaccines e.g., influenza and yellow fever vaccines, using systems biology tools demonstrated the power of such strategies in understanding the immunological mechanisms that underpin a protective phenotype. Applying similar tools in isolated human tissues such as PBMCs from healthy individuals infected with live attenuated parasites such as LdCen1-/- in vitro followed by human microarray hybridization experiments will enable us to understand how early vaccine-induced gene expression profiles and the associated immune responses are coordinately regulated

  10. Influence of parenteral administration routes and additional factors on vaccine safety and immunogenicity: a review of recent literature.

    Science.gov (United States)

    Herzog, Christian

    2014-03-01

    Vaccines have to be administered via an appropriate route, i.e. a route, which is optimal regarding safety, immunogenicity and practicability. In addition, there are factors, such as body site, needle length, injection technique, depth of injection, type of antigen, vaccine formulation, adjuvants, age, sex, race/ethnicity, body mass, and pre-existing immunity, which can have an impact on the reactogenicity and tolerability and/or on the immunogenicity of a given vaccine. For parenteral vaccine administration there are currently three routes licensed: intramuscular, subcutaneous and intradermal, either by using conventional hypodermic needles or by using alternative or needle-free injection devices. The factors potentially impacting on the 'performance' of a given route of administration, as reported in recent literature, are outlined and discussed in view of their importance. These factors need to be accounted and controlled for when designing vaccine studies and should be reported in a transparent and standardised way in publications. PMID:24512188

  11. Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults

    OpenAIRE

    Wu, Ting; Huang, Shou-Jie; Zhu, Feng-Cai; Zhang, Xue-Feng; AI, XING; Yan, Qiang; Wang, Zhong-Ze; Yang, Chang-Lin; Jiang, Han-Min; Liu, Xiao-Hui; Guo, Meng; Du, Hai-Lian; Ng, Mun-Hon; Zhang, Jun; Xia, Ningshao

    2013-01-01

    A recombinant hepatitis E vaccine, Hecolin®, has been proven safe and effective in healthy adults. As hepatitis B surface antigen (HBsAg) positive individuals have a higher risk of poor prognosis after super-infection with hepatitis E virus (HEV), the safety and immunogenicity of Hecolin® in this population should be assessed. The present study is an extending analysis of data from a large randomized controlled clinical trial of Hecolin®. Healthy participants (n = 14,065) without current or p...

  12. Pre- and post-exposure safety and efficacy of attenuated rabies virus vaccines are enhanced by their expression of IFNγ

    OpenAIRE

    Barkhouse, Darryll A.; Faber, Milosz; Hooper, D. Craig

    2014-01-01

    Consistent with evidence of a strong correlation between interferon gamma (IFNγ) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFNγ highly attenuates the virus. Reasoning that IFNγ expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFNγ. Mortality and morbidity were monitored during suckling mice infection, im...

  13. Safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use in post-exposure prophylaxis.

    Science.gov (United States)

    Wang, Ling-yun; Sun, Mei-ping; Zhang, Xue-chun; Suo, Luo-dan; Xu, Ruo-hui; Zou, Yan-jie; Zuo, Li-bo; Qi, Hua

    2011-03-24

    To provide basis for human rabies vaccination in China, the safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use were assessed. A total of 250 volunteers were enrolled and divided into two groups: volunteers in Group A (n=200) were vaccinated five doses of Speeda Vero cell rabies vaccine manufactured by Liaoning Chengda Biotechnology Co. Ltd. on day 0, 3, 7, 14, 28 after exposure. Volunteers in Group B (n=50) were treated with Verorab Vero cell rabies vaccine manufactured by Sanofi Pasteur on the same schedule. The local and systematic adverse reactions were observed. Serum neutralizing antibody levels of 80 individuals in Group A and 50 individuals in Group B were tested with RFFIT on day 7, 14, 45, 180, 360 after the first dose. The seroconversion rates in Groups A and B were 40.3% and 37.0% on day 7 after the first dose, 95.5% and 97.7% on day 14, 100% and 100% on day 45, 100% and 100% on day 180, 89.1% and 89.5% on day 360 respectively, indicating no significant differences between the two groups. And no significant differences were found between the neutralizing antibody geometric mean titers (GMTs) of the two groups on day 7, 14, 45, 180 and 360 after the first dose, with the GMTs of day 14, 45, 180 and 360 all higher than 0.5IU/ml. Antibody levels of the two groups peaked around 2 weeks after the full vaccination program, followed by a 55% decrease up to day 180 and another 76% decrease up to day 360. Both groups experienced occasions of transient fever, rash, edema, and scleroma after vaccination. Neither group had any severe adverse reactions. It was concluded that both vaccines showed satisfactory safety and immunogenicity. Booster vaccination is recommended following another exposure after six months since the full vaccination program. PMID:21296694

  14. Pre-Clinical Efficacy and Safety of Experimental Vaccines Based on Non-Replicating Vaccinia Vectors against Yellow Fever

    OpenAIRE

    Schäfer, Birgit; Holzer, Georg W.; Joachimsthaler, Alexandra; Coulibaly, Sogue; Schwendinger, Michael; Crowe, Brian A.; Kreil, Thomas R.; Barrett, P. Noel; Falkner, Falko G.

    2011-01-01

    Background Currently existing yellow fever (YF) vaccines are based on the live attenuated yellow fever virus 17D strain (YFV-17D). Although, a good safety profile was historically attributed to the 17D vaccine, serious adverse events have been reported, making the development of a safer, more modern vaccine desirable. Methodology/Principal Findings A gene encoding the precursor of the membrane and envelope (prME) protein of the YFV-17D strain was inserted into the non-replicating modified vac...

  15. Comparison of Immunogenicity and Safety of a Virosome Influenza Vaccine with Those of a Subunit Influenza Vaccine in Pediatric Patients with Cystic Fibrosis

    OpenAIRE

    Schaad, U B; Bühlmann, U.; Burger, R.; Ruedeberg, A.; Wilder-Smith, A.; Rutishauser, M.; Sennhauser, F; Herzog, C; Zellmeyer, M.; Glück, R

    2000-01-01

    The objective of this study was to compare the immunogenicity and safety of a single-dose regimen and a two-dose regimen of a trivalent virosome influenza vaccine (Inflexal Berna V) with those of a trivalent subunit influenza vaccine (Influvac) in children and adolescents with cystic fibrosis (CF). In an open, randomized, multicenter study with parallel groups, 11 young children with CF (1 to 6 years old) and 53 older children and adolescents with CF (>6 years old) were randomly assigned to o...

  16. Immunogenicity and safety of a trivalent inactivated 2010-2011 influenza vaccine in Taiwan infants aged 6-12 months.

    Science.gov (United States)

    Hwang, Kao-Pin; Hsu, Yu-Lung; Hsieh, Tsung-Hsueh; Lin, Hsiao-Chuan; Yen, Ting-Yu; Wei, Hsiu-Mei; Lin, Hung-Chih; Chen, An-Chyi; Chow, Julie Chi; Huang, Li-Min

    2014-05-01

    This prospective study aimed to investigate the immune responses and safety of an influenza vaccine in vaccine-naïve infants aged 6-12 months, and was conducted from November 2010 to May 2011. Fifty-nine infants aged 6-12 months received two doses of trivalent inactivated influenza vaccine 4 weeks apart. Hemagglutination inhibition titers were measured 4 weeks after the two doses of study vaccine. Based on the assumption that a hemagglutination inhibition titer of 1:40 or greater against the antigen would be protective in adults, two doses of the study vaccine generated a protective immune response of 63.2% against influenza A(H1N1), 82.5% against influenza A(H3N2) and 38.6% against influenza B viruses in infants aged 6-12 months. The geometric mean fold rises against influenza type A and B viruses also met the European Medicines Agency criteria for flu vaccines. The solicited events within 7 days after vaccination were mild in intensity. No deaths or adverse events such as optic neuritis, cranial neuropathy, and brachial neuropathy or Guillain-Barre syndrome were reported. Two doses of inactivated influenza vaccine were well tolerated and induced a protective immune response against influenza in infants aged 6-12 months. PMID:24625341

  17. Pre- and post-exposure safety and efficacy of attenuated rabies virus vaccines are enhanced by their expression of IFNγ

    International Nuclear Information System (INIS)

    Consistent with evidence of a strong correlation between interferon gamma (IFNγ) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFNγ highly attenuates the virus. Reasoning that IFNγ expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFNγ. Mortality and morbidity were monitored during suckling mice infection, immunize/challenge experiments and mixed intracranial infections. We demonstrate that GASγ and GASγGAS are significantly attenuated in suckling mice compared to the GASGAS vaccine. GASγ better protects mice from lethal DRV4 RABV infection in both pre- and post-exposure experiments compared to GASGAS. Finally, GASγGAS reduces post-infection neurological sequelae, compared to control, during mixed intracranial infection with DRV4. These data show IFNγ expression by a vaccine vector can enhance its safety while increasing its efficacy as pre- and post-exposure treatment. - Highlights: • IFNγ expression improves attenuated rabies virus safety and immunogenicity. • IFNγ expression is safer and more immunogenic than doubling glycoprotein expression. • Co-infection with IFNγ-expressing RABV prevents wild-type rabies virus lethality. • Vaccine safety and efficacy is additive for IFNγ and double glycoprotein expression

  18. Pre- and post-exposure safety and efficacy of attenuated rabies virus vaccines are enhanced by their expression of IFNγ

    Energy Technology Data Exchange (ETDEWEB)

    Barkhouse, Darryll A. [Department of Cancer Biology, 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107 (United States); Center for Neurovirology 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107 (United States); Faber, Milosz [Center for Neurovirology 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107 (United States); Department of Microbiology and Immunology 1020 Locust St., Jefferson Alumni Hall, Room 465, Philadelphia, PA 19107 (United States); Hooper, D. Craig, E-mail: douglas.hooper@jefferson.edu [Department of Cancer Biology, 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107 (United States); Department of Neurological Surgery, 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107 (United States); Center for Neurovirology 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107 (United States)

    2015-01-01

    Consistent with evidence of a strong correlation between interferon gamma (IFNγ) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFNγ highly attenuates the virus. Reasoning that IFNγ expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFNγ. Mortality and morbidity were monitored during suckling mice infection, immunize/challenge experiments and mixed intracranial infections. We demonstrate that GASγ and GASγGAS are significantly attenuated in suckling mice compared to the GASGAS vaccine. GASγ better protects mice from lethal DRV4 RABV infection in both pre- and post-exposure experiments compared to GASGAS. Finally, GASγGAS reduces post-infection neurological sequelae, compared to control, during mixed intracranial infection with DRV4. These data show IFNγ expression by a vaccine vector can enhance its safety while increasing its efficacy as pre- and post-exposure treatment. - Highlights: • IFNγ expression improves attenuated rabies virus safety and immunogenicity. • IFNγ expression is safer and more immunogenic than doubling glycoprotein expression. • Co-infection with IFNγ-expressing RABV prevents wild-type rabies virus lethality. • Vaccine safety and efficacy is additive for IFNγ and double glycoprotein expression.

  19. Towards development of stable formulations of a live attenuated bacterial vaccine: a preformulation study facilitated by a biophysical approach.

    Science.gov (United States)

    Zeng, Yuhong; Fan, Haihong; Chiueh, Gary; Pham, Binh; Martin, Russ; Lechuga-Ballesteros, David; Truong, Vu L; Joshi, Sangeeta B; Middaugh, C Russell

    2009-05-01

    Development of optimal formulation conditions stabilizing live attenuated bacterial vaccines is impeded by traditional methods used for viability measurement. To facilitate preformulation studies of such vaccines, spectroscopic techniques capable of providing real-time and high throughput information have been employed to obtain a global stability profile for a live attenuated Ty21a bacterial typhoid vaccine over a wide range of pH (4 to 8) and temperature (10 to 85 degrees C). Using the data obtained from fluorescence and circular dichroism techniques, an empirical phase diagram (EPD) has been subsequently constructed, which suggests that Ty21a cells exist in at least four apparent physical phases related to different viability states, with the most stable phase at pH 6 and 7 at temperatures below 30 degrees C. A slightly basic pH (pH 8) appears to decrease the fluidity of the cell membrane, whereas acidic pH conditions are detrimental to membrane integrity over the entire temperature range. Based on the above stability profile, a fluorescence-based high throughput screening assay has been developed to test the stabilizing effects of various compounds at different concentrations. Amongst other promising stabilizers, 10% sucrose and 0.15 M glutamic acid display the greatest protective effects, with an increase of about 10 degrees C in the transition temperature of Ty21a cells. Preliminary studies have also been performed on foam dried formulations as an alternative approach to further stabilize Ty21a cells. The data show that 10% sucrose and trehalose both increase the in-process and storage stabilities of the cells. PMID:19221516

  20. Immunogenicity and safety of hepatitis B vaccine (Shanvac-B) using a novel pre-filled single use injection device uniject in Indian subjects

    OpenAIRE

    Joshi N; Kumar A; Raghu M.; Bhave S; Arulprakash R; Bhusari P; Rao Raman

    2004-01-01

    BACKGROUND: Hepatitis B is a major public health problem, which has now been controlled to some extent by vaccination especially with the recombinant hepatitis B vaccine, which has been proven to be safe and efficacious since its introduction in the 1990s. But problems of unsafe injection practices still persist. Now newer delivery devices like uniject are available for making vaccination very safe. OBJECTIVE: To evaluate the immunogenicity and safety of the Hepatitis-B (Shanvac-B) vaccine in...

  1. Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety.

    OpenAIRE

    Milstien, J. B.; J. J. Gibson

    1990-01-01

    WHO oversees the quality control of BCG vaccine via a system that includes regular testing of products by in vitro methods and clinical trials. Three parent strains of BCG (Glaxo-1077, Tokyo-172, and Pasteur-1173P2) account for over 90% of the vaccines currently in use worldwide. Important characteristics of the vaccine preparations are summarized here, along with their physical-chemical properties. In instances where diagnostic criteria for tuberculosis are stringent, there is no evidence th...

  2. The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP~T) Vaccines: a Randomized Clinical Trial in South Korean Infants.

    Science.gov (United States)

    Kang, Jin Han; Lee, Hoan Jong; Kim, Kyung Hyo; Oh, Sung Hee; Cha, Sung Ho; Lee, Jin; Kim, Nam Hee; Eun, Byung Wook; Kim, Chang Hwi; Hong, Young Jin; Kim, Hyun Hee; Lee, Kyung Yil; Kim, Yae Jean; Cho, Eun Young; Kim, Hee Soo; Guitton, Fabrice; Ortiz, Esteban

    2016-09-01

    Recommended infant vaccination in Korea includes DTaP-IPV and Hib vaccines administered as separate injections. In this randomized, open, controlled study we assessed the non-inferiority of immunogenicity of DTaP-IPV//Hib pentavalent combination vaccine (Pentaxim™) compared with licensed DTaP-IPV and Hib (PRP~T) vaccines. We enrolled 418 healthy Korean infants to receive either separate DTaP-IPV and Hib vaccines (n = 206) or the pentavalent DTaP-IPV//Hib (n = 208) vaccine at 2, 4, 6 months of age. Antibodies to all components were measured before the first vaccination and one month after the third, and safety was assessed after each vaccination including recording of reactions by parents. We confirmed the non-inferiority of DTaP-IPV//Hib compared with DTaP-IPV and Hib vaccines; 100% of both groups achieved seroprotection against D, T, IPV and PRP~T, and 97.5%-99.0% demonstrated seroresponses to pertussis antigens. Antibody levels were similar in both groups, except for those to the Hib component, PRP~T. In separate and combined groups geometric mean concentrations of anti-PRP~T antibodies were 23.9 and 11.0 μg/mL, respectively, but 98.3% and 97.4% had titers ≥ 1 μg/mL, indicative of long-term protection. All vaccines were well tolerated, with no vaccine-related serious adverse event. Both groups had similar safety profiles, but the combined vaccine group had fewer injection site reactions. The immunological non-inferiority and similar safety profile of DTaP-IPV//Hib vaccine to separate DTaP-IPV and Hib vaccines, with the advantage of fewer injections and injection site reactions, supports the licensure and incorporation of DTaP-IPV//Hib into the Korean national vaccination schedule (Clinical trial registry, NCT01214889). PMID:27510380

  3. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study

    Science.gov (United States)

    Lombardi, Francesca; Belmonti, Simone; Fabbiani, Massimiliano; Morandi, Matteo; Rossetti, Barbara; Tordini, Giacinta; Cauda, Roberto; De Luca, Andrea; Di Giambenedetto, Simona; Montagnani, Francesca

    2016-01-01

    Objectives Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) versus the 23-valent polysaccharide vaccine (PPSV23) in HIV-infected adults. Methods We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18–65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50) received two doses of PCV13 eight weeks apart, and group 2 (n = 50) received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100) were also enrolled as baseline controls. Results Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group. Conclusions In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated. Trial Registration ClinicalTrials.gov NCT02123433 PMID:27258647

  4. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

    Directory of Open Access Journals (Sweden)

    Francesca Lombardi

    Full Text Available Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13 versus the 23-valent polysaccharide vaccine (PPSV23 in HIV-infected adults.We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50 received two doses of PCV13 eight weeks apart, and group 2 (n = 50 received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100 were also enrolled as baseline controls.Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group.In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated.ClinicalTrials.gov NCT02123433.

  5. Salmonella typhi Ty21a bacterial ghost vector augments HIV-1 gp140 DNA vaccine-induced peripheral and mucosal antibody responses via TLR4 pathway.

    Science.gov (United States)

    Wen, Jing; Yang, Yi; Zhao, Guangyu; Tong, Shuang; Yu, Hong; Jin, Xia; Du, Lanying; Jiang, Shibo; Kou, Zhihua; Zhou, Yusen

    2012-08-24

    Because of their stability and ease of manipulation, DNA vaccines have considerable potential for eliciting immune responses. However, they are limited by their weak immunogenicity, especially in humans. To address this challenge, we explored a new strategy of HIV vaccine delivery using Salmonella typhi Ty21a bacterial ghosts (BGs). We found that Ty21a BGs loaded with an HIV gp140 DNA vaccine (Ty21a BG-DNA) were readily taken up by murine macrophage RAW264.7 cells, and gp140 was efficiently expressed in these cells. Peripheral and intestinal mucosal anti-gp120 antibody responses in mice vaccinated with BGs-DNA vaccine were significantly higher than those in mice immunized with naked DNA vaccine. The enhancement of antibody responses was associated with BG-induced production of IL-10 through TLR4 pathway. These results demonstrate that Ty21a BGs is a novel and effective delivery vehicle for DNA vaccines, which could therefore be used as a new strategy for development of HIV vaccines. PMID:22819719

  6. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection.

    Directory of Open Access Journals (Sweden)

    Eric S Rosenberg

    Full Text Available BACKGROUND: An effective therapeutic vaccine that could augment immune control of HIV-1 replication may abrogate or delay the need for antiretroviral therapy. AIDS Clinical Trials Group (ACTG A5187 was a phase I/II, randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of an HIV-1 DNA vaccine (VRC-HVDNA 009-00-VP in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. (clinicaltrials.gov NCT00125099 METHODS: Twenty healthy HIV-1 infected subjects who were treated with antiretroviral therapy during acute/early HIV-1 infection and had HIV-1 RNA<50 copies/mL were randomized to receive either vaccine or placebo. The objectives of this study were to evaluate the safety and immunogenicity of the vaccine. Following vaccination, subjects interrupted antiretroviral treatment, and set-point HIV-1 viral loads and CD4 T cell counts were determined 17-23 weeks after treatment discontinuation. RESULTS: Twenty subjects received all scheduled vaccinations and discontinued antiretroviral therapy at week 30. No subject met a primary safety endpoint. No evidence of differences in immunogenicity were detected in subjects receiving vaccine versus placebo. There were also no significant differences in set-point HIV-1 viral loads or CD4 T cell counts following treatment discontinuation. Median set-point HIV-1 viral loads after treatment discontinuation in vaccine and placebo recipients were 3.5 and 3.7 log(10 HIV-1 RNA copies/mL, respectively. CONCLUSIONS: The HIV-1 DNA vaccine (VRC-HIVDNA 009-00-VP was safe but poorly immunogenic in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. Viral set-points were similar between vaccine and placebo recipients following treatment interruption. However, median viral load set-points in both groups were lower than in historical controls, suggesting a possible role for antiretroviral therapy in persons with acute or early HIV-1

  7. Mucosal SIV vaccines comprising inactivated virus particles and bacterial adjuvants induce CD8+T-regulatory cells that suppress SIV positive CD4+cell activation and prevent SIV infection in the macaque model.

    OpenAIRE

    Jean Marie eAndrieu; song echen; Chunhui eLAI; weizhong eguo; Wei eLu

    2014-01-01

    A new paradigm of mucosal vaccination against HIV infection has been investigated in the macaque model. A vaccine consisting of inactivated SIVmac239 particles together with a living bacterial adjuvant (either the Calmette & Guerin bacillus, lactobacillus plantarum or Lactobacillus rhamnosus) was administered to macaques via the vaginal or oral/intragastic route. In contrast to all established human and veterinary vaccines, these three vaccine regimens did not elicit SIV-specific antibodies n...

  8. [Local Immune response in rabbits following enteral immunization with live attenuated bacterial Enterobacteriaceae vaccines].

    Science.gov (United States)

    Dentschev, W; Marinova, S; Sumerska, T; Nenkov, P; Koitschev, T; Trifonowa, A

    1980-01-01

    Streptomycin-dependent and inactivated Shigella flexneri 2a and Shigella sonnei strains were intra-intestinally applied to rabbits for immunisation. Rosette and plaque tests and well as indirect haemagglutination gave short-time secretion of low titres of specific copro-antibody, following monovaccines and bivaccines. High titres of secretory antibody were induced, depending on doses, by re-immunisation. No antigen competition was established. The localised immune response caused by Shigella live vaccines was found to be much stronger than that induced by inactivated vaccines PMID:6998404

  9. Safety, immunogenicity, and efficacy of the ML29 reassortant vaccine for Lassa fever in small non-human primates.

    Science.gov (United States)

    Lukashevich, Igor S; Carrion, Ricardo; Salvato, Maria S; Mansfield, Keith; Brasky, Kathleen; Zapata, Juan; Cairo, Cristiana; Goicochea, Marco; Hoosien, Gia E; Ticer, Anysha; Bryant, Joseph; Davis, Harry; Hammamieh, Rasha; Mayda, Maria; Jett, Marti; Patterson, Jean

    2008-09-26

    A single injection of ML29 reassortant vaccine for Lassa fever induces low, transient viremia, and low or moderate levels of ML29 replication in tissues of common marmosets depending on the dose of the vaccination. The vaccination elicits specific immune responses and completely protects marmosets against fatal disease by induction of sterilizing cell-mediated immunity. DNA array analysis of human peripheral blood mononuclear cells from healthy donors exposed to ML29 revealed that gene expression patterns in ML29-exposed PBMC and control, media-exposed PBMC, clustered together confirming safety profile of the ML29 in non-human primates. The ML29 reassortant is a promising vaccine candidate for Lassa fever. PMID:18692539

  10. Safety, immunogenicity, and efficacy of the ML29 reassortant vaccine for Lassa fever in small non-human primates✩

    Science.gov (United States)

    Lukashevich, Igor S.; Carrion, Ricardo; Salvato, Maria S.; Mansfield, Keith; Brasky, Kathleen; Zapata, Juan; Cairo, Cristiana; Goicochea, Marco; Hoosien, Gia E.; Ticer, Anysha; Bryant, Joseph; Davis, Harry; Hammamieh, Rasha; Mayda, Maria; Jett, Marti; Patterson, Jean

    2008-01-01

    A single injection of ML29 reassortant vaccine for Lassa fever induces low, transient viremia, and low or moderate levels of ML29 replication in tissues of common marmosets depending on the dose of the vaccination. The vaccination elicits specific immune responses and completely protects marmosets against fatal disease by induction of sterilizing cell-mediated immunity. DNA array analysis of human peripheral blood mononuclear cells from healthy donors exposed to ML29 revealed that gene expression patterns in ML29-exposed PBMC and control, media-exposed PBMC, clustered together confirming safety profile of the ML29 in non-human primates. The ML29 reassortant is a promising vaccine candidate for Lassa fever. PMID:18692539

  11. Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mahamadou A Thera

    Full Text Available BACKGROUND: The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria. METHODOLOGY/PRINCIPAL FINDINGS: A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1 based on apical membrane antigen-1 (AMA-1 from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert. Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively. CONCLUSION/SIGNIFICANCE: The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.

  12. Comparative in vivo safety and efficacy of a glycoprotein G-deficient candidate vaccine strain of infectious laryngotracheitis virus delivered via eye drop.

    Science.gov (United States)

    Coppo, Mauricio J C; Noormohammadi, Amir H; Hartley, Carol A; Gilkerson, James R; Browning, Glenn F; Devlin, Joanne M

    2011-08-01

    Infectious laryngotracheitis (ILT) is an acute respiratory disease in poultry that is commonly controlled by vaccination with conventionally attenuated virus strains. Despite the use of these vaccines, ILT remains a threat to the intensive poultry industry. Our laboratory has developed a novel candidate vaccine strain of infectious laryngotracheitis virus (ILTV) lacking glycoprotein G (ΔgG-ILTV). The aim of the present study was to directly compare this candidate vaccine with three currently available commercial vaccines in vivo. Five groups of specific-pathogen-free chickens were eye-drop inoculated with one of the three commercial vaccine strains (SA2-ILTV, A20-ILTV or Serva-ILTV), or ΔgG-ILTV, or sterile medium. Vaccine safety was assessed by examining clinical signs, weight gain and persistence of virus in the trachea. Vaccine efficacy was assessed by scoring clinical signs and conducting post-mortem analyses following challenge with virulent virus. Following vaccination, birds that received ΔgG-ILTV had the highest weight gain among the vaccinated groups and had clinical scores that were significantly lower than birds vaccinated with SA2-ILTV or A20-ILTV, but not significantly different from those of birds vaccinated with Serva-ILTV. Analysis of clinical scores, weight gain, tracheal pathology and virus replication after challenge revealed a comparable level of efficacy for all vaccines. Findings from this study further demonstrate the suitability of ΔgG-ILTV as a vaccine to control ILT. PMID:21812721

  13. Reproductive toxicity testing of vaccines

    International Nuclear Information System (INIS)

    Vaccines play a major role in the prevention of human birth defects by protecting the pregnant woman from teratogenic or otherwise harmful infections. Until now, it has not been common practice to perform preclinical developmental toxicity tests for new vaccines. Despite the excellent safety record of vaccines, increased attention is now being given to the feasibility of screening new vaccines for developmental hazards in animals before their use in humans. Contrary to previous assumptions, many vaccines are now given to potentially pregnant women. Any new components of the vaccine formulation (adjuvants, excipients, stabilisers, preservatives, etc...) could also be tested for influences on development, although based on past experience the risks are limited by the very low dosages used. The conferred immunity following vaccination lasts for several years. Therefore, the developing conceptus may theoretically be exposed to the induced antibodies and/or sensitised T-cells, even if the pregnant woman was last vaccinated during childhood (particularly if she encounters the antigen during pregnancy through exposure to infection). However, it should be kept in mind that viral or bacterial infections represent a higher risk for a pregnant woman than the potential adverse effects related to vaccination or the associated immune response. Non-clinical safety studies may be employed as an aid for hazard identification. In these studies interactions of the vaccine with the maternal immune system or with the developmental systems of the offspring are considered. Post-natal examinations are necessary to detect all possible manifestations of developmental toxicity, such as effects on the immune system. Species selection for the preclinical studies is based on immunogenicity to the vaccine and the relative timing and rate of transfer of maternal antibodies to the offspring. A single study design is proposed for the pre- and post-natal developmental assessments of vaccines in

  14. Meta-Analysis on Randomized Controlled Trials of Vaccines with QS-21 or ISCOMATRIX Adjuvant: Safety and Tolerability

    Science.gov (United States)

    Bigaeva, Emilia; van Doorn, Eva; Liu, Heng; Hak, Eelko

    2016-01-01

    Background and Objectives QS-21 shows in vitro hemolytic effect and causes side effects in vivo. New saponin adjuvant formulations with better toxicity profiles are needed. This study aims to evaluate the safety and tolerability of QS-21 and the improved saponin adjuvants (ISCOM, ISCOMATRIX and Matrix-M™) from vaccine trials. Methods A systematic literature search was conducted from MEDLINE, EMBASE, Cochrane library and Clinicaltrials.gov. We selected for the meta-analysis randomized controlled trials (RCTs) of vaccines adjuvanted with QS-21, ISCOM, ISCOMATRIX or Matrix-M™, which included a placebo control group and reported safety outcomes. Pooled risk ratios (RRs) and their 95% confidence intervals (CIs) were calculated using a random-effects model. Jadad scale was used to assess the study quality. Results Nine RCTs were eligible for the meta-analysis: six trials on QS-21-adjuvanted vaccines and three trials on ISCOMATRIX-adjuvanted, with 907 patients in total. There were no studies on ISCOM or Matrix-M™ adjuvanted vaccines matching the inclusion criteria. Meta-analysis identified an increased risk for diarrhea in patients receiving QS21-adjuvanted vaccines (RR 2.55, 95% CI 1.04–6.24). No increase in the incidence of the reported systemic AEs was observed for ISCOMATRIX-adjuvanted vaccines. QS-21- and ISCOMATRIX-adjuvanted vaccines caused a significantly higher incidence of injection site pain (RR 4.11, 95% CI 1.10–15.35 and RR 2.55, 95% CI 1.41–4.59, respectively). ISCOMATRIX-adjuvanted vaccines also increased the incidence of injection site swelling (RR 3.43, 95% CI 1.08–10.97). Conclusions Our findings suggest that vaccines adjuvanted with either QS-21 or ISCOMATRIX posed no specific safety concern. Furthermore, our results indicate that the use of ISCOMATRIX enables a better systemic tolerability profile when compared to the use of QS-21. However, no better local tolerance was observed for ISCOMATRIX-adjuvanted vaccines in immunized non

  15. Composite sequential Monte Carlo test for post-market vaccine safety surveillance.

    Science.gov (United States)

    Silva, Ivair R

    2016-04-30

    Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper introduces a valid method for a true management of the alpha spending at each one of a sequence of Monte Carlo tests. The method also enables the use of a sequential simulation strategy for each Monte Carlo test, which is useful for saving computational execution time. Thus, the proposed procedure allows for sequential Monte Carlo test in sequential analysis, and this is the reason that it is called 'composite sequential' test. An upper bound for the potential power losses from the proposed method is deduced. The composite sequential design is illustrated through an application for post-market vaccine safety surveillance data. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26561330

  16. Reevaluating the Concept of Treating Experimental Tumors with a Mixed Bacterial Vaccine: Coley's Toxin

    OpenAIRE

    Maletzki, C.; Klier, U.; W. Obst; Kreikemeyer, B.; Linnebacher, M

    2012-01-01

    Several decades after Coley's initial work, we here systematically analyzed tumoricidal as well as immunostimulatory effects of the historical preparation Coley's Toxin (CT), a safe vaccine made of heat-inactivated S. pyogenes and S. marcescens. First, by performing in vitro analysis, established human pancreatic carcinoma cell lines responded with dose- and time-dependent growth inhibition. Effects were attributed to necrotic as well as apoptotic cell death as determined by increased Caspase...

  17. Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.

    Science.gov (United States)

    Onions, David; Egan, William; Jarrett, Ruth; Novicki, Deborah; Gregersen, Jens-Peter

    2010-09-01

    Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 10(34). Residual MDCK-DNA is < or =10 ng per dose and the ss-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200 base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production. PMID:20537553

  18. Generation of a safety enhanced Salmonella Gallinarum ghost using antibiotic resistance free plasmid and its potential as an effective inactivated vaccine candidate against fowl typhoid.

    Science.gov (United States)

    Jawale, Chetan V; Chaudhari, Atul A; Lee, John Hwa

    2014-02-19

    A safety enhanced Salmonella Gallinarum (SG) ghost was constructed using an antibiotic resistance gene free plasmid and evaluated its potential as fowl typhoid (FT) vaccine candidate. The antibiotic resistance free pYA3342 plasmid possesses aspartate semialdehyde dehydrogenase gene which is complimentary to the deletion of the chromosomal asd gene in the bacterial host. This plasmid was incorporated with a ghost cassette containing the bacteriophage PhiX174 lysis gene E, designated as pJHL101. The plasmid pJHL101 was transformed into a two virulence genes-deleted SG. The SG ghosts with tunnel formation and loss of cytoplasmic contents were observed by scanning electron microscopy and transmission electron microscopy. The cell viability of the culture solution was decreased to 0% at 24h after the induction of gene E expression by an increase in temperature from 37°C to 42°C. The safety and protective efficacy of the SG ghost vaccine was further examined in chickens which were divided into three groups: group A (non-immunized control), group B (orally immunized), and group C (intramuscularly immunized). The birds were immunized at 7d of age. No clinical symptoms associated with FT such as anorexia, depression and greenish diarrhea were observed in the immunized chickens. Upon challenge with a virulent SG strain at 3 week post-immunization, the chickens immunized with the SG ghost via various routes were efficiently protected, as shown by significantly lower mortality and post-mortem lesions in comparison with control group. In addition, all the immunized chickens showed significantly higher antibody responses accompanied by a potent antigen-specific lymphocyte proliferative response along with significantly increased numbers of CD4⁺ and CD8⁺ T lymphocytes. Overall, our results provide a promising approach of generating SG ghosts using the antibiotic resistance free plasmid in order to prepare a non-living bacterial vaccine candidate which could be

  19. Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers

    Directory of Open Access Journals (Sweden)

    Miguel Tregnaghi

    2014-09-01

    Conclusions: MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.

  20. Phase I Study of Safety and Immunogenicity of an Escherichia coli-Derived Recombinant Protective Antigen (rPA) Vaccine to Prevent Anthrax in Adults

    OpenAIRE

    Brown, Bruce K.; Josephine Cox; Anita Gillis; VanCott, Thomas C.; Mary Marovich; Mark Milazzo; Tanya Santelli Antonille; Lindsay Wieczorek; Mckee, Kelly T.; Karen Metcalfe; Mallory, Raburn M.; Deborah Birx; Polonis, Victoria R.; Merlin L Robb

    2010-01-01

    BACKGROUND: The fatal disease caused by Bacillus anthracis is preventable with a prophylactic vaccine. The currently available anthrax vaccine requires a lengthy immunization schedule, and simpler and more immunogenic options for protection against anthrax are a priority for development. In this report we describe a phase I clinical trial testing the safety and immunogenicity of an anthrax vaccine using recombinant Escherichia coli-derived, B. anthracis protective antigen (rPA). METHODOLOGY/P...

  1. Safety and immunogenicity of a vaccine bait containing ERA strain of attenuated rabies virus.

    OpenAIRE

    Lawson, K F; Black, J G; Charlton, K M; Johnston, D. H.; Rhodes, A. J.

    1987-01-01

    Ninety percent of foxes fed commercial ERA vaccine in a specially designed bait developed rabies serum neutralizing antibodies. The vaccine bait did not cause clinical signs of rabies when consumed by foxes, raccoons, skunks, dogs, cats, cattle and monkeys. When presented, in the laboratory, to wild rodents of the species Microtus, Mus musculus and Peromyscus, the vaccine baits caused vaccine-induced rabies only in Mus musculus. Laboratory mice of the CD-1 and CLL strain were susceptible to v...

  2. The safety and efficacy of immunizing foxes (Vulpes vulpes) using bait containing attenuated rabies virus vaccine.

    OpenAIRE

    Black, J. G.; Lawson, K. F.

    1980-01-01

    Foxes given ERA rabies vaccine baits were challenged at one, six, 12 and 24 months later and showed a resistance to challenge in 80%, 78%, 60% and 44% of individuals respectively. All animals showing seroconversion following vaccination, resisted challenge at 24 months, suggesting that successful vaccination by the oral route could confer a relatively long term duration of immunity. The trials showed that fox pups did not immunize as easily as adult foxes using ERA rabies vaccine baits. Back-...

  3. Vaccines Stop Illness

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Vaccines Stop Illness Past Issues / Spring 2008 Table of ... meningitis won't infect, cripple, or kill children. Vaccine Safety In light of recent questions about vaccine ...

  4. Rabies vaccines: a review of progress towards improved efficacy and safety.

    Science.gov (United States)

    Tsiang, H

    1998-10-01

    Over the years, the technology for producing human rabies vaccines has undergone many improvements. These improvements consist in the use of tissue cultures for the production of viral antigens, replacing the former nervous tissue substrate vaccines. The low virus yields in tissue cultures led to the development of the concentration and purification of virus supernatants. Another technical improvement was obtained by using microcarriers for virus production in VERO cell suspension cultures. This technique permits commercial-scale production of rabies vaccine, lowering production costs and thus extending the availability of the vaccine to a broader population in developing countries. Besides improvements in rabies vaccine production technology, the use of various vaccination regimens and routes of administration in field trials has resulted in considerable gains in our experience of postexposure treatment (PET) of this disease. The standard WHO recommended regimen for PET using concentrated and purified tissue culture vaccines consists of a 5-dose course of intramuscular injections at days 0, 3, 7, 14 and 28. Reduced vaccination regimens such as the 2-1-1 have been proven to be efficient in raising protective antibody responses. Reduction in the total volume of rabies vaccine is also possible by using the intradermal route of injection, provided the vaccine is administered at several sites. The overall consequence is a progressive shift in the worldwide use of rabies vaccines from those of nervous tissue origin to the contemporary tissue culture vaccines. PMID:18020604

  5. Guillain-Barre Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009-2011.

    Directory of Open Access Journals (Sweden)

    Sharon K Greene

    Full Text Available Guillain-Barré Syndrome (GBS can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1 pandemic in the United States, monovalent inactivated influenza vaccine (MIV availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited.We identified patients enrolled in health plans participating in the Vaccine Safety Datalink and diagnosed with GBS from July 2009 through June 2011. Medical records of GBS cases with 2009-10 MIV, 2010-11 trivalent inactivated influenza vaccine (TIV, and/or a medically-attended respiratory or gastrointestinal infection in the 1 through 141 days prior to GBS diagnosis were reviewed and classified according to Brighton Collaboration criteria for diagnostic certainty. Using a case-centered design, logistic regression models adjusted for patient-level time-varying sources of confounding, including seasonal vaccinations and infections in GBS cases and population-level controls.Eighteen confirmed GBS cases received vaccination in the 6 weeks preceding onset, among 1.27 million 2009-10 MIV recipients and 2.80 million 2010-11 TIV recipients. Forty-four confirmed GBS cases had infection in the 6 weeks preceding onset, among 3.77 million patients diagnosed with medically-attended infection. The observed-versus-expected odds that 2009-10 MIV/2010-11 TIV was received in the 6 weeks preceding GBS onset was odds ratio = 1.54, 95% confidence interval (CI, 0.59-3.99; risk difference = 0.93 per million doses, 95% CI, -0.71-5.16. The association between GBS and medically-attended infection was: odds ratio = 7.73, 95% CI, 3.60-16.61; risk difference = 11.62 per million infected patients, 95% CI, 4.49-26.94. These findings were consistent in sensitivity analyses using alternative infection definitions and risk intervals for prior

  6. Efficacy and safety of human papillomavirus vaccine for primary prevention of cervical cancer: A review of evidence from phase III trials and national programs

    Directory of Open Access Journals (Sweden)

    Partha Basu

    2013-01-01

    Full Text Available The Human Papillomavirus (HPV vaccines have been widely introduced in the national immunization programs in most of the medium and high income countries following endorsement from national and international advisory bodies. HPV vaccine is unique and its introduction is challenging in many ways - it is the first vaccine developed to prevent any cancer, the vaccine is gender specific, it targets adolescent females who are difficult to reach by any health intervention programs. It is not unusual for such a vaccine to face scepticism and reservations not only from lay public but also from professionals in spite of the clinical trial results convincingly and consistently proving their efficacy and safety. Over the last few years millions of doses of the HPV vaccine have been administered round the world and the efficacy and safety data have started coming from the real life programs. A comprehensive cervical cancer control program involving HPV vaccination of the adolescent girls and screening of the adult women has been proved to be the most cost-effective approach to reduce the burden of cervical cancer. The present article discusses the justification of HPV vaccination in the backdrop of natural history of cervical cancer, the mechanism of action of the vaccines, efficacy and safety data from phase III randomized controlled trials as well as from the national immunization programs of various countries.

  7. Bacterial Antigen Expression Is an Important Component in Inducing an Immune Response to Orally Administered Salmonella-Delivered DNA Vaccines

    OpenAIRE

    Gahan, Michelle E.; Webster, Diane E.; Wesselingh, Steven L.; Richard A. Strugnell; Yang, Ji

    2009-01-01

    Background The use of Salmonella to deliver heterologous antigens from DNA vaccines is a well-accepted extension of the success of oral Salmonella vaccines in animal models. Attenuated S. typhimurium and S. typhi strains are safe and efficacious, and their use to deliver DNA vaccines combines the advantages of both vaccine approaches, while complementing the limitations of each technology. An important aspect of the basic biology of the Salmonella/DNA vaccine platform is the relative contribu...

  8. The Effect of Falsely Balanced Reporting of the Autism-Vaccine Controversy on Vaccine Safety Perceptions and Behavioral Intentions

    Science.gov (United States)

    Dixon, Graham; Clarke, Christopher

    2013-01-01

    Controversy surrounding an autism-vaccine link has elicited considerable news media attention. Despite being widely discredited, research suggests that journalists report this controversy by presenting claims both for and against a link in a relatively "balanced" fashion. To investigate how this reporting style influences judgments of vaccine…

  9. Study on the efficacy and safety of different antigens and oil formulations of infectious coryza vaccines containing an NAD-independent strain of Avibacterium paragallinarum

    Directory of Open Access Journals (Sweden)

    B. Dungu

    2009-09-01

    Full Text Available The present study was designed to assess and compare three different formulations of the new Onderstepoort infectious coryza (IC quadrivalent vaccine, which contain an NAD-independent strain of Avibacterium paragallinarum (previously known as Haemophilus paragallinarum, and a commercial IC vaccine, not containing an NAD-independent strain, for their safety and ability to protect chickens of varying ages against virulent challenges with four different serovars of A. paragallinarum, including the NAD-independent strain of the C-3 serovar. Four groups of 140 chickens each were vaccinated at the age of 17 weeks and revaccinated at the age of 19 weeks with each of the four vaccine formulations. A similar sized group of non-vaccinated chickens was used as control. Two rounds of challenge were conducted: a group of chicken in each vaccination group was challenged between 31 and 35 weeks of age, while another group was challenged between 51 and 55 weeks of age. The ''in-contact'' challenge model was used in this experiment. For each vaccination group, the four challenge strains representing four local serovars were used in each challenge round. The efficacy of the vaccines was compared based on overall protection levels obtained and the duration of protection. The safety of the different vaccines was determined by the severity of post-vaccination reactions. The need for the incorporation of the NAD-independent strain in the vaccine was evidenced by the low protection level against NAD-independent challenge recorded in the group of birds vaccinated with the commercial vaccine. The results obtained confirmed not only the variation in virulence of different South African serovars, with serovar C-3 being the most virulent and serovar B having almost no virulence but also the age related increase in susceptibility. The importance of a suitable formulation of the vaccine is discussed.

  10. Safety and immunogenicity of Ontario Rabies Vaccine Bait (ONRAB) in the first us field trial in raccoons (Procyon lotor).

    Science.gov (United States)

    Slate, Dennis; Chipman, Richard B; Algeo, Timothy P; Mills, Samuel A; Nelson, Kathleen M; Croson, Christopher K; Dubovi, Edward J; Vercauteren, Kurt; Renshaw, Randall W; Atwood, Todd; Johnson, Shylo; Rupprecht, Charles E

    2014-07-01

    In 2011, we conducted a field trial in rural West Virginia, USA to evaluate the safety and immunogenicity of a live, recombinant human adenovirus (AdRG1.3) rabies virus glycoprotein vaccine (Ontario Rabies Vaccine Bait; ONRAB) in wild raccoons (Procyon lotor) and striped skunks (Mephitis mephitis). We selected ONRAB for evaluation because of its effectiveness in raccoon rabies management in Ontario and Quebec, Canada, and significantly higher antibody prevalence rates in raccoons compared with a recombinant vaccinia-rabies glycoprotein (V-RG) vaccine, Raboral V-RG®, in US-Canada border studies. Raccoon rabies was enzootic and oral rabies vaccination (ORV) had never been used in the study area. We distributed 79,027 ONRAB baits at 75 baits/km(2) mostly by fixed-wing aircraft along parallel flight lines at 750-m intervals. Antibody prevalence was significantly higher at 49.2% (n=262) in raccoons after ONRAB was distributed than the 9.6% (n=395) before ORV. This was the highest antibody prevalence observed in raccoons by US Department of Agriculture Wildlife Services for areas with similar management histories evaluated before and after an initial ORV campaign at 75 baits/km(2) with Raboral V-RG. Tetracycline biomarker (TTCC) was significantly higher among antibody-positive raccoons after ONRAB baiting and was similar among raccoons before ORV had been conducted, an indication of vaccine-induced rabies virus-neutralizing antibody production following consumption of bait containing TTCC. Skunk sample size was inadequate to assess ONRAB effects. Safety and immunogenicity results supported replication of this field trial and led to a recommendation for expanded field trials in 2012 to evaluate safety and immunogenicity of ground-distributed ONRAB at 150 baits/km(2) in residential and commercial habitats in Ohio, USA and aerially distributed ONRAB at 75 baits/km(2) in rural habitats along US-Quebec border. PMID:24807178

  11. Clinical study on safety and immunogenicity of therapeutic dual-plasmid HBV DNA vaccine mediated by in vivo electroporation

    Directory of Open Access Journals (Sweden)

    Hai-yan YANG

    2013-03-01

    Full Text Available Objective  To evaluate the safety and immunogenicity of the therapeutic dual-plasmid HBV DNA vaccine mediated by electroporation (EP in vivo against the hepatitis B virus in healthy adult volunteers. Methods The enrolled 30 healthy volunteers were randomly divided into three dosage groups (10 volunteers in each group, namely: high-dose (4mg, middle-dose (2mg and low-dose (1mg groups. Volunteers received four intramuscular injections of HBV DNA vaccine mediated by in vivo EP at the 0, 4th, 12th and 24th week. Each dose group was further divided into 2 sub-groups (5 persons/per group with different EP frequencies, i.e. 36 and 60 volt. The changes in response was determined by physical diagnosis (ECG, chest X-ray, type-B ultrasound, lab findings (blood and urine routine, blood biochemistry, prothrombin time, thyroid function, tumor biomarkers, immunological variables (IFN-γ, ANA, anti-dsDNA Ab, serological variables pertaining to HBV (HBsAg, HBcAb, HBeAg, HBeAb, HBV DNA and serum anti-HBs status in volunteers before and after receiving EP mediated HBV DNA vaccination. Results The dual-plasmid HBV DNA vaccination mediated by in vivo EP was well tolerated in all healthy volunteers with a stable life signs. It was found that EP-mediated immunization of the therapeutic DNA vaccine against hepatitis B virus had a specific and obvious anti-HBs humoral immune response in one volunteer (17.22mU/ml. Four repeated intramuscular injections of the vaccine did not show any significant adverse effects in the receptors. Although mild elevation of serum ALT and enlarged spleen were found in one individual, the abnormalities disappeared spontaneously at the end of the trial. Conclusions EP-mediated dual-plasmid HBV DNA vaccine is safe and well tolerated with certain degree of humoral immunogenicity.

  12. Pre- and post-exposure safety and efficacy of attenuated rabies virus vaccines are enhanced by their expression of IFNγ.

    Science.gov (United States)

    Barkhouse, Darryll A; Faber, Milosz; Hooper, D Craig

    2015-01-01

    Consistent with evidence of a strong correlation between interferon gamma (IFNγ) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFNγ highly attenuates the virus. Reasoning that IFNγ expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFNγ. Mortality and morbidity were monitored during suckling mice infection, immunize/challenge experiments and mixed intracranial infections. We demonstrate that GASγ and GASγGAS are significantly attenuated in suckling mice compared to the GASGAS vaccine. GASγ better protects mice from lethal DRV4 RABV infection in both pre- and post-exposure experiments compared to GASGAS. Finally, GASγGAS reduces post-infection neurological sequelae, compared to control, during mixed intracranial infection with DRV4. These data show IFNγ expression by a vaccine vector can enhance its safety while increasing its efficacy as pre- and post-exposure treatment. PMID:25463615

  13. Bacterial Meningitis

    Science.gov (United States)

    ... Schedules Preteen & Teen Vaccines Meningococcal Disease Sepsis Bacterial Meningitis Recommend on Facebook Tweet Share Compartir On this ... serious disease. Laboratory Methods for the Diagnosis of Meningitis This manual summarizes laboratory methods used to isolate, ...

  14. Peracetic Acid Treatment Generates Potent Inactivated Oral Vaccines from a Broad Range of Culturable Bacterial Species.

    Science.gov (United States)

    Moor, Kathrin; Wotzka, Sandra Y; Toska, Albulena; Diard, Médéric; Hapfelmeier, Siegfried; Slack, Emma

    2016-01-01

    Our mucosal surfaces are the main sites of non-vector-borne pathogen entry, as well as the main interface with our commensal microbiota. We are still only beginning to understand how mucosal adaptive immunity interacts with commensal and pathogenic microbes to influence factors such as infectivity, phenotypic diversity, and within-host evolution. This is in part due to difficulties in generating specific mucosal adaptive immune responses without disrupting the mucosal microbial ecosystem itself. Here, we present a very simple tool to generate inactivated mucosal vaccines from a broad range of culturable bacteria. Oral gavage of 10(10) peracetic acid-inactivated bacteria induces high-titer-specific intestinal IgA in the absence of any measurable inflammation or species invasion. As a proof of principle, we demonstrate that this technique is sufficient to provide fully protective immunity in the murine model of invasive non-typhoidal Salmonellosis, even in the face of severe innate immune deficiency. PMID:26904024

  15. Safety and risk assessment of the genetically modified Lactococci on rats intestinal bacterial flora.

    Science.gov (United States)

    Lee, Kai-Chien; Liu, Chin-Feng; Lin, Tzu-Hsing; Pan, Tzu-Ming

    2010-08-15

    The interaction between Lactococcus lactis NZ9000/pNZPNK and intestinal microflora was evaluated as a method to assess safety of genetically modified microorganisms (GMMs). L. lactis NZ9000/pNZPNK is one kind of GMM and able to produce the intracellular subtilisin NAT (nattokinase) under induction with nisin. The host strain L. lactis NZ9000 was a generally recognized as safe (GRAS) microorganism. Six groups of Wistar rats were orally administered with L. lactis NZ9000/pNZPNK and L. lactis NZ9000 for 6 weeks. Fecal and cecal contents were collected to determine the number of L. lactis NZ9000, L. lactis NZ9000/pNZPNK, Lactobacillus, coliform bacteria, beneficial bacteria Bifidobacterium and harmful bacteria Clostridium perfringens. The liver, spleen, kidney and blood were evaluated for the bacterial translocation. After 6 weeks consumption with GM and non-GM Lactococcus, no adverse effects were observed on the rat's body weight, hematological or serum biochemical parameters, or intestinal microflora. The bacterial translocation test showed that L. lactis NZ9000/pNZPNK did not translocate to any organ or blood. Bifidobacterium was significantly increased in feces after administration of both Lactococcus strains (L. lactis NZ9000 and L. lactis NZ9000/pNZPNK), while C. perfringens remained undetectable during the experiment. These results suggested that L. lactis NZ9000/pNZPNK could be safe in animal experiments and monitoring of the interaction between test strains and intestinal microflora might be applied as a method for other GMM safety assessments. PMID:20619909

  16. Properly folded bacterially expressed H1N1 hemagglutinin globular head and ectodomain vaccines protect ferrets against H1N1 pandemic influenza virus.

    Directory of Open Access Journals (Sweden)

    Surender Khurana

    Full Text Available BACKGROUND: In the face of impending influenza pandemic, a rapid vaccine production and mass vaccination is the most effective approach to prevent the large scale mortality and morbidity that was associated with the 1918 "Spanish Flu". The traditional process of influenza vaccine production in eggs is time consuming and may not meet the demands of rapid global vaccination required to curtail influenza pandemic. METHODOLOGY/PRINCIPAL FINDINGS: Recombinant technology can be used to express the hemagglutinin (HA of the emerging new influenza strain in a variety of systems including mammalian, insect, and bacterial cells. In this study, two forms of HA proteins derived from the currently circulating novel H1N1 A/California/07/2009 virus, HA1 (1-330 and HA (1-480, were expressed and purified from E. coli under controlled redox refolding conditions that favoured proper protein folding. However, only the recombinant HA1 (1-330 protein formed oligomers, including functional trimers that bound receptor and caused agglutination of human red blood cells. These proteins were used to vaccinate ferrets prior to challenge with the A/California/07/2009 virus. Both proteins induced neutralizing antibodies, and reduced viral loads in nasal washes. However, the HA1 (1-330 protein that had higher content of multimeric forms provided better protection from fever and weight loss at a lower vaccine dose compared with HA (1-480. Protein yield for the HA1 (1-330 ranged around 40 mg/Liter, while the HA (1-480 yield was 0.4-0.8 mg/Liter. CONCLUSIONS/SIGNIFICANCE: This is the first study that describes production in bacterial system of properly folded functional globular HA1 domain trimers, lacking the HA2 transmembrane protein, that elicit potent neutralizing antibody responses following vaccination and protect ferrets from in vivo challenge. The combination of bacterial expression system with established quality control methods could provide a mechanism for rapid large

  17. Mucosal SIV Vaccines Comprising Inactivated Virus Particles and Bacterial Adjuvants Induce CD8+ T-Regulatory Cells that Suppress SIV-Positive CD4+ T-Cell Activation and Prevent SIV Infection in the Macaque Model

    OpenAIRE

    Andrieu, Jean-Marie; Chen, Song; Lai, Chunhui; Guo, Weizhong; Lu, Wei

    2014-01-01

    A new paradigm of mucosal vaccination against human immunodeficiency virus (HIV) infection has been investigated in the macaque model. A vaccine consisting of inactivated simian immunodeficiency virus (SIV)mac239 particles together with a living bacterial adjuvant (either the Calmette and Guerin bacillus, Lactobacillus plantarum or Lactobacillus rhamnosus) was administered to macaques via the vaginal or oral/intragastric route. In contrast to all established human and veterinary vaccines, the...

  18. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia

    OpenAIRE

    Desai, Sachin N.; Akalu, Zenebe; Teshome, Samuel; Teferi, Mekonnen; Yamuah, Lawrence; Kim, Deok Ryun; Yang, Jae Seung; Hussein, Jemal; Park, Ju Yeong; Jang, Mi Seon; Mesganaw, Chalachew; Taye, Hawult; Beyene, Demissew; Bedru, Ahmed; Singh, Ajit Pal

    2015-01-01

    Killed whole-cell oral cholera vaccine (OCV) has been a key component of a comprehensive package including water and sanitation measures for recent cholera epidemics. The vaccine, given in a two-dose regimen, has been evaluated in a large number of human volunteers in India, Vietnam, and Bangladesh, where it has demonstrated safety, immunogenicity, and clinical efficacy. We conducted a double-blind randomized placebo-controlled trial in Ethiopia, where we evaluated the safety and immunogenici...

  19. Safety and immunogenicity of recombinant poxvirus HIV-1 vaccines in young adults on highly active antiretroviral therapy

    OpenAIRE

    Greenough, Thomas C.; Cunningham, Coleen K; Muresan, Petronella; McManus, Margaret; Persaud, Deborah; Fenton, Terry; Barker, Piers; Gaur, Aditya; Panicali, Dennis; Sullivan, John L.; Luzuriaga, Katherine

    2008-01-01

    A trial to evaluate the safety and immunogenicity of recombinant modified vaccinia Ankara (MVA) and fowlpox (FP) vectors expressing multiple HIV-1 proteins was conducted in twenty HIV-1 infected youth with suppressed viral replication on HAART. The MVA and FP-based multigene HIV-1 vaccines were safe and well tolerated. Increased frequencies of HIV-1 specific CD4+ proliferative responses and cytokine secreting cells were detected following immunization. Increased frequencies and breadth of HIV...

  20. 75 FR 75682 - Reclassification of Category IIIA Biological Products, Bacterial Vaccines and Related Biological...

    Science.gov (United States)

    2010-12-06

    ... order finalizes the proposed order published in the Federal Register of May 15, 2000 (65 FR 31003) (May..., 1973 (38 FR 4319), FDA issued procedures for the review by independent advisory panels of the safety... codified in Sec. 601.25 (21 CFR 601.25) (38 FR 32048 at 32052, November 20, 1973). Under Sec. 601.25,...

  1. A novel rabies vaccine based-on toll-like receptor 3 (TLR3) agonist PIKA adjuvant exhibiting excellent safety and efficacy in animal studies.

    Science.gov (United States)

    Zhang, Yi; Zhang, Shoufeng; Li, Wei; Hu, Yuchi; Zhao, Jinyan; Liu, Fang; Lin, Haixiang; Liu, Yuan; Wang, Liliang; Xu, Shu; Hu, Rongliang; Shao, Hui; Li, Lietao

    2016-02-01

    Vaccination alone is not sufficiently effective to protect human from post-exposure rabies virus infection due to delayed generation of rabies virus neutralizing antibodies and weak cellular immunity. Therefore, it is vital to develop safer and more efficacious vaccine against rabies. PIKA, a stabilized chemical analog of double-stranded RNA that interacts with TLR3, was employed as adjuvant of rabies vaccine. The efficacy and safety of PIKA rabies vaccine were evaluated. The results showed that PIKA rabies vaccine enhanced both humoral and cellular immunity. After viral challenge, PIKA rabies vaccine protected 70-80% of animals, while the survival rate of non-adjuvant vaccine group (control) was 20-30%. According to the results of toxicity tests, PIKA and PIKA rabies vaccine are shown to be well tolerated in mice. Thus, this study indicates that PIKA rabies vaccine is an effective and safe vaccine which has the potential to develop next-generation rabies vaccine and encourage the start of clinical studies. PMID:26765968

  2. Immunogenicity and safety of a tetravalent dengue vaccine during a five-year follow-up period

    Directory of Open Access Journals (Sweden)

    Maria Rosario Capeding

    2015-01-01

    Full Text Available This study assessed the safety and persistence of dengue neutralising antibodies for five years after administration of a recombinant live, attenuated, tetravalent dengue vaccine (TDV. Participants aged 2–45 years (n = 126 were randomised at a single centre in the Philippines to receive TDV vaccinations at months 0, 3–4, and 12 (TDV–TDV–TDV group or licensed typhoid vaccination (TyVi at month 0 and TDV at months 3–4 and 12 (TyVi–TDV–TDV group. Dengue antibodies were measured annually (plaque reduction neutralisation test. Participants with suspected dengue underwent laboratory testing. No safety concerns were reported throughout the study. Six dengue cases were virologically confirmed, but assessed as non-severe dengue disease. Geometric mean titres throughout the follow-up period remained 2- to 4-fold higher than at baseline for all serotypes, ages and study groups. Approximately 10% of participants annually were exposed to wild-type dengue, which contributed to persistently higher titres compared with non-infected participants. In conclusion, TDV appears to have good safety and persistence of antibodies over five years.

  3. Safety and immunogenicity of the RIVM hexavalent meningococcal B vesicle vaccine for Rotterdam children aged 2-3 and 7-8

    OpenAIRE

    Labadie J; de Kleijn ED; Lafeber AB; Mees MMM; Booy K; de Groot R; van Omme GW; van Dijken H; Kuipers AJ; Dobbelsteen G van den; Juttmann RE; Wala M; van Alphen AJW; Rumke HC; Sophia Kinderziekenhuis / Academisch Ziekenhuis Rotterdam

    2000-01-01

    This report documents the results of a randomised controlled phase-II clinical study into the safety and immunogenicity of the RIVM hexavalent MenB vesicle vaccine among 189 children aged 2-3 and 168 children aged 7-8 in the city of Rotterdam, the Netherlands. Two concentrations of the MenB vesicle were investigated where hepatitis B vaccine (HB-VAX(registered trademark) DNA) was used as a control and administered according to the same schedule as the RIVM MenB vaccine. The vaccination schedu...

  4. 流感疫苗接种安全性的研究%Study on the safety of influenza vaccination

    Institute of Scientific and Technical Information of China (English)

    寇妍

    2011-01-01

    季节性流行性感冒(流感)是一种常见的呼吸道传染病,人群发病率高、传染性强、危害大,接种流感疫苗是预防流感及减少流感传播的有效措施.因<2岁婴儿、>65岁老年人、妊娠妇女及鸡蛋过敏人群感染流感病毒后出现并发症风险大、病死率高或易出现接种不良反应,视为特殊人群.随着流感疫苗生产水平的提高及人们埘流感疫苗研究的深入,特殊人群接种流感疫苗的安全性及有效性受到人们的重视.该文综述目前常用流感疫苗生产的相关研究及其在特殊人群中接种安全性的研究.%Seasonal influenza is a common respiratory infectious disease with high morbidity and strong infectivity, and it is harmful to people. Influenza vaccination is an effective measure to prevent influenza and reduce the spread of the influenza. People who are in great risk of influenza or tend to have adverse reactions should be considered as a special population, including the young child less than 2 years, the men or women older than 65 years, children with egg allergy and pregnant women. The attitudes about the safety and efficacy of influenza vaccine in special populations should be changed following the improvement of the influenza vaccine production and the deeply research. This paper reviewed the production of common flu vaccines and the safety of influenza vaccination in special populations.

  5. Safety Overview of a Recombinant Live-Attenuated Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Sophia Gailhardou

    2016-07-01

    Full Text Available A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2-16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2-60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2-60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged <9 years in the CYD-TDV group compared with the placebo group was not observed for participants aged ≥9 years. In Year 4, this imbalance in participants aged <9 years was less marked, giving an overall lower risk of dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target

  6. Safety Overview of a Recombinant Live-Attenuated Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials.

    Science.gov (United States)

    Gailhardou, Sophia; Skipetrova, Anna; Dayan, Gustavo H; Jezorwski, John; Saville, Melanie; Van der Vliet, Diane; Wartel, T Anh

    2016-07-01

    A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV) has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2-16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2-60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2-60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target population for vaccination (≥9 years old) for which CYD-TDV has a satisfactory safety profile. Long-term safety will continue to be monitored in the ongoing follow-up of efficacy trials. Safety and effectiveness in real-life settings will

  7. Estimation of General Toxicity and Immunological Safety of a Novel Therapeutic Vaccine Against Human Papillomavirus-Assosiated Diseases

    Directory of Open Access Journals (Sweden)

    A.E. Kukharenko

    2015-06-01

    Full Text Available The aim of the investigation was to study in experiment total toxicity and immunological safety of a novel domestic therapeutic vaccine against recurrent respiratory papillomatosis and anogenital condylomatosis, the vaccine injected intramuscularly. Materials and Methods. We studied acute toxicity of the vaccine by the following parameters: clinical presentation of intoxication, median lethal dose size, the change of body weight of the surviving animals; chronic toxicity — by dynamics of general condition of the animals, body weight, hematological and biochemical indices of peripheral blood, functional status of central nervous system, cardiovascular system, kidneys, as well as pathomorphological changes of viscera. Allergenicity was studied by systemic and active cutaneous anaphylactic tests. We assessed immunotoxicity by direct a hemagglutination assay and a delayed-type hypersensitivity test, as well as by neutrophilic activity using luminal-dependent chemiluminescence. Proliferative activity of В- and Т-lymphocytes to lipopolysaccharides and concanavalin А (ConА was estimated in a direct immunofluorescence test using immunocytochemical assay with anti-Ki-67 monoclonal antibodies. Results. Mean lethal doses (LD50 were not reached in white outbread rats injected intramuscularly by the tested vaccine at a maximum possible single dose (25 ml/kg. Multi-dose administration to white outbread rats and chinchilla rabbits at doses of 0.043; 0.43; 0.86 ml/kg and 0.023; 0.23; 0.4 ml/kg respectively, did not cause significant damage of functional status of basal organs and systems of experimental animals. The findings of systemic anaphylaxis and active cutaneous anaphylactic response to the vaccine in albino guinea pigs at the doses of 0.033 and 0.33 ml/kg intramuscularly indicated the vaccine to exhibit no allergenic properties. Intramuscular vaccine injected to first filial hybrid mice (СВА×С57BL/6F1 at the doses of 0.084; 2.5 and 25 ml

  8. Safety and immunogenicity of Onderstepoort Biological Products’ Rift Valley fever Clone 13 vaccine in sheep and goats under field conditions in Senegal

    Directory of Open Access Journals (Sweden)

    Modou M. Lo

    2015-02-01

    Full Text Available This blinded field safety study was conducted in Senegal to assess safety and immunogenicity of administration of the registered dose of Rift Valley fever virus (RVFV Clone 13 vaccine (Onderstepoort Biological Products to sheep and goats of West African breeds under natural conditions. A total of 267 small ruminants (220 sheep, 47 goats were included; half received RVFV Clone 13 vaccine at the recommended dose and half received the diluent (as placebo only. The study was performed on three commercial farms in the northern and eastern region of Senegal in accordance with veterinary good clinical practices. The animals were observed daily for 3 days after vaccination, and then weekly for 1 year. In both sheep and goats vaccinated against RVFV seroconversion rates above 70% were recorded. No seroconversion related to RVFV was observed in placebo-treated animals. No statistically significant differences were determined between placebo and vaccinated groups for mean rectal temperatures for the first 3 days after administration (p > 0.05. No abnormal clinical signs related to treatment were noted, and only one slight injection site reaction was observed in one vaccinated animal for 2 days after vaccination. Out of 176 births assessed over 1 year (93 from the vaccinated group, 83 from the placebo group, 9 were abnormal in the placebo group and 3 in the vaccinated group (p > 0.05. The frequency of adverse events was similar in the placebo and vaccinated groups. RVFV Clone 13 vaccine administered according to the manufacturer’s instructions was safe and well tolerated in West African breeds of sheep and goats, including animals of approximately 6 months of age and pregnant females, under field conditions in Senegal. Antibody levels persisted up to 1 year after vaccination.

  9. Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial.

    Science.gov (United States)

    Zhang, Wei; Kong, Yujia; Jiang, Zhiwei; Li, Chanjuan; Wang, Ling; Xia, Jielai

    2016-04-01

    Human enterovirus 71 (EV71) is a causative agent of hand, foot, and mouth disease (HFMD). In a previous phase III trial in children, a human diploid cell-based inactivated EV71 vaccine elicited EV71 specific immune responses and protection against EV71 associated HFMD. This study aimed to assess the factors influencing the severity of adverse events observed in this previous trial. This was a randomized, double-blinded, placebo-controlled, phase III clinical trial of a human diploid vaccine carried out in 12,000 children in Guangxi Zhuang Autonomous Region, China (ClinicalTrials.gov: NCT01569581). Solicited events were recorded for 7 days and unsolicited events were reported for 28 days after each injection. Age trend analysis of adverse reaction was conducted in each treatment group. Multiple logistic regression models were built to identify factors influencing the severity of adverse reactions. Fewer solicited adverse reactions were observed in older participants within the first 7 days after vaccination (P vaccine achieved a satisfactory safety profile. PMID:26837471

  10. A meta-analysis of efficacy and safety of doripenem for treating bacterial infections

    Directory of Open Access Journals (Sweden)

    Xiao-Yu Qu

    2015-04-01

    Full Text Available Objective:The aim of this article is to compare the efficacy and safety of doripenem for bacterial infections.Methods:We included six randomized clinical trials identified from PubMed and Embase up to July 31, 2014. The included trials compared efficacy and safety of doripenem for complicated intra-abdominal infections, complicated urinary tract infection, nosocomial pneumonia, and acute biliary tract infection. The meta-analysis was carried on by the statistical software of Review Manager, version 5.2.Results:Compared with empirical antimicrobial agents on overall treatment efficacy, doripenem was associated with similar clinical and microbiological treatment success rates (for the clinical evaluable population, odds ratio [OR] = 1.26, 95% confidence interval [CI] 0.93-1.69, p= 0.13; for clinical modified intent-to-treatment population, OR = 0.88, 95% CI 0.55-1.41, p= 0.60; for microbiology evaluable population, OR = 1.16, 95% CI 0.90-1.50, p= 0.26; for microbiological modified intent-to-treatment (m-mITT, OR = 0.98, 95% CI 0.81-1.20, p= 0.87. We compared incidence of adverse events and all-cause mortality to analyze treatment safety. The outcomes suggested that doripenem was similar to comparators in terms of incidence of adverse events and all-cause mortality on modified intent-to-treatment population (for incidence of AEs, OR = 1.10, 95% CI 0.90-1.35, p= 0.33; for all-cause mortality, OR = 1.08, 95% CI 0.77-1.51, p= 0.67. In nosocomial pneumonia and ventilator-associated pneumonia treatment, doripenem was not inferior to other antibacterial agents in terms of efficacy and safety.Conclusion:From this meta-analysis, we can conclude that doripenem is as valuable and well-tolerated than empirical antimicrobial agents for complicated intra-abdominal infections, complicated urinary tract infection, acute biliary tract infection and nosocomial pneumonia treatment.

  11. Vaccination with Brucella abortus recombinant in vivo-induced antigens reduces bacterial load and promotes clearance in a mouse model for infection.

    Directory of Open Access Journals (Sweden)

    Jake E Lowry

    Full Text Available Current vaccines used for the prevention of brucellosis are ineffective in inducing protective immunity in animals that are chronically infected with Brucella abortus, such as elk. Using a gene discovery approach, in vivo-induced antigen technology (IVIAT on B. abortus, we previously identified ten loci that encode products up-regulated during infection in elk and consequently may play a role in virulence. In our present study, five of the loci (D15, 0187, VirJ, Mdh, AfuA were selected for further characterization and compared with three additional antigens with virulence potential (Hia, PrpA, MltA. All eight genes were PCR-amplified from B. abortus and cloned into E. coli. The recombinant products were then expressed, purified, adjuvanted, and delivered subcutaneously to BALB/c mice. After primary immunization and two boosts, mice were challenged i.p. with 5 x 10⁴ CFU of B. abortus strain 19. Spleens from challenged animals were harvested and bacterial loads determined by colony count at various time points. While vaccination with four of the eight individual proteins appeared to have some effect on clearance kinetics, mice vaccinated with recombinant Mdh displayed the most significant reduction in bacterial colonization. Furthermore, mice immunized with Mdh maintained higher levels of IFN-γ in spleens compared to other treatment groups. Collectively, our in vivo data gathered from the S19 murine colonization model suggest that vaccination with at least three of the IVIAT antigens conferred an enhanced ability of the host to respond to infection, reinforcing the utility of this methodology for the identification of potential vaccine candidates against brucellosis. Mechanisms for immunity to one protein, Mdh, require further in vitro exploration and evaluation against wild-type B. abortus challenge in mice, as well as other hosts. Additional studies are being undertaken to clarify the role of Mdh and other IVI antigens in B. abortus virulence

  12. Vaccination with Brucella abortus recombinant in vivo-induced antigens reduces bacterial load and promotes clearance in a mouse model for infection.

    Science.gov (United States)

    Lowry, Jake E; Isaak, Dale D; Leonhardt, Jack A; Vernati, Giulia; Pate, Jessie C; Andrews, Gerard P

    2011-01-01

    Current vaccines used for the prevention of brucellosis are ineffective in inducing protective immunity in animals that are chronically infected with Brucella abortus, such as elk. Using a gene discovery approach, in vivo-induced antigen technology (IVIAT) on B. abortus, we previously identified ten loci that encode products up-regulated during infection in elk and consequently may play a role in virulence. In our present study, five of the loci (D15, 0187, VirJ, Mdh, AfuA) were selected for further characterization and compared with three additional antigens with virulence potential (Hia, PrpA, MltA). All eight genes were PCR-amplified from B. abortus and cloned into E. coli. The recombinant products were then expressed, purified, adjuvanted, and delivered subcutaneously to BALB/c mice. After primary immunization and two boosts, mice were challenged i.p. with 5 x 10⁴ CFU of B. abortus strain 19. Spleens from challenged animals were harvested and bacterial loads determined by colony count at various time points. While vaccination with four of the eight individual proteins appeared to have some effect on clearance kinetics, mice vaccinated with recombinant Mdh displayed the most significant reduction in bacterial colonization. Furthermore, mice immunized with Mdh maintained higher levels of IFN-γ in spleens compared to other treatment groups. Collectively, our in vivo data gathered from the S19 murine colonization model suggest that vaccination with at least three of the IVIAT antigens conferred an enhanced ability of the host to respond to infection, reinforcing the utility of this methodology for the identification of potential vaccine candidates against brucellosis. Mechanisms for immunity to one protein, Mdh, require further in vitro exploration and evaluation against wild-type B. abortus challenge in mice, as well as other hosts. Additional studies are being undertaken to clarify the role of Mdh and other IVI antigens in B. abortus virulence and induction of

  13. The safety and immunogenicity of a MF59-adjuvanted H5N1 prepandemic influenza vaccine in healthy adults primed with homologous or heterologous H5N1 vaccines: an observational study

    OpenAIRE

    Wei, Sung-Hsi; Liu, Ming-Tsan; Tsai, Yao-Chou; Liao, Chung-Hsin; Chen, Chih-Ming; Wang, Wei-Yao; Huang, Yi-Lung; Chang, Feng-Yee; Chou, Pesus

    2014-01-01

    Background World Health Organization (WHO) has recommended individuals with increased risk of contracting influenza A H5N1 infection to be immunized against the virus during the inter-pandemic period. Safety and immunogenicity of H5N1 vaccine among participants primed with homologous or heterologous H5N1 vaccines produced by diverse manufactures have not been reported. Methods Healthy individuals aged 20 to 60 years old were recruited and stratified into three groups: participants without pri...

  14. A UMLS-based spell checker for natural language processing in vaccine safety

    Directory of Open Access Journals (Sweden)

    Liu Fang

    2007-02-01

    Full Text Available Abstract Background The Institute of Medicine has identified patient safety as a key goal for health care in the United States. Detecting vaccine adverse events is an important public health activity that contributes to patient safety. Reports about adverse events following immunization (AEFI from surveillance systems contain free-text components that can be analyzed using natural language processing. To extract Unified Medical Language System (UMLS concepts from free text and classify AEFI reports based on concepts they contain, we first needed to clean the text by expanding abbreviations and shortcuts and correcting spelling errors. Our objective in this paper was to create a UMLS-based spelling error correction tool as a first step in the natural language processing (NLP pipeline for AEFI reports. Methods We developed spell checking algorithms using open source tools. We used de-identified AEFI surveillance reports to create free-text data sets for analysis. After expansion of abbreviated clinical terms and shortcuts, we performed spelling correction in four steps: (1 error detection, (2 word list generation, (3 word list disambiguation and (4 error correction. We then measured the performance of the resulting spell checker by comparing it to manual correction. Results We used 12,056 words to train the spell checker and tested its performance on 8,131 words. During testing, sensitivity, specificity, and positive predictive value (PPV for the spell checker were 74% (95% CI: 74–75, 100% (95% CI: 100–100, and 47% (95% CI: 46%–48%, respectively. Conclusion We created a prototype spell checker that can be used to process AEFI reports. We used the UMLS Specialist Lexicon as the primary source of dictionary terms and the WordNet lexicon as a secondary source. We used the UMLS as a domain-specific source of dictionary terms to compare potentially misspelled words in the corpus. The prototype sensitivity was comparable to currently available

  15. Immunogenicity and safety of hepatitis B vaccine (Shanvac-B using a novel pre-filled single use injection device uniject in Indian subjects

    Directory of Open Access Journals (Sweden)

    Joshi N

    2004-11-01

    Full Text Available BACKGROUND: Hepatitis B is a major public health problem, which has now been controlled to some extent by vaccination especially with the recombinant hepatitis B vaccine, which has been proven to be safe and efficacious since its introduction in the 1990s. But problems of unsafe injection practices still persist. Now newer delivery devices like uniject are available for making vaccination very safe. OBJECTIVE: To evaluate the immunogenicity and safety of the Hepatitis-B (Shanvac-B vaccine in Uniject pre-filled device administered to healthy adults and infants at 0, 1, 2 months schedule. METHODS: A total of 122 healthy subjects (62 adults and 60 infants were administered three doses of the recombinant Hepatitis-B vaccine using Uniject pre-filled device. Blood samples for antibody titer estimation were taken before vaccination and 4-6 weeks after third dose. Subjects, parents or guardians were given diary cards to record any adverse reactions. RESULTS: Protective immune responses to the vaccine were seen in 96.4% of adults and 100% of infants who completed the study. The Geometric Mean Titers (GMT in adults and infants were 518.5 and 385.41 mIU/ml respectively. Mild fever, itching, and swelling at injection site were the most common side effects observed. CONCLUSION: The safety and immunogenicity of the Hepatitis B Vaccine in the novel pre-filled device Uniject was effectively demonstrated in the present study.

  16. Safety and immunogenicity of the malaria candidate vaccines FP9 CS and MVA CS in adult Gambian men.

    Science.gov (United States)

    Imoukhuede, E B; Berthoud, T; Milligan, P; Bojang, K; Ismaili, J; Keating, S; Nwakanma, D; Keita, S; Njie, F; Sowe, M; Todryk, S; Laidlaw, S M; Skinner, M A; Lang, T; Gilbert, S; Greenwood, B M; Hill, A V S

    2006-10-30

    We assessed the safety and immunogenicity of prime-boost vectors encoding the Plasmodium falciparum circumsporozoite (CS) protein expressed either in the attenuated fowl-pox virus (FP9) or modified vaccinia virus Ankara (MVA). Thirty-two adult Gambians in groups of four to eight received one, two or three doses of FP9 CS and/or MVA CS. No serious adverse event was observed following vaccination. The most immunogenic regimen was two doses of FP9 followed by a single dose of MVA 4 weeks later (an average of 1000 IFN-gamma spot forming units/million PBMCs). This level of effector T-cell responses appears higher than that seen in previously reported studies of CS-based candidate malaria vaccines. PMID:16842888

  17. Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China.

    Science.gov (United States)

    Li, Rong Cheng; Li, Feng Xiang; Li, Yan Ping; Hou, Qi Ming; Li, Chang Gui; Li, Ya Nan; Chen, Fu Sheng; Hu, Xue Zhong; Su, Wen Bin; Zhang, Shu Min; Fang, Han Hua; Ye, Qiang; Zeng, Tian De; Liu, Tao Xuan; Li, Xiu Bi; Huang, Yun Neng; Deng, Man Ling; Zhang, Yan Ping; Ortiz, Esteban

    2011-02-24

    The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib(®)) and IPV (Imovax(®) Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules. PMID:21219984

  18. Evaluation of the safety of the dietary antioxidant ergothioneine using the bacterial reverse mutation assay

    International Nuclear Information System (INIS)

    The dietary antioxidant L-(+)-ergothioneine was tested for its potential mutagenic activity using the bacterial reverse mutation assay. The experiments were carried out using histidine-requiring auxotrophic strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and the tryptophan-requiring auxotrophic strain of Escherichia coli (Escherichia coli WP2 uvrA) in the presence and absence of a post-mitochondrial supernatant (S9) prepared from livers of phenobarbital/β-naphthoflavone-induced rats. The revertant colony numbers of vehicle control plates with and without S9 Mix were within the corresponding historical control data ranges. The reference mutagen treatments (positive controls) showed the expected, biologically relevant increases in induced revertant colonies in all experimental phases in all tester strains. No biologically relevant increases were observed in revertant colony numbers of any of the five test strains following treatment with L-(+)-ergothioneine at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. On the basis of the data reported, it can be concluded that L-(+)-ergothioneine did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Thus L-(+)-ergothioneine has no mutagenic activity on the applied bacteria tester strains under the test conditions used in this study. Research is continuing to define the role of L-(+)-ergothioneine in disease pathophysiology. Further studies on its safety are suggested.

  19. Non-chromatographic preparation of a bacterially produced single-shot modular virus-like particle capsomere vaccine for avian influenza.

    Science.gov (United States)

    Wibowo, Nani; Wu, Yang; Fan, Yuanyuan; Meers, Joanne; Lua, Linda H L; Middelberg, Anton P J

    2015-11-01

    Highly pathogenic avian influenza (HPAI) causes significant economic loss, reduced food security and poses an ongoing pandemic threat. Poultry vaccination significantly decreases these problems and recognizes that the health of humans, animals and ecosystems are connected. Low-cost manufacture of poultry vaccine matched quickly to the ever-changing circulating strain is needed for effective vaccination. Here, we re-engineered the process to manufacture bacterially synthesized modular capsomere comprising influenza M2e, previously shown to confer complete protection in challenged mice, for application in poultry. Modular capsomere was prepared using a simplified non-chromatographic salting-out precipitation method and its immunogenicity tested in vivo in poultry. Modular capsomere crudely purified by precipitation (pCapM2e) contained more contaminants than equivalent product purified by chromatography (cCapM2e). Unadjuvanted pCapM2e containing 80 EU of endotoxin per dose was inferior to highly purified and adjuvanted cCapM2e (2 EU per dose). However, addition of adjuvant to pCapM2e resulting in high immunogenicity after only a single dose of vaccination, yet without any local adverse reaction. This finding suggests a strong synergy between adjuvant, antigen and contaminants, and the possible existence of a "Goldilocks" level of contaminants, where high immunogenicity and low reactogenicity can be obtained in a single-shot vaccination. The simplified process offers potential cost and speed advantages to address the needs in influenza poultry vaccination in low-cost veterinary markets. PMID:26407921

  20. Immunity induced shortly after DNA vaccination of rainbow trout against rhabdoviruses protects against heterologous virus but not against bacterial pathogens

    DEFF Research Database (Denmark)

    Lorenzen, Niels; Lorenzen, Ellen; Einer-Jensen, Katja; LaPatra, Scott E.

    2002-01-01

    It was recently reported that DNA vaccination of rainbow trout fingerlings against viral hemorrhagic septicaemia virus (VHSV) induced protection within 8 days after intramuscular injection of plasmid DNA. In order to analyse the specificity of this early immunity, fish were vaccinated with plasmid...... DNA encoding the VHSV or the infectious haematopoietic necrosis virus (IHNV) glycoprotein genes and later challenged with homologous or heterologous pathogens. Challenge experiments revealed that immunity established shortly after vaccination was cross-protective between the two viral pathogens...

  1. Randomized Trial: Immunogenicity and Safety of Coadministered Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine and Combined Hepatitis A and B Vaccine in Girls

    DEFF Research Database (Denmark)

    Pedersen, Court; Breindahl, Morten; Aggarwal, Naresh;

    2012-01-01

    This randomized, open, controlled, multicenter study (110886/NCT00578227) evaluated human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (HPV-16/18 vaccine) coadministered with inactivated hepatitis A and B (HAB) vaccine. Coprimary objectives were to demonstrate noninferiority of hepatitis A......, hepatitis B, and HPV-16/18 immune responses at month 7 when vaccines were coadministered, compared with the same vaccines administered alone....

  2. Improving the Immunogenicity of the Mycobacterium bovis BCG Vaccine by Non-Genetic Bacterial Surface Decoration Using the Avidin-Biotin System

    OpenAIRE

    Ting-Yu Angela Liao; Alice Lau; Sunil Joseph; Vesa Hytönen; Zakaria Hmama

    2015-01-01

    Current strategies to improve the current BCG vaccine attempt to over-express genes encoding specific M. tuberculosis (Mtb) antigens and/or regulators of antigen presentation function, which indeed have the potential to reshape BCG in many ways. However, these approaches often face serious difficulties, in particular the efficiency and stability of gene expression via nucleic acid complementation and safety concerns associated with the introduction of exogenous DNA. As an alternative, we deve...

  3. Treatment guided by rapid diagnostic tests for malaria in Tanzanian children: safety and alternative bacterial diagnoses

    Directory of Open Access Journals (Sweden)

    Sykes Alma

    2011-10-01

    Full Text Available Abstract Background WHO guidelines for the treatment of young children with suspected malaria have recently changed from presumptive treatment to anti-malarial treatment guided by a blood slide or malaria rapid diagnostic test (RDT. However, there is limited evidence of the safety of this policy in routine outpatient settings in Africa. Methods Children 3-59 months of age with a non-severe febrile illness and no obvious cause were enrolled over a period of one year in a malaria endemic area of Tanzania. Treatment was determined by the results of a clinical examination and RDT result, and blood culture and serum lactate were also collected. RDT-negative children were followed up over 14 days. Results Over the course of one year, 965 children were enrolled; 158 (16.4% were RDT-positive and treated with artemether-lumefantrine and 807 (83.4% were RDT-negative and treated with non-anti-malarial medicines. Compared with RDT-positives, RDT-negative children were on average younger with a lower axillary temperature and more likely to have a history of cough or difficulty in breathing. Six (0.6% children became RDT-positive after enrolment, all of whom were PCR-negative for Plasmodium falciparum DNA at enrolment. In addition, 12 (1.2% children were admitted to hospital, one with possible malaria, none of whom died. A bacterial pathogen was identified in 9/965 (0.9% children, eight of whom were RDT-negative and one was RDT-positive, but slide-negative. Excluding three children with Salmonella typhi, all of the children with bacteraemia were ≤12 months of age. Compared to double-read research slide results RDTs had a sensitivity of 97.8% (95%CI 96.9-98.7 and specificity of 96.3% (95%CI 96.3-98.4. Conclusions Use of RDTs to direct the use of anti-malarial drugs in young children did not result in any missed diagnoses of malaria although new infections soon after a consultation with a negative RDT result may undermine confidence in results. Invasive

  4. Preclinical Safety Pharmacology Study of a Novel Protein-Based Cancer Vaccine CHP-NY-ESO-1

    OpenAIRE

    Harada, Naozumi; Hoshiai, Kiyotaka; Takahashi, Yoshiyasu; Sakaguchi, Yasue; Kuno, Takayoshi; Hishida, Tadashi; Shiku, Hiroshi

    2008-01-01

    CHP-NY-ESO-1 is a novel therapeutic cancer vaccine consisting of a recombinantprotein of cancer antigen NY-ESO-1 and a polysaccharide-based delivery system,cholesteryl pullulan. A pilot clinical study of CHP-NY-ESO-1 in cancer patients waspreviously conducted, and the adverse events related to this drug were observed to belimited to skin reactions at injection sites. To further establish the safety ofCHP-NY-ESO-1, we studied the effects of its subcutaneous injection on vital functionssuch as ...

  5. Vaccination sequence effects on immunological response and tissue bacterial burden in paratuberculosis infection in a rabbit model.

    Science.gov (United States)

    Arrazuria, Rakel; Molina, Elena; Garrido, Joseba M; Pérez, Valentín; Juste, Ramón A; Elguezabal, Natalia

    2016-01-01

    Paratuberculosis (PTB), a chronic granulomatous enteritis produced by Mycobacterium avium subspecies paratuberculosis (MAP), is considered as one of the diseases with the highest economic impact in the ruminant industry. Vaccination against MAP is recommended during the first months after birth on the basis that protection would be conferred before the first contact with mycobacteria. However, little is known about the therapeutic effect of MAP vaccination in controlled experimental conditions. The current study was designed to evaluate the efficacy of vaccination before and after challenge with MAP in a rabbit infection model. The rabbits were divided into four groups: non-infected control (NIC, n = 4), infected control challenged with MAP (IC, n = 5), vaccinated and challenged 1 month after with MAP (VSI, n = 5) and challenged with MAP and vaccinated 2 months later (IVS, n = 5). The results from this study show a quick increase in IFN-γ release upon stimulation with bovine, avian and johnin PPD in animals vaccinated before MAP challenge. All vaccinated animals show an increased humoral response as seen by western blot and ELISA. The final bacteriology index (considering tissue culture and qPCR) shows that the IC group was the most affected. Vaccination after infection (IVS) produced the lowest bacteriology index showing significant differences with the IC group (p = 0.034). In conclusion, vaccination against MAP shows positive effects in a rabbit model. However, vaccination after infection shows a slightly stronger protective effect compared to vaccination before infection, suggesting a therapeutic effect. This feature could be applied to previously infected adult animals under field conditions. PMID:27496043

  6. Evaluation of the Safety, Tolerability, and Immunogenicity of an Oral, Inactivated Whole-Cell Shigella flexneri 2a Vaccine in Healthy Adult Subjects.

    Science.gov (United States)

    Chakraborty, Subhra; Harro, Clayton; DeNearing, Barbara; Bream, Jay; Bauers, Nicole; Dally, Len; Flores, Jorge; Van de Verg, Lillian; Sack, David A; Walker, Richard

    2016-04-01

    Shigellacauses high morbidity and mortality worldwide, but there is no licensed vaccine for shigellosis yet. We evaluated the safety and immunogenicity of a formalin-inactivated whole-cellShigella flexneri2a vaccine, Sf2aWC, given orally to adult volunteers. In a double-blind, placebo-controlled trial, 82 subjects were randomized to receive three doses of vaccine in dose escalation (2.6 ± 0.8 × 10(8), × 10(9), × 10(10), and × 10(11)vaccine particles/ml). Vaccine safety was actively monitored, and antigen-specific systemic and mucosal immune responses were determined in serum, antibody in lymphocyte supernatant (ALS), and fecal samples. Cytokines were measured in the serum. Sf2aWC was well tolerated and generally safe at all four dose levels. The vaccine resulted in a dose-dependent immune response. At the highest dose, the vaccine induced robust responses to lipopolysaccharide (LPS) in both serum and ALS samples. The highest magnitude and frequency of responses occurred after the first dose in almost all samples but was delayed for IgG in serum. Fifty percent of the vaccinees had a >4-fold increase in anti-LPS fecal antibody titers. Responses to invasion plasmid antigens (Ipa) were low. The levels of interleukin-17 (IL-17), IL-2, gamma interferon (IFN-γ), tumor necrosis factor alpha (TNF-α), and IL-10 were increased, and IL-8 was decreased immediately after first dose, but these changes were very transient. This phase I trial demonstrated that the Sf2aWC vaccine, a relatively simple vaccine concept, was safe and immunogenic. The vaccine elicited immune responses which were comparable to those induced by a live, attenuatedShigellavaccine that was protective in prior human challenge studies. PMID:26865592

  7. Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children.

    Science.gov (United States)

    Watanaveeradej, Veerachai; Simasathien, Sriluck; Mammen, Mammen P; Nisalak, Ananda; Tournay, Elodie; Kerdpanich, Phirangkul; Samakoses, Rudiwilai; Putnak, Robert J; Gibbons, Robert V; Yoon, In-Kyu; Jarman, Richard G; De La Barrera, Rafael; Moris, Philippe; Eckels, Kenneth H; Thomas, Stephen J; Innis, Bruce L

    2016-06-01

    We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1-4 waned during the 1-3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response. PMID:27022153

  8. Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children

    Science.gov (United States)

    Watanaveeradej, Veerachai; Simasathien, Sriluck; Mammen, Mammen P.; Nisalak, Ananda; Tournay, Elodie; Kerdpanich, Phirangkul; Samakoses, Rudiwilai; Putnak, Robert J.; Gibbons, Robert V.; Yoon, In-Kyu; Jarman, Richard G.; De La Barrera, Rafael; Moris, Philippe; Eckels, Kenneth H.; Thomas, Stephen J.; Innis, Bruce L.

    2016-01-01

    We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1–4 waned during the 1–3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response. PMID:27022153

  9. Efficacious recombinant influenza vaccines produced by high yield bacterial expression: a solution to global pandemic and seasonal needs.

    Directory of Open Access Journals (Sweden)

    Langzhou Song

    Full Text Available It is known that physical linkage of TLR ligands and vaccine antigens significantly enhances the immunopotency of the linked antigens. We have used this approach to generate novel influenza vaccines that fuse the globular head domain of the protective hemagglutinin (HA antigen with the potent TLR5 ligand, flagellin. These fusion proteins are efficiently expressed in standard E. coli fermentation systems and the HA moiety can be faithfully refolded to take on the native conformation of the globular head. In mouse models of influenza infection, the vaccines elicit robust antibody responses that mitigate disease and protect mice from lethal challenge. These immunologically potent vaccines can be efficiently manufactured to support pandemic response, pre-pandemic and seasonal vaccines.

  10. A Recombinant Multi-Stage Vaccine against Paratuberculosis Significantly Reduces Bacterial Level in Tissues without Interference in Diagnostics

    DEFF Research Database (Denmark)

    Jungersen, Gregers; Thakur, Aneesh; Aagaard, C.; Mikkelsen, H.; Andersen, P.

    -γ assay responses from 40 to 52 weeks compared to non-vaccinated calves. These results indicate the FET11 vaccine can be used to accelerate eradication of paratuberculosis while surveillance or test-and-manage control programs for tuberculosis and Johne’s disease remain in place. Funded by EMIDA ERA......A new (FET11) recombinant vaccine against paratuberculosis was developed based on recombinant antigens from acute and latent stages of Mycobacterium avium subsp. paratuberculosis (Map) infection. In two experiments 28 calves and 15 goats were orally inoculated with live Map in their third week of...... PCR and revealed significantly reduced levels of Map and reduced histopathology. Diagnostic tests for antibody responses and cell-mediated immune responses, used as surrogates of infection, corroborated the observed vaccine efficacy: Five of seven non‐vaccinated calves seroconverted in ID Screen...

  11. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1 influenza vaccine in healthy Japanese adults

    Directory of Open Access Journals (Sweden)

    Dramé Mamadou

    2010-11-01

    Full Text Available Abstract Background Promising clinical data and significant antigen-sparing have been demonstrated for a pandemic H5N1 influenza split-virion vaccine adjuvanted with AS03A, an α-tocopherol-containing oil-in-water emulsion-based Adjuvant System. Although studies using this formulation have been reported, there have been no data for Japanese populations. This study therefore aimed to assess the immunogenicity and tolerability of a prepandemic (H5N1 influenza vaccine adjuvanted with AS03A in Japanese adults. Methods This open-label, single-group study was conducted at two centres in Japan in healthy Japanese males and females aged 20-64 years (n = 100. Subjects received two doses of vaccine, containing 3.75 μg haemagglutinin of the A/Indonesia/5/2005-like IBCDC-RG2 Clade 2.1 (H5N1 strain adjuvanted with AS03A, 21 days apart. The primary endpoint evaluated the humoral immune response in terms of H5N1 haemagglutination inhibition (HI antibody titres against the vaccine strain (Clade 2.1 21 days after the second dose. Ninety five percent confidence intervals for geometric mean titres, seroprotection, seroconversion and seropositivity rates were calculated. Secondary and exploratory endpoints included the assessment of the humoral response in terms of neutralising antibody titres, the response against additional H5N1 strains (Clade 1 and Clade 2.2, as well as the evaluation of safety and reactogenicity. Results Robust immune responses were elicited after two doses of the prepandemic influenza vaccine adjuvanted with AS03A. Overall, vaccine HI seroconversion rates and seroprotection rates were 91% 21 days after the second vaccination. This fulfilled all regulatory acceptance criteria for the vaccine-homologous HI antibody level. A substantial cross-reactive humoral immune response was also observed against the virus strains A/turkey/Turkey/1/2005 (Clade 2.2 and A/Vietnam/1194/2004 (Clade 1 after the second vaccine administration. A marked post-vaccination

  12. Immunogenicity and safety of a NeuGcGM3 based cancer vaccine: Results from a controlled study in metastatic breast cancer patients.

    Science.gov (United States)

    Mulens, Vladimir; de la Torre, Ana; Marinello, Patricia; Rodríguez, Ronald; Cardoso, Jorge; Díaz, René; O'Farrill, Miguel; Macias, Amparo; Viada, Carmen; Saurez, Giselle; Carr, Adriana; Crombet, Tania; Mazorra, Zaima; Perez, Rolando; Fernandez, Luis Enrique

    2010-09-14

    Increased levels of NeuGc-containing gangliosides have been described in human breast cancer. A controlled Phase II clinical trial was conducted in patients with metastatic breast cancer to evaluate immunogenicity, safety and to identify evidences of biological activity of a cancer vaccine composed by NeuGcGM3 in a proteoliposome of Neisseria meningitidis together with Montanide ISA 51 as adjuvant. After first line chemotherapy, 79 women were randomized 1:1 to receive the vaccine candidate or best supportive care. All patients achieved at least stable disease to the first line therapy for the metastatic condition. Treatment consisted on 5 vaccine doses every 2 weeks and then, monthly re-immunization to complete 15 doses. Vaccination with the NeuGcGM3 based vaccine was safe and the most frequent adverse events consisted on injection site reactions, fever, arthralgia and chills. The vaccine was immunogenic and a sustained increase of both IgG and IgM antibody titters against NGcGM3 was observed after the second vaccination month. Antibodies were able to recognize the NeuGcGM3(+) murine tumor cell line L1210 and the myeloma cell line P3X63. Humoral response was specific since vaccination did not result in Neu-Acetyl GM3 or GM2-antibody response. Hyperimmune sera from vaccinated patients were able to prevent the NeuGcGM3 mediated CD4 down-modulation on T lymphocytes. In the intent to treat analysis, there was a trend toward a survival advantage for the vaccine group and this effect was significant for women bearing non-visceral metastasis. Two phase III clinical studies with this vaccine candidate are ongoing. PMID:20855939

  13. Safety, immunogenicity and dose ranging of a new Vi-CRM₁₉₇ conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults.

    Directory of Open Access Journals (Sweden)

    Pierre van Damme

    Full Text Available BACKGROUND: Typhoid fever causes more than 21 million cases of disease and 200,000 deaths yearly worldwide, with more than 90% of the disease burden being reported from Asia. Epidemiological data show high disease incidence in young children and suggest that immunization programs should target children below two years of age: this is not possible with available vaccines. The Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM₁₉₇ for infant vaccination concomitantly with EPI vaccines, either starting at 6 weeks with DTP or at 9 months with measles vaccine. We report the results from a Phase 1 and a Phase 2 dose ranging trial with Vi-CRM₁₉₇ in European adults. METHODOLOGY: Following randomized blinded comparison of single vaccination with either Vi-CRM₁₉₇ or licensed polysaccharide vaccines (both containing 25·0 µg of Vi antigen, a randomised observer blinded dose ranging trial was performed in the same center to compare three concentrations of Vi-CRM₁₉₇ (1·25 µg, 5·0 µg and 12·5 µg of Vi antigen with the polysaccharide vaccine. PRINCIPAL FINDINGS: All vaccines were well tolerated. Compared to the polysaccharide vaccine, Vi-CRM₁₉₇ induced a higher incidence of mild to moderate short lasting local pain. All Vi-CRM₁₉₇ formulations induced higher Vi antibody levels compared to licensed control, with clear dose response relationship. CONCLUSIONS: Vi-CRM₁₉₇ did not elicit safety concerns, was highly immunogenic and is therefore suitable for further clinical testing in endemic populations of South Asia. TRIAL REGISTRATION: ClinicalTrials.gov NCT01123941 NCT01193907.

  14. Apparent field safety of a raccoon poxvirus-vectored plague vaccine in free-ranging prairie dogs (Cynomys spp.), Colorado, USA

    Science.gov (United States)

    Tripp, Daniel W.; Rocke, Tonie E.; Streich, Sean P.; Abbott, Rachel C.; Osorio, Jorge E.; Miller, Michael W.

    2015-01-01

    Prairie dogs (Cynomys spp.) suffer high rates of mortality from plague. An oral sylvatic plague vaccine using the raccoon poxvirus vector (designated RCN-F1/V307) has been developed for prairie dogs. This vaccine is incorporated into palatable bait along with rhodamine B as a biomarker. We conducted trials in August and September 2012 to demonstrate uptake and apparent safety of the RCN-F1/V307 vaccine in two prairie dog species under field conditions. Free-ranging prairie dogs and other associated small rodents readily consumed vaccine-laden baits during field trials with no apparent adverse effects; most sampled prairie dogs (90%) and associated small rodents (78%) had consumed baits. Visual counts of prairie dogs and their burrows revealed no evidence of prairie dog decline after vaccine exposure. No vaccine-related morbidity, mortality, or gross or microscopic lesions were observed. Poxviruses were not isolated from any animal sampled prior to bait distribution or on sites that received placebo baits. We isolated RCN-F1/V307 from 17 prairie dogs and two deer mice (Peromyscus maniculatus) captured on sites where vaccine-laden baits were distributed. Based on these findings, studies examining the utility and effectiveness of oral vaccination to prevent plague-induced mortality in prairie dogs and associated species are underway.

  15. Review of hepatitis B surface antigen-1018 ISS adjuvant-containing vaccine safety and efficacy.

    Science.gov (United States)

    Barry, Mazin; Cooper, Curtis

    2007-11-01

    Existing hepatitis B virus (HBV) vaccines produce seroprotective titers in > 90% of healthy adult recipients following 3 doses administered over 6 months. The durability of this response is variable. Vaccine efficacy is greatly diminished in immune compromised patients. Given the high worldwide prevalence and burden of disease produced by chronic HBV infection, vaccines capable of producing high rates of durable seroprotective HBV surface antibody titers are required. Immunostimulatory sequences (ISS) containing repeating sequences of cytosine phosphoguanosine (CpG) dinucleotide motifs have emerged as useful tools for modulating immune responses. Dynavax Technologies produced a synthetic oligodexynucleotide (ODN) containing these motifs, resulting in an unmethylated cytosine and phosphoguanosine ODN called 1018 ISS. Dynavax's hepatitis B virus vaccine HEPLISAV is comprised of 1018 ISS mixed with recombinant hepatitis B surface antigen. Clinical trials, to date, have shown that HEPLISAV produces rapid, high titer, sustained seroprotection in healthy adults and vaccine hyporesponsive populations. Although additional supporting data are required, this represents a promising strategy to facilitate worldwide HBV prevention efforts. PMID:17961095

  16. Safety and immunogenicity of a malaria vaccine, Plasmodium falciparum AMA-1/MSP-1 chimeric protein formulated in montanide ISA 720 in healthy adults.

    Directory of Open Access Journals (Sweden)

    Jinhong Hu

    Full Text Available BACKGROUND: The P. falciparum chimeric protein 2.9 (PfCP-2.9 consisting of the sequences of MSP1-19 and AMA-1 (III is a malaria vaccine candidate that was found to induce inhibitory antibodies in rabbits and monkeys. This was a phase I randomized, single-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of the PfCP-2.9 formulated with a novel adjuvant Montanide ISA720. Fifty-two subjects were randomly assigned to 4 dose groups of 10 participants, each receiving the test vaccine of 20, 50, 100, or 200 microg respectively, and 1 placebo group of 12 participants receiving the adjuvant only. METHODS AND FINDINGS: The vaccine formulation was shown to be safe and well-tolerated, and none of the participants withdrew. The total incidence of local adverse events (AEs was 75%, distributed among 58% of the placebo group and 80% of those vaccinated. Among the vaccinated, 65% had events that were mild and 15% experienced moderate AEs. Almost all systemic adverse reactions observed in this study were graded as mild and required no therapy. The participants receiving the test vaccine developed detectable antibody responses which were boosted by the repeated vaccinations. Sixty percent of the vaccinated participants had high ELISA titers (>1:10,000 of antigen-specific antibodies which could also recognize native parasite proteins in an immunofluorescence assay (IFA. CONCLUSION: This study is the first clinical trial for this candidate and builds on previous investigations supporting PfCP-2.9/ISA720 as a promising blood-stage malaria vaccine. Results demonstrate safety, tolerability (particularly at the lower doses tested and immunogenicity of the formulation. Further clinical development is ongoing to explore optimizing the dose and schedule of the formulation to decrease reactogenicity without compromising immunogenicity. TRIAL REGISTRATION: Chinese State Food and Drug Administration (SFDA 2002SL0046; Controlled

  17. Safety and efficacy of levofloxacin versus ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients

    Institute of Scientific and Technical Information of China (English)

    Zhi-Chao Zhang; Feng-Shuo Jin; Dong-Ming Liu; Zhou-Jun Shen; Ying-Hao Sun; Ying-Lu Guo

    2012-01-01

    Levofloxacin is a synthetic fluoroquinolone that is usually used to treat chronic bacterial prostatitis.We investigated the safety and efficacy of levofloxacin compared with ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients.This was a multicenter,open-label,randomized controlled non-inferiority trial.Four hundred and seventy-one patients with clinical symptoms/signs were enrolled into the study,and 408 patients were microbiologically confirmed chronic bacterial prostatitis,who were randomized to either oral levofloxacin (500 mg q.d.) or ciprofloxacin (500 mg b.i.d.) for 4 weeks.Bacterial clearance rate,clinical symptoms/signs,adverse reactions and disease recurrence were assessed.The clinical symptoms and signs (including dysuria,perineal discomfort or pain) and bacteria cultures in 209 patients treated with levofloxacin and 199 patients treated with ciprofloxacin were similar.The most common bacteria were Escherichia coliand Staphylococcus aureus.One to four weeks after the end of 4 weeks treatment,the bacterial clearance rate (86.06% vs.60.03%; P<O.05) and the clinical efficacy (including clinical cure and clinical improvement(93.30% vs.71.86%; P<O.05)) were significantly higher in the levofioxacin-treated group than in the ciprofloxacin-treated group.The microbiological recurrence rate was significantly lower in the levofloxacin-treated group than in the ciprofloxacin-treated group (4.00% vs.19.25%; P<O.05).Rates of adverse events and treatment-related adverse events were slightly lower in the levofloxacin-treated group than in ciprofloxacin-treated group.Levofloxacin showed some advantages over ciprofloxacin in terms of clinical efficacy and disease recurrence,with a low rate of adverse events,for the treatment of chronic bacterial prostatitis in Chinese patients.

  18. Safety assessment of genetically modified rice expressing human serum albumin from urine metabonomics and fecal bacterial profile.

    Science.gov (United States)

    Qi, Xiaozhe; Chen, Siyuan; Sheng, Yao; Guo, Mingzhang; Liu, Yifei; He, Xiaoyun; Huang, Kunlun; Xu, Wentao

    2015-02-01

    The genetically modified (GM) rice expressing human serum albumin (HSA) is used for non-food purposes; however, its food safety assessment should be conducted due to the probability of accidental mixture with conventional food. In this research, Sprague Dawley rats were fed diets containing 50% (wt/wt) GM rice expressing HSA or non-GM rice for 90 days. Urine metabolites were detected by (1)H NMR to examine the changes of the metabolites in the dynamic process of metabolism. Fecal bacterial profiles were detected by denaturing gradient gel electrophoresis to reflect intestinal health. Additionally, short chain fatty acids and fecal enzymes were investigated. The results showed that compared with rats fed the non-GM rice, some significant differences were observed in rats fed with the GM rice; however, these changes were not significantly different from the control diet group. Additionally, the gut microbiota was associated with blood indexes and urine metabolites. In conclusion, the GM rice diet is as safe as the traditional daily diet. Furthermore, urine metabonomics and fecal bacterial profiles provide a non-invasive food safety assessment rat model for genetically modified crops that are used for non-food/feed purposes. Fecal bacterial profiles have the potential for predicting the change of blood indexes in future. PMID:25478734

  19. Efficacy and safety of a live canine adenovirus-vectored rabies virus vaccine in swine.

    Science.gov (United States)

    Liu, Ye; Zhang, Shoufeng; Ma, Guangpeng; Zhang, Fei; Hu, Rongliang

    2008-10-01

    Rabies infections in swine have been reported occasionally in recent years in certain geographic locations. Although a protective vaccine consisting of inactivated rabies virus is available for use in swine, searching for a more economically viable formulation for use in developing countries is always a priority. This work describes the testing of a canine adenovirus that expresses a rabies viral epitope (CAV-2-E3Delta-RGP) in a porcine rabies model. The data presented here show that the recombinant viral vaccine was effective in protecting swine against rabies if administered intramuscularly, but not orally or intranasally, and that protection was probably related to the development of a humoral response that lasted at least 28 weeks. Following vaccination, no behavioral abnormalities were observed in vaccinated swine and virus particles were not detected in either tissues or body fluids, indicating that this formulation was safe. The recombinant virus stimulated an effective level of antibody response in the immunized swine after a single intramuscular inoculation. PMID:18721839

  20. A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon.

    Directory of Open Access Journals (Sweden)

    Bertrand Lell

    Full Text Available BACKGROUND: The malaria vaccine candidate antigen RTS,S includes parts of the pre-erythrocytic stage circumsporozoite protein fused to the Hepatitis B surface antigen. Two Adjuvant Systems are in development for this vaccine, an oil-in water emulsion--based formulation (AS02 and a formulation based on liposomes (AS01. METHODS & PRINCIPAL FINDINGS: In this Phase II, double-blind study (NCT00307021, 180 healthy Gabonese children aged 18 months to 4 years were randomized to receive either RTS,S/AS01(E or RTS,S/AS02(D, on a 0-1-2 month vaccination schedule. The children were followed-up daily for six days after each vaccination and monthly for 14 months. Blood samples were collected at 4 time-points. Both vaccines were well tolerated. Safety parameters were distributed similarly between the two groups. Both vaccines elicited a strong specific immune response after Doses 2 and 3 with a ratio of anti-CS GMT titers (AS02(D/AS01(E of 0.88 (95% CI: 0.68-1.15 post-Dose 3. After Doses 2 and 3 of experimental vaccines, anti-CS and anti-HBs antibody GMTs were higher in children who had been previously vaccinated with at least one dose of hepatitis B vaccine compared to those not previously vaccinated. CONCLUSIONS: RTS,S/AS01(E proved similarly as well tolerated and immunogenic as RTS,S/AS02(D, completing an essential step in the age de-escalation process within the RTS,S clinical development plan. TRIAL REGISTRATION: ClinicalTrials.gov. NCT00307021.

  1. Evaluation of safety and protection efficacy on cpxR and lon deleted mutant of Salmonella Gallinarum as a live vaccine candidate for fowl typhoid.

    Science.gov (United States)

    Matsuda, Kiku; Chaudhari, Atul A; Lee, John Hwa

    2011-01-17

    We evaluated a recently developed live fowl typhoid (FT) vaccine candidate, JOL916, the cpxR/lon mutant of Salmonella Gallinarum (SG), for safety and protection efficacy in 5-week-old layer chickens. Intramuscular vaccination with JOL916 revealed no or very few lesions in livers and spleens of the animals until the fourth week post-vaccination (wpv). This candidate clearly induced cellular immune responses in 5 of 5 chickens on the first and second wpv based on the peripheral lymphocyte proliferation assay. Systemic IgG responses were observed in 5 of 5 chickens from the first wpv and dramatic elevations were observed on the second and third wpv. Vaccination of chickens offered efficient protection against challenge by a wild-type SG; only slight anorexia and depression were temporarily observed after challenge in the vaccinated group while 100% mortality was observed in the positive control group. Body weight increases per day were slightly reduced between the 3rd and 6th day post challenge (dpc) compared to the negative control group; it was recovered from the 6th dpc. Collectively, these results demonstrate the safety and protective efficacy of JOL916 as a live vaccine for systemic FT. PMID:21115058

  2. An overview of food safety and bacterial foodborne zoonoses in food production animals in the Caribbean region.

    Science.gov (United States)

    Guerra, Maria Manuela Mendes; de Almeida, Andre M; Willingham, Arve Lee

    2016-08-01

    Foodborne diseases (FBDs) in the Caribbean have a high economic burden. Public health and tourism concerns rise along with the increasing number of cases and outbreaks registered over the last 20 years. Salmonella spp., Shigella spp., and Campylobacter spp. are the main bacteria associated with these incidents. In spite of undertaking limited surveillance on FBD in the region, records related to bacterial foodborne zoonoses in food-producing animals and their associated epidemiologic significance are poorly documented, giving rise to concerns about the importance of the livestock, food animal product sectors, and consumption patterns. In this review, we report the available published literature over the last 20 years on selected bacterial foodborne zoonoses in the Caribbean region and also address other food safety-related aspects (e.g., FBD food attribution, importance, surveillance), mainly aiming at recognizing data gaps and identifying possible research approaches in the animal health sector. PMID:27215411

  3. Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON(®)-TB Gold (+) Kenyan adults without evidence of tuberculosis.

    Science.gov (United States)

    Walsh, Douglas S; Owira, Victorine; Polhemus, Mark; Otieno, Lucas; Andagalu, Ben; Ogutu, Bernhards; Waitumbi, John; Hawkridge, Anthony; Shepherd, Barbara; Pau, Maria Grazia; Sadoff, Jerald; Douoguih, Macaya; McClain, J Bruce

    2016-05-01

    In a Phase 1 trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON(®)-TB Gold In-Tube test (QFT-G)(-) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G(-) and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4+ and CD8+ T cell responses to Mtb Ag85A/b peptide pools among both QFT-G(-) and (+) subjects, with trends in the CD4+ T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects. PMID:27026148

  4. Thimerosal-containing hepatitis b vaccination and the risk for diagnosed specific delays in development in the united states: A case-control study in the vaccine safety datalink

    Directory of Open Access Journals (Sweden)

    David A Geier

    2014-01-01

    Full Text Available Background: Within the first 3 years of life, the brain develops rapidly. Its development is characterized by critical developmental periods for speech, vision, hearing, language, balance, etc.; and alteration in any of the processes occurring in those critical periods can lead to specific delays in development. Aims: The present study evaluated the potential toxic effects of organic-mercury exposure from Thimerosal (49.55% mercury by weight in childhood vaccines and its hypothesized possible relationship with specific delays in development. Materials and Methods: A hypothesis testing case-control study was undertaken to evaluate the relationship between exposure to Thimerosal-containing hepatitis B vaccines administered at specific intervals in the first 6 months among cases diagnosed with specific delays in development and controls born between 1991-2000, utilizing data in the Vaccine Safety Datalink database. Results: Cases were significantly more likely than controls to have received increased organic-mercury from Thimerosal-containing hepatitis B vaccine administered in the first, second, and sixth month of life. Conclusion: Though routine childhood vaccination may be an important public health tool to reduce the morbidity and mortality associated with infectious diseases, the present study supports an association between increasing organic-mercury exposure from Thimerosal-containing childhood vaccines and the subsequent risk of specific delays in development among males and females.

  5. Are HPV vaccination services accessible to high-risk communities? A spatial analysis of HPV-associated cancer and Chlamydia rates and safety-net clinics

    OpenAIRE

    Tsui, J; Rodriguez, HP; Gee, GC; Escobedo, LA; Kominski, GF; Bastani, R

    2013-01-01

    Purpose: While HPV vaccines can greatly benefit adolescents and young women from high-risk areas, little is known about whether safety-net immunization services are geographically accessible to communities at greatest risk for HPV-associated diseases. We explore the spatial relationship between areas with high HPV risk and proximity to safety-net clinics from an ecologic perspective. Methods: We used cancer registry data and Chlamydia surveillance data to identify neighborhoods within Los Ang...

  6. Extended safety and efficacy studies of a live attenuated double leucine and pantothenate auxotroph of Mycobacterium tuberculosis as a vaccine candidate

    OpenAIRE

    Sampson, Samantha L.; Mansfield, Keith G; Carville, Angela; Magee, D Mitchell; Quitugua, Teresa; Howerth, Elizabeth W.; Bloom, Barry R.; Hondalus, Mary K.

    2011-01-01

    We have previously described the development of a live, fully attenuated Mycobacterium tuberculosis (Mtb) vaccine candidate strain with two independent attenuating auxotrophic mutations in leucine and pantothenate biosynthesis. In the present work, those studies have been extended to include testing for protective efficacy in a long-term guinea pig survival model and safety testing in the highly tuberculosis susceptible Rhesus macaque. To model the safety of the ΔleuD ΔpanCD strain in HIV-inf...

  7. Towards universal influenza vaccines?

    OpenAIRE

    Osterhaus, Ab; Fouchier, Ron; Rimmelzwaan, Guus

    2011-01-01

    Vaccination is the most cost-effective way to reduce the considerable disease burden of seasonal influenza. Although seasonal influenza vaccines are effective, their performance in the elderly and immunocompromised individuals would benefit from improvement. Major problems related to the development and production of pandemic influenza vaccines are response time and production capacity as well as vaccine efficacy and safety. Several improvements can be envisaged. Vaccine production technologi...

  8. Safety and immunogenicity of GMZ2 - a MSP3-GLURP fusion protein malaria vaccine candidate

    DEFF Research Database (Denmark)

    Esen, Meral; Kremsner, Peter G; Schleucher, Regina; Gässler, Michael; Imoukhuede, Egeruan Babatunde; Imbault, Nathalie; Leroy, Odile; Jepsen, Søren; Knudsen, Birgitte Walther; Schumm, Michael; Knobloch, Jürgen; Theisen, Michael; Mordmüller, Benjamin

    2009-01-01

    -immune individuals. Ten, 30 and 100 microg of GMZ2 were well tolerated in 30 healthy malaria-naïve German volunteers when given three times in monthly intervals. Antigen-specific antibodies as well as memory B-cells were induced and detectable throughout the one year follow-up of the study. We conclude that GMZ2 is......Malaria is a major public health problem in Sub-Saharan Africa. In highly endemic regions infants, children and pregnant women are mostly affected. An effective malaria vaccine would complement existing malaria control strategies because it can be integrated in existing immunization programs easily....... Here we present the results of the first phase Ia clinical trial of GMZ2 adjuvanted in aluminium hydroxide. GMZ2 is a malaria vaccine candidate, designed upon the rationale to induce immune responses against asexual blood stages of Plasmodium falciparum similar to those encountered in semi...

  9. Safety and immunogenicity of the RIVM hexavalent meningococcal B vesicle vaccine for Rotterdam children aged 2-3 and 7-8

    NARCIS (Netherlands)

    Labadie J; Kleijn ED de; Lafeber AB; Mees MMM; Booy K; Groot R de; Omme GW van; Dijken H van; Kuipers AJ; Dobbelsteen G van den; Juttmann RE; Wala M; Alphen AJW van; Rumke HC; Sophia Kinderziekenhuis /; LVO

    2000-01-01

    This report documents the results of a randomised controlled phase-II clinical study into the safety and immunogenicity of the RIVM hexavalent MenB vesicle vaccine among 189 children aged 2-3 and 168 children aged 7-8 in the city of Rotterdam, the Netherlands. Two concentrations of the MenB vesicle

  10. Evaluation of immunogenicity and safety of Genevac B: A new recombinant hepatitis b vaccine in comparison with Engerix B and Shanvac B in healthy adults

    Directory of Open Access Journals (Sweden)

    Vijayakumar V

    2004-01-01

    Full Text Available PURPOSE: Genevac B, a new indigenous recombinant hepatitis B vaccine was evaluated for its immunogenicity and safety in comparison with Engerix B (Smithkline Beecham Biologicals, Belgium and Shanvac B (Shantha Biotechnics, India in healthy adult volunteers. METHODS: While 240 study subjects were included in the Genevac B group, 80 each were the subjects for Engerix B and Shanvac B. A three dose regimen of 0,1,2 months was adopted with 20 gm dosage uniformly in all the three groups. Vaccinees were assessed during prevaccination, followup and post vaccination periods for clinical, haematological, biochemical and immunological parameters for safety and immunogenicity. RESULTS: Successful follow-up in all parameters for four months could be achieved in 92.5% (222/240 for Genevac B study subjects and the same was 85% (68/80 and 80% (64/80 for Engerix B and Shanvac B respectively. While 100% seroconversion was observed in all the three groups, the rate of seroprotectivity was 99.5% by Genevac B, 98.5% by Engerix B and 98.4% for Shanvac B. However the difference was not statistically significant (p>0.05. The GMT values of anti HBs after one month of completion of the vaccination were 735.50, 718.23 and 662.20 mIU/mL respectively. No systemic reaction was either seen or reported by the volunteers during the vaccination process of Genevac B and other two vaccines. Clinical, haematological and biochemical safety parameters remained within normal limits throughout the study period. CONCLUSION: The study confirms that Genevac B, the new recombinant Hepatitis B vaccine has the acceptable international standards of safety and immunogenicity.

  11. Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study.

    Science.gov (United States)

    Mitra, Monjori; Shah, Nitin; Ghosh, Apurba; Chatterjee, Suparna; Kaur, Iqbal; Bhattacharya, Nisha; Basu, Suparna

    2016-04-01

    Vi polysaccharide typhoid vaccines cannot be used in children tetanus toxoids (Vi-TT) induces protective levels even in children <2 years. We evaluated efficacy and safety following vaccination with a Vi-TT vaccine in children 6 months to 12 years of age. Overall, 1765 subjects were recruited from two registered municipal urban slums of southern Kolkata. Most of the children of the slum dwellers attended the schools in the locality which was selected with permission from the school authority. Schools were randomly divided into vaccinated (Test group) and unvaccinated group (Control group). Children and their siblings of test group received 2-doses of PedaTyph™ vaccine at 6 weeks interval. Control group received vaccines as per national guidelines. Adverse events (AEs) were examined after 30 minutes, 1 month and clinical events were observed till 12 months post-vaccination. Incidence of culture positive typhoid fever in the control group was 1.27% vis-a-vis none in vaccine group during 12 months. In subgroup evaluated for immunogenicity, an antibody titer value of 1.8 EU/ml (95% CI: 1.5 EU/ml, 2.2 EU/ml), 32 EU/ml (95% CI: 27.0 EU/ml, 39.0 EU/ml) and 14 EU/ml (95% CI: 12.0 EU/ml, 17.0 EU/ml) at baseline, 6 weeks and 12 months, respectively was observed. Sero-conversion among the sub-group was 100% after 6 weeks of post-vaccination and 83% after 12 months considering 4-fold rise from baseline. The efficacy of vaccine was 100 % (95% CI: 97.6%, 100%) in the first year of follow-up with minimal AEs post vaccination. Vi conjugate typhoid vaccine conferred 100% protection against typhoid fever in 1765 children 6 months to 12 years of age with high immunogenicity in a subgroup from the vaccine arm. PMID:26901576

  12. Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults.

    Science.gov (United States)

    Campbell, James D; Edelman, Robert; King, James C; Papa, Thomas; Ryall, Robert; Rennels, Margaret B

    2002-12-15

    Healthy adults, 18-55 years old, were immunized once with a tetravalent (serogroups A, C, Y, and W-135) meningococcal vaccine conjugated to diphtheria toxoid at 1 of 3 doses and were monitored for safety, reactogenicity, and immunogenicity. No immediate reactions were observed. Only 1 of 89 subjects reported fever; only 1 reported any severe reactogenicity (local pain/soreness, chills, arthralgia, anorexia, and malaise). For each serogroup and in each dose group, the geometric mean serum bactericidal antibody (SBA) titer and immunoglobulin G concentration increased after immunization. In the 4- and 10-microg-dose groups, all subjects had SBA titers >/=8 against serogroups A and C, and 89% and 93% of subjects had SBA titers >/=8 against serogroups Y and W-135, respectively. The A, C, Y, and W-135 Neisseria meningitidis-diphtheria toxoid conjugate vaccine, when given to healthy adults as a single intramuscular injection of 1, 4, or 10 microg/serogroup, is acceptably tolerated and immunogenic and deserves further development. PMID:12447774

  13. Combined prime-boost vaccination against tick-borne encephalitis (TBE using a recombinant vaccinia virus and a bacterial plasmid both expressing TBE virus non-structural NS1 protein

    Directory of Open Access Journals (Sweden)

    Zakharova LG

    2005-08-01

    Full Text Available Abstract Background Heterologous prime-boost immunization protocols using different gene expression systems have proven to be successful tools in protecting against various diseases in experimental animal models. The main reason for using this approach is to exploit the ability of expression cassettes to prime or boost the immune system in different ways during vaccination procedures. The purpose of the project was to study the ability of recombinant vaccinia virus (VV and bacterial plasmid, both carrying the NS1 gene from tick-borne encephalitis (TBE virus under the control of different promoters, to protect mice against lethal challenge using a heterologous prime-boost vaccination protocol. Results The heterologous prime-boost vaccination protocol, using a VV recombinant and bacterial plasmid, both containing the NS1 TBE virus protein gene under the control of different promoters, achieved a high level of protection in mice against lethal challenge with a highly pathogenic TBE virus strain. No signs of pronounced TBE infection were detected in the surviving animals. Conclusion Heterologous prime-boost vaccination protocols using recombinant VV and bacterial plasmids could be used for the development of flavivirus vaccines.

  14. Immunogenicity and safety of monovalent RIVM meningococcal B OMP vesicle F91 vaccine administered to children that received hexavalent meningococcal B vaccine 2.5 years ago

    OpenAIRE

    Lafeber AB; Limpt CJP van; Berbers GAM; Labadie J; de Kleijn ED; de Groot R; Rumke HC; van Alphen AJW; LVO

    2000-01-01

    Dit rapport beschrijft een follow-up studie naar veiligheid en immunogeniciteit van monovalent P1.7h,4 OMV vaccin (MonoMen) gebruikt als boostervaccinatie in kinderen eerder gevaccineerd met hexavalent MenB vaccin. De deelnemers aan deze studie zijn in het kader van een eerdere studie gevaccineerd met hexavalent MenB vesicle vaccin of met HepB vaccin (controle groep). Tijdens de studie traden geen ernstige bijwerkingen op. Systemische bijwerkingen werden vooral gerapporteerd tijdens de 2e en ...

  15. Longitudinal study to assess the safety and efficacy of a live-attenuated SHIV vaccine in long term immunized rhesus macaques

    International Nuclear Information System (INIS)

    Live-attenuated viruses derived from SIV and SHIV have provided the most consistent protection against challenge with pathogenic viruses, but concerns regarding their long-term safety and efficacy have hampered their clinical usefulness. We report a longitudinal study in which we evaluated the long-term safety and efficacy of ΔvpuSHIVPPC, a live virus vaccine derived from SHIVPPC. Macaques were administered two inoculations of ΔvpuSHIVPPC, three years apart, and followed for eight years. None of the five vaccinated macaques developed an AIDS-like disease from the vaccine. At eight years, macaques were challenged with pathogenic SIV and SHIV. None of the four macaques with detectable cellular-mediated immunity prior to challenge had detectable viral RNA in the plasma. This study demonstrates that multiple inoculations of a live vaccine virus can be used safely and can significantly extend the efficacy of the vaccine, as compared to a single inoculation, which is efficacious for approximately three years

  16. Attempt to develop live attenuated bacterial vaccines by selecting resistance to gossypol, proflavine hemisulfate, novobiocin, or ciprofloxacin

    Science.gov (United States)

    In an attempt to develop attenuated bacteria as potential live vaccines, four chemicals (gossypol, proflavine hemisulfate, novobiocin, and ciprofloxacin) were used to modify the following four genera of bacteria through chemical-resistance strategy: (1) Aeromonas hydrophila (9 isolates); (2) Edwards...

  17. Randomized, double-blind, active-controlled study evaluating the safety and immunogenicity of three vaccination schedules and two dose levels of AV7909 vaccine for anthrax post-exposure prophylaxis in healthy adults.

    Science.gov (United States)

    Hopkins, Robert J; Kalsi, Gurdyal; Montalvo-Lugo, Victor M; Sharma, Mona; Wu, Yukun; Muse, Derek D; Sheldon, Eric A; Hampel, Frank C; Lemiale, Laurence

    2016-04-19

    AV7909 vaccine being developed for post-exposure prophylaxis of anthrax disease may require fewer vaccinations and reduced amount of antigen to achieve an accelerated immune response over BioThrax(®) (Anthrax Vaccine Adsorbed). A phase 2, randomized, double-blind, BioThrax vacccine-controlled study was conducted to evaluate the safety and immunogenicity of three intramuscular vaccination schedules and two dose levels of AV7909 in 168 healthy adults. Subjects were randomized at a 4:3:2:4:2 ratio to 5 groups: (1) AV7909 on Days 0/14; (2) AV7909 on Days 0/28; (3) AV7909 on Days 0/14/28; (4) half dose AV7909 on Days 0/14/28; and (5) BioThrax vaccine on Days 0/14/28. Vaccinations in all groups were well tolerated. The incidences of adverse events (AEs) were 79% for AV7909 subjects and 65% for BioThrax subjects; 92% of AV7909 subjects and 87% of BioThrax subjects having AEs reported Grade 1-2 AEs. No serious AEs were assessed as potentially vaccine-related, and no AEs of potential autoimmune etiology were reported. There was no discernible pattern indicative of a safety concern across groups in the incidence or severity of reactogenicity events. Groups 2-4 achieved success for the primary endpoint, demonstrated by a lower 95% confidence limit of the percentage of subjects with protective toxin neutralizing antibody NF50 values (≥0.56) to be ≥40% at Day 63. Group 1 marginally missed the criterion (lower bound 95% confidence limit of 39.5%). Immune responses were above this threshold for Groups 1, 3 and 4 at Day 28 and all groups at Day 42. Further study of an AV7909 two-dose schedule given 2 weeks apart is warranted in light of the favorable tolerability profile and immunogenicity response relative to three doses of BioThrax vaccine, as well as preliminary data from nonclinical studies indicating similar immune responses correlate with higher survival for AV7909 than BioThrax vaccine. PMID:26979136

  18. A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens : article

    Directory of Open Access Journals (Sweden)

    C. Purchase

    2008-05-01

    Full Text Available This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks post-vaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %, by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05 in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine.

  19. 9 CFR 113.69 - Pasteurella Multocida Vaccine, Bovine.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Pasteurella Multocida Vaccine, Bovine... REQUIREMENTS Live Bacterial Vaccines § 113.69 Pasteurella Multocida Vaccine, Bovine. Pasteurella Multocida Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent...

  20. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children.

    Directory of Open Access Journals (Sweden)

    Tawee Chotpitayasunondh

    Full Text Available BACKGROUND: Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia, Africa and Europe. It has also infected people, especially children, causing severe illness and death. Although the virus shows limited ability to transmit between humans, A/H5N1 represents a potential source of the next influenza pandemic. This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted (Al and non adjuvanted influenza A/Vietnam/1194/2004 NIBRG-14 (H5N1 vaccine in children. METHODS AND FINDINGS: In a Phase II, open, randomised, multicentre trial 180 children aged 6 months to 17 years received two injections, 21 days apart, of vaccine containing either: 30 microg haemagglutinin (HA with adjuvant (30 microg+Al or 7.5 microg HA without adjuvant. An additional 60 children aged 6-35 months received two "half dose" injections (ie 15 microg+Al or 3.8 microg. Safety was followed for 21 days after vaccination. Antibody responses were assessed 21 days after each injection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30 microg+Al formulation was more immunogenic than 7.5 microg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres > or =32 (1/dil. Among 6-35 month-olds, the full doses were more immunogenic than their half dose equivalents. Vaccination induced a predominantly Th2 response against H5 HA. CONCLUSIONS: This influenza A(H5N1 vaccine was well tolerated and immunogenic in children and infants, with Al adjuvant providing a clear immunogenic advantage. These results demonstrate that an H5N1 Al-adjuvanted vaccine, previously shown to be immunogenic and safe in adults, can also be used in children, the group most at risk for pandemic influenza.

  1. Safety and protective efficacy of a spiC and crp deletion mutant of Salmonella gallinarum as a live attenuated vaccine for fowl typhoid.

    Science.gov (United States)

    Cheng, Zhao; Yin, Junlei; Kang, Xilong; Geng, Shizhong; Hu, Maozhi; Pan, Zhiming; Jiao, Xinan

    2016-08-01

    With an aim to develop a safe, immunogenic fowl typhoid (FT) vaccine, the safety and efficacy of 1009ΔspiCΔcrp, a spiC and crp deletion mutant of Salmonella gallinarum, were evaluated in chickens. Three-day-old chickens were intramuscularly immunized with 1009ΔspiCΔcrp (1×10(7)CFU) and boosted 7days later (at 10-days old) with the same dose and via the same route (vaccinated group). The vaccinated group showed no clinical symptoms and no differences in body weight compared to the unvaccinated control group. 1009ΔspiCΔcrp bacteria colonized and persisted in the liver and spleen of vaccinated chickens for >14days, and significant specific humoral and cellular immune responses were induced. Vaccinated chickens were challenged with S. gallinarum strain SG9 at 21days post-immunization (24-day-old chickens), and efficient protection was observed based on the mortality and clinical symptoms, as compared to those in the control group. These results demonstrate that 1009ΔspiCΔcrp can be used as a live attenuated vaccine. PMID:27473974

  2. Comparison of the safety and protective efficacy of vaccination with glycoprotein-G-deficient infectious laryngotracheitis virus delivered via eye-drop, drinking water or aerosol.

    Science.gov (United States)

    Devlin, J M; Browning, G F; Gilkerson, J R; Fenton, S P; Hartley, C A

    2008-02-01

    Infectious laryngotracheitis virus (ILTV), an alphaherpesvirus, causes respiratory disease in chickens and is commonly controlled by vaccination with conventionally attenuated virus strains. These vaccines have limitations due to residual pathogenicity and reversion to virulence. To avoid these problems and to better control disease, attention has recently turned towards developing a novel vaccine strain that lacks virulence gene(s). Glycoprotein G (gG) is a virulence factor in ILTV. A gG-deficient strain of ILTV has been shown to be less pathogenic than currently available vaccine strains following intratracheal inoculation of specific pathogen free chickens. Intratracheal inoculation of gG-deficient ILTV has also been shown to induce protection against disease following challenge with virulent virus. Intratracheal inoculation, however, is not suitable for large-scale vaccination of commercial poultry flocks. In this study, inoculation of gG-deficient ILTV via eye-drop, drinking water and aerosol were investigated. Aerosol inoculation resulted in undesirably low levels of safety and protective efficacy. Inoculation via eye-drop and drinking water was safe, and the levels of protective efficacy were comparable with intratracheal inoculation. Thus, gG-deficient ILTV appears to have potential for use in large-scale poultry vaccination programmes when administered via eye-drop or in drinking water. PMID:18202954

  3. Immunogenicity and safety of monovalent RIVM meningococcal B OMP vesicle F91 vaccine administered to children that received hexavalent meningococcal B vaccine 2.5 years ago

    NARCIS (Netherlands)

    Lafeber AB; van Limpt CJP; Berbers GAM; Labadie J; de Kleijn ED; de Groot R; Rumke HC; van Alphen AJW; LVO

    2000-01-01

    Dit rapport beschrijft een follow-up studie naar veiligheid en immunogeniciteit van monovalent P1.7h,4 OMV vaccin (MonoMen) gebruikt als boostervaccinatie in kinderen eerder gevaccineerd met hexavalent MenB vaccin. De deelnemers aan deze studie zijn in het kader van een eerdere studie gevaccineerd

  4. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study.

    Science.gov (United States)

    Ferrera, Giuseppe; Gajdos, Vincent; Thomas, Stéphane; Tran, Clément; Fiquet, Anne

    2009-07-01

    The safety of a single injection of the refrigerator-stable formulation of varicella vaccine VARIVAX was assessed in a blind, randomized, cross-over trial. Five hundred seven healthy children aged 12 to 15 months received subcutaneous injections of VARIVAX on day 0 and the measles, mumps and rubella vaccine (M-M-R II) on day 42 or M-M-R II on day 0 and VARIVAX on day 42. To maintain blinding, injections were given by a study nurse not involved in safety assessments. M-M-R II acted as a reference to validate the safety assessment, as its safety profile is well known in this age range. Parents or legal guardians recorded adverse events for 42 days following each injection. Solicited injection-site reactions (erythema, swelling, pain) were recorded on days 0 to 4. Other injection-site reactions, daily temperature, rashes and systemic adverse events were recorded on days 0 to 42, and serious adverse events until the final study visit. The safety profile of M-M-R II was consistent with previous reports. Following VARIVAX administration, 47.7% of children had at least one vaccine-related adverse event. Solicited injection-site reactions were reported in 13.0% of children, and 17.2% had at least one other injection-site reaction between days 0 and 42. Most reactions were small (vaccine-related systemic adverse event. Varicella or varicella-like rashes were reported in 16 children (3.2%), of which seven cases were varicella-like rashes at the injection site. In summary, the refrigerator-stable formulation of VARIVAX had a good safety profile and was well tolerated in healthy children aged 12 to 15 months, consistent with experience with the frozen formulation of VARIVAX. PMID:19305145

  5. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience

    OpenAIRE

    Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

    2014-01-01

    Purpose To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). Methods We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008–2010). Results Spontaneous ...

  6. Safety and efficacy of a new octavalent combined Erysipelas, Parvo and Leptospira vaccine in gilts against Leptospira interrogans serovar Pomona associated disease and foetal death.

    Science.gov (United States)

    Jacobs, A A C; Harks, F; Hoeijmakers, M; Collell, M; Segers, R P A M

    2015-07-31

    The safety and protective efficacy of a new octavalent combination vaccine containing inactivated Erysipelothrix rhusiopathiae, Parvovirus, and Leptospira interrogans (sensu lato) serogroups Canicola, Icterohaemorrhagiae, Australis (Bratislava), Grippotyphosa, Pomona and Tarassovi - Porcilis(®) Ery+Parvo+Lepto - was evaluated in laboratory studies and under field conditions. The safety (2× overdose and repeated dose) was tested in 26 gilts. In this study, neither vaccine related temperature increase nor other systemic reactions were observed after intramuscular vaccination. No local reactions were observed except for one animal that had a small local reaction (2cm diameter) that lasted for 5 days after the third vaccination. Efficacy was tested in 40 gilts. A group of 20 gilts was vaccinated at 20 and 24 weeks of age with Porcilis(®) Ery+Parvo+Lepto and a group of 20 age- and source-matched animals served as the control group. The gilts were inseminated at 41 weeks or 66 weeks of age and were challenged with serovar Pomona 10 weeks after insemination, corresponding to 6 months (n=2×10) and 12 months (n=2×10) after the last vaccination. After both the 6- and 12-month challenges the control animals developed clinical signs (fever, lethargy and anorexia) and leptospiraemia as determined by positive blood culture. In addition, both the 6- and 12-month challenges resulted in death of 21% and 27% of the total number of foetuses in the control groups, respectively. Clinical signs and leptospiraemia were statistically significantly lower in vaccinated gilts after both the 6- and 12-month challenges. In addition, foetal death was statistically significantly lower (3% and 2%, respectively) in vaccinated gilts after both the 6- and 12 month challenges. The vaccine was tested further under field conditions on a Portuguese farm with a history of an increasing abortion rate associated with a Leptospira serovar Pomona infection (confirmed by PCR and serology). This study was

  7. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE®

    Science.gov (United States)

    von Krempelhuber, Alfred; Vollmar, Jens; Pokorny, Rolf; Rapp, Petra; Wulff, Niels; Petzold, Barbara; Handley, Amanda; Mateo, Lyn; Siersbol, Henriette; Kollaritsch, Herwig; Chaplin, Paul

    2009-01-01

    IMVAMUNE® is a Modified Vaccinia Ankara-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE® in 164 healthy volunteers. All three IMVAMUNE® doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1×108 TCID50 IMVAMUNE® dose induced a total antibody response in 94% of the subjects following the first vaccination and the highest peak seroconversion rates by ELISA (100%) and PRNT (71%). This IMVAMUNE® dose was considered to be optimal for the further clinical development of this highly attenuated poxvirus as a safer smallpox vaccine. PMID:19944151

  8. Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study.

    Science.gov (United States)

    Anh, Dang Duc; Van Der Meeren, Olivier; Karkada, Naveen; Assudani, Deepak; Yu, Ta-Wen; Han, Htay Htay

    2016-03-01

    The introduction of combination vaccines plays a significant role in increasing vaccine acceptance and widening vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study vaccine. DTPa-IPV/Hib conjugate vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years. PMID:26337197

  9. Integration of selective breeding and vaccination to improve disease resistance in aquaculture: Application to control bacterial cold water disease

    Science.gov (United States)

    Bacterial cold water disease (BCWD) is a frequent cause of elevated mortality in rainbow trout and the development of effective control strategies is a priority within the U.S. A goal of the NCCCWA breeding program is to produce germplasm with superior growth and survival following exposure to infe...

  10. Antibody persistence at 18-20 months of age and safety and immunogenicity of a booster dose of a combined DTaP-IPV//PRP∼T vaccine compared to separate vaccines (DTaP, PRP∼T and IPV) following primary vaccination of healthy infants in the People's Republic of China.

    Science.gov (United States)

    Li, Rong Cheng; Li, Feng Xiang; Li, Yan Ping; Hou, Qi Ming; Li, Chang Gui; Li, Ya Nan; Chen, Fu Sheng; Hu, Xue Zhong; Su, Wen Bin; Zhang, Shu Min; Fang, Han Hua; Ye, Qiang; Zeng, Tian De; Liu, Tao Xuan; Li, Xiu Bi; Huang, Yun Neng; Deng, Man Ling; Zhang, Yan Ping; Ortiz, Esteban

    2011-11-21

    This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP-IPV//PRP∼T (Pentaxim®, Sanofi Pasteur's AcXim family) combined vaccine and of standalone vaccines one year after primary vaccination in the People's Republic of China. Participants (N=719) previously primed with DTaP-IPV//PRP∼T at 2, 3, 4 months (Group A, N=255), 3, 4, 5 months (Group B, N=233), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib®) and IPV (Imovax® Polio) at 3, 4, 5 months (Group C, N=231) received boosters of the same vaccines at 18-20 months of age. Seroprotection (SP) and seroconversion (SC) were determined before and 1 month after the booster. Safety was monitored from parental reports. In all groups 87.6-100% of participants had pre-booster protective anti-PRP, -diphtheria, -tetanus and -poliovirus antibody titers; post-booster, all SP rates were 100% and SC was ≥ 80.4% for anti-pertussis titers ≥ 4-fold increase. Reactogenicity was low for each group. These data support the use of the DTaP-IPV//PRP∼T vaccine in the People's Republic of China compared to separate DTaP, IPV, and PRP∼T administration in terms of both safety and immunogenicity. PMID:22001281

  11. Assessment of the safety and efficacy of low pathogenic avian influenza (H9N2) virus in inactivated oil emulsion vaccine in laying hens

    Science.gov (United States)

    Shin, Jeong-Hwa; Mo, Jong Seo; Kim, Jong-Nyeo; Mo, In-pil

    2016-01-01

    In Korea, several outbreaks of low pathogenic AI (H9N2) viral infections leading to decreased egg production and increased mortality have been reported on commercial farms since 1996, resulting in severe economic losses. To control the H9N2 LPAI endemic, the Korea Veterinary Authority has permitted the use of the inactivated H9N2 LPAI vaccine since 2007. In this study, we developed a killed vaccine using a low pathogenic H9N2 AI virus (A/chicken/Korea/ADL0401) and conducted safety and efficacy tests in commercial layer farms while focusing on analysis of factors that cause losses to farms, including egg production rate, egg abnormality, and feed efficiency. The egg production rate of the control group declined dramatically 5 days after the challenge. There were no changes in feed consumption of all three groups before the challenge, but rates of the control declined afterward. Clinical signs in the vaccinated groups were similar, and a slight decline in feed consumption was observed after challenge; however, this returned to normal more rapidly than the control group and commercial layers. Overall, the results of this study indicate that the safety and efficacy of the vaccine are adequate to provide protection against the AI field infection (H9N2) epidemic in Korea. PMID:27051337

  12. Vaccine Safety and Efficacy Evaluation of a Recombinant Bovine Respiratory Syncytial Virus (BRSV) with Deletion of the SH Gene and Subunit Vaccines Based On Recombinant Human RSV Proteins: N-nanorings, P and M2-1, in Calves with Maternal Antibodies

    OpenAIRE

    Blodorn, Krister; Hagglund, Sara; Fix, Jenna; Dubuquoy, Catherine; Makabi-Panzu, Boby; Thom, Michelle; Karlsson, Per; Roque, Jean-Louis; Karlstam, Erika; Pringle, John; Eleouet, Jean Francois; Riffault, Sabine; Taylor, Geraldine; Valarcher, Jean Francois

    2014-01-01

    The development of safe and effective vaccines against both bovine and human respiratory syncytial viruses (BRSV, HRSV) to be used in the presence of RSV-specific maternally-derived antibodies (MDA) remains a high priority in human and veterinary medicine. Herein, we present safety and efficacy results from a virulent BRSV challenge of calves with MDA, which were immunized with one of three vaccine candidates that allow serological differentiation of infected from vaccinated animals (DIVA): a...

  13. The safety and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) booster vaccine in healthy Vietnamese children.

    Science.gov (United States)

    Anh, Dang Duc; Jayadeva, Girish; Kuriyakose, Sherine; Han, Htay Htay

    2016-08-17

    Despite effective infant immunization against pertussis, the disease continues to circulate due to waning immunity. Booster vaccinations against pertussis beyond infancy are widely recommended. In Vietnam, however, no recommendations for pertussis boosters beyond the second year of life exist. This open-label, single-centre study was designed to assess the safety of a single booster dose of reduced-antigen-content-diphtheria-tetanus-acellular-pertussis vaccine (dTpa) in 300 healthy Vietnamese children (mean age 7.9years), who had completed primary vaccination against diphtheria, tetanus and pertussis. Solicited symptoms were recorded for 4days and unsolicited and serious adverse events (SAEs) for 31days post-vaccination. Pain and fatigue were the most common solicited local and general symptoms in 35.0% and 14.0% of children, respectively. Grade 3 swelling occurred in 3 children; no large injection site reactions or SAEs were reported. The dTpa booster vaccine was well tolerated and this study supports its administration in school age Vietnamese children. PMID:27435387

  14. Vaccination during pregnancy

    OpenAIRE

    Bozzo, Pina; Narducci, Andrea; Einarson, Adrienne

    2011-01-01

    Question One of my patients is studying to become a dental hygienist. Owing to the program requirements, she received several vaccinations last week, including measles-mumps-rubella, varicella, and hepatitis B (HB) vaccines, as well as a tetanus booster. However, today a blood test confirmed that she is currently 6 weeks pregnant. What is known about the safety of these vaccines during pregnancy, and are there any general recommendations for vaccines for women who are planning to become pregn...

  15. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE®

    OpenAIRE

    von Krempelhuber, Alfred; Vollmar, Jens; Pokorny, Rolf; Rapp, Petra; Wulff, Niels; Petzold, Barbara; Handley, Amanda; Mateo, Lyn; Siersbol, Henriette; Kollaritsch, Herwig; Chaplin, Paul

    2009-01-01

    IMVAMUNE® is a Modified Vaccinia Ankara-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE® in 164 healthy volunteers. All three IMVAMUNE® doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1×108 TCID50 IMVAMUNE® dose induced a total antibody response i...

  16. Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions

    OpenAIRE

    KULPA-EDDY Jodie; Srinivas, Geetha; HALDER Maria; Brown, Karen; DRAAYER Hans; GALVIN Jeffrey; CLAASEN Ivo; WOODLAND Ralph; DOELLING Vivian; JONES Brett; Stokes, William

    2011-01-01

    NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. Six topics were addressed in detail by speakers and workshop participants and are reported in a series of six reports. This workshop report, the last in the series, addresses methods and strategies for veterinary vacci...

  17. Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

    Directory of Open Access Journals (Sweden)

    Lauren A V Orenstein

    Full Text Available BACKGROUND: Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa. METHODS: We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM, low birth weight (LBW, prematurity, and major congenital malformations (MCM in Sub-Saharan African countries were also performed. FINDINGS: Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3 per 1,000 total births, and the most common causes were hemorrhage (34%, dystocia (22%, and severe hypertensive disorders of pregnancy (22%. Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4 or premature (median 15.4%, IQR: 10.6-19.1 were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6, with the musculoskeletal system comprising 30%. INTERPRETATION: Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies

  18. Phase 1 Safety and Immunogenicity Study of a Quadrivalent Seasonal Flu Vaccine Comprising Recombinant Hemagglutinin-Flagellin Fusion Proteins.

    Science.gov (United States)

    Tussey, Lynda; Strout, Cynthia; Davis, Matthew; Johnson, Casey; Lucksinger, Gregg; Umlauf, Scott; Song, Langzhou; Liu, Ge; Abraham, Katalin; White, C Jo

    2016-01-01

    Background.  We evaluated the safety and immunogenicity of VAX2012Q, a quadrivalent influenza vaccine comprising 4 hemagglutinin subunits fused to flagellin. Methods.  In this dose-ranging, open-label study, healthy adults (18-40 years) were divided into 7 cohorts for evaluation of 5 dose levels and 3 component ratios. Dose levels were as follows: (1) 1 mcg per component of VAX128C (H1N1), VAX181 (H3N2), VAX173 (B-YAM), and VAX172 (B-VIC), respectively; (2) 2 mcg per component, respectively; (3) 2, 4, 4, and 4 mcg of each component, respectively; (4) 2, 4, 6, and 6 mcg of each component, respectively; and (5) 3 mcg per component, respectively. Tolerability and immunogenicity data were analyzed. Results.  Three hundred sixteen subjects received VAX2012Q (309 per protocol). At all dose levels, 54% to 65% of subjects reported mild injection site pain, the most common local reaction. Moderate injection site pain increased at dose levels 2 through 5 (22%-42%, compared with 20% at dose level 1). Systemic symptoms were mostly mild to moderate with moderate symptoms increasing in dose levels 3 and 4. Three dose level 3 subjects (6%) reported severe, transient chills and or fever. Mean fold rises in hemagglutination inhibition titers ranged from 2.5 to 6.9 despite high baseline titers. Mean seroprotection rates were ≥90% and mean seroconversion rates were ≥40% for all strains in all groups postvaccination. Conclusions.  VAX2012Q elicited immune responses at all dose levels with no significant safety concerns. Doses of 2 or 3 mcg per component provided a favorable balance of tolerability and immunogenicity. PMID:26925433

  19. Antibacterials: A sweet vaccine

    Science.gov (United States)

    Bundle, David

    2016-03-01

    Vaccination with a synthetic glycoconjugate, in combination with the administration of an inhibitor that blocks capsular polysaccharide synthesis in bacteria, could offer an alternative route to combat bacterial infections.

  20. Safety and vaccine efficacy of a glycoprotein G deficient strain of infectious laryngotracheitis virus delivered in ovo.

    Science.gov (United States)

    Legione, Alistair R; Coppo, Mauricio J C; Lee, Sang-Won; Noormohammadi, Amir H; Hartley, Carol A; Browning, Glenn F; Gilkerson, James R; O'Rourke, Denise; Devlin, Joanne M

    2012-11-26

    Infectious laryngotracheitis virus (ILTV), an alphaherpesvirus, causes respiratory disease in chickens and is commonly controlled by vaccination with conventionally attenuated vaccines. Glycoprotein G (gG) is a virulence factor in ILTV and a gG deficient strain of ILTV (ΔgG-ILTV) has shown potential for use as a vaccine. In the poultry industry vaccination via drinking water is common, but technology is now available to allow quicker and more accurate in ovo vaccination of embryos at 18 days of incubation. In this study ΔgG-ILTV was delivered to chicken embryos at three different doses (10(2), 10(3) and 10(4) plaque forming units per egg) using manual in ovo vaccination. At 20 days after hatching, birds were challenged intra-tracheally with wild type ILTV and protection was measured. In ovo vaccination was shown to be safe, as there were no developmental differences between birds from hatching up to 20 days of age, as measured by weight gain. The highest dose of vaccine was the most efficacious, resulting in a weight gain not significantly different from unvaccinated/unchallenged birds seven days after challenge. In contrast, birds vaccinated with the lowest dose showed weight gains not significantly different from unvaccinated/challenged birds. Gross pathology and histopathology of the trachea reflected these observations, with birds vaccinated with the highest dose having less severe lesions. However, qPCR results suggested the vaccine did not prevent the challenge virus replicating in the trachea. This study is the first to assess in ovo delivery of a live attenuated ILTV vaccine and shows that in ovo vaccination with ΔgG-ILTV can be both safe and efficacious. PMID:23084851

  1. 国产甲型肝炎减毒活疫苗和灭活疫苗安全性评价%Evaluation on Safety of Domestic Hepatitis A Attenuated Live Vaccine and Hepatitis A Inactivated Vaccine

    Institute of Scientific and Technical Information of China (English)

    张晓曙; 安婧; 刘建锋; 付鸿; 高丽; 李慧

    2012-01-01

    Objective To evaluate safety of domestic hepatitis A attenuated live vaccine (HepA-L) and hepatitis A inactivated vaccine (HepA-I), and provide reference for emergency vaccination after hepatitis A outbreaks. Methods 493 children aged 6-9 years confirmed negative with antibody to hepatitis A virus (Anti-HAV) produced by Abbott. U.S were divided randomly into four groups. Group A were vaccinated with domestic HepA-L, group B were vaccinated with domestic HepA-I, group C were vaccinated with hepatitis B vaccine made by recombinant deoxyribonucleic acid technigues in sacchararomyces cerevisiae yeast ( HepB-SCY ) as negative control and group D were vaccinated HepA-I produced by GlaxoSmithKline Biologicals S.A. (GSK)as positive control. The adverse events following immunization (AEFIs) were observed after 30 minutes, 24, 48 and 72 hours after vaccination with double-blind method. Results The main AEFIs were fever, local pain and scleroma. There were no other severe AEFIs. The rate of AEFIs was 13.95% in Group A, 15.25% in group B, 16.80% in group C and 25.62% in group D. There were no statistical differences between different groups (x2=6.953, P=0.073). Conclusion Domestic HepA-L, domestic HepA-I and imported HepA-I are Safe.%目的 评价国产甲型病毒性肝炎(甲肝)减毒活疫苗(Hepatitis A Attenuated Live Vaccine,HepA-L)和灭活疫苗(Hepatitis A Inactivated Vaccine,HepA-I)的安全性,为开展甲肝爆发疫情应急接种提供参考.方法 用美国雅培(Abbott)公司生产的抗甲肝病毒抗体(Antibody to Hepatitis A Virus,Anti-HAV)试剂,筛查未感染HAV的6~9岁儿童.将入选对象随机分为4组,分别接种国产HepA-L和国产HepA-I,以国产的重组乙型肝炎疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Technigues in Sacchararomyces Cerevisiae Yeast,HepB-SCY)为阴性对照,以GlaxoSmithKline Biologicals S.A.(GSK)生产的HepA-I为阳性对照,采取随机双盲方法,观察接种疫苗后30min

  2. Vexing Vaccines

    Science.gov (United States)

    Bowman, Darcia Harris

    2004-01-01

    Schools play a key role in ensuring that children are being immunized against diseases, but conflicting research is making enforcement difficult. This article discusses a growing trend of vaccine avoidance and the endless supply of conflicting information and research about immunization safety. Despite the controversy, many people appear to accept…

  3. Poliovirus Vaccines

    OpenAIRE

    Isik Yalcin

    2008-01-01

    The two types of poliovirus vaccines are inactivated vaccine, given parenterally, and live virus vaccine, given orally. Oral poliovirus is the vaccine of choice for global eradication. Either inactivated vaccine or oral vaccine may be given concurrently with other routinely recommended childhood vaccines. No serious adverse events have been associated with the vaccine. Oral poliovirus vaccine can cause vaccine associated paralytic poliomyelitis.

  4. Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA vaccine to prevent anthrax in adults.

    Directory of Open Access Journals (Sweden)

    Bruce K Brown

    Full Text Available BACKGROUND: The fatal disease caused by Bacillus anthracis is preventable with a prophylactic vaccine. The currently available anthrax vaccine requires a lengthy immunization schedule, and simpler and more immunogenic options for protection against anthrax are a priority for development. In this report we describe a phase I clinical trial testing the safety and immunogenicity of an anthrax vaccine using recombinant Escherichia coli-derived, B. anthracis protective antigen (rPA. METHODOLOGY/PRINCIPAL FINDINGS: A total of 73 healthy adults ages 18-40 were enrolled and 67 received 2 injections separated by 4 weeks of either buffered saline placebo, or rPA formulated with or without 704 µg/ml Alhydrogel® adjuvant in increasing doses (5, 25, 50, 100 µg of rPA. Participants were followed for one year and safety and immunologic data were assessed. Tenderness and warmth were the most common post-injection site reactions. No serious adverse events related to the vaccine were observed. The most robust humoral immune responses were observed in subjects receiving 50 µg of rPA formulated with Alhydrogel® with a geometric mean concentration of anti-rPA IgG antibodies of 283 µg/ml and a toxin neutralizing geometric 50% reciprocal geometric mean titer of 1061. The highest lymphoproliferative peak cellular response (median Lymphocyte Stimulation Index of 29 was observed in the group receiving 25 µg Alhydrogel®-formulated rPA. CONCLUSIONS/SIGNIFICANCE: The vaccine was safe, well tolerated and stimulated a robust humoral and cellular response after two doses. TRIAL REGISTRATION: ClinicalTrials.gov NCT00057525.

  5. Safety and immunogenicity of human papillomavirus-16/18AS04-adjuvanted vaccine in healthy Chinese females aged 15 to 45 years: a phase I trial

    Institute of Scientific and Technical Information of China (English)

    Feng-Cai Zhu; Chang-Gui Li; Hong-Xing Pan; Yi-Ju Zhang; Dan Bi; Hai-Wen Tang; Sanjoy Datta

    2011-01-01

    Globally,about 70% of cervical cancers are associated with human papillomavirus (HPV)-16 or HPV-18 infection. A meta-analysis of epidemiologic studies in China showed that HPV was present in 98% of cervical cancer samples. The HPV-16/18 AS04-adjuvanted vaccine Cervarix(R)* has shown a high level of protection against HPV-16/18 infections and associated cervical lesions. This phase I trial (NCT00549900)assessed the safety, tolerability, and immunogenicity of the vaccine in Chinese. Thirty healthy Chinese females, aged 15 to 45 years with a median age of 29.5 years, received three doses of Cervarix(R) in Months 0, 1, and 6. Safety was assessed via recording solicited local and systemic symptoms within 7days and unsolicited symptoms within 30 days after each vaccination. Serious adverse events, new onset of chronic diseases, and other medically significant conditions were recorded throughout this trial. As an exploratory objective, HPV-16/18 antibody titers were determined by enzyme-linked immunosorbent assay in serum samples collected in Months 0 and 7. Pain at the injection site was the most frequently reported local symptom. Two subjects reported medically significant adverse events. Both cases were assessed as unrelated to vaccination by the investigator. In Month 7, 100% seroconversion was observed for both anti-HPV-16 and anti-HPV-18 with high geometric mean antibody titers. HPV-16/18 AS04-adjuvanted vaccine,evaluated for the first time in Chinese females, was generally well tolerated and immunogenic, as previously shown in global studies.

  6. Safety, immunogenicity, and efficacy of the ML29 reassortant vaccine for Lassa fever in small non-human primates✩

    OpenAIRE

    Lukashevich, Igor S.; Carrion, Ricardo; Salvato, Maria S.; Mansfield, Keith; Brasky, Kathleen; Zapata, Juan; Cairo, Cristiana; Goicochea, Marco; Hoosien, Gia E.; Ticer, Anysha; Bryant, Joseph; Davis, Harry; Hammamieh, Rasha; Mayda, Maria; Jett, Marti

    2008-01-01

    A single injection of ML29 reassortant vaccine for Lassa fever induces low, transient viremia, and low or moderate levels of ML29 replication in tissues of common marmosets depending on the dose of the vaccination. The vaccination elicits specific immune responses and completely protects marmosets against fatal disease by induction of sterilizing cell-mediated immunity. DNA array analysis of human peripheral blood mononuclear cells from healthy donors exposed to ML29 revealed that gene expres...

  7. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults

    OpenAIRE

    Beran, Jirí; Hobzova, Lenka; Wertzova, Veronika; Kuriyakose, Sherine; Leyssen, Maarten; Surquin, Murielle; Houard, Sophie

    2010-01-01

    HB-AS 02 is an investigational adjuvanted hepatitis B virus (HBV) vaccine for potential use in patients with renal insufficiency and other immunocompromised individuals. In this Phase III lot-to-lot consistency study, 450 healthy adult volunteers who had not previously been vaccinated against HBV were randomized to one of three production lots of HBAS 02 at 0 and 1 month and followed until one month after the last vaccine dose. Lot-to-lot consistency was established. High seroprotection rates...

  8. Animal Drug Safety FAQs

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  9. Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    William S Pomat

    Full Text Available BACKGROUND: Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7 given in a 0-1-2-month (neonatal schedule with that of the routine 1-2-3-month (infant schedule. METHODS: We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV at age 9 months. Serotype-specific serum IgG for PCV7 (VT serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV. RESULTS: We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001 and 9V (p<0.05 and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001 at age 2 months in the neonatal (one month post-dose2 PCV7 than in the infant group (one month post-dose1 PCV7. PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months. CONCLUSIONS: PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months. TRIAL REGISTRATION

  10. Influence of IFNgamma co-expression on the safety and antiviral efficacy of recombinant fowlpox virus HIV therapeutic vaccines following interruption of antiretroviral therapy.

    Science.gov (United States)

    Emery, S; Kelleher, A D; Workman, C; Puls, R L; Bloch, M; Baker, D; Anderson, J; Hoy, J; Ip, S; Nalliah, K; Ward, L D; Law, M G; Cooper, D A

    2007-01-01

    Therapeutic immunization to stimulate host immune responses and control human immunodeficiency virus (HIV-1) replication is being investigated as a supplementary treatment for the management of HIV infection. On completion of an earlier study involving three vaccinations while taking combination antiretroviral therapy (CART), twenty-five subjects with plasma viral load (pVL) fowl pox vaccine (rFPV) expressing HIV-1 Gag/Pol; [partial construct- PC (n = 8)] or rFPV coexpressing HIV-1 Gag/Pol and human interferon gamma[full construct - FC (n = 10)]. One week after the booster vaccination, participants stopped ART and were monitored for safety, pVL and immunological parameters for < or =20 weeks. The time weighted mean change (SD) from baseline plasma HIV RNA was 1.80 (0.72), 1.78 (0.91) and 0.96 (0.91) log(10) copies/mL for placebo, PC and FC recipients respectively (p = 0.06; mean differences between placebo and FC). Laboratory evaluations did not reveal differences in anti-HIV specific immune responses between study arms. No difference between treatment arms for host genetic factors known to affect pVL was demonstrated. In conclusion, vaccination with FC was associated with a trend toward lower rates of HIV replication following cessation of ART relative to placebo or PC. The promising antiretrovirological effect supports further study of FC in a larger trial with a broader population of patients with HIV disease. PMID:18340117

  11. The experimental study on safety of the simultaneous immunization of anthrax vaccine and leptospira vaccine%炭疽疫苗和钩端螺旋体疫苗联合接种安全性实验研究

    Institute of Scientific and Technical Information of China (English)

    王亚玉; 邵中军; 李东力; 闫永平

    2012-01-01

    Objective An animal experiment was established to evaluate the safety of the simultaneous vaccination of anthrax vaccine and leptospira vaccine, preparing for the further use in the large population, and to find the optimal dose of simultaneous immunization for the evaluation of safety. Methods 96 mice were randomly divided into 6 groups and the number of male and female was equal. Mice were injected subcutaneously with different doses of vaccine. A combination of 1/10, 1/20, and 1/40 dose of live attenuated anthrax vaccine and 1/5 and 1/3 dose of leptospira vaccine were experimented in 5 groups and 1 group was employed as blank control. Body weight, pathology indices, biochemical indices and spontaneous activity were used to evaluate the safety of immunization. Results Local edema was the main side effect at 48~72 h after simultaneous immunization. 2 mice died in 2 groups (1,1) separately. The white blood cells (WBC) counts increased at the beginning and then became normal after the first simultaneous immunization. This phenomenon could be repeated in the later immunization. There was no significant difference in the other indexes among groups (P>0.05). Conclusions Simultaneous immunization of the optimal doses of live attenuated anthrax vaccine and leptospira vaccine on mice is practicable.%目的 对炭疽疫苗和钩端螺旋体(简称钩体)疫苗进行联合接种动物实验研究,评价联合接种疫苗的安全性,确定最佳实验免疫剂量,为炭疽疫苗和钩体疫苗的人群联合接种提供理论依据.方法 96只实验鼠分层随机分为6组,每组16只,雌雄各半.采用背部皮下接种,取炭疽疫苗1/10、钩体疫苗1/5的人用剂量进行联合接种,同时组合两种疫苗的临近剂量组,即炭疽疫苗1/20、1/40,钩体疫苗1/3的人用剂量进行联合接种,运用体重、血液学指标以及病理组织学等指标对疫苗的安全性进行评价.结果 实验动物接种2种疫苗48~72 h后,部分动物

  12. 9 CFR 113.68 - Pasteurella Haemolytica Vaccine, Bovine.

    Science.gov (United States)

    2010-01-01

    ..., Bovine. 113.68 Section 113.68 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS Live Bacterial Vaccines § 113.68 Pasteurella Haemolytica Vaccine, Bovine. Pasteurella Haemolytica Vaccine, Bovine, shall be prepared as a desiccated live culture bacterial vaccine of an avirulent...

  13. Rapid and efficient introduction of a foreign gene into bacterial artificial chromosome-cloned varicella vaccine by Tn7-mediated site-specific transposition

    International Nuclear Information System (INIS)

    Using a rapid and reliable system based on Tn7-mediated site-specific transposition, we have successfully constructed a recombinant Oka varicella vaccine (vOka) expressing the mumps virus (MuV) fusion protein (F). The backbone of the vector was our previously reported vOka-BAC (bacterial artificial chromosome) genome. We inserted the transposon Tn7 attachment sequence, LacZα-mini-attTn7, into the region between ORF12 and ORF13 to generate a vOka-BAC-Tn genome. The MuV-F expressing cassette was transposed into the vOka-BAC genome at the mini-attTn7 transposition site. MuV-F protein was expressed in recombinant virus, rvOka-F infected cells. In addition, the MuV-F protein was cleaved in the rvOka-F infected cells as in MuV-infected cells. The growth of rvOka-F was similar to that of the original recombinant vOka without the F gene. Thus, we show that Tn7-mediated transposition is an efficient method for introducing a foreign gene expression cassette into the vOka-BAC genome as a live virus vector.

  14. Safety and efficacy of reduced doses of Brucella melitensis strain Rev. 1 vaccine in pregnant Iranian fat-tailed ewes

    Directory of Open Access Journals (Sweden)

    Mohammad Ebrahimi

    2012-12-01

    Full Text Available Brucellosis is one of the most important zoonotic diseases and is a significant cause of abortion in animals. Brucella melitensis strain Rev. 1 is recommended as the most effective vaccine for small ruminants but the application of full doses in adult animals is restricted. This study was conducted to determine a proper reduced dose of vaccine which confers protection but which is not abortifacient in Iranian fat-tailed sheep. A total of 51 non-vaccinated pregnant ewes were divided into three main groups and several subgroups. Ewes in different groups were vaccinated at different stages of pregnancy and various subgroups were subcutaneously immunised with different quantities of the micro-organism (7.5 × 106, 106, 5 × 105. Ewes again became pregnant a year later and were challenged with the wild-type strain to evaluate the protection conferred. Results revealed that the proportion of vaccination-induced abortions was significantly higher in ewes immunised with 7.5 × 106 Rev. 1 organisms than in those which received 106 or 5 × 105 bacteria. While 80% of non-vaccinated ewes aborted after challenge, none of the vaccinated ewes aborted post-challenge. This study indicated that a reduced dose of Rev. 1 vaccine containing 106 or 5 × 105 live cells could be safely used to induce protection in Iranian fat-tailed sheep at various stages of pregnancy.

  15. The safety and immunogenicity of an in ovo vaccine against Newcastle disease virus differ between two lines of chicken.

    Science.gov (United States)

    Dilaveris, Dimitrios; Chen, Changlin; Kaiser, Pete; Russell, Peter H

    2007-05-10

    Newcastle disease virus is a major threat to poultry and in ovo vaccines are needed. A live in ovo vaccine for Newcastle disease virus, which was licensed but not marketed, was unsafe. It killed 32% of line 0 chicks and 10% of vaccine Lohmann (VALO) chicks using the maximum recommended dose that infected about 40% of the embryos. VALO's made more antibody than line 0's whether infected in ovo or by contact. The vaccine interrupted the massive development of the air capillaries between injection and hatch 3 days later. Cytokines, delivered as DNA in plasmids, did not function as adjuvants. IFN-gamma prevented infection. IL-4 or IL-18 had little or no effect. Line 0 chicks that had been infected by contact were protected and so the unsafe in ovo vaccination of a minority could protect the majority. PMID:17321645

  16. Mucosal SIV vaccines comprising inactivated virus particles and bacterial adjuvants induce CD8+T-regulatory cells that suppress SIV positive CD4+cell activation and prevent SIV infection in the macaque model.

    Directory of Open Access Journals (Sweden)

    Jean Marie eAndrieu

    2014-06-01

    Full Text Available A new paradigm of mucosal vaccination against HIV infection has been investigated in the macaque model. A vaccine consisting of inactivated SIVmac239 particles together with a living bacterial adjuvant (either the Calmette & Guerin bacillus, lactobacillus plantarum or Lactobacillus rhamnosus was administered to macaques via the vaginal or oral/intragastic route. In contrast to all established human and veterinary vaccines, these three vaccine regimens did not elicit SIV-specific antibodies nor cytotoxic T-lymphocytes but induced a previously unrecognized population of non-cytolytic MHCIb/E-restricted CD8+T regulatory cells that suppressed the activation of SIV positive CD4+ T-lymphocytes. SIV reverse transcription was thereby blocked in inactivated CD4+ T-cells; the initial burst of virus replication was prevented and the vaccinated macaques were protected from a challenge infection. Three to 14 months after intragastric immunization, 24 macaques were challenged intrarectally with a high dose of SIVmac239 or with the heterologous strain SIV B670 (both strains grown on macaques PBMC. Twenty-three of these animals were found to be protected for up to 48 months while all 24 control macaques became infected. This protective effect against SIV challenge together with the concomitant identification of a robust ex-vivo correlate of protection suggests a new approach for developing an HIV vaccine in humans. The induction of this new class of CD8+ T regulatory cells could also possibly be used therapeutically for suppressing HIV replication in infected patients and this novel tolerogenic vaccine paradigm may have potential applications for treating a wide range of immune disorders and is likely to may have profound implications across immunology generally.

  17. Transport ways and safety research progress of DNA vaccine%DNA疫苗的转运途径及其安全性研究进展

    Institute of Scientific and Technical Information of China (English)

    邓璐; 邹墨; 刘艳; 罗恩杰

    2011-01-01

    目的总结DNA疫苗主要转运途径及其安全性的研究现状,探讨DNA疫苗的不同转运途径在动物实验和人类试验中的应用。方法应用Medline、PubMed及CNKI期刊全文数据库检索系统,以“DNA疫苗、电穿孔、基因枪、直接注射、喷雾、脂质体包裹”等为关键词,检索2008-2011年的相关文献,总共检索到英文文献97条。纳入标准:①DNA疫苗的一般特性;②DNA疫苗电传孔转运途径;③DNA疫苗基因枪注射途径;④DNA疫苗直接注射途径;⑤DNA疫苗黏膜免疫途径。根据纳入标准,符合分析的文献33篇。结果DNA疫苗自偶然被发现以来,显示出了无法比拟的优越性,一举成为第三代疫苗。使用合适的转运途径能增加DNA疫苗在体内的免疫原性和转染效率。然而,转染效率的增加,使得人们对基因整合等安全性问题的担心更甚。结论DNA疫苗通过合适的转运途径能够增加其在体内的免疫原形和转染效率,各种转运途径均是安全的。在不久的将来,DNA疫苗将能应用于人类,造福世界。但是在实验或临床试验中还是要关注并防止DNA疫苗安全性问题的发生。%Objective To summarize the research situation of DNA vaccine main transferring ways and safety, and explore the application of different transferring ways in animal experiments and human trial. Method Using Medline, PubMed and CNKI journal full text database retrieval system, selected DNA vaccine, electroporation, gene gun, direct injection, atomization, liposomal encapsulated as keywords to retrieve pertinent literature from 2008 to 2011, and in all 97 English literatures were retrieved. Inclusive criterias were that, ①The ordinary characters of DNA vaccine. ②Electroporation transport way of DNA vaccine. ③Gene gun injection way. ④Direct injection way. ⑤Mucosal Immune way. According to the criterions, corresponding literatures were 33 piece of writing

  18. The estimation of safety booster vaccination children is more senior than 1,5 years against diphtheria, perussis, tetanus, poliomyelitis and Haemophilus influenzae type B with Pentaxim

    Directory of Open Access Journals (Sweden)

    S. M. Harit

    2009-01-01

    Full Text Available Supervision over 200 children in the age of 18–42 months (64 healthy and 136 with allergic displays, defeats CNS, often ill, and also having in the anamnesis of reaction to previous introduction DTP or Infanriks, revaccination with Pentaxim. It is shown, that 77% from them had asymptomatic current, only in 1,5% of cases strong reactions with temperature above 38,6°С were observed. Local reactions were marked at 25,5%, essentially more often at children with an allergy, defeat CNS and often ill, than at healthy (7,8%, but did not one child was not adverse events. The estimation safety vaccines Pentaxim confirms expediency of application as 1 revaccination against perussis, diphtheria, tetanus, poliomyelitis and unitary vaccination against Haemophilus influenzae type B in children are more senior than year with a various state of health.

  19. Efficacy and safety of oral tinidazole and metronidazole in treatment of bacterial vaginosis: a randomized control trial

    Directory of Open Access Journals (Sweden)

    Zahra Abbaspoor

    2014-05-01

    Full Text Available Aims: Oral metronidazole 500 mg twice a day for one week is currently the treatment of choice for bacterial vaginosis (BV. Complete treatment by this regimen takes time and occurs less often. This drug has significant side effects too. Using a drug in the shortest treatment course may increases the success of treatment. To evaluate the effectiveness and safety of oral tinidazole compare to metronidazole in treatment of BV.Methods: In this randomized, controlled, double-blind, comparative, clinical trial, 110 non-pregnant women aged between 15-45 years with confirmed diagnosis of BV by Amsels criteria were randomly assigned to receive either 2 g tinidazole tablet once daily for 2 days (n=55 or 500 mg metronidazole table twice daily for 7 days (n=55.The cure and recurrence rate were evaluated in both groups after 2 and 4 weeks follow up visits. For statistical analysis t-test,   test, fisher's exact test and Mann-Whitney test were used.Results: The results showed that cure rate after 2 weeks in tinidazole tablet group was 84.6٪ and in metronidazole group was 85.4٪ (p=0.9, and after 4 weeks recurrence rate in tinidazole and metronidazole groups was 6.9٪and 12.1٪respectively (P=0.3.Conclusions: Tinidazole table 2 g once daily for 2 days is as effective as metronidazole tablet 500 mg twice a day for 7 days in treatment of BV.

  20. A clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion IP (Pandemic Influenza (H1N1 2009 Monovalent Vaccine; VaxiFlu-S ™ in healthy Indian adult population

    Directory of Open Access Journals (Sweden)

    A H Kubavat

    2011-01-01

    Full Text Available Background : The pandemic of H1N1 2009 influenza has spread world over and low degree of virus transmission has continued in several regions of India. Aims : To assess the immunogenicity and safety of Pandemic Influenza (H1N1 2009 Monovalent Vaccine in healthy adult Indian population. Settings and Design : Prospective, open label, multicentric, phase 2/3 clinical trial. Materials and Methods : Healthy adult Indian subjects belonging to either 18-59 years or ≥60 years age groups were enrolled and administered a single 0.5 ml (≥15 mcg of hemagglutinin antigen dose of vaccine in the deltoid muscle. Anti-hemagglutinin antibody titer was assessed at baseline and 21 (±2 days after vaccination by Hemagglutination Inhibition (HI test. Safety assessments were done for a period of 42 days. Statistical Analysis Used : Percentages of appropriate population with 95% confidence intervals calculated, log transformation of the data to calculate Geometric Mean Titers (GMTs and chi-square test and student′s t-test applied for significance testing. Results : 182/198 and 53/63 volunteers in age groups of 18-59 years and ≥60 years, respectively, achieved an HI titer ≥1 : 40 at Day 21 (91.9% [95% confidence interval: 88.1-95.7%] and 84.1% [75.1-93.2%]; P=0.072. Further, 171/198 and 50/63 volunteers in the respective age groups achieved seroconversion/four-fold increase in titer at Day 21 (86.4% [81.6-91.1%] and 79.4% [69.4-89.4%]; P=0.179. A significant rise of 22.6-fold [18.0-28.4] and 10.5-fold [7.4-15.0] was noted in GMT in the respective age groups (P<0.001 for both groups as compared to baseline. Nine vaccine-related adverse events were reported (3.4% incidence [1.2-5.6%], which were of low severity only. Conclusions : Pandemic Influenza (H1N1 2009 Monovalent Vaccine produces excellent immunogenic response with a good tolerability profile in adult Indian population.

  1. Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009–2011

    OpenAIRE

    Sharon K Greene; Rett, Melisa D.; Claudia Vellozzi; Lingling Li; Martin Kulldorff; S Michael Marcy; Matthew F Daley; Belongia, Edward A.; Roger Baxter; Fireman, Bruce H.; Jackson, Michael L.; Omer, Saad B; Nordin, James D.; Robert Jin; Weintraub, Eric S.

    2013-01-01

    Background: Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited. Methods: We identified patients enrolled in health plans partic...

  2. New tuberculosis vaccines.

    Science.gov (United States)

    Martín Montañés, Carlos; Gicquel, Brigitte

    2011-03-01

    The current tuberculosis (TB) vaccine, bacille Calmette-Guerin (BCG), is a live vaccine used worldwide, as it protects against severe forms of the disease, saving thousands of lives every year, but its efficacy against pulmonary forms of TB, responsible for transmission of the diseases, is variable. For more than 80 years now no new TB vaccines have been successfully developed. Over the last decade the effort of the scientific community has resulted in the design and construction of promising vaccine candidates. The goal is to develop a new generation of vaccines effective against respiratory forms of the disease. We will focus this review on new prophylactic vaccine candidates that aim to prevent TB diseases. Two are the main strategies used to improve the immunity conferred by the current BCG vaccine, by boosting it with new subunit vaccines, and a second strategy is focused on the construction of new more effective live vaccines, capable to replace the current BCG and to be used as prime vaccines. After rigorous preclinical studies in different animal models new TB vaccine candidates enter in clinical trials in humans. First, a small Phase I for safety followed by immunological evaluation in Phase II trials and finally evaluated in large population Phase III efficacy trials in endemic countries. At present BCG prime and boost with different subunit vaccine candidates are the more advanced assessed in Phase II. Two prime vaccines (based on recombinant BCG) have been successfully evaluated for safety in Phase I trials. A short number of live attenuated vaccines are in advance preclinical studies and the candidates ready to enter Phase I safety trials are produced under current good manufacturing practices. PMID:21420568

  3. Safety, immunogenicity, and early evidence of antitumor response with the use of the vaccine formulation NeuGcGM3 / VSSPs in patients with advanced melanoma

    International Nuclear Information System (INIS)

    Introduction. Melanoma is now considered an epidemic around the world. Its high lethality, constitutes a serious problem despite the continuous pharmacological and technological advances. NeuGcGM3/VSSP is a vaccine formulation containing ganglioside NeuGcGM3 incorporated in the acting of Neisseria meningitidis. It may be a choice therapeutic given this ganglioside in primary melanoma expression and immunogenicity and safety demonstrated by this vaccine in advanced breast cancer. This study evaluated the safety, immunogenicity and the anti-tumor response in patients with advanced melanoma to manage it via IM or SC. Material and methods: The expression of ganglioside in primary melanomas and its metastases was identified by immunohistochemical methods with the AcM 14F7 (anti-NGCGM3). 2 clinical trials Phase Ib/IIa escalation of doses with NeuGcGM3 /VSSP were conducted in patients with melanoma Advanced IM and SC routes. Safety and anti-tumour response were evaluated with the CTC and RECIST criteria. The statistical analysis was performed with the SPSS statistical package. Results: NeuGcGM3 is expressed in primary tumors and the studied lymph nodes metastases. NeuGcGM3/VSSP was safely managed by the SC and IM, roads without limiting toxicity. Immunogenic with IgM and IgG isotype antibody response resulted in 75% patients. There was anti-tumoral response in 38.5% with increase in median SV mainly associated with anti-tumor response. The appearance of vitiligo and the response of antibodies against other not present in the vaccine formulation gangliosides may be considered a manifestation of immune restoration. Conclusions. NeuGcGM3/VSSP managed IM and SC in patients with advanced melanoma was safe, immunogenic and antitumor activity associated with overall survival advantage. (author)

  4. Safety and Efficacy of an Intravaginal Prebiotic Gel in the Prevention of Recurrent Bacterial Vaginosis: A Randomized Double-Blind Study

    OpenAIRE

    Isabelle Coste; Philippe Judlin; Jean-Pierre Lepargneur; Sami Bou-Antoun

    2012-01-01

    Objective. This study was performed to evaluate the efficacy and safety of a prebiotic treatment in the balance recovery of the vaginal flora in subjects previously treated for bacterial vaginosis (BV). Study Design. A randomized trial was carried out on 42 subjects with an active prebiotic group compared to a placebo group. The main evaluation criterion was the quantification of the vaginal flora measured by the Nugent score. Secondary criteria included vaginal pH and BV recurrence. Results....

  5. Study on the efficacy and safety of different antigens and oil formulations of infectious coryza vaccines containing an NAD-independent strain of Avibacterium paragallinarum

    OpenAIRE

    Dungu, B; BRETT, B; Macdonald, R.; S. Deville; Dupuis, L.; Theron, J.; R.R. Bragg

    2009-01-01

    The present study was designed to assess and compare three different formulations of the new Onderstepoort infectious coryza (IC) quadrivalent vaccine, which contain an NAD-independent strain of Avibacterium paragallinarum (previously known as Haemophilus paragallinarum), and a commercial IC vaccine, not containing an NAD-independent strain, for their safety and ability to protect chickens of varying ages against virulent challenges with four different serovars of A. paragallinarum, inc...

  6. Extended Safety and Efficacy Studies of the Attenuated Brucella Vaccine Candidates 16MΔvjbR and S19ΔvjbR in the Immunocompromised IRF-1−/− Mouse Model

    OpenAIRE

    Arenas-Gamboa, A. M.; Rice-Ficht, A C; Fan, Y.; Kahl-McDonagh, M. M.; Ficht, T A

    2012-01-01

    The global distribution of brucellosis and high incidence in certain areas of the world warrant the development of a safer and efficacious vaccine. For the past 10 years, we have focused our attention on the development of a safer, but still highly protective, live attenuated vaccine for human and animal use. We have demonstrated the safety and protective efficacy of the vaccine candidates 16MΔvjbR and S19ΔvjbR against homologous and heterologous challenge in multiple immunocompetent animal m...

  7. Demonstrating Bacterial Flagella.

    Science.gov (United States)

    Porter, John R.; And Others

    1992-01-01

    Describes an effective laboratory method for demonstrating bacterial flagella that utilizes the Proteus mirabilis organism and a special harvesting technique. Includes safety considerations for the laboratory exercise. (MDH)

  8. Experience with registered mucosal vaccines.

    Science.gov (United States)

    Dietrich, Guido; Griot-Wenk, Monika; Metcalfe, Ian C; Lang, Alois B; Viret, Jean-François

    2003-01-30

    Most pathogens gain access to their host through mucosal surfaces. It is therefore desirable to develop vaccination strategies that lead to mucosal immune responses. Ideally, a vaccine should be administered mucosally in order to elicit mucosal protection. Several attenuated live viral and bacterial pathogens are registered as oral vaccines for human use, including the oral polio vaccine (Sabin) as well as attenuated strains of Salmonella typhi and Vibrio cholerae. These attenuated bacterial live vaccines-S. typhi Ty21a as well as V. cholerae CVD 103-HgR-are employed as vaccines against typhoid and cholera, respectively. In this manuscript, we review the immune responses that are induced by these vaccines, with a focus on mucosal immunity. PMID:12531339

  9. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial.

    Directory of Open Access Journals (Sweden)

    Kanokporn Chaiklang

    Full Text Available BACKGROUND: HBV vaccination is recommended in HIV-infected adults with CD4+ cell count >200/mm(3 although the efficacy is only 33.3% -65%. We conducted a randomized, controlled trial to evaluate the efficacy and safety of three regimens of HBV vaccination at Chiang Mai University Hospital, Thailand. METHODS: From February 4, 2011 to May 4, 2012, 132 HIV-infected adults with CD4+ cell counts >200 cells/mm(3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of three recombinant vaccine (Hepavax-Gene(® Berna, Korea regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44, 20 μg IM at months 0, 1, 2, 6 (four doses group, n=44, or 40 μg IM at months 0, 1, 2, and 6 (four double doses group, n=44. The primary outcomes were to compare the immunogenicity and safety between the four-doses groups with the Standard doses group. RESULTS: At months 7 and 12, the percentages of responders (anti-HBs ≥ 10 mIU/mL were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (P=0.713 and 0.119, and 95.4% and 88.6% in the four double doses group, (P=0.434 and 0.062, respectively. Factors associated with a high titer level (anti-HBs ≥ 100 mIU/mL were vaccination schedule and younger age. The most common adverse event was pain at the injection site (42.4%; this was significantly more frequent in the four double doses group compared to the Standard doses group. No serious adverse events were observed. CONCLUSIONS: In Northern Thailand, the standard three-doses HBV vaccination in HIV-infected adults with CD4+ cell counts >200 cells/mm(3 and undetectable plasma HIV-1 RNA is highly effective. Although regimens of four injections of either standard or double doses could not significantly increase the response rate, these regimens may induce higher levels of antibody to the virus. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; NCT1289106; http://clinicaltrials.gov/ct2

  10. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons

    Directory of Open Access Journals (Sweden)

    Bouveret Nancy

    2010-03-01

    Full Text Available Abstract Background Seasonal influenza imposes a substantial personal morbidity and societal cost burden. Vaccination is the major strategy for influenza prevention; however, because antigenically drifted influenza A and B viruses circulate annually, influenza vaccines must be updated to provide protection against the predicted prevalent strains for the next influenza season. The aim of this study was to assess the efficacy, safety, reactogenicity, and immunogenicity of a trivalent inactivated split virion influenza vaccine (TIV in healthy adults over two influenza seasons in the US. Methods The primary endpoint of this double-blind, randomized study was the average efficacy of TIV versus placebo for the prevention of vaccine-matched, culture-confirmed influenza (VMCCI across the 2005-2006 and 2006-2007 influenza seasons. Secondary endpoints included the prevention of laboratory-confirmed (defined by culture and/or serology influenza, as well as safety, reactogenicity, immunogenicity, and consistency between three consecutive vaccine lots. Participants were assessed actively during both influenza seasons, and nasopharyngeal swabs were collected for viral culture from individuals with influenza-like illness. Blood specimens were obtained for serology one month after vaccination and at the end of each influenza season's surveillance period. Results Although the point estimate for efficacy in the prevention of all laboratory-confirmed influenza was 63.2% (97.5% confidence interval [CI] lower bound of 48.2%, the point estimate for the primary endpoint, efficacy of TIV against VMCCI across both influenza seasons, was 46.3% with a 97.5% CI lower bound of 9.8%. This did not satisfy the pre-specified success criterion of a one-sided 97.5% CI lower bound of >35% for vaccine efficacy. The VMCCI attack rates were very low overall at 0.6% and 1.2% in the TIV and placebo groups, respectively. Apart from a mismatch for influenza B virus lineage in 2005

  11. Vaccination of pigs with attenuated Lawsonia intracellularis induced acute phase protein responses and primed cell-mediated immunity without reduction in bacterial shedding after challenge

    DEFF Research Database (Denmark)

    Riber, Ulla; Heegaard, Peter M. H.; Hvass, Henriette Cordes; Ståhl, Marie; Jensen, Tim Kåre; Jungersen, Gregers

    2015-01-01

    same extent as non-vaccinated pigs after challenge,however less L. intracellularis in ileum and lymph nodes was seen post mortem. In the RE group, challengedid not lead to L. intracellularis shedding and no challenge bacteria were found post mortem. In both VACand RE the acute phase haptoglobin...... response was diminished and L. intracellularis specific IgG responseswere delayed and reduced compared to non-vaccinated pigs. On the other hand L. intracellularis specificIFN- responses tended to develop faster in the VAC group compared to controls.Conclusion: Although vaccinated and non-vaccinated pigs...

  12. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma

    International Nuclear Information System (INIS)

    The sole effective option for patients with advanced HCC is sorafenib and there is an urgent need to develop new therapeutic approaches. Immunotherapy is a promising option that deserves major investigation. In this open label, single arm clinical trial, we analyzed the effect of a low dose cyclophosphamide treatment in combination with a telomerase peptide (GV1001) vaccination in patients with advanced HCC. 40 patients with advanced HCC were treated with 300 mg/m2 cyclophosphamide on day -3 followed by GM-CSF + GV1001 vaccinations on days 1, 3, 5, 8, 15, 22, 36 followed by 4-weekly injections. Primary endpoint of this phase II trial was tumor response; secondary endpoints evaluated were TTP, TTSP, PFS, OS, safety and immune responses. None of the patients had a complete or partial response to treatment, 17 patients (45.9%) demonstrated a stable disease six months after initiation of treatment. The median TTP was 57.0 days; the median TTSP was estimated to be 358.0 days. Cyclophosphamide, GV1001 and GM-CSF treatment were well tolerated and most adverse events, which were of grade 1 or 2, were generally related to the injection procedure and injection site reactions. GV1001 treatment resulted in a decrease in CD4+CD25+Foxp3+ regulatory T cells; however, no GV1001 specific immune responses were detected after vaccination. Low dose cyclophosphamide treatment followed by GV1001 vaccinations did not show antitumor efficacy as per tumor response and time to progression. Further studies are needed to analyze the effect of a combined chemo-immunotherapy to treat patients with HCC. NCT00444782

  13. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Ayuso Carmen

    2010-05-01

    Full Text Available Abstract Background The sole effective option for patients with advanced HCC is sorafenib and there is an urgent need to develop new therapeutic approaches. Immunotherapy is a promising option that deserves major investigation. In this open label, single arm clinical trial, we analyzed the effect of a low dose cyclophosphamide treatment in combination with a telomerase peptide (GV1001 vaccination in patients with advanced HCC. Methods 40 patients with advanced HCC were treated with 300 mg/m2 cyclophosphamide on day -3 followed by GM-CSF + GV1001 vaccinations on days 1, 3, 5, 8, 15, 22, 36 followed by 4-weekly injections. Primary endpoint of this phase II trial was tumor response; secondary endpoints evaluated were TTP, TTSP, PFS, OS, safety and immune responses. Results None of the patients had a complete or partial response to treatment, 17 patients (45.9% demonstrated a stable disease six months after initiation of treatment. The median TTP was 57.0 days; the median TTSP was estimated to be 358.0 days. Cyclophosphamide, GV1001 and GM-CSF treatment were well tolerated and most adverse events, which were of grade 1 or 2, were generally related to the injection procedure and injection site reactions. GV1001 treatment resulted in a decrease in CD4+CD25+Foxp3+ regulatory T cells; however, no GV1001 specific immune responses were detected after vaccination. Conclusions Low dose cyclophosphamide treatment followed by GV1001 vaccinations did not show antitumor efficacy as per tumor response and time to progression. Further studies are needed to analyze the effect of a combined chemo-immunotherapy to treat patients with HCC. Trial registration NCT00444782

  14. Efficacy of Nursing Safety Management in Child Vaccination%儿童预防接种护理安全管理的实施效果观察

    Institute of Scientific and Technical Information of China (English)

    卢立娜; 朱会群

    2015-01-01

    目的:分析儿童安全预防接种护理的实施效果。方法选取200例接受预防接种儿童,随机分为对照组(100例)与研究组(100例),对照组采取常规免疫接种,研究组采取安全预防接种护理,对比两组护理效果。结果研究组家长满意度、知晓率分别为98.00%(98/100)、92.00%(92/100),对照组分别为89.00%(89/100)、81.00%(81/100),研究组高于对照组(P<0.05)。研究组儿童配合率、疫苗接种率分别为80.00%(80/100)、96.00%(96/100),对照组分别为67.00%(67/100)、88.00%(88/100),研究组高于对照组(P<0.05)。结论采取儿童安全预防接种护理能提高儿童配合度与接种率。%ObjectiveTo analysis effect of safety nursing inoculation against child.Methods Chose 200 patients who underwent vaccination of children,were randomly divided into control group(100)and(100)study group,control group adopted routine immunization and vaccination team take safety nursing,nursing effect compared to two groups.ResultsThe team parents satisfaction and witting rate were 98.00% and 98.00% respectively,the control group were 89.00%,81.00%,the team was higher than the control group(P<0.05). Group children matching rate,vaccination rates were 80.00%,96.00%,the control group were 67.00%,88.00%,the team was higher than the control group(P<0.05).Conclusion Take vaccinating children against safety nursing can improve children's cooperation degree and coverage.

  15. Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial

    OpenAIRE

    Einstein, Mark H.; Takacs, Peter; Chatterjee, Archana; Sperling, Rhoda S.; Chakhtoura, Nahida; Blatter, Mark M; Lalezari, Jacob; David, Marie-Pierre; Lin, Lan; Struyf, Frank; Dubin, Gary

    2014-01-01

    The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAb) responses induced by HPV-16/18 vaccine remained 7.8-fold (18-26-y stratum), 5.6-fold (27-35-y stratum) and 2...

  16. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1 malaria vaccine adjuvanted with Alhydrogel, Montanide ISA 720 or AS02.

    Directory of Open Access Journals (Sweden)

    Meta Roestenberg

    Full Text Available BACKGROUND: Plasmodium falciparum Apical Membrane Antigen 1 (PfAMA1 is a candidate vaccine antigen expressed by merozoites and sporozoites. It plays a key role in red blood cell and hepatocyte invasion that can be blocked by antibodies. METHODOLOGY/PRINCIPAL FINDINGS: We assessed the safety and immunogenicity of recombinant PfAMA1 in a dose-escalating, phase Ia trial. PfAMA1 FVO strain, produced in Pichia pastoris, was reconstituted at 10 microg and 50 microg doses with three different adjuvants, Alhydrogel, Montanide ISA720 and AS02 Adjuvant System. Six randomised groups of healthy male volunteers, 8-10 volunteers each, were scheduled to receive three immunisations at 4-week intervals. Safety and immunogenicity data were collected over one year. Transient pain was the predominant injection site reaction (80-100%. Induration occurred in the Montanide 50 microg group, resulting in a sterile abscess in two volunteers. Systemic adverse events occurred mainly in the AS02 groups lasting for 1-2 days. Erythema was observed in 22% of Montanide and 59% of AS02 group volunteers. After the second dose, six volunteers in the AS02 group and one in the Montanide group who reported grade 3 erythema (>50 mm were withdrawn as they met the stopping criteria. All adverse events resolved. There were no vaccine-related serious adverse events. Humoral responses were highest in the AS02 groups. Antibodies showed activity in an in vitro growth inhibition assay up to 80%. Upon stimulation with the vaccine, peripheral mononuclear cells from all groups proliferated and secreted IFNgamma and IL-5 cytokines. CONCLUSIONS/SIGNIFICANCE: All formulations showed distinct reactogenicity profiles. All formulations with PfAMA1 were immunogenic and induced functional antibodies. TRIAL REGISTRATION: (Clinicaltrials.gov NCT00730782.

  17. Extended safety and efficacy studies of the attenuated Brucella vaccine candidates 16 M(Delta)vjbR and S19(Delta)vjbR in the immunocompromised IRF-1-/- mouse model.

    Science.gov (United States)

    Arenas-Gamboa, A M; Rice-Ficht, A C; Fan, Y; Kahl-McDonagh, M M; Ficht, T A

    2012-02-01

    The global distribution of brucellosis and high incidence in certain areas of the world warrant the development of a safer and efficacious vaccine. For the past 10 years, we have focused our attention on the development of a safer, but still highly protective, live attenuated vaccine for human and animal use. We have demonstrated the safety and protective efficacy of the vaccine candidates 16 MΔvjbR and S19ΔvjbR against homologous and heterologous challenge in multiple immunocompetent animal models, including mice and deer. In the present study, we conducted a series of experiments to determine the safety of the vaccine candidates in interferon regulatory factor-1-knockout (IRF-1(-/-)) mice. IRF-1(-/-) mice infected with either wild-type Brucella melitensis 16 M or the vaccine strain Brucella abortus S19 succumb to the disease within the first 3 weeks of infection, which is characterized by a marked granulomatous and neutrophilic inflammatory response that principally targets the spleen and liver. In contrast, IRF-1(-/-) mice inoculated with either the 16 MΔvjbR or S19ΔvjbR vaccine do not show any clinical or major pathological changes associated with vaccination. Additionally, when 16 MΔvjbR- or S19ΔvjbR-vaccinated mice are challenged with wild-type Brucella melitensis 16M, the degree of colonization in multiple organs, along with associated pathological changes, is significantly reduced. These findings not only demonstrate the safety and protective efficacy of the vjbR mutant in an immunocompromised mouse model but also suggest the participation of lesser-known mechanisms in protective immunity against brucellosis. PMID:22169089

  18. HPV vaccines: a controversial issue?

    Directory of Open Access Journals (Sweden)

    A.F. Nicol

    2016-01-01

    Full Text Available Controversy still exists over whether the benefits of the available HPV vaccines outweigh the risks and this has suppressed uptake of the HPV vaccines in comparison to other vaccines. Concerns about HPV vaccine safety have led some physicians, healthcare officials and parents to withhold the recommended vaccination from the target population. The most common reason for not administering the prophylactic HPV vaccines are concerns over adverse effects. The aim of this review is the assessment of peer-reviewed scientific data related to measurable outcomes from the use of HPV vaccines throughout the world with focused attention on the potential adverse effects. We found that the majority of studies continue to suggest a positive risk-benefit from vaccination against HPV, with minimal documented adverse effects, which is consistent with other vaccines. However, much of the published scientific data regarding the safety of HPV vaccines appears to originate from within the financially competitive HPV vaccine market. We advocate a more independent monitoring system for vaccine immunogenicity and adverse effects to address potential conflicts of interest with regular systematic literature reviews by qualified individuals to vigilantly assess and communicate adverse effects associated with HPV vaccination. Finally, our evaluation suggests that an expanded use of HPV vaccine into more diverse populations, particularly those living in low-resource settings, would provide numerous health and social benefits.

  19. HPV vaccines: a controversial issue?

    Science.gov (United States)

    Nicol, A F; Andrade, C V; Russomano, F B; Rodrigues, L L S; Oliveira, N S; Provance, D W

    2016-01-01

    Controversy still exists over whether the benefits of the available HPV vaccines outweigh the risks and this has suppressed uptake of the HPV vaccines in comparison to other vaccines. Concerns about HPV vaccine safety have led some physicians, healthcare officials and parents to withhold the recommended vaccination from the target population. The most common reason for not administering the prophylactic HPV vaccines are concerns over adverse effects. The aim of this review is the assessment of peer-reviewed scientific data related to measurable outcomes from the use of HPV vaccines throughout the world with focused attention on the potential adverse effects. We found that the majority of studies continue to suggest a positive risk-benefit from vaccination against HPV, with minimal documented adverse effects, which is consistent with other vaccines. However, much of the published scientific data regarding the safety of HPV vaccines appears to originate from within the financially competitive HPV vaccine market. We advocate a more independent monitoring system for vaccine immunogenicity and adverse effects to address potential conflicts of interest with regular systematic literature reviews by qualified individuals to vigilantly assess and communicate adverse effects associated with HPV vaccination. Finally, our evaluation suggests that an expanded use of HPV vaccine into more diverse populations, particularly those living in low-resource settings, would provide numerous health and social benefits. PMID:27074168

  20. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  1. CHIMERIC WEST NILE/DENGUE VIRUS VACCINE CANDIDATE: PRECLINICAL EVALUATION IN MICE, GEESE, AND MONKEYS FOR SAFETY AND IMMUNOGENICITY

    Science.gov (United States)

    A live attenuated virus vaccine is being developed to protect against West Nile virus (WN) disease in humans. Previously, it was found that chimeric West Nile/dengue viruses (WN/DEN4 and WN/DEN4-delta-30) bearing the membrane precursor and envelope protein genes of WN on a backbone of dengue type 4 ...

  2. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan.

    Directory of Open Access Journals (Sweden)

    Shin-Yu Lin

    Full Text Available BACKGROUND: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women. METHODS: This prospective trial (NCT01514708 enrolled 46 pregnant women who received a single intramuscular dose of trivalent flu vaccine (AdimFlu-S® containing 15 mcg of hemagglutinin for each strain/0.5 mL from influenza A (H1N1, influenza A (H3N2, and influenza B after the first trimester. Blood samples were collected at day 0 and 28 after vaccination, and at delivery. Cord blood was also collected. Hemagglutination inhibition (HAI assays were performed to determine seroprotection and seroconversion rates and fold increase in the HAI geometric mean titer (GMT. RESULTS: Twenty-eight days after vaccination the seroprotection rate against H1N1, H3N2, and influenza B was 91.3%, 84.8% and 56.5%, respectively. The GMT fold increase was 12.8, 8.4, and 4.6 for H1N1, H3N2, and influenza B, respectively. At delivery, both the seroprotection rate (86.4%, 68.2%, and 47.7% and GMT fold increase (9.4, 5.7 and 3.8 were slightly lower than day 28. The seroprotection rate and GMT fold increase in maternal and cord blood samples were comparable. No significant adverse effects were detected. CONCLUSIONS: Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects. TRIAL REGISTRATION: Clinical Trials. gov NCT01514708.

  3. Nieuw vaccin tegen campylobacter

    OpenAIRE

    Wagenaar, J.A.

    2008-01-01

    Het vaccin dat de kip moet beschermen tegen de bacterie Campylobacter werkt in het laboratorium. Dat wil bacterioloog Jaap Wagenaar wel kwijt. Wanneer het er komt en zelfs of het er komt, daarover laat Wagenaar zich niet uit. "Het is een hele klus om het immuunsysteem van kippen effectief op te laten treden tegen Campylobacter", zegt Wagenaar die werkt bij het CVI en hoogleraar is aan de Universiteit Utrecht. "Geen van de vaccins die onderzoekers tot nu hebben uitgeprobeerd werken"

  4. Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial.

    Directory of Open Access Journals (Sweden)

    Emma-Jo Hayton

    Full Text Available TRIAL DESIGN: HIV-1 vaccine development has advanced slowly due to viral antigenic diversity, poor immunogenicity and recently, safety concerns associated with human adenovirus serotype-5 vectors. To tackle HIV-1 variation, we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome, which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA, a non-replicating simian (chimpanzee adenovirus ChAdV-63 and a non-replicating poxvirus, modified vaccinia virus Ankara. A block-randomized, single-blind, placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1- vaccines or placebo to 32 healthy HIV-1/2-uninfected adults in Oxford, UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro. Here, detail safety and tolerability of these vaccines are reported. METHODS: Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards. Data on all other adverse events were collected using open questions. Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination. RESULTS: Two volunteers withdrew for vaccine-unrelated reasons. No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up. Local and systemic events after vaccination occurred in 27/32 individuals and most were mild (severity grade 1 and predominantly transient (<48 hours. Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo. There were no intercurrent HIV-1 infections during follow-up. 2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median (range of 633 (231-1533 post-vaccination, which is of no safety concern. CONCLUSIONS: These data demonstrate

  5. Safety

    International Nuclear Information System (INIS)

    This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

  6. Novel Vaccine against Venezuelan Equine Encephalitis Combines Advantages of DNA Immunization and a Live Attenuated Vaccine

    OpenAIRE

    Tretyakova, Irina; Lukashevich, Igor S; Glass, Pamela; Wang, Eryu; Weaver, Scott; Pushko, Peter

    2012-01-01

    DNA vaccines combine remarkable genetic and chemical stability with proven safety and efficacy in animal models, while remaining less immunogenic in humans. In contrast, live-attenuated vaccines have the advantage of inducing rapid, robust, long-term immunity after a single-dose vaccination. Here we describe novel iDNA vaccine technology that is based on an infectious DNA platform and combines advantages of DNA and live attenuated vaccines. We applied this technology for vaccination against i...

  7. HPV vaccine

    Science.gov (United States)

    Vaccine - HPV; Immunization - HPV; Gardasil; Cervarix; HPV2; HPV4; Vaccine to prevent cervical cancer ... Girls ages 11 and 12 should receive the HPV vaccine series: The vaccine is given in three shots ...

  8. Immune enhancement by novel vaccine adjuvants in autoimmune-prone NZB/W F1 mice: relative efficacy and safety

    Directory of Open Access Journals (Sweden)

    Ghosh Swapan K

    2011-10-01

    Full Text Available Abstract Background Vaccines have profoundly impacted global health although concerns persist about their potential role in autoimmune or other adverse reactions. To address these concerns, vaccine components like immunogens and adjuvants require critical evaluation not only in healthy subjects but also in those genetically averse to vaccine constituents. Evaluation in autoimmune-prone animal models of adjuvants is therefore important in vaccine development. The objective here was to assess the effectiveness of experimental adjuvants: two phytol-derived immunostimulants PHIS-01 (phytanol and PHIS-03 (phytanyl mannose, and a new commercial adjuvant from porcine small intestinal submucosa (SIS-H, relative to a standard adjuvant alum. Phytol derivatives are hydrophobic, oil-in water diterpenoids, while alum is hydrophilic, and SIS is essentially a biodegradable and collagenous protein cocktail derived from extracellular matrices. Results We studied phthalate -specific and cross-reactive anti-DNA antibody responses, and parameters associated with the onset of autoimmune disorders. We determined antibody isotype and cytokine/chemokine milieu induced by the above experimental adjuvants relative to alum. Our results indicated that the phytol-derived adjuvant PHIS-01 exceeded alum in enhancing anti-phthalate antibody without much cross reactivity with ds-DNA. Relatively, SIS and PHIS-03 proved less robust, but they were also less inflammatory. Interestingly, these adjuvants facilitated isotype switching of anti-hapten, but not of anti-DNA response. The current study reaffirms our earlier reports on adjuvanticity of phytol compounds and SIS-H in non autoimmune-prone BALB/c and C57BL/6 mice. These adjuvants are as effective as alum also in autoimmune-prone NZB/WF1 mice, and they have little deleterious effects. Conclusion Although all adjuvants tested impacted cytokine/chemokine milieu in favor of Th1/Th2 balance, the phytol compounds fared better in

  9. Predicted Coverage and Immuno-Safety of a Recombinant C-Repeat Region Based Streptococcus pyogenes Vaccine Candidate.

    Science.gov (United States)

    McNeilly, Celia; Cosh, Samantha; Vu, Therese; Nichols, Jemma; Henningham, Anna; Hofmann, Andreas; Fane, Anne; Smeesters, Pierre R; Rush, Catherine M; Hafner, Louise M; Ketheesan, Natkuman; Sriprakash, Kadaba S; McMillan, David J

    2016-01-01

    The C-terminal region of the M-protein of Streptococcus pyogenes is a major target for vaccine development. The major feature is the C-repeat region, consisting of 35-42 amino acid repeat units that display high but not perfect identity. SV1 is a S. pyogenes vaccine candidate that incorporates five 14mer amino acid sequences (called J14i variants) from differing C-repeat units in a single recombinant construct. Here we show that the J14i variants chosen for inclusion in SV1 are the most common variants in a dataset of 176 unique M-proteins. Murine antibodies raised against SV1 were shown to bind to each of the J14i variants present in SV1, as well as variants not present in the vaccine. Antibodies raised to the individual J14i variants were also shown to bind to multiple but different combinations of J14i variants, supporting the underlying rationale for the design of SV1. A Lewis Rat Model of valvulitis was then used to assess the capacity of SV1 to induce deleterious immune response associated with rheumatic heart disease. In this model, both SV1 and the M5 positive control protein were immunogenic. Neither of these antibodies were cross-reactive with cardiac myosin or collagen. Splenic T cells from SV1/CFA and SV1/alum immunized rats did not proliferate in response to cardiac myosin or collagen. Subsequent histological examination of heart tissue showed that 4 of 5 mice from the M5/CFA group had valvulitis and inflammatory cell infiltration into valvular tissue, whereas mice immunised with SV1/CFA, SV1/alum showed no sign of valvulitis. These results suggest that SV1 is a safe vaccine candidate that will elicit antibodies that recognise the vast majority of circulating GAS M-types. PMID:27310707

  10. Live virus vaccines based on a yellow fever vaccine backbone: Standardized template with key considerations for a risk/benefit assessment

    OpenAIRE

    Monath, Thomas P.; Seligman, Stephen J.; Robertson, James S; Guy, Bruno; Hayes, Edward B.; Condit, Richard C.; Excler, Jean Louis; Mac, Lisa Marie; Carbery, Baevin; Chen, Robert T.

    2014-01-01

    The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viruses inserted into the backbone of another virus (so-called "chimeric virus vaccines"). Many viral vector vaccines are in advanced clinical trials. The first such vaccine to be approved for mark...

  11. A new recombinant BCG vaccine induces specific Th17 and Th1 effector cells with higher protective efficacy against tuberculosis.

    Science.gov (United States)

    da Costa, Adeliane Castro; Costa-Júnior, Abadio de Oliveira; de Oliveira, Fábio Muniz; Nogueira, Sarah Veloso; Rosa, Joseane Damaceno; Resende, Danilo Pires; Kipnis, André; Junqueira-Kipnis, Ana Paula

    2014-01-01

    Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis (Mtb) that is a major public health problem. The vaccine used for TB prevention is Mycobacterium bovis bacillus Calmette-Guérin (BCG), which provides variable efficacy in protecting against pulmonary TB among adults. Consequently, several groups have pursued the development of a new vaccine with a superior protective capacity to that of BCG. Here we constructed a new recombinant BCG (rBCG) vaccine expressing a fusion protein (CMX) composed of immune dominant epitopes from Ag85C, MPT51, and HspX and evaluated its immunogenicity and protection in a murine model of infection. The stability of the vaccine in vivo was maintained for up to 20 days post-vaccination. rBCG-CMX was efficiently phagocytized by peritoneal macrophages and induced nitric oxide (NO) production. Following mouse immunization, this vaccine induced a specific immune response in cells from lungs and spleen to the fusion protein and to each of the component recombinant proteins by themselves. Vaccinated mice presented higher amounts of Th1, Th17, and polyfunctional specific T cells. rBCG-CMX vaccination reduced the extension of lung lesions caused by challenge with Mtb as well as the lung bacterial load. In addition, when this vaccine was used in a prime-boost strategy together with rCMX, the lung bacterial load was lower than the result observed by BCG vaccination. This study describes the creation of a new promising vaccine for TB that we hope will be used in further studies to address its safety before proceeding to clinical trials. PMID:25398087

  12. Enhanced protective immunity of the chimeric vector-based vaccine rAdV-SFV-E2 against classical swine fever in pigs by a Salmonella bacterial ghost adjuvant.

    Science.gov (United States)

    Xia, Shui-Li; Lei, Jian-Lin; Du, Mingliang; Wang, Yimin; Cong, Xin; Xiang, Guang-Tao; Li, Lian-Feng; Yu, Shenye; Du, Enqi; Liu, Siguo; Sun, Yuan; Qiu, Hua-Ji

    2016-01-01

    Classical swine fever (CSF) is a highly contagious swine disease caused by classical swine fever virus (CSFV). Previously, we demonstrated that rAdV-SFV-E2, an adenovirus-delivered, Semliki Forest virus replicon-vectored marker vaccine against CSF, is able to protect pigs against lethal CSFV challenge. From an economical point of view, it will be beneficial to reduce the minimum effective dose of the vaccine. This study was designed to test the adjuvant effects of Salmonella enteritidis-derived bacterial ghosts (BG) to enhance the protective immunity of rAdV-SFV-E2 in pigs. Groups of 5-week-old pigs (n = 4) were immunized intramuscularly twice with 10(5) median tissue culture infective doses (TCID50) rAdV-SFV-E2 combined with 10(10) colony forming units (CFU) BG, 10(6) or 10(5) TCID50 rAdV-SFV-E2 alone or 10(10) CFU BG alone at an interval of 3 weeks, and challenged with the highly virulent CSFV Shimen strain at 1 week post-booster immunization. The results show that the pigs inoculated with 10(5) TCID50 rAdV-SFV-E2 plus BG or 10(6) TCID50 rAdV-SFV-E2 alone were completely protected from lethal CSFV challenge, in contrast with the pigs vaccinated with 10(5) TCID50 rAdV-SFV-E2 or BG alone, which displayed partial or no protection following virulent challenge. The data indicate that BG are a promising adjuvant to enhance the efficacy of rAdV-SFV-E2 and possibly other vaccines. PMID:27301745

  13. Promising Rabies Vaccine for Postexposure Prophylaxis in Developing Countries, a Purified Vero Cell Vaccine Produced in China▿

    OpenAIRE

    Wang, Chuanlin; Zhang, Xiaowei; Song, Qingkun; Tang, Kun

    2010-01-01

    We evaluated the immunogenicity, safety, and antibody persistence of a Vero cell rabies vaccine manufactured in China, compared with those of Verorab. Adequate titers of antibody were observed for the two vaccines. ChengDa rabies vaccine could be a promising alternative vaccine for many developing countries which cannot afford expensive rabies vaccines.

  14. Differential effect of auxotrophies on the release of macromolecules by Salmonella enterica vaccine strains.

    OpenAIRE

    Loessner, Holger; Endmann, Anne; Rohde, Manfred; Curtiss, Roy; Weiss, Siegfried

    2006-01-01

    Attenuated Salmonella enterica strains have been widely used as live carriers for vaccines and therapeutic molecules. Appropriate attenuation has been introduced into such bacteria for safety reasons and the improvement of strain properties. Here, we compared two strains that were rendered auxotroph for diaminopimelic acid or thymidine monophosphate precursors by deletion of the genes asd or thyA, respectively. Upon removal of the complementing compound from bacterial cultures, both strains q...

  15. Screening of Viral Pathogens from Pediatric Ileal Tissue Samples after Vaccination

    Directory of Open Access Journals (Sweden)

    Laura Hewitson

    2014-01-01

    Full Text Available In 2010, researchers reported that the two US-licensed rotavirus vaccines contained DNA or DNA fragments from porcine circovirus (PCV. Although PCV, a common virus among pigs, is not thought to cause illness in humans, these findings raised several safety concerns. In this study, we sought to determine whether viruses, including PCV, could be detected in ileal tissue samples of children vaccinated with one of the two rotavirus vaccines. A broad spectrum, novel DNA detection technology, the Lawrence Livermore Microbial Detection Array (LLMDA, was utilized, and confirmation of viral pathogens using the polymerase chain reaction (PCR was conducted. The LLMDA technology was recently used to identify PCV from one rotavirus vaccine. Ileal tissue samples were analyzed from 21 subjects, aged 15–62 months. PCV was not detected in any ileal tissue samples by the LLMDA or PCR. LLMDA identified a human rotavirus A from one of the vaccinated subjects, which is likely due to a recent infection from a wild type rotavirus. LLMDA also identified human parechovirus, a common gastroenteritis viral infection, from two subjects. Additionally, LLMDA detected common gastrointestinal bacterial organisms from the Enterobacteriaceae, Bacteroidaceae, and Streptococcaceae families from several subjects. This study provides a survey of viral and bacterial pathogens from pediatric ileal samples, and may shed light on future studies to identify pathogen associations with pediatric vaccinations.

  16. Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST evaluating the human-bovine (WC3 reassortant pentavalent rotavirus vaccine (RV5

    Directory of Open Access Journals (Sweden)

    Van Damme Pierre

    2010-06-01

    Full Text Available Abstract Background The Rotavirus Efficacy and Safety Trial was a placebo-controlled Phase III study that evaluated the safety and efficacy of a three-dose pentavalent rotavirus vaccine (RV5 including its effect on healthcare utilization for rotavirus gastroenteritis (RVGE. The per-protocol (PP analyses, which counted events occurring 14 days after dose 3 among infants without protocol violations, have already been published. This paper evaluates the consistency of the healthcare utilization results based on the modified intention to treat (MITT analyses with the PP analyses. The MITT analyses include all infants receiving at least one dose of vaccine or placebo and follow-up begins after dose 1. The paper also explores the consistency of the results for different subgroups of the study population with different types of surveillance. Methods Data on healthcare utilization for acute gastroenteritis were collected via telephone interviews after administration of the first dose. Parents were either contacted every 6 weeks or every 2 weeks depending on the substudy in which they were enrolled. Those contacted every 2 weeks were also asked to complete symptom diaries. Poisson regression was used to evaluate the effect of RV5 on the rates of RVGE-associated healthcare encounters in all of the analyses. Results In the first 2 years after vaccination, RV5 reduced the combined rate of hospitalizations and emergency department (ED visits 88.9% (95% CI: 84.9, 91.9 for all RVGE regardless of serotype in the MITT analysis compared with a 94.5% (95% CI: 91.2, 96.6 reduction based on the G1-G4 PP analysis. By type of surveillance, the rate reductions for the G1-G4 PP analysis were 91.0% (95% CI: 81.7, 95.5 and 95.9% (95% CI: 92.2, 97.8 among parents contacted every 2 weeks (number evaluable = 4,451 and every 6 weeks (number evaluable = 52,683 respectively. Conclusions Our analyses demonstrated that the effect of RV5 on reducing the rate of hospitalizations

  17. Vaccinating captive chimpanzees to save wild chimpanzees

    OpenAIRE

    Warfield, Kelly L.; Goetzmann, Jason E.; Julia E. Biggins; Kasda, Mary Beth; Unfer, Robert C.; Vu, Hong; Aman, M. Javad; Olinger, Gene Gerrard; Walsh, Peter D.

    2014-01-01

    Although infectious disease is now recognized as a major threat to wild gorillas and chimpanzees, safety fears have stifled the use of a powerful disease control tool, vaccination. To illustrate that safety can be rigorously evaluated before vaccines are used on wild apes, we conducted what is, to our knowledge, the first conservation-oriented vaccine trial on captive chimpanzees. We tested an experimental virus-like particle (VLP) vaccine against Ebola virus, a leading killer of wild apes. O...

  18. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

    Directory of Open Access Journals (Sweden)

    Abdulla Salim

    2013-01-01

    Full Text Available Abstract Background The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. Methods This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. Results From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2 and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2. The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072 and 26.7% (95% CI: -33.1 to 59.6, p = 0.307 over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20

  19. Safety and Efficacy of an Attenuated Infectious Bovine Rhinotracheitis Virus Vaccine%牛传染性鼻气管炎活疫苗安全性和免疫保护效果研究

    Institute of Scientific and Technical Information of China (English)

    冷雪; 郭利; 张淑琴; 武华

    2011-01-01

    The attenuated infectious bovine rhinotracheitis virus (IBRV) vaccine was tested for its safety and efficacy in host animals. In order to test the safety of the vaccine,one-month-old calves,6 to 8 month old calves,and heifers were inoculated with 2 mL (10 doses) of the vaccine. In the efficacy study,6 to 8 month old calves were vaccinated with single dose 1 mL of the vaccine. Then, the animals were challenged with a virulent challenge virus on 28 days post vaccination for immunogenicity of the vaccine. The results revealed that the calves of different ages did not show any clinical diseases post-vaccination. The newborn calves are normal and healthy,and no abortion,stillbirth or mummy fetus occurred in the pregnant cows. Immunogenicity study demonstrated that the vaccine provided five fifths protection to calves against the IBRV infection and clinical diseases caused by the challenge. The results indicated that the vaccine is safe and have a good efficacy to host animals.%本试验使用牛传染性鼻气管炎弱毒活疫苗进行安全性和免疫保护效果研究,将该疫苗分别接种1月龄犊牛、6~8月龄牛及后备母牛,接种剂量为2mL(10头份),检验疫苗安全性.将疫苗接种6~8月龄牛,接种剂量为1 mL(1头份),疫苗接种后28 d使用检验用强毒进行攻毒,检验疫苗对攻击用强毒的保护效力.结果表明,不同月龄牛接种疫苗后体温正常,无任何临床可见异常,后备母牛接种疫苗后精神状态及食欲均良好,无流产、死胎及木乃伊胎出现.疫苗接种牛对强毒攻击可产生较好的抵抗力,攻毒保护率达5/5.研究结果表明,该疫苗对牛安全,且免疫保护效果良好.

  20. [Poliovirus vaccine].

    Science.gov (United States)

    Shimizu, Hiroyuki

    2012-06-01

    To avoid the risk of vaccine-associated paralytic poliomyelitis (VAPP) and polio outbreaks due to circulating vaccine-derived polioviruses, an inactivated poliovirus vaccine (IPV) was introduced for routine immunization in a number of countries with a low risk of polio outbreaks. Currently, production and marketing of a standalone conventional IPV and two diphtheria-pertussis-tetanus-IPV (Sabin-derived IPV; sIPV) products have been submitted, and it is expected that the IPV products will be introduced in Japan in the autumn of 2012. At the same time, a decline in the OPV immunization rate became apparent in Japan due to serious public concerns about a remaining risk of VAPP and introduction of IPV in the near future. Therefore, the recent development of polio immunity gaps should be carefully monitored, and surveillance of suspected polio cases and laboratory diagnosis of polioviruses have to be intensified for the transition period from OPV to IPV in Japan. The development of sIPV is one of the most realistic options to introduce affordable IPV to developing countries. In this regard, further clinical studies on its efficacy, safety, and interchangeability of sIPV will be needed after the introduction of the sIPV products, which will be licensed in Japan for the first time in the world. PMID:23189825

  1. Vaccine against human Papilloma Virus

    Directory of Open Access Journals (Sweden)

    Julio Cesar Reina

    2014-11-01

    Full Text Available At present two prophylactic human papilloma virus (HPV vaccines are commercially available. The Tetravalent vaccine against infection with four VPH types (6, 11, 16, and 18 distributed in the national program in Colombia and the Bivalent vaccine against the VPH types 16 and 18, respectively.  The efficacy and safety of both vaccines has periodically been assessed and they have been declared efficacious and safe by the health authorities of several countries and the Global Advisory Committee on Vaccine Safety ( GACVS of the World’s Health Organization (WHO.In its report of March 2014 the GACVS analyzed the evidence of the relationship between the  Human Papillomavirus Vaccine with  >175 million of doses distributed worldwide and autoimmune diseases, particularly Multiple Sclerosis, Aluminum as adjuvant, Vasculitis caused by vaccine DNA fragments and the Complex Regional Pain Syndrome described in Japan.   The Committee ratified the strict vaccine safety control and based on a thorough examination of existing evidence, reaffirmed that the risk-benefit profile remains favorable. The case of the children of Carmen de Bolivar in Colombia has been described by several authors in other countries as "Massive Psychogenic Event", which has absolute no relationship with the vaccine but its high media dissemination resulted into disastrous consequences for the national vaccination program

  2. New recombinant vaccines for the prevention of meningococcal B disease

    Directory of Open Access Journals (Sweden)

    Taha MK

    2012-06-01

    Full Text Available Muhamed-Kheir Taha, Ala-Eddine DeghmaneInstitut Pasteur, Unit of Invasive Bacterial Infections and National Reference Center for Meningococci, Paris, FranceAbstract: Meningococcal disease is a life-threatening invasive infection (mainly septicemia and meningitis that occurs as epidemic or sporadic cases. The causative agent, Neisseria meningitidis or meningococcus, is a capsulated Gram-negative bacterium. Current vaccines are prepared from the capsular polysaccharides (that also determine serogroups and are available against strains of serogroups A, C, Y, and W-135 that show variable distribution worldwide. Plain polysaccharide vaccines were first used and subsequently conjugate vaccines with enhanced immunogenicity were introduced. The capsular polysaccharide of meningococcal serogroup B is poorly immunogenic due to similarity to the human neural cells adhesion molecule. Tailor-made, strain-specific vaccines have been developed to control localized and clonal outbreaks due to meningococci of serogroup B but no “universal” vaccine is yet available. This unmet medical need was recently overcome using several subcapsular proteins to allow broad range coverage of strains and to reduce the risk of escape variants due to genetic diversity of the meningococcus. Several vaccines are under development that target major or minor surface proteins. One vaccine (Bexsero®; Novartis, under registration, is a multicomponent recombinant vaccine that showed an acceptable safety profile and covers around 80% of the currently circulating serogroup B isolates. However, its reactogenicity in infants seems to be high and the long term persistence of the immune response needs to be determined. Its activity on carriage, and therefore transmission, is under evaluation. Indirect protection is expected through restricting strain circulation and acquisition. This vaccine covers the circulating strains according to the presence of the targeted antigens in the

  3. Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development

    OpenAIRE

    Samantha Sayers; Guerlain Ulysse; Zuoshuang Xiang; Yongqun He

    2012-01-01

    Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bi...

  4. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu®.

    Science.gov (United States)

    Shen, Yonggang; Hu, Yuansheng; Meng, Fanya; Du, Wenjun; Li, Wei; Song, Yufei; Ji, Xiaoci; Huo, Liqun; Fu, Zhenping; Yin, Weidong

    2016-05-01

    Anflu® is a seasonal trivalent inactivated split-virion influenza vaccine manufactured by Sinovac Biotech Co., Ltd. The objectives of this study were to evaluate the safety of Anflu® (2013-14 formulation: H1N1, H3N2 and BYAM) in infants and adults and its immunogenicity and cross-reactivity against mismatched influenza B lineage and avian influenza A(H7N9) viruses (hereafter BVIC and H7N9, respectively) in adults. In this phase IV open label trial, infants 6-35 months old (n=61) each received two injections with 28 days apart; adults 18-60 yrs old (n=60) and elderly >60 yrs old (n=61) each received one injection. Information of adverse events was collected through safety observation and follow-up visits. Pre- and post-immune blood samples (day 0 and 21) were collected from subjects ≥18 yrs old to detect hemagglutination inhibition antibody titers and calculate seroprotection rates (SPRs) and seroconversion rates (SCRs). The overall adverse reaction incidence was 1.6% (3/182), and no serious adverse event was reported during the study period. For subjects ≥18 yrs old, the SCRs, SPRs, and the geometric mean titers (GMTs) met the European criteria for all three strains. In addition, the point estimations of SCR, SPR and GMT for BVIC also met the European criteria. Six subjects were seroconverted against H7N9; however the serological results did not meet the European criteria. In conclusion, the results showed a satisfactory safety and immunogenicity profile of Anflu® and cross-reactivity against BVIC, but did not demonstrate cross-reactivity against H7N9 (Clinicaltrials.gov ID: NCT02269852). PMID:26934750

  5. Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children

    DEFF Research Database (Denmark)

    Lusingu, John; Olotu, Ally; Leach, Amanda;

    2010-01-01

    ) recipient and nine episodes among eight rabies vaccine recipients met the criteria for severe malaria. Unsolicited AEs were reported in 78% of subjects in the RTS,S/AS01(E) group and 74% of subjects in the rabies vaccine group. In both vaccine groups, gastroenteritis and pneumonia were the most frequently...

  6. LOW-COST BACTERIAL DETECTION SYSTEM FOR FOOD SAFETY BASED ON AUTOMATED DNA EXTRACTION, AMPLIFICATION AND READOUT

    OpenAIRE

    Hoehl, Melanie Margarete; Bocholt, Eva Schulte; Karippai, Nobu; Zengerle, Roland; Steigert, Juergen; Slocum, Alexander H.

    2013-01-01

    To ensure food, medical and environmental safety and quality, rapid, low-cost and easy-to-use detection methods are desirable. Here, the LabSystem is introduced for integrated, automated DNA purification and amplification. It consists of a disposable, centrifugally-driven DNA purification platform (LabTube) and the subsequent amplification in a low-cost UV/vis-reader (LabReader). In this paper, food safety was chosen as the first sample application with pathogenic verotoxin-producing (VTEC) E...

  7. Flu vaccination in pregnancy

    Directory of Open Access Journals (Sweden)

    Maria Siettou

    2012-04-01

    Full Text Available In periods of seasonal influenza, during pandemic flu in the past and from recent experience that we have the emergence of influenza A (H1N1, pregnant compared with non-pregnant women are at increased risk to get sick and to develop serious complications up to mortality. Purpose: This paper examines the risks that arise for pregnant from contamination with the flu virus and the safety of influenza vaccination in pregnancy. Method: The method involves searching review and research studies in Pubmed data base mainly of the 2000 until 2009 and the words were used is pregnancy, flu vaccination, complications of the flu vaccination at the period of pregnancy. Results: Morbidity during periods of seasonal influenza in pregnant women is increased, while in times of pandemic are recorded fatalities. Based on this, specific recommendations have been made for a flu vaccination in pregnant women, both from the CDC, the American College of Obstetricians and Gynecologists in the U.S. and other official bodies like the World Health Organization, according to that the constitution of influenza vaccine in the pregnancy is necessary, given that the probability of morbidity in this period is increased at 10%. Conclusions: The studies so far to influenza vaccination in pregnancy, do not record serious complications for pregnant women and infants. However more research needs to be done on the safety of influenza vaccination in pregnancy.

  8. Pneumococcal vaccine.

    OpenAIRE

    1999-01-01

    Streptococcus pneumoniae is a frequent cause of pneumonia and meningitis. This article looks at the pneumococcal vaccine, its uses, efficacy, and adverse effects and how vaccination may be improved. We also look at the role of the new conjugate vaccines.

  9. Polio Vaccination

    Science.gov (United States)

    ... to its advantages over IPV in providing intestinal immunity and providing secondary spread of the vaccine to unprotected contacts. Who needs this vaccine and when? Side Effects Excerpt from Vaccine Information Statement A Polio-Free ...

  10. Smallpox Vaccination

    Science.gov (United States)

    ... Newsletters Events Also Known As Smallpox = Vaccinia Smallpox Vaccination Recommend on Facebook Tweet Share Compartir The smallpox ... like many other vaccines. For that reason, the vaccination site must be cared for carefully to prevent ...

  11. Safety and immunogenicity of the Intradermal thai red cross (2-2-2-0-1-1) post exposure vaccination regimen in the Indian population using purified chick embryo cell rabies vaccine

    OpenAIRE

    Chhabra Mala; Ichhpujani R; Bhardwaj M; Tiwari K; Panda R; Lal S

    2005-01-01

    PURPOSE: To test the immunogenicity of the WHO recommended "2-2-2-0-1-1" post-exposure rabies vaccination regimen in Indian subjects to determine the feasibility of replacing crude sheep brain nerve tissue rabies vaccine with modern tissue culture rabies vaccine at major anti-rabies treatment centers throughout India. METHODS: Purified chick embryo cell vaccine (PCECV) was administered in the dosage of 0.1mL per site to 53 Indian subjects. RESULTS: All subjects produced rabies antibodies abov...

  12. Evaluation of protective efficacy of a novel inactivated Salmonella Pullorum ghost vaccine against virulent challenge in chickens.

    Science.gov (United States)

    Guo, Rongxian; Geng, Shizhong; Jiao, Hongmei; Pan, Zhiming; Chen, Xiang; Jiao, Xinan

    2016-05-01

    Salmonella Gallinarum biovar Pullorum is the causative agent of pullorum disease in poultry, an acute systemic disease that results in a high mortality rate in young chickens. Vaccines have been considered in many developing countries where levels of infection are high and eradication is not a realistic option. An attenuated strain combined with protein E-mediated cell lysis was used to generate a safety enhanced Salmonella Pullorum ghost vaccine. Immune responses and protection induced by ghost vaccine in chickens were investigated following a prime-boost immunization administered via intramuscular and oral routes. Chickens from vaccinated groups showed significant increases in antigen-specific IgG, especially after booster immunization. Lymphocyte proliferation responses were also significantly increased in all immunized groups at 2-weeks post-final vaccination. The Salmonella Pullorum ghost vaccine provided satisfactory protection against virulent Salmonella Pullorum infection, as shown by the robust stimulation of both humoral and cell-mediated immune responses as well as the reduction in the number of bacterial recovered post-challenge. Moreover, the immune effects and survival rates indicated intramuscular injection is more efficient than oral vaccination. In conclusion, our results suggest that Salmonella Pullorum ghosts may be used as a safe and effective novel inactivated vaccine candidate to protect against virulent Salmonella Pullorum infection. PMID:27090623

  13. Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya.

    Science.gov (United States)

    Stoute, José A; Gombe, Joash; Withers, Mark R; Siangla, Joram; McKinney, Denise; Onyango, Melanie; Cummings, James F; Milman, Jessica; Tucker, Kathryn; Soisson, Lorraine; Stewart, V Ann; Lyon, Jeffrey A; Angov, Evelina; Leach, Amanda; Cohen, Joe; Kester, Kent E; Ockenhouse, Christian F; Holland, Carolyn A; Diggs, Carter L; Wittes, Janet; Heppner, D Gray

    2007-01-01

    We report the first trial of candidate malaria vaccine antigen FMP1, a 42kDa fragment from the C-terminus of merozoite surface protein-1 (MSP-1) from the 3D7 strain of Plasmodium falciparum, in an endemic area. Forty adult male and female residents of western Kenya were enrolled to receive 3 doses of either FMP1/AS02A or Imovax rabies vaccine by intra-deltoid injection on a 0, 1, 2 month schedule. Thirty-seven volunteers received all three immunizations and 38 completed the 12-month evaluation period. Slightly more recipients of the FMP1/AS02A vaccine experienced any instance of pain at 24 h post-immunization than in the Imovax group (95% versus 65%), but otherwise the two vaccines were equally safe and well-tolerated. Baseline antibody levels were high in both groups and were boosted in the FMP1/AS02A group. Longitudinal models revealed a highly significant difference between groups for both the average post-baseline antibody responses to MSP-1(42) (F1,335=13.16; P<0.001) and the Day 90 responses to MSP-1(42) (F1,335=16.69; P<0.001). The FMP1/AS02A vaccine is safe and immunogenic in adults and should progress to safety testing in children at greatest risk of malaria. PMID:16388879

  14. Universal varicella vaccine immunization in Japan.

    Science.gov (United States)

    Yoshikawa, Tetsushi; Kawamura, Yoshiki; Ohashi, Masahiro

    2016-04-01

    In 1974, Japanese scientists developed a live attenuated varicella vaccine based on the Oka strain. The efficacy of the vaccine for the prevention of varicella has been primarily demonstrated in studies conducted in the United States following the adoption of universal immunization using the Oka strain varicella vaccine in 1996. Although the vaccine was developed by Japanese scientists, until recently, the vaccine has been administered on a voluntary basis in Japan resulting in a vaccine coverage rate of approximately 40%. Therefore, Japan initiated universal immunization using the Oka strain varicella vaccine in November 2014. Given the transition from voluntary to universal immunization in Japan, it will also be important to monitor the epidemiology of varicella and herpes zoster. The efficacy and safety of co-administration of the varicella vaccine and measles, mumps, and rubella vaccine have been demonstrated in many countries; however, there was no data from Japan. In order to adopt the practice of universal immunization using the Oka strain varicella vaccine in Japan, data demonstrating the efficacy and safety of co-administration of varicella vaccine and measles and rubella (MR) vaccine were required. Additionally, we needed to elucidate the appropriate time interval between the first and second administrations of the vaccine. It is also important to differentiate between wild type and Oka vaccine type strains in herpes zoster patient with past history of varicella vaccine. Thus, there are many factors to consider regarding the adoption of universal immunization in Japan to control varicella zoster virus (VZV) infections. PMID:26944711

  15. A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age.

    Directory of Open Access Journals (Sweden)

    Alphonse Ouédraogo

    Full Text Available BACKGROUND: Ad35.CS.01 is a pre-erythrocytic malaria candidate vaccine. It is a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite (CS surface antigen inserted in a replication deficient Adenovirus 35 backbone. A Phase 1a trial has been conducted in the USA in naïve adults and showed that the vaccine was safe. The aim of this study is to assess the safety and immunogenicity of ascending dosages in sub Saharan Africa. METHODS: A double blind, randomized, controlled, dose escalation, phase Ib trial was conducted in a rural area of Balonghin, the Saponé health district (Burkina Faso. Forty-eight healthy adults aged 18-45 years were randomized into 4 cohorts of 12 to receive three vaccine doses (day 0, 28 and 84 of 10(9, 10(10, 5X10(10, 10(11 vp of Ad35.CS.01 or normal saline by intra muscular injection. Subjects were monitored carefully during the 14 days following each vaccination for non serious adverse events. Severe and serious adverse events were collected throughout the participant study duration (12 months from the first vaccination. Humoral and cellular immune responses were measured on study days 0, 28, 56, 84, 112 and 140. RESULTS: Of the forty-eight subjects enrolled, forty-four (91.7% received all three scheduled vaccine doses. Local reactions, all of mild severity, occurred in thirteen (27.1% subjects. Severe (grade 3 laboratory abnormalities occurred in five (10.4% subjects. One serious adverse event was reported and attributed to infection judged unrelated to vaccine. The vaccine induced both antibody titers and CD8 T cells producing IFNγ and TNFα with specificity to CS while eliciting modest neutralizing antibody responses against Ad35. CONCLUSION: Study vaccine Ad35.CS.01 at four different dose levels was well-tolerated and modestly immunogenic in this population. These results suggest that Ad35.CS.01 should be further investigated for preliminary efficacy in human challenge models and as part

  16. Vacuna contra la fiebre hemorrágica argentina Candid#1 producida en la Argentina: Inmunogenicidad y seguridad Candid#1 vaccine against Argentine Hemorrhagic Fever produced in Argentina: Immunogenicity and safety

    Directory of Open Access Journals (Sweden)

    Delia A. Enria

    2010-06-01

    Full Text Available Se realizó un estudio clínico en 946 voluntarios humanos sanos, donde se comparó la vacuna Candid#1 producida en Argentina con la elaborada en EE.UU., que había sido utilizada en estudios previos. Como objetivo primario se evaluó la equivalencia en la eficacia utilizando como marcador subrogante a la inmunogenicidad medida por detección de anticuerpos neutralizantes. Como objetivo secundario se evaluó la equivalencia en inocuidad comparando las tasas de reacciones adversas. Ambas vacunas mostraron una tasa equivalente de inmunogenicidad ligeramente superior al 95.5%, que es la eficacia estimada para Candid #1 en estudios previos. No se observaron eventos adversos graves relacionados con la vacuna. Los eventos adversos generales considerados relacionados fueron de escasa significación clínica y de resolución espontánea o con tratamiento sintomático; se presentaron en los receptores de ambas vacunas en tasas equivalentes (29.9% para la vacuna fabricada en la Argentina y 35.0% para la fabricada en EE.UU., e incluyeron: cefalea, decaimiento, mialgias, plaquetopenia leve (A clinical study in 946 human volunteers was done to compare Candid #1 vaccine manufactured in Argentina with the vaccine produced in USA that had been previously used. The efficacy was evaluated using immunogenicity measured by the detection of neutralizing antibodies as a subrogate marker. Safety was evaluated comparing the rate of adverse events. Both vaccines showed a comparable rate of seroconversion, slighty higher than the efficacy estimated from previous studies (95.5%. There were no severe adverse events related to the vaccines. The general events considered related to the vaccines were not clinically relevant and disappeared either spontaneously or with symptomatic treatment. Similar rates of adverse events (29.9% for the Argentine vaccine and 35.0% for the USA vaccine were found for both vaccines. These included: headache, weakness, myalgias, mild low blood

  17. Current scenario of malaria vaccine

    Directory of Open Access Journals (Sweden)

    Jarnail Singh Braich

    2012-04-01

    Full Text Available Malaria is one of the deadliest infectious diseases that affects millions of people worldwide including India. As an addition to chemoprophylaxis and other antimalarial interventions malaria vaccine is under extensive research since decades. The vaccine development is more difficult to predict than drug development and presents a unique challenge as already there has been no vaccine effective against a parasite. Effective malaria vaccine could help eliminate and eradicate malaria; there are currently 63 vaccine candidates, 41 in preclinical and clinical stages of development. Vaccines are being designed to target pre-erythrocytic stages, erythrocytic stage or the sexual stages of Plasmodium taken up by a feeding mosquito, or the multiple stages. Two vaccines in preclinical and clinical development target P. falciparum; and the most advanced candidate is the pre-erythrocytic vaccine RTS,S which is in phase-III clinical trials. It is likely that world's first malaria vaccine will be available by 2015 at the country level. More efficacious second generation malaria vaccines are on the way to development. Safety, efficacy, cost and provision of the vaccine to all communities are major concerns in malaria vaccine issue. [Int J Basic Clin Pharmacol 2012; 1(2.000: 60-66

  18. Vaccine Hesitancy.

    Science.gov (United States)

    Jacobson, Robert M; St Sauver, Jennifer L; Finney Rutten, Lila J

    2015-11-01

    Vaccine refusal received a lot of press with the 2015 Disneyland measles outbreak, but vaccine refusal is only a fraction of a much larger problem of vaccine delay and hesitancy. Opposition to vaccination dates back to the 1800 s, Edward Jenner, and the first vaccine ever. It has never gone away despite the public's growing scientific sophistication. A variety of factors contribute to modern vaccine hesitancy, including the layperson's heuristic thinking when it comes to balancing risks and benefits as well as a number of other features of vaccination, including falling victim to its own success. Vaccine hesitancy is pervasive, affecting a quarter to a third of US parents. Clinicians report that they routinely receive requests to delay vaccines and that they routinely acquiesce. Vaccine rates vary by state and locale and by specific vaccine, and vaccine hesitancy results in personal risk and in the failure to achieve or sustain herd immunity to protect others who have contraindications to the vaccine or fail to generate immunity to the vaccine. Clinicians should adopt a variety of practices to combat vaccine hesitancy, including a variety of population health management approaches that go beyond the usual call to educate patients, clinicians, and the public. Strategies include using every visit to vaccinate, the creation of standing orders or nursing protocols to provide vaccination without clinical encounters, and adopting the practice of stating clear recommendations. Up-to-date, trusted resources exist to support clinicians' efforts in adopting these approaches to reduce vaccine hesitancy and its impact. PMID:26541249

  19. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  20. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  1. Immunogenicity and Tolerance of a 7-Valent Pneumococcal Conjugate Vaccine in Nonresponders to the 23-Valent Pneumococcal Vaccine

    OpenAIRE

    Zielen, S; Bühring, I.; Strnad, N.; Reichenbach, J; Hofmann, D.

    2000-01-01

    There is still a lack of effective vaccination strategies for patients with a deficient antibody response to bacterial polysaccharide antigens. In an open trial, we evaluated the immunogenicity and tolerance of a new 7-valent pneumococcal conjugate vaccine in 22 infection-prone nonresponders to pneumococcal polysaccharide vaccine and 21 controls. In the patient group, nonresponsiveness was confirmed by repeated vaccination with a 23-valent pneumococcal polysaccharide vaccine. The study protoc...

  2. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP142 administered intramuscularly with adjuvant system AS01

    Directory of Open Access Journals (Sweden)

    Otsyula Nekoye

    2013-01-01

    Full Text Available Abstract Background The development of an asexual blood stage vaccine against Plasmodium falciparum malaria based on the major merozoite surface protein-1 (MSP1 antigen is founded on the protective efficacy observed in preclinical studies and induction of invasion and growth inhibitory antibody responses. The 42 kDa C-terminus of MSP1 has been developed as the recombinant protein vaccine antigen, and the 3D7 allotype, formulated with the Adjuvant System AS02A, has been evaluated extensively in human clinical trials. In preclinical rabbit studies, the FVO allele of MSP142 has been shown to have improved immunogenicity over the 3D7 allele, in terms of antibody titres as well as growth inhibitory activity of antibodies against both the heterologous 3D7 and homologous FVO parasites. Methods Two Phase 1 clinical studies were conducted to examine the safety, reactogenicity and immunogenicity of the FVO allele of MSP142 in the adjuvant system AS01 administered intramuscularly at 0-, 1-, and 2-months: one in the USA and, after evaluation of safety data results, one in Western Kenya. The US study was an open-label, dose escalation study of 10 and 50 μg doses of MSP142 in 26 adults, while the Kenya study, evaluating 30 volunteers, was a double-blind, randomized study of only the 50 μg dose with a rabies vaccine comparator. Results In these studies it was demonstrated that this vaccine formulation has an acceptable safety profile and is immunogenic in malaria-naïve and malaria-experienced populations. High titres of anti-MSP1 antibodies were induced in both study populations, although there was a limited number of volunteers whose serum demonstrated significant inhibition of blood-stage parasites as measured by growth inhibition assay. In the US volunteers, the antibodies generated exhibited better cross-reactivity to heterologous MSP1 alleles than a MSP1-based vaccine (3D7 allele previously tested at both study sites. Conclusions Given that the primary

  3. Safety, immunogenicity and duration of protection of the RTS,S/AS02(D malaria vaccine: one year follow-up of a randomized controlled phase I/IIb trial.

    Directory of Open Access Journals (Sweden)

    Pedro Aide

    Full Text Available BACKGROUND: The RTS,S/AS02(D vaccine has been shown to have a promising safety profile, to be immunogenic and to confer protection against malaria in children and infants. METHODS AND FINDINGS: We did a randomized, controlled, phase I/IIb trial of RTS,S/AS02(D given at 10, 14 and 18 weeks of age staggered with routine immunization vaccines in 214 Mozambican infants. The study was double-blind until the young child completed 6 months of follow-up over which period vaccine efficacy against new Plasmodium falciparum infections was estimated at 65.9% (95% CI 42.6-79.8, p<0.0001. We now report safety, immunogenicity and estimated efficacy against clinical malaria up to 14 months after study start. Vaccine efficacy was assessed using Cox regression models. The frequency of serious adverse events was 32.7% in the RTS,S/AS02(D and 31.8% in the control group. The geometric mean titers of anti-circumsporozoite antibodies declined from 199.9 to 7.3 EU/mL from one to 12 months post dose three of RTS,S/AS02(D, remaining 15-fold higher than in the control group. Vaccine efficacy against clinical malaria was 33% (95% CI: -4.3-56.9, p = 0.076 over 14 months of follow-up. The hazard rate of disease per 2-fold increase in anti-CS titters was reduced by 84% (95% CI 35.1-88.2, p = 0.003. CONCLUSION: The RTS,S/AS02(D malaria vaccine administered to young infants has a good safety profile and remains efficacious over 14 months. A strong association between anti-CS antibodies and risk of clinical malaria has been described for the first time. The results also suggest a decrease of both anti-CS antibodies and vaccine efficacy over time. TRIAL REGISTRATION: ClinicalTrials.gov NCT00197028.

  4. Safety and Immunogenicity of a Diphtheria, Tetanus, and Acellular Pertussis-Inactivated Poliovirus Vaccine / Haemophilus Influenzae Type B Combination Vaccine Administered to Taiwanese Infants at 2, 4, and 6 Months of Age

    Directory of Open Access Journals (Sweden)

    Tzou-Yien Lin

    2003-05-01

    Full Text Available Background: Combined vaccines are urgently needed to ensure compliance with theincreasing number of recommended vaccines for children. We evaluated thesafety and antibody response to a diphtheria, tetanus, and acellular pertussisinactivatedpoliovirus vaccine / Haemophilus influenzae type b (DTaPIPV/ Hib combination vaccine administrated to infants at 2, 4, and 6 monthsof age.Methods: Sixty healthy infants between 6 and 12 weeks of age were enrolled. Onegroup of vaccines received the DTaP-IPV/Hib in a single injection, whileanother group concurrently received DTaP-IPV and Hib at separate injectionsites. Solicited adverse events were monitored by parental observation andwere recorded on a diary card. Levels of serum antibodies to DTaP andpolyribosyl-ribitolphosphate-tetanus (PRP-T antigens were collected beforethe first vaccine dose and 1 month after the third vaccine dose.Results: The combined-injection group tended to have lower local reactions, andthere was no increase in reactogenicity when compared with the separateinjectiongroup. Seroconversion rates were 100% in both groups for all antigens,except for the anti-polio 2 antibody in the combined-injection group(96.4%. The combined-injection group had lower antibody levels of PRP(8.45 μg/ml than did the separate-injection group (20.61 μg/ml. However,the percentage of vaccines achieving protective levels of antibody to PRP(≥ 0.15 μg/ml or ≥ 1.0 μg/ml was similar in both groups.Conclusions: DTaP-IPV/Hib may be safely and effectively administered to healthy infants,using a 2-, 4-, and 6-month vaccination schedule. This combined vaccine iscost-effective, more acceptable to parents and physicians, and minimizes distressto infants.

  5. Bacterial gastroenteritis

    Science.gov (United States)

    Infectious diarrhea - bacterial gastroenteritis; Acute gastroenteritis; Gastroenteritis - bacterial ... Bacterial gastroenteritis can affect 1 person or a group of people who all ate the same food. It is ...

  6. Adolescent Vaccination

    OpenAIRE

    Mustafa Hacımustafaoğlu

    2008-01-01

    Adolescent period usually are omitted regarding the vaccination and the other health evaluations, in our country. Adolescent period is usually considered as between the ages of 8-18 years. During this period, it is important to evaluate routine adolescent examination as well as vaccination status.Childhood (0-18 years) vaccination can be considered in three stages; infantil period vaccinations (

  7. Bacterial persistence and immunity in goats vaccinated with a purE deletion mutant or the parental 16M strain of Brucella melitensis.

    OpenAIRE

    Cheville, N. F.; Olsen, S. C.; Jensen, A E; Stevens, M G; Florance, A M; Houng, H S; Drazek, E S; Warren, R. L.; Hadfield, T. L.; Hoover, D L

    1996-01-01

    To evaluate host responses, young goats were inoculated subcutaneously with a genetic deletion mutant (deltapurE201) of Brucella melitensis (n = 6), its virulent parental strain 16M (n = 6), or saline (n = 6). No clinical evidence of brucellosis was seen in any goat. Serum antibody titers peaked at postinoculation day (PID) 14. Bacteria in lymph nodes that drained sites of vaccination reached peak numbers of >10(6) CFU/g in both infected groups at PID 7 and progressively declined to PID 84. A...

  8. Vaccination with Brucella abortus Recombinant In Vivo-Induced Antigens Reduces Bacterial Load and Promotes Clearance in a Mouse Model for Infection

    OpenAIRE

    Jake E Lowry; Isaak, Dale D.; Leonhardt, Jack A.; Giulia Vernati; Jessie C Pate; Andrews, Gerard P.

    2011-01-01

    Current vaccines used for the prevention of brucellosis are ineffective in inducing protective immunity in animals that are chronically infected with Brucella abortus, such as elk. Using a gene discovery approach, in vivo-induced antigen technology (IVIAT) on B. abortus, we previously identified ten loci that encode products up-regulated during infection in elk and consequently may play a role in virulence. In our present study, five of the loci (D15, 0187, VirJ, Mdh, AfuA) were selected for ...

  9. The Safety of Yellow Fever Vaccine 17D or 17DD in Children, Pregnant Women, HIV+ Individuals, and Older Persons: Systematic Review

    OpenAIRE

    Thomas, Roger E.; Lorenzetti, Diane L; Spragins, Wendy; Jackson, Dave; Williamson, Tyler

    2012-01-01

    Yellow fever vaccine provides long-lasting immunity. Rare serious adverse events after vaccination include neurologic or viscerotropic syndromes or anaphylaxis. We conducted a systematic review of adverse events associated with yellow fever vaccination in vulnerable populations. Nine electronic bibliographic databases and reference lists of included articles were searched. Electronic databases identified 2,415 abstracts for review, and 32 abstracts were included in this review. We identified ...

  10. Human papillomavirus vaccination catch-up campaign in 2009 for girls born 1993 to 1996 in the Netherlands in 2009 : Results of the post-marketing safety suveillance

    OpenAIRE

    van 't Klooster TM; Kemmeren JM; Vermeer-de Bondt PE; Oostvogels B; PHaff TAJ; de Melker HE; van der Maas NAT; EPI; cib

    2011-01-01

    In 2009 zijn over de humaan papillomavirus (HPV) vaccinatie inhaalcampagne geen ernstige verschijnselen na vaccinatie gemeld die door het vaccin zijn veroorzaakt. Het vaccin kan daardoor op de korte termijn als veilig worden beoordeeld. Dit blijkt uit onderzoek naar de mogelijke bijwerkingen van het HPV vaccin van dat jaar. De meisjes hebben veelvuldig verschijnselen als pijn in de arm en spierpijn gemeld, maar deze bleken over het algemeen mild en kortdurend.
    In Nederland is in 2009...

  11. The effect of radurization on the bacterial flora, safety and keeping quality of rough washed bovine ruminal wall (offal)

    International Nuclear Information System (INIS)

    Rough washed bovine ruminal wall is available at low cost in many African countries to traditional consumers of such offal. The consumers consistently oppose any further cleaning or processing which would alter its appearance or elevate its cost. Such offal undoubtedly possesses high nutritional value but is highly perishable product contaminated with numerous bacteria some of which are potential pathogens or toxigens. A preliminary investigation showed that the bacterial counts could be reduced by more that 90% by gamma radiation of such offal with doses of 100-200 krad. Such radiation doubled or trebled the keeping quality of the offal at 40C. Some of the organisms present in offal survive low doses of radiation. They were mainly species of the genera Bacillus, Micrococcus, Streptococcus, Staphylococcus and Clostridium, some of which survived 600 krad. Irradiation doses of 600 krad were in any event necessary to numerically reduce experimental contamination of minced ruminal wall with Staphylococcus aureus, Salmonella dublin and Clostridium perfringens to a level where these organisms could not be recovered by ordinary cultural procedures (the two strains of S. aureus tested varied in their radiation resistance). (orig.)

  12. Henoch-Schönlein purpura and meningococcal B vaccination.

    Science.gov (United States)

    Sexton, K; McNicholas, A; Galloway, Y; Radke, S; Kieft, C; Stehr-Green, P; Reid, S; Neutze, J; Drake, R

    2009-03-01

    The risk of Henoch-Schönlein purpura (HSP) following vaccination with a group B meningococcal vaccine was assessed through active hospital safety monitoring. There was no increase in the relative incidence of HSP within 30 days after vaccination nor recurrence in HSP cases who received one or more further vaccine doses (re-challenge). PMID:18650242

  13. Bath vaccination of rainbow trout against yersiniosis

    DEFF Research Database (Denmark)

    Raida, Martin Kristian; Buchmann, Kurt

    2007-01-01

    Studies have been conducted on the temperature-dependent effect of bath vaccination of rainbow trout against Yersinia ruckeri O1. Protection of rainbow trout fry against challenge, following bath vaccination with a bacterin of Yersinia ruckeri O1, the bacterial pathogen causing enteric red mouth...... disease (ERM), was investigated at 5, 15 and 25° C. Rainbow trout fry were kept at controlled temperatures for two month before they were immersed in a commercial Yersinia ruckeri O1 bacterin for 10 minutes. Control groups were sham vaccinated using pure water. Fish were challenged with Yersinia ruckeri O......1 one and two month post vaccination at the three temperatures. Protection of vaccinated fish was seen one and two month post vaccination in rainbow trout reared at 15° C. There was no effect of vaccination in rainbow trout reared at 5 and 25° C. Spleen tissue was sampled from 5 vaccinated and 5...

  14. Directed vaccination against pneumococcal disease.

    Science.gov (United States)

    Li, Yi; Hill, Andrew; Beitelshees, Marie; Shao, Shuai; Lovell, Jonathan F; Davidson, Bruce A; Knight, Paul R; Hakansson, Anders P; Pfeifer, Blaine A; Jones, Charles H

    2016-06-21

    Immunization strategies against commensal bacterial pathogens have long focused on eradicating asymptomatic carriage as well as disease, resulting in changes in the colonizing microflora with unknown future consequences. Additionally, current vaccines are not easily adaptable to sequence diversity and immune evasion. Here, we present a "smart" vaccine that leverages our current understanding of disease transition from bacterial carriage to infection with the pneumococcus serving as a model organism. Using conserved surface proteins highly expressed during virulent transition, the vaccine mounts an immune response specifically against disease-causing bacterial populations without affecting carriage. Aided by a delivery technology capable of multivalent surface display, which can be adapted easily to a changing clinical picture, results include complete protection against the development of pneumonia and sepsis during animal challenge experiments with multiple, highly variable, and clinically relevant pneumococcal isolates. The approach thus offers a unique and dynamic treatment option readily adaptable to other commensal pathogens. PMID:27274071

  15. Hepatitis Vaccines

    OpenAIRE

    Ogholikhan, Sina; Schwarz, Kathleen B

    2016-01-01

    Viral hepatitis is a serious health problem all over the world. However, the reduction of the morbidity and mortality due to vaccinations against hepatitis A and hepatitis B has been a major component in the overall reduction in vaccine preventable diseases. We will discuss the epidemiology, vaccine development, and post-vaccination effects of the hepatitis A and B virus. In addition, we discuss attempts to provide hepatitis D vaccine for the 350 million individuals infected with hepatitis B ...

  16. The Bacterial Ghost platform system: production and applications.

    Science.gov (United States)

    Langemann, Timo; Koller, Verena Juliana; Muhammad, Abbas; Kudela, Pavol; Mayr, Ulrike Beate; Lubitz, Werner

    2010-01-01

    The Bacterial Ghost (BG) platform technology is an innovative system for vaccine, drug or active substance delivery and for technical applications in white biotechnology. BGs are cell envelopes derived from Gram-negative bacteria. BGs are devoid of all cytoplasmic content but have a preserved cellular morphology including all cell surface structures. Using BGs as delivery vehicles for subunit or DNA-vaccines the particle structure and surface properties of BGs are targeting the carrier itself to primary antigen-presenting cells. Furthermore, BGs exhibit intrinsic adjuvant properties and trigger an enhanced humoral and cellular immune response to the target antigen. Multiple antigens of the native BG envelope and recombinant protein or DNA antigens can be combined in a single type of BG. Antigens can be presented on the inner or outer membrane of the BG as well as in the periplasm that is sealed during BG formation. Drugs or supplements can also be loaded to the internal lumen or periplasmic space of the carrier. BGs are produced by batch fermentation with subsequent product recovery and purification via tangential flow filtration. For safety reasons all residual bacterial DNA is inactivated during the BG production process by the use of staphylococcal nuclease A and/or the treatment with β-propiolactone. After purification BGs can be stored long-term at ambient room temperature as lyophilized product. The production cycle from the inoculation of the pre-culture to the purified BG concentrate ready for lyophilization does not take longer than a day and thus meets modern criteria of rapid vaccine production rather than keeping large stocks of vaccines. The broad spectrum of possible applications in combination with the comparably low production costs make the BG platform technology a safe and sophisticated product for the targeted delivery of vaccines and active agents as well as carrier of immobilized enzymes for applications in white biotechnology. PMID:21326832

  17. The safety and efficacy of bacterial nanocellulose wound dressing incorporating sericin and polyhexamethylene biguanide: in vitro, in vivo and clinical studies.

    Science.gov (United States)

    Napavichayanun, Supamas; Yamdech, Rungnapha; Aramwit, Pornanong

    2016-03-01

    In our previous work, we have attempted to develop a novel bacterial nanocellulose wound dressing which composed of both polyhexamethylene biguanide (PHMB) as an antimicrobial agent and sericin as an accelerative wound healing component. The loading sequence and concentration of PHMB and sericin were optimized to provide the wound dressing with the most effective antimicrobial activity and enhanced collagen production. In this study, further in vitro, in vivo, and clinical studies of this novel wound dressing were performed to evaluate its safety, efficacy, and applicability. For the in vitro cytotoxic test with L929 mouse fibroblast cells, our novel dressing was not toxic to the cells and also promoted cell migration as good as the commercially available dressing, possibly due to the component of sericin released. When implanted subcutaneously in rats, the lower inflammation response was observed for the novel dressing implanted, comparing to the commercially available dressing. This might be that the antimicrobial PHMB component of the novel dressing played a role to reduce infection and inflammation reaction. The clinical trial patch test was performed on the normal skin of healthy volunteers to evaluate the irritation effect of the dressing. Our novel dressing did not irritate the skin of any volunteers, as characterized by the normal levels of erythema and melanin and the absence of edema, papule, vesicle, and bullae. Then, the novel dressing was applied for the treatment of full-thickness wounds in rats. The wounds treated with our novel dressing showed significantly lower percentage of wound size and higher extent of collagen formation mainly due to the activity of sericin. We concluded that our novel bacterial nanocellulose incorporating PHMB and sericin was a safe and efficient wound dressing material for further investigation in the wound healing efficacy in clinic. PMID:26796543

  18. Improved ERM vaccination efficacy using combined vaccine administration methods

    DEFF Research Database (Denmark)

    Buchmann, Kurt; Desmukh, Sidhartha; Chettri, Jiwan Kumar;

    2012-01-01

    We have previously shown that immersion vaccination (30 sec) using the Aquavac Relera vaccine (containing formalin killed Yersinia ruckeri serotype O1 of both biotypes 1 and 2) provides the best protection (when compared to other commercial ERM vaccines on the Danish market) against infection...... following i. p. challenge using Y. ruckeri O1, biotype 2, which at present is the main bacterial pathogen in fingerling trout production in Denmark. Despite a significant protection conferred by this vaccine (immersion) some mortality could be observed following challenge. We have therefore performed a...... study in order to elucidate if different vaccine administration methods (using Aquavac Relera) can improve protection and reduce mortality of exposed trout following challenge with this particular pathogen. Rainbow trout (mean weight 7.8 g) reared at the Bornholm Salmon Hatchery under pathogen free...

  19. A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults.

    Science.gov (United States)

    Sagara, Issaka; Ellis, Ruth D; Dicko, Alassane; Niambele, Mohamed B; Kamate, Beh; Guindo, Ousmane; Sissoko, Mahamadou S; Fay, Michael P; Guindo, Merepen A; Kante, Ousmane; Saye, Renion; Miura, Kazutoyo; Long, Carole; Mullen, Gregory E D; Pierce, Mark; Martin, Laura B; Rausch, Kelly; Dolo, Amagana; Diallo, Dapa A; Miller, Louis H; Doumbo, Ogobara K

    2009-12-01

    A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donéguébougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 microg AMA1-C1/Alhydrogel or 80 microg AMA1-C1/Alhydrogel + 564 microg CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all padjuvant CPG 7909 in a malaria-exposed population. PMID:19874925

  20. Immunization by a bacterial aerosol

    OpenAIRE

    Garcia-Contreras, Lucila; Wong, Yun-Ling; Muttil, Pavan; Padilla, Danielle; Sadoff, Jerry; DeRousse, Jessica; Germishuizen, Willem Andreas; Goonesekera, Sunali; Elbert, Katharina; Bloom, Barry R.; Miller, Rich; Fourie, P. Bernard; Hickey, Anthony; Edwards, David

    2008-01-01

    By manufacturing a single-particle system in two particulate forms (i.e., micrometer size and nanometer size), we have designed a bacterial vaccine form that exhibits improved efficacy of immunization. Microstructural properties are adapted to alter dispersive and aerosol properties independently. Dried “nanomicroparticle” vaccines possess two axes of nanoscale dimensions and a third axis of micrometer dimension; the last one permits effective micrometer-like physical dispersion, and the form...

  1. DNA vaccines for aquacultured fish

    DEFF Research Database (Denmark)

    Lorenzen, Niels; LaPatra, S.E.

    2005-01-01

    in various animal species as well as in humans, the vaccines against rhabdovirus diseases in fish have given some of the most promising results. A single intramuscular (IM) injection of microgram amounts of DNA induces rapid and long-lasting protection in farmed salmonids against economically important...... viruses such as infectious haematopoietic necrosis virus (IHNV) and viral haemorrhagic septicaemia virus (VHSV). DNA vaccines against other types of fish pathogens, however, have so far had limited success. The most efficient delivery route at present is IM injection, and suitable delivery strategies...... for mass vaccination of small fish have yet to be developed. In terms of safety, no adverse effects in the vaccinated fish have been observed to date. As DNA vaccination is a relatively new technology, various theoretical and long-term safety issues related to the environment and the consumer remain...

  2. Gardening Health and Safety Tips

    Science.gov (United States)

    ... Health History Parent Information Vaccines & Immunizations Healthy Living Gardening Health and Safety Tips Recommend on Facebook Tweet Share Compartir Gardening can be a great way to enjoy the ...

  3. Safety and enhanced immunogenicity of a hepatitis B core particle Plasmodium falciparum malaria vaccine formulated in adjuvant Montanide ISA 720 in a phase I trial.

    NARCIS (Netherlands)

    Oliveira, G.A.; Wetzel, K.; Calvo-Calle, J.M.; Nussenzweig, R.; Schmidt, A.; Birkett, A.; Dubovsky, F.; Tierney, E.; Gleiter, C.H.; Boehmer, G.; Luty, A.J.F.; Ramharter, M.; Thornton, G.B.; Kremsner, P.G.; Nardin, E.H.

    2005-01-01

    Highly purified subunit vaccines require potent adjuvants in order to elicit optimal immune responses. In a previous phase I trial, an alum formulation of ICC-1132, a malaria vaccine candidate comprising hepatitis B core (HBc) virus-like particle containing Plasmodium falciparum circumsporozoite (CS

  4. Study of the safety, immunogenicity and efficacy of attenuated and killed Leishmania (Leishmania major vaccines in a rhesus monkey (Macaca mulatta model of the human disease

    Directory of Open Access Journals (Sweden)

    VF Amaral

    2002-10-01

    Full Text Available We have compared the efficacy of two Leishmania (Leishmania major vaccines, one genetically attenuated (DHFR-TS deficient organisms, the other inactivated [autoclaved promastigotes (ALM with bacillus Calmete-Guérin (BCG], in protecting rhesus macaques (Macaca mulatta against infection with virulent L. (L. major. Positive antigen-specific recall proliferative response was observed in vaccinees (79% in attenuated parasite-vaccinated monkeys, versus 75% in ALM-plus-BCG-vaccinated animals, although none of these animals exhibited either augmented in vitro gamma interferon (IFN-g production or positive delayed-type hypersensitivity (DTH response to the leishmanin skin test prior to the challenge. Following challenge, there were significant differences in blastogenic responses (p < 0.05 between attenuated-vaccinated monkeys and naïve controls. In both vaccinated groups very low levels of antibody were found before challenge, which increased after infective challenge. Protective immunity did not follow vaccination, in that monkeys exhibited skin lesion at the site of challenge in all the groups. The most striking result was the lack of pathogenicity of the attenuated parasite, which persisted in infected animals for up to three months, but were incapable of causing disease under the conditions employed. We concluded that both vaccine protocols used in this study are safe in primates, but require further improvement for vaccine application.

  5. A Randomised Trial Evaluating the Safety and Immunogenicity of the Novel Single Oral Dose Typhoid Vaccine M01ZH09 in Healthy Vietnamese Children

    NARCIS (Netherlands)

    T.H. Tran; T.D. Nguyen; T.T. Nguyen; T.T.V. Ninh; N.B.C. Tran; V.M.H. Nguyen; T.T.N. Tran; T.T. Cao; V.M. Pham; T.C.B. Nguyen; T.D.H. Tran; V.T. Pham; S.D. To; J.I. Campbell; E. Stockwell; C. Schultsz; C.P. Simmons; C. Glover; W. Lam; F. Marques; J.P. May; A. Upton; R. Budhram; G. Dougan; J. Farrar; V.V.C. Nguyen; C. Dolecek

    2010-01-01

    Background: The emergence of drug resistant typhoid fever is a major public health problem, especially in Asia. An oral single dose typhoid vaccine would have major advantages. M01ZH09 is a live oral single dose candidate typhoid vaccine containing Salmonella enterica serovar Typhi (Ty2 aroC(-) ssaV

  6. Human papillomavirus vaccination catch-up campaign in 2009 for girls born 1993 to 1996 in the Netherlands in 2009 : Results of the post-marketing safety suveillance

    NARCIS (Netherlands)

    van ' t Klooster TM; Kemmeren JM; Vermeer-de Bondt PE; Oostvogels B; PHaff TAJ; de Melker HE; van der Maas NAT; EPI; cib

    2011-01-01

    In 2009 zijn over de humaan papillomavirus (HPV) vaccinatie inhaalcampagne geen ernstige verschijnselen na vaccinatie gemeld die door het vaccin zijn veroorzaakt. Het vaccin kan daardoor op de korte termijn als veilig worden beoordeeld. Dit blijkt uit onderzoek naar de mogelijke bijwerkingen van het

  7. Targeting vaccines to dendritic cells

    DEFF Research Database (Denmark)

    Foged, Camilla; Sundblad, Anne; Hovgaard, Lars

    2002-01-01

    be far superior to that of B-cells and macrophages. DC are localized at strategic places in the body at sites used by pathogens to enter the organism, and are thereby in an optimal position to capture antigens. In general, vaccination strategies try to mimic the invasiveness of the pathogens. DC are...... considered to play a central role for the provocation of primary immune responses by vaccination. A rational way of improving the potency and safety of new and already existing vaccines could therefore be to direct vaccines specifically to DC. There is a need for developing multifunctional vaccine drug...... delivery systems (DDS) with adjuvant effect that target DC directly and induce optimal immune responses. This paper will review the current knowledge of DC physiology as well as the progress in the field of novel vaccination strategies that directly or indirectly aim at targeting DC....

  8. Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development

    Directory of Open Access Journals (Sweden)

    Samantha Sayers

    2012-01-01

    Full Text Available Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO in the Web Ontology Language (OWL format.

  9. Antibody response of patients after postexposure rabies vaccination with small intradermal doses of purified chick embryo cell vaccine or purified Vero cell rabies vaccine

    OpenAIRE

    Briggs, D. J.; A. Banzhoff; U. Nicolay; Sirikwin, S.; B. Dumavibhat; S. Tongswas; C. Wasi

    2000-01-01

    Although the introduction of tissue culture vaccines for rabies has dramatically improved the immunogenicity and safety of rabies vaccines, they are often prohibitively expensive for developing countries. To examine whether smaller doses of these vaccines could be used, we tested the safety and immunogenicity of purified chick embryo cell vaccine (PCECV) on 211 patients in Thailand with World Health Organization (WHO) category II and III exposures to rabies. The patients presented at two Thai...

  10. Study on the safety and effectiveness of multiple vaccines to BALB/c mice%BALB/c小鼠多疫苗接种的安全性和有效性研究

    Institute of Scientific and Technical Information of China (English)

    魏茂提; 寇志华; 曹务春; 杨红; 詹琳; 赵秋敏; 张松乐; 张泮河; 吴晓明

    2005-01-01

    [Objective] Our aim is to study the safety and effectiveness of multiple vaccines when combine used to immunize BALB/c mice. [Methods] The study was designed to administrate six vaccines, which can be used in the emergency condition in human, simultaneously in a short period to mice (the whole immune plan will be completed in two or three weeks) considering each vaccine immune protocols. Three administration proposals which considered mainly on the order of each vaccine were tested according to the interval of each vaccine and the whole period of the multiple immunization.Three multiple vaccine administration groups and one control group were treated with different proposal but with the same dosage of multiple vaccines respectively. Body weight, immunological response, biochemical indices and spontaneous activity were monitored for 119 days. [Results] Although animals in all groups remained generally healthy and active without visible adverse signs throughout the study, there were still minor changes in body weight, WBC counts, lymphocyte percentage, AST, ALT and creatitine in sometime. Obvious immune reactions to each vaccine were observed with some changes in different schedule, and this is especially distinct to the vaccine against hemorrhage fever with renal syndrome (HFRS). [Conclusion] The results suggest that these six vaccines may be used in some emergency condition with proper order and immune period, but there may remain some risks in the multiple vaccines administration especially these with plague and anthrax vaccine.%[目的]研究小鼠多疫苗联合接种的安全性和有效性.[方法]研究要求6种(炭疽、鼠疫、出血热、霍乱、痢疾、钩体疫苗)疫苗进行联合接种,根据6种疫苗的联合接种方式、疫苗接种间隔和接种的先后顺序,设计3种疫苗快速接种方案(2~3 w完成接种).对研究对象连续观测了119 d,以体重、免疫反应、生化指标及自发活动等指标对疫苗联合接种的安

  11. Phase 1 Dose-ranging Safety Trial of Lactobacillus crispatus CTV-05 (LACTIN-V) for the Prevention of Bacterial Vaginosis

    Science.gov (United States)

    Hemmerling, Anke; Harrison, William; Schroeder, Adrienne; Park, Jeanna; Korn, Abner; Shiboski, Stephen; Cohen, Craig R.

    2009-01-01

    Background Bacterial vaginosis is a very common vaginal infection. The lack of endogenous lactobacilli and overgrowth of pathogens facilitate numerous gynecological complications. Methods A phase I dose-ranging safety trial tested the safety, tolerability and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by vaginal applicator. Twelve healthy volunteers were enrolled in three blocks of four (5 × 108, 1 × 109 and 2 × 109 cfu/dose). Each block was randomized in a 3:1 ratio of active product to placebo. Participants used study product for 5 consecutive days, returned for follow up on Days 7 and 14, and had phone interviews on Days 2 and 35. Results All 12 participants took 5 doses and completed study follow-up. Overall, 45 adverse events (AEs) occurred, of which 31 (69%) were genitourinary (GU) AEs. GU AEs appeared evenly distributed between the three treatment blocks and between LACTIN-V and placebo arms. The most common GU AEs were vaginal discharge in 5 subjects (42%), abdominal pain in 4 subjects (33%), metrorrhagia in 4 subjects (33%), vulvovaginitis in 4 subjects (33%), vaginal candidiasis in 3 subjects (25%), and vaginal odor in 3 subjects (25%). Forty one (91%) AEs were mild (grade 1) in severity. All four moderate AEs (grade 2) were unrelated to product use. No grade 3 or 4 AEs or serious adverse events (SAE) occurred. Laboratory parameters and colposcopy findings were within normal limits or clinically insignificant. The product was well tolerated and accepted. Conclusion All three dose levels of LACTIN-V appeared to be safe and acceptable in healthy volunteers. PMID:19543144

  12. 9 CFR 113.66 - Anthrax Spore Vaccine-Nonencapsulated.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Anthrax Spore Vaccine-Nonencapsulated... REQUIREMENTS Live Bacterial Vaccines § 113.66 Anthrax Spore Vaccine—Nonencapsulated. Anthrax Spore Vaccine... in 9 CFR 113.64 and the requirements in this paragraph. Any serial or subserial found...

  13. Study of Domestic and Imported Recombinant Hepatitis B Vaccine Safety%国产与进口重组乙型肝炎疫苗安全性的研究

    Institute of Scientific and Technical Information of China (English)

    杨海云; 陈乐锋; 黄金凤; 梁小媚; 陈雪玲

    2015-01-01

    Objective:Understand the difference between domestic and imported vaccines the safety of both the two hepatitis B ,hepatitis Bvaccination to promote and improve immunization coverage .Methods:In Maoming City area choose healthy children aged 0~1 total 300 ,a voluntary set of principles into domestic and imported vaccines vaccine group were vaccinated with a recombinant hepatitis B vaccine and recombinant hepatitis B vaccine imported in vaccina‐tion 7 days after the follow‐up observation of systemic reactions and local swelling reactions .Results:Compared with domestic recombinant vaccine and imported recombinant hepatitis B vaccine has a similar safety profile .300 cases of re‐cipients had no local reaction ,the incidence was 3 .33% in 4 .67% ,systemic reaction ,the difference in the aspect of safety was not statistically significant (χ2 =0 .35 ,P>0 .05) .In 12 cases of adverse reactions occurred in 83 .33% (10/12) ,occurs within 1 days after inoculation ,16 .67% (2/12) occurred in 2~3 days after inoculation;the male to female ratio was 1 .40∶1 25.00% (3/12) ,occurred in inoculated first agents ,41 .67% (5/12) occurred within second agents , 33 .33% (4/12) occurred in third when the inoculation agent .Domestic vaccine group and imported vaccines group had adverse reactions in the time distribution ,population distribution ,the distribution of the inoculating needle on the same trend .Conclusion:Whether domestic or imported hepatitis B vaccine hepatitis B vaccination are part of the children after the occurrence of adverse reactions may be related to factors related to children's individual differences ,without serious consequences occur after the intervention ,the security is high ,while the domestic vaccine vaccines for national immu‐nization programs ,children free vaccinated three times ,compared with the high price of imported vaccines ,more suit‐able for the prevention and control of hepatitis .%目的:了解国产和进口两种乙肝疫苗安

  14. 甲流了解程度、疫苗安全感知、接种行为及其影响机制%The Familiarity of Influenza A (H1N1), Perception of Vaccine Safety, Vaccination Behaviour and Their Influential Mechanism

    Institute of Scientific and Technical Information of China (English)

    秦昕; 牛丛; 黄振雷; 徐敏亚

    2011-01-01

    采用问卷调查的方法,对甲流了解程度、疫苗安全感知、接种行为及其影响机制进行了研究,并运用结构方程对提出的模型进行了验证和调整.结果表明:(1)民众对甲流疫情基本情况、疫苗接种要求和传播途径等方面有较高的了解程度,但对预防措施和疫苗信息了解较少.(2)交流卷入对了解程度不存在显著影响;而新闻卷入对了解程度有显著正向影响,并且新闻卷入对感知疫苗安全程度的正向影响受到了解程度的部分中介.(3)感知甲流疫苗越安全,越倾向于选择接种疫苗.(4)人格对疫苗的风险认知存在显著影响,个人随和性(Agreeableness)程度越高,则感知疫苗的安全程度越高,而年龄和性别对其均没有显著影响.%Breaking out in Mexico, influenza A (H1N1) spread rapidly throughout the world and caused thousands of deaths. In China, the government took several measures to control the disease's transmission, such as licensing vaccine production and setting up a vaccination system. Researchers have conducted a number of investigations on risk perceptions of past public health crises and natural disasters, but little systematic empirical research has been done for vaccine or vaccination behaviour. Also, up until now, there seems to be no explicit research conducted on influenza A (H1N1). In this study, we examined the public's familiarity with influenza A (H1N1), perception of vaccine safety, vaccination behaviour and the mechanism of influence.We employed a questionnaire to collect data from several universities located in Beijing. Before conducting the survey, we first performed a pretest with a group of 30 people, and made adjustments based on their opinions and suggestions. The measurements in the questionnaire included: respondents' demographics, the Big Five Scales, degree of prudence, involvement, degree of familiarity, perception of vaccine safety, vaccination behaviour and two open questions about

  15. Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy.

    Directory of Open Access Journals (Sweden)

    Jason W Bennett

    2016-02-01

    Full Text Available A vaccine to prevent infection and disease caused by Plasmodium vivax is needed both to reduce the morbidity caused by this parasite and as a key component in efforts to eradicate malaria worldwide. Vivax malaria protein 1 (VMP001, a novel chimeric protein that incorporates the amino- and carboxy- terminal regions of the circumsporozoite protein (CSP and a truncated repeat region that contains repeat sequences from both the VK210 (type 1 and the VK247 (type 2 parasites, was developed as a vaccine candidate for global use.We conducted a first-in-human Phase 1 dose escalation vaccine study with controlled human malaria infection (CHMI of VMP001 formulated in the GSK Adjuvant System AS01B. A total of 30 volunteers divided into 3 groups (10 per group were given 3 intramuscular injections of 15 μg, 30 μg, or 60 μg respectively of VMP001, all formulated in 500 μL of AS01B at each immunization. All vaccinated volunteers participated in a P. vivax CHMI 14 days following the third immunization. Six non-vaccinated subjects served as infectivity controls.The vaccine was shown to be well tolerated and immunogenic. All volunteers generated robust humoral and cellular immune responses to the vaccine antigen. Vaccination did not induce sterile protection; however, a small but significant delay in time to parasitemia was seen in 59% of vaccinated subjects compared to the control group. An association was identified between levels of anti-type 1 repeat antibodies and prepatent period.This trial was the first to assess the efficacy of a P. vivax CSP vaccine candidate by CHMI. The association of type 1 repeat-specific antibody responses with delay in the prepatency period suggests that augmenting the immune responses to this domain may improve strain-specific vaccine efficacy. The availability of a P. vivax CHMI model will accelerate the process of P. vivax vaccine development, allowing better selection of candidate vaccines for advancement to field trials.

  16. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule

    Directory of Open Access Journals (Sweden)

    Collard Alix

    2010-10-01

    Full Text Available Abstract Background Combination vaccines improve coverage, compliance and effectively introduce new antigens to mass vaccination programmes. This was a phase III, observer-blind, randomized study of GSK Biologicals diphtheria-tetanus-whole cell pertussis vaccine combined with hepatitis B and Haemophilus influenzae type b vaccines, containing a reduced amount of polyribosyl-ribitol-phosphate (PRP and a DTPw component manufactured at a different site (DTPw-HBV/Hib2.5 [Kft]. The primary aim of this study was to demonstrate that DTPw-HBV/Hib2.5 [Kft] was not inferior to the licensed DTPw-HBV/Hib (Tritanrix(tm-HepB/Hiberix(tm vaccine or the DTPw-HBV/Hib2.5 vaccine, also containing a reduced amount of PRP, with respect to the immune response to the PRP antigen, when administered to healthy infants, according to the Expanded Programme for Immunization (EPI schedule at 6, 10 and 14 weeks of age. Methods 299 healthy infants were randomised to receive either DTPw-HBV/Hib2.5 [Kft] DTPw-HBV/Hib2.5 or DTPw-HBV/Hib according to the 6-10-14 week EPI schedule. Blood samples were analysed prior to the first dose of study vaccine and one month after the third vaccine dose for the analysis of immune responses. Solicited local and general symptoms such as pain, redness and swelling at the injection site and drowsiness and fever, unsolicited symptoms (defined as any additional adverse event and serious adverse events (SAEs were recorded up to 20 weeks of age. Results One month after the third vaccine dose, 100% of subjects receiving DTPw-HBV/Hib2.5 [Kft] or DTPw-HBV/Hib and 98.8% of subjects receiving DTPw-HBV/Hib2.5 vaccine had seroprotective levels of anti-PRP antibodies (defined as anti-PRP antibody concentration ≥0.15 μg/ml. Seroprotective antibody concentrations were attained in over 98.9% of subjects for diphtheria, tetanus and hepatitis B. The vaccine response rate to pertussis antigen was at least 97.8% in each group. Overall, the DTPw-HBV/Hib2.5 [Kft

  17. Vaccine safety and efficacy evaluation of a recombinant bovine respiratory syncytial virus (BRSV with deletion of the SH gene and subunit vaccines based on recombinant human RSV proteins: N-nanorings, P and M2-1, in calves with maternal antibodies.

    Directory of Open Access Journals (Sweden)

    Krister Blodörn

    Full Text Available The development of safe and effective vaccines against both bovine and human respiratory syncytial viruses (BRSV, HRSV to be used in the presence of RSV-specific maternally-derived antibodies (MDA remains a high priority in human and veterinary medicine. Herein, we present safety and efficacy results from a virulent BRSV challenge of calves with MDA, which were immunized with one of three vaccine candidates that allow serological differentiation of infected from vaccinated animals (DIVA: an SH gene-deleted recombinant BRSV (ΔSHrBRSV, and two subunit (SU formulations based on HRSV-P, -M2-1, and -N recombinant proteins displaying BRSV-F and -G epitopes, adjuvanted by either oil emulsion (Montanide ISA71VG, SUMont or immunostimulating complex matrices (AbISCO-300, SUAbis. Whereas all control animals developed severe respiratory disease and shed high levels of virus following BRSV challenge, ΔSHrBRSV-immunized calves demonstrated almost complete clinical and virological protection five weeks after a single intranasal vaccination. Although mucosal vaccination with ΔSHrBRSV failed to induce a detectable immunological response, there was a rapid and strong anamnestic mucosal BRSV-specific IgA, virus neutralizing antibody and local T cell response following challenge with virulent BRSV. Calves immunized twice intramuscularly, three weeks apart with SUMont were also well protected two weeks after boost. The protection was not as pronounced as that in ΔSHrBRSV-immunized animals, but superior to those immunized twice subcutaneously three weeks apart with SUAbis. Antibody responses induced by the subunit vaccines were non-neutralizing and not directed against BRSV F or G proteins. When formulated as SUMont but not as SUAbis, the HRSV N, P and M2-1 proteins induced strong systemic cross-protective cell-mediated immune responses detectable already after priming. ΔSHrBRSV and SUMont are two promising DIVA-compatible vaccines, apparently inducing

  18. Analysis of the Safety of 375 HI NI Influenza Vaccine Inoculators%375位医务人员接种甲流疫苗不良反应分析

    Institute of Scientific and Technical Information of China (English)

    李金兰; 黄红林

    2011-01-01

    Objective:To probe into the incidence rate of ADR and safety of H1N1 influenza A vaccine. Method :375 medical workers inoculated with influenza A ( H1N1 ) vaccines were included in this study. The incidence, occurrence time , duration and outcome of their adverse reactions were observed. Result:The total incidence of adverse reactions in 375 vaccinated people was 2. 7% ( 10 of 375). All the adverse reactions were able to heal spontaneously or were cured.Conclusion:H1N1 influenza A vaccine caused mild adverse drug reactions in a few subjects, and the symptoms could be quickly recovered spontaneously. The vaccine is relatively safe.%目的:了解医务人员接种甲型H1N1流感裂解疫苗的不良反应(ADR)发生情况.方法:观察该医院375名医务工作者接种甲型H1N1流感裂解疫苗后的ADR,统计分析ADR发生率、出现时间、持续时间、转归等.结果:375例甲型H1N1流感裂解疫苗接种者中发生ADR10例,发生率2.7%.均为一般ADR,所有的ADR经对症治疗后均可治愈.结论:甲型H1N1流感裂解疫苗总体ADR以轻度ADR为主,均可治愈,疫苗的安全性较好.

  19. Safety and immunogenicity of the Intradermal thai red cross (2-2-2-0-1-1 post exposure vaccination regimen in the Indian population using purified chick embryo cell rabies vaccine

    Directory of Open Access Journals (Sweden)

    Chhabra Mala

    2005-01-01

    Full Text Available PURPOSE: To test the immunogenicity of the WHO recommended "2-2-2-0-1-1" post-exposure rabies vaccination regimen in Indian subjects to determine the feasibility of replacing crude sheep brain nerve tissue rabies vaccine with modern tissue culture rabies vaccine at major anti-rabies treatment centers throughout India. METHODS: Purified chick embryo cell vaccine (PCECV was administered in the dosage of 0.1mL per site to 53 Indian subjects. RESULTS: All subjects produced rabies antibodies above 0.5IU/mL by day 14 post-vaccination. Only minor adverse reactions including swelling (6.6%, erythema (5.4% and pain (1.4% were observed for which no treatment was required. CONCLUSIONS: This study demonstrated that PCECV is safe and highly immunogenic in Indian subjects when administered intradermally as 0.1mL/site using the "2-2-2-0-1-1" post-exposure regimen.

  20. HPV vaccine

    Science.gov (United States)

    Vaccine - HPV; Immunization - HPV; Gardasil; Cervarix; HPV2; HPV4; Vaccine to prevent cervical cancer ... HPV is a common virus that is spread through sexual contact. There are several types of HPV. ...

  1. Diphtheria Vaccination

    Science.gov (United States)

    ... children and adults - Tetanus-diphtheria-acellular Pertussis vaccine Diphtheria Vaccination Pronounced (dif-THEER-ee-a) Recommend on Facebook Tweet Share Compartir Diphtheria causes a thick covering in the back of ...

  2. Mining of vaccine-associated IFN-γ gene interaction networks using the Vaccine Ontology

    OpenAIRE

    2011-01-01

    Background Interferon-gamma (IFN-γ) is vital in vaccine-induced immune defense against bacterial and viral infections and tumor. Our recent study demonstrated the power of a literature-based discovery method in extraction and comparison of the IFN-γ and vaccine-mediated gene interaction networks. The Vaccine Ontology (VO) contains a hierarchy of vaccine names. It is hypothesized that the application of VO will enhance the prediction of IFN-γ and vaccine-mediated gene interaction network. Resu...

  3. Prophylactic HPV vaccines

    Directory of Open Access Journals (Sweden)

    Mandić Aljoša

    2009-01-01

    Full Text Available Human papillomavirus (HPV is one of the most common sexually transmitted diseases worldwide. Cervical and other anogenital cancers, cervical and anal intraepithelial neoplasia, genital warts, and recurrent respiratory papillomatosis are HPV associated diseases. Prophylactic HPV vaccines are composed of HPV L1 capsid protein that self-assemble into virus-like particles (VLPs when expressed in recombinant systems. Two types of prophylactic vaccines are designed as a bivalent vaccine to protect against high-risk HPV types 16 and 18 and a quadrivalent vaccine designed to protect against HPV 16 and 18, and low-risk, genital wart-causing HPV 6 and 11. Proof-of-principle trials have suggested that intramuscular injections of VLPs result in strong adaptive immune responses that are capable of neutralizing subsequent natural infections. Recent research on the safety and efficacy of candidate prophylactic vaccines against HPV have shown very promising results with nearly 100% efficacy in preventing the development of persistent infections and cervical precancerous lesions in vaccinated individuals.

  4. Oral vaccination of dogs with recombinant rabies virus vaccines.

    Science.gov (United States)

    Rupprecht, Charles E; Hanlon, Cathleen A; Blanton, Jesse; Manangan, Jamie; Morrill, Patricia; Murphy, Staci; Niezgoda, Michael; Orciari, Lillian A; Schumacher, Carolin L; Dietzschold, Bernhard

    2005-07-01

    Oral rabies virus (RV) vaccines are used to immunize a diversity of mammalian carnivores, but no single biological is effective for all major species. Recently, advances in reverse genetics have allowed the design of recombinant RV for consideration as new vaccines. The objective of this experiment was to examine the safety, immunogenicity and efficacy of recombinant RV vaccines administered to captive dogs by the oral route, compared to a commercial vaccinia-rabies glycoprotein (V-RG) recombinant virus vaccine. Animals consisted of naive purpose-bred beagles of both sexes, and were 6 months of age or older. Dogs were randomly assigned to one of six groups, and received either diluent or vaccine (PBS; V-RG; RV SN10-333; RV SPBN-Cyto c; RV SPBNGA; RV SPBNGAGA), with at least six animals per group. On day 0, 1 ml of each vaccine (or PBS) was administered to the oral cavity of each dog, at an approximate concentration of 10(8) to 10(9) TCID50. After vaccination, dogs were observed daily and bled weekly, for 5 weeks, prior to RV challenge. No signs of illness related to vaccination were detected during the observation period. Excluding the controls, RV neutralizing antibodies were detected in the majority of animals within 1-2 weeks of primary vaccination. Thereafter, all dogs were inoculated in the masseter muscle with a street virus of canine origin. All control animals developed rabies, but no vaccinates succumbed, with the exception of a single dog in the V-RG group. Review of these preliminary data demonstrates the non-inferiority of recombinant RV products, as concerns both safety and efficacy, and supports the suggestion that these vaccines may hold promise for future development as oral immunogens for important carnivore species, such as dogs. PMID:15896409

  5. DNA vaccines

    OpenAIRE

    Coban, Cevayir; Kobiyama, Kouji; Jounai, Nao; Tozuka, Miyuki; Ishii, Ken J.

    2013-01-01

    Since the introduction of DNA vaccines two decades ago, this attractive strategy has been hampered by its low immunogenicity in humans. Studies conducted to improve the immunogenicity of DNA vaccines have shown that understanding the mechanism of action of DNA vaccines might be the key to successfully improving their immunogenicity. Our current understanding is that DNA vaccines induce innate and adaptive immune responses in two ways: (1) encoded protein (or polypeptide) antigen(s) by the DNA...

  6. Progress towards meningitis prevention in the conjugate vaccines era

    Directory of Open Access Journals (Sweden)

    Cristina Aparecida Borges Laval

    2003-10-01

    Full Text Available Acute bacterial meningitis is an important cause of morbidity and mortality among children less than five years old. Haemophilus influenzae, Streptococcus pneumoniae and Neisseria meningitidis are the most important agents of bacterial meningitis in developing countries. The development of the conjugate vaccines in the beginning of the 90's, especially type b H. influenzae (Hib, and more recently the heptavalent pneumococcal and the serogroup C meningococcal vaccines, have contributed directly to changes in the epidemiological profile of these invasive diseases (direct effect and of their carriage status (indirect effect. We review the impact of the Hib conjugate vaccine in Latin American countries, where this vaccine has been implemented, and the potential of pneumococcal and meningococcal conjugate vaccines for the reduction of meningitis worldwide. We also address constraints for the development and delivery of these vaccines and review new candidate state-of-the-art vaccines. The greatest challenge, undoubtedly, is to implement these vaccines worldwide, especially in the developing regions.

  7. The best method of hepatitis B vaccination in hemodialysis patients?

    OpenAIRE

    Momeni Ali

    2013-01-01

    Implication for health policy/practice/research/medical education:After a long time, the efficacy of vaccination against hepatitis B could be decreased and thus for maintenance of protective antibody titer, booster dose of vaccine is required. It seems that additional studies with different dose of vaccine, duration and method are necessary for finding of the best method of vaccination in terms of safety, effectiveness and convenience application of vaccine among hemodialysis patients.

  8. How society should respond to the risk of vaccine rejection

    OpenAIRE

    Ropeik, David

    2013-01-01

    While vaccine acceptance remains high in general, fear of vaccines has grown dramatically in the past several years in many developed countries. In some communities, this fear has led to significantly increased rates of vaccine refusal which are associated with increases in illness and death from vaccine-preventable diseases, and large economic costs for health care and society. Despite overwhelming evidence supporting the safety and benefits of vaccination, this fear has proven resistant to ...

  9. Deaths following vaccination: What does the evidence show?

    Science.gov (United States)

    Miller, Elaine R; Moro, Pedro L; Cano, Maria; Shimabukuro, Tom T

    2015-06-26

    Vaccines are rigorously tested and monitored and are among the safest medical products we use. Millions of vaccinations are given to children and adults in the United States each year. Serious adverse reactions are rare. However, because of the high volume of use, coincidental adverse events including deaths, that are temporally associated with vaccination, do occur. When death occurs shortly following vaccination, loved ones and others might naturally question whether it was related to vaccination. A large body of evidence supports the safety of vaccines, and multiple studies and scientific reviews have found no association between vaccination and deaths except in rare cases. During the US multi-state measles outbreak of 2014-2015, unsubstantiated claims of deaths caused by measles, mumps, and rubella (MMR) vaccine began circulating on the Internet, prompting responses by public health officials to address common misinterpretations and misuses of vaccine safety surveillance data, particularly around spontaneous reports submitted to the US Vaccine Adverse Event Reporting System (VAERS). We summarize epidemiologic data on deaths following vaccination, including examples where reasonable scientific evidence exists to support that vaccination caused or contributed to deaths. Rare cases where a known or plausible theoretical risk of death following vaccination exists include anaphylaxis, vaccine-strain systemic infection after administration of live vaccines to severely immunocompromised persons, intussusception after rotavirus vaccine, Guillain-Barré syndrome after inactivated influenza vaccine, fall-related injuries associated with syncope after vaccination, yellow fever vaccine-associated viscerotropic disease or associated neurologic disease, serious complications from smallpox vaccine including eczema vaccinatum, progressive vaccinia, postvaccinal encephalitis, myocarditis, and dilated cardiomyopathy, and vaccine-associated paralytic poliomyelitis from oral

  10. Sustaining Vaccine Confidence in the 21st Century

    Directory of Open Access Journals (Sweden)

    Karin Hardt

    2013-06-01

    Full Text Available Vaccination provides many health and economic benefits to individuals and society, and public support for immunization programs is generally high. However, the benefits of vaccines are often not fully valued when public discussions on vaccine safety, quality or efficacy arise, and the spread of misinformation via the internet and other media has the potential to undermine immunization programs. Factors associated with improved public confidence in vaccines include evidence-based decision-making procedures and recommendations, controlled processes for licensing and monitoring vaccine safety and effectiveness and disease surveillance. Community engagement with appropriate communication approaches for each audience is a key factor in building trust in vaccines. Vaccine safety/quality issues should be handled rapidly and transparently by informing and involving those most affected and those concerned with public health in effective ways. Openness and transparency in the exchange of information between industry and other stakeholders is also important. To maximize the safety of vaccines, and thus sustain trust in vaccines, partnerships are needed between public health sector stakeholders. Vaccine confidence can be improved through collaborations that ensure high vaccine uptake rates and that inform the public and other stakeholders of the benefits of vaccines and how vaccine safety is constantly assessed, assured and communicated.

  11. A Randomized, Controlled, Phase 1 Study of the Safety and Immunogenicity of the AMA1-C1/Alhydrogel® + CPG 7909 Vaccine for Plasmodium falciparum Malaria, in Semi-immune Malian Adults

    OpenAIRE

    Sagara, Issaka; Ellis, Ruth D.; Dicko, Alassane; Niambele, Mohamed B.; Kamate, Beh; Guindo, Ousmane; Sissoko, Mahamadou S.; Fay, Michael P.; Guindo, Merepen A; Kante, Ousmane; Saye, Renion; Miura, Kazutoyo; Long, Carole; Gregory E D Mullen; Pierce, Mark

    2009-01-01

    A double blind, randomized, controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1- Combination 1 (AMA1-C1)/Alhydrogel® with and without the novel adjuvant CPG 7909. Participants were healthy adults 18–45 years old living in the village of Donéguébougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 μg AMA1-C1/Alhydrog...

  12. Immunogenicity and some safety features of a VEGF-based cancer therapeutic vaccine in rats, rabbits and non-human primates.

    Science.gov (United States)

    Morera, Yanelys; Bequet-Romero, Mónica; Ayala, Marta; Velazco, Jorge Castro; Pérez, Pedro Puente; Alba, Jesús Suárez; Ancizar, Julio; Rodríguez, Meilyn; Cosme, Karelia; Gavilondo, Jorge V

    2010-04-26

    We have developed a cancer vaccine candidate (hereafter denominated CIGB-247), based on recombinant modified human vascular endothelial growth factor (VEGF) as antigen, and the adjuvant VSSP (very small sized proteoliposomes of Neisseria meningitidis outer membrane). In mice, previous work of our group had shown that vaccination with CIGB-247 extended tumor-take time, slowed tumor growth, and increased animal survival. Immunization elicited anti-human and murine VEGF-neutralizing antibodies, and spleen cells of vaccinated mice are cytotoxic in vitro to tumor cells that produce VEGF. We have now tested the immunogenicity of CIGB-247 in Wistar rats, New Zealand White rabbits and the non-human primate Chlorocebus aethiops sabaeus. Using weekly, biweekly and biweekly plus montanide immunization schemes, all three species develop antigen-specific IgG antibodies that can block the interaction of VEGF and VEGF receptor 2 in an ELISA assay. Antibody titers decline after vaccination stops, but can be boosted with new immunizations. In monkeys, DTH and direct cell cytotoxicity experiments suggest that specific T-cell responses are elicited by vaccination. Immunization with CIGB-247 had no effect on normal behavior, hematology, blood biochemistry and histology of critical organs, in the tested animals. Skin deep wound healing was not affected in vaccinated rats and monkeys. PMID:20197134

  13. Immune responses and protection induced by Brucella suis S2 bacterial ghosts in mice.

    Science.gov (United States)

    Liu, Jun; Li, Yi; Sun, Yang; Ji, Xue; Zhu, Lingwei; Guo, Xuejun; Zhou, Wei; Zhou, Bo; Liu, Shuang; Zhang, Ruian; Feng, Shuzhang

    2015-08-15

    With the purpose of generating Brucella suis bacterial ghosts and investigating the immunogenicity of bacterial ghosts as a vaccine candidate, the lysis gene E and temperature-sensitive regulator cassette were cloned into a shuttle plasmid, pBBR1MCS-2, for construction of a recombinant temperature-sensitive shuttle lysis plasmid, pBBR1MCS-E. pBBR1MCS-E was then introduced into attenuated B. suis live vaccine S2 bacteria, and the resultant transformants were used for production of B. suis ghosts (BSGs) by inducing lysis gene E expression. The BSGs were characterized by observing their morphology by transmission electron microscopy. The safety and immunogenicity of BSGs were further evaluated using a murine model, the result suggested that BSG was as safe as formalin-killed B. suis. In mice, BSG demonstrated a similar capacity of inducing pathogen-specific serum IgG antibody response, spleen CD3(+) and CD4(+) T cell responses, induce secretion of gamma interferon and interleukin-4, and protection levels against Brucella melitensis 16M challenge, as the attenuated B. suis live vaccine. These data suggesting that BSG could confer protection against Brucella infection in a mouse model of disease and may be developed as a new vaccine candidate against Brucella infection. PMID:26022514

  14. Use of Vaccines to Prevent Meningitis in Persons with Cochlear Implants

    Science.gov (United States)

    ... conjugate vaccine=MenACWY Use of Vaccines to Prevent Meningitis in Persons with Cochlear Implants Recommend on Facebook ... cochlear implants are more likely to get bacterial meningitis than children without cochlear implants. In addition, some ...

  15. Analysis on Immune Effect and Safety of Recombinant Hepatitis B Vaccine in Healthy Population%重组乙型肝炎疫苗在健康人群中的免疫效果及安全性评价

    Institute of Scientific and Technical Information of China (English)

    钟群; 谌稳国; 罗述斌

    2012-01-01

    目的 分析常用的两种国产重组乙肝疫苗在健康人群中接种的免疫效果及安全性. 方法 选择2010年1月-2011年1月在本门诊接种乙肝疫苗的532例健康人群,按接种疫苗类别分为A组(酵母疫苗10 μg)与B组(CHO疫苗20μg),观察两组间的不良反应发生率和发生程度.于第2、3针接种前及3针全程接种后1月和1年时分别应用放射免疫法(RIA)检测血清HBsAb滴度水平,并比较两组抗体的阳性率. 结果 两组疫苗接种不良反应发生率差异无统计学意义(P>0.05).全程接种后1月时,B组的HBsAb GMT峰值高于A组(P<0.05).全程接种后1年B组抗体阳性率和HBsAb滴度均高于A组(P<0.05). 结论 在可按受的、等同少而轻的接种不良反应基础上,应用20 μg的CHO疫苗可使健康人群获得更大的保护效力.%Objective To analyze the immune effect and safety of two kinds of homemade recombinant hepatitis B vaccines in healthy people. Methods Altogether 532 cases of healthy people with hepatitis R vaccines in Outpatient Department from January 2010 to January 2011 were divided into group A (yeast vaccine, lOjug) and group B (CHO vaccine, 20jng) according to the category of vaccines. The incidence and degree of adverse reactions were observed between the two groups. The serum HBsAb titers were detected with radioimmunoassay before the second and third shots, one month and one year after the full course vaccination. The antibody - positive rate was compared between the two groups. Results There was no statistically significant difference in the incidence of adverse reaction between the two groups (F>0. 05). One month after the full course vaccination, the HBsAb GMT peak value of group B was significantly higher than that in group A (P< 0.05). One year after the full course vaccination, the antibody - positive rate and HBsAb titers in group B were both significantly higher than those in group A (P<0.05). Conclusions On the basis of acceptable

  16. FLU VACCINATION

    CERN Multimedia

    2007-01-01

    People working on the CERN site who wish to be vaccinated may go to the Infirmary (ground-floor, bldg. 57), with their vaccine, without a prior appointment. The vaccine can be reimbursed directly by Uniqa providing you attach the receipt and the prescription that you will receive from the Medical Service the day of your injection at the infirmary. Ideally, the vaccination should take place between 1st October and 30th November 2007 (preferably between 14:00 and 16:00). CERN staff aged 50 or over are recommended to have influenza vaccinations. Vaccination is particularly important for those suffering from chronic lung, cardio-vascular or kidney problems, for diabetics and those convalescing from serious medical problems or after serious surgical operations. The Medical Service will not administer vaccines for family members or retired staff members, who must contact their normal family doctor. Medical Service

  17. Food Safety for Seniors

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Foodborne Illness & Contaminants People at Risk of Foodborne Illness To Your Health! Food Safety for Seniors Share Tweet Linkedin Pin it ...

  18. The safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine%冻干甲型肝炎减毒活疫苗的安全性及免疫原性观察

    Institute of Scientific and Technical Information of China (English)

    陈念良; 忻亚娟; 马景臣; 吴洁; 金巧军; 庄昉成

    2012-01-01

    目的 观察采用不含明胶、不含人血白蛋白保护剂制备的冻干甲型肝炎(甲肝)减毒活疫苗接种后的安全性及免疫原性.方法 在浙江杭州及河北正定二个点,筛选了183名甲肝病毒易感者,给予冻干甲肝减毒活疫苗一针免疫.观察疫苗接种后7d内的局部和全身反应,同时采集接种后的血清样本,检测甲肝抗体阳转率及抗体产生的水平.结果 观察期间主要表现为轻度反应,肝功能检测未见异常,未发生与疫苗有关的重度反应、皮疹及不良事件.疫苗接种后2个月的抗体阳转率为98.2%,抗体的几何平均滴度为135.5 mIU/mL.结论 不含明胶、不含人血白蛋白的保护剂制备的疫苗安全性及免疫原性良好.%Objective To observe the safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine prepared by a protective additive without gelatin and human albumin.Methods One hundred and eighty-three persons susceptible to hepatitis A virus were screened from 2 sites in Hangzhou,Zhejiang and Zhengding,Hebei.Each person was inoculated by one dose live attenuated hepatitis A vaccine and observed for local and systemic reaction in 7 days.Serum samples were collected after vaccination for determining the seroconversion rates and antibody levels.Results Most of the reactions were mild in period of observation,and there were no abnormal liver function and severe reactions such as rashes,adverse events related with the vaccine.The seroconversion rate was 98.2% after 2 months of vaccination,the geometric mean titer of anti-HAV was 135.5 mIU/mL.Conclusions The study indicates that freeze-dried live attenuated hepatitis A vaccine without gelatin and human albumin is safe and has a good immunogenicity.

  19. Live-vaccinia virus encapsulation in pH-sensitive polymer increases safety of a reservoir-targeted Lyme disease vaccine by targeting gastrointestinal release.

    Science.gov (United States)

    Kern, Aurelie; Zhou, Chensheng W; Jia, Feng; Xu, Qiaobing; Hu, Linden T

    2016-08-31

    The incidence of Lyme disease has continued to rise despite attempts to control its spread. Vaccination of zoonotic reservoirs of human pathogens has been successfully used to decrease the incidence of rabies in raccoons and foxes. We have previously reported on the efficacy of a vaccinia virus vectored vaccine to reduce carriage of Borrelia burgdorferi in reservoir mice and ticks. One potential drawback to vaccinia virus vectored vaccines is the risk of accidental infection of humans. To reduce this risk, we developed a process to encapsulate vaccinia virus with a pH-sensitive polymer that inactivates the virus until it is ingested and dissolved by stomach acids. We demonstrate that the vaccine is inactive both in vitro and in vivo until it is released from the polymer. Once released from the polymer by contact with an acidic pH solution, the virus regains infectivity. Vaccination with coated vaccinia virus confers protection against B. burgdorferi infection and reduction in acquisition of the pathogen by naïve feeding ticks. PMID:27502570

  20. A nonhuman primate scrub typhus model: protective immune responses induced by pKarp47 DNA vaccination in cynomolgus macaques.

    Science.gov (United States)

    Paris, Daniel H; Chattopadhyay, Suchismita; Jiang, Ju; Nawtaisong, Pruksa; Lee, John S; Tan, Esterlina; Dela Cruz, Eduardo; Burgos, Jasmin; Abalos, Rodolfo; Blacksell, Stuart D; Lombardini, Eric; Turner, Gareth D; Day, Nicholas P J; Richards, Allen L

    2015-02-15

    We developed an intradermal (ID) challenge cynomolgus macaque (Macaca fascicularis) model of scrub typhus, the leading cause of treatable undifferentiated febrile illness in tropical Asia, caused by the obligate intracellular bacterium, Orientia tsutsugamushi. A well-characterized animal model is required for the development of clinically relevant diagnostic assays and evaluation of therapeutic agents and candidate vaccines. We investigated scrub typhus disease pathophysiology and evaluated two O. tsutsugamushi 47-kDa, Ag-based candidate vaccines, a DNA plasmid vaccine (pKarp47), and a virus-vectored vaccine (Kp47/47-Venezuelan equine encephalitis virus replicon particle) for safety, immunogenicity, and efficacy against homologous ID challenge with O. tsutsugamushi Karp. Control cynomolgus macaques developed fever, classic eschars, lymphadenopathy, bacteremia, altered liver function, increased WBC counts, pathogen-specific Ab (IgM and IgG), and cell-mediated immune responses. Vaccinated macaques receiving the DNA plasmid pKarp47 vaccine had significantly increased O. tsutsugamushi-specific, IFN-γ-producing PBMCs (p = 0.04), reduced eschar frequency and bacteremia duration (p ≤ 0.01), delayed bacteremia onset (p < 0.05), reduced circulating bacterial biomass (p = 0.01), and greater reduction of liver transaminase levels (p < 0.03) than controls. This study demonstrates a vaccine-induced immune response capable of conferring sterile immunity against high-dose homologous ID challenge of O. tsutsugamushi in a nonhuman primate model, and it provides insight into cell-mediated immune control of O. tsutsugamushi and dissemination dynamics, highlights the importance of bacteremia indices for evaluation of both natural and vaccine-induced immune responses, and importantly, to our knowledge, has determined the first phenotypic correlates of immune protection in scrub typhus. We conclude that this model is suitable for detailed investigations into vaccine-induced immune

  1. Hepatitis Vaccines.

    Science.gov (United States)

    Ogholikhan, Sina; Schwarz, Kathleen B

    2016-01-01

    Viral hepatitis is a serious health problem all over the world. However, the reduction of the morbidity and mortality due to vaccinations against hepatitis A and hepatitis B has been a major component in the overall reduction in vaccine preventable diseases. We will discuss the epidemiology, vaccine development, and post-vaccination effects of the hepatitis A and B virus. In addition, we discuss attempts to provide hepatitis D vaccine for the 350 million individuals infected with hepatitis B globally. Given the lack of a hepatitis C vaccine, the many challenges facing the production of a hepatitis C vaccine will be shown, along with current and former vaccination trials. As there is no current FDA-approved hepatitis E vaccine, we will present vaccination data that is available in the rest of the world. Finally, we will discuss the existing challenges and questions facing future endeavors for each of the hepatitis viruses, with efforts continuing to focus on dramatically reducing the morbidity and mortality associated with these serious infections of the liver. PMID:26978406

  2. Hepatitis Vaccines

    Directory of Open Access Journals (Sweden)

    Sina Ogholikhan

    2016-03-01

    Full Text Available Viral hepatitis is a serious health problem all over the world. However, the reduction of the morbidity and mortality due to vaccinations against hepatitis A and hepatitis B has been a major component in the overall reduction in vaccine preventable diseases. We will discuss the epidemiology, vaccine development, and post-vaccination effects of the hepatitis A and B virus. In addition, we discuss attempts to provide hepatitis D vaccine for the 350 million individuals infected with hepatitis B globally. Given the lack of a hepatitis C vaccine, the many challenges facing the production of a hepatitis C vaccine will be shown, along with current and former vaccination trials. As there is no current FDA-approved hepatitis E vaccine, we will present vaccination data that is available in the rest of the world. Finally, we will discuss the existing challenges and questions facing future endeavors for each of the hepatitis viruses, with efforts continuing to focus on dramatically reducing the morbidity and mortality associated with these serious infections of the liver.

  3. Experimental studies of a vaccine formulation of recombinant human VEGF antigen with aluminum phosphate

    Science.gov (United States)

    Pérez Sánchez, Lincidio; Morera Díaz, Yanelys; Bequet-Romero, Mónica; Ramses Hernández, Gerardo; Rodríguez, Yadira; Castro Velazco, Jorge; Puente Pérez, Pedro; Ayala Avila, Marta; Gavilondo, Jorge V

    2015-01-01

    CIGB-247 is a cancer vaccine that is a formulation of a recombinant protein antigen representative of the human vascular endothelial growth factor (VEGF) with a bacterially-derived adjuvant (VSSP). The vaccine has shown an excellent safety profile in mice, rats, rabbits, not-human primates and in recent clinical trials in cancer patients. Response to the vaccine is characterized by specific antibody titers that neutralize VEGF/VEGFR2 binding and a cytotoxic tumor-specific response. To expand our present anti-VEGF active immunotherapy strategies, we have now studied in mice and non-human primates the effects of vaccination with a formulation of our recombinant VEGF antigen and aluminum phosphate adjuvant (hereafter denominated CIGB-247-A). Administered bi-weekly, CIGB-247-A produces high titers of anti-VEGF IgG blocking antibodies in 2 mice strains. Particularly in BALB/c, the treatment impaired subcutaneous F3II mammary tumor growth and reduced the number of spontaneous lung macro metastases, increasing animals' survival. Spleen cells from specifically immunized mice directly killed F3II tumor cells in vitro. CIGB-247-A also showed to be immunogenic in non-human primates, which developed anti-VEGF blocking antibodies and the ability for specific direct cell cytotoxic responses, all without impairing the healing of deep skin wounds or other side effect. Our results support consideration of aluminum phosphate as a suitable adjuvant for the development of new vaccine formulations using VEGF as antigen. PMID:25891359

  4. The Evolution of Poxvirus Vaccines

    Directory of Open Access Journals (Sweden)

    Lucas Sánchez-Sampedro

    2015-04-01

    Full Text Available After Edward Jenner established human vaccination over 200 years ago, attenuated poxviruses became key players to contain the deadliest virus of its own family: Variola virus (VARV, the causative agent of smallpox. Cowpox virus (CPXV and horsepox virus (HSPV were extensively used to this end, passaged in cattle and humans until the appearance of vaccinia virus (VACV, which was used in the final campaigns aimed to eradicate the disease, an endeavor that was accomplished by the World Health Organization (WHO in 1980. Ever since, naturally evolved strains used for vaccination were introduced into research laboratories where VACV and other poxviruses with improved safety profiles were generated. Recombinant DNA technology along with the DNA genome features of this virus family allowed the generation of vaccines against heterologous diseases, and the specific insertion and deletion of poxvirus genes generated an even broader spectrum of modified viruses with new properties that increase their immunogenicity and safety profile as vaccine vectors. In this review, we highlight the evolution of poxvirus vaccines, from first generation to the current status, pointing out how different vaccines have emerged and approaches that are being followed up in the development of more rational vaccines against a wide range of diseases.

  5. Knowledge of Hepatitis B Vaccine among Operating Room Personnel in Nigeria and Their Vaccination Status

    Directory of Open Access Journals (Sweden)

    Emeka B. Kesieme

    2011-01-01

    Full Text Available Background. Hepatitis B virus (HBV infection is a well recognised occupational health hazard preventable by vaccination. Objectives. To determine the knowledge of operating room personnel (ORP in Nigeria about the Hepatitis B vaccine, their perception of Hepatitis B vaccination and vaccination status against HBV. Methods. Four university hospitals were selected by simple random sampling. A structured questionnaire was administered to 228 ORP after obtaining consent. Result. Only 26.8% of ORP were vaccinated against HBV. The primary reason for not being vaccinated or for defaulting from vaccination was lack of time. Differences in age, sex, duration of practice and respondent's institution between vaccinated and unvaccinated ORP were not significant (P>0.05. The majority (86.8% had the awareness of the existence of Hepatitis B vaccine. 83.8% of respondents believed that the vaccine should be given to the ORP as part of work place safety measures. The majority were aware of the modes of transmission of HBV infection. 78.9% of respondents believed that Hepatitis B vaccine is safe and 81.1% would recommend it to another staff. Conclusion. Despite a good knowledge about HBV infection and vaccine, most of ORP are still not vaccinated. Hepatitis B vaccination should be a prerequisite for working in the theatre, hence putting surgical patients at reduced risk.

  6. Comparative safety and immunogenicity of an acellular versus whole- cell pertussis component of Diphteria-Tetanus-Pertussis vaccines in senegalese infants

    OpenAIRE

    Simondon, François; Yam, A.; Gagnepain, J.Y.; Wassilak, S.; Danve, B; Cadoz, M.

    1996-01-01

    A diphtheria and tetanus toxoid two-component acellular pertussis vaccine (DTaP), consisting of 25 microg glutaraldehyde-detoxified pertussis toxin (PT) and 25 microg native filamentous hemagglutinin (FHA), was compared with diphtheria and tetanus toxoid whole-cell pertussis vaccine (DTwP) in a randomized, double-blind manner in 286 Senegalese infants inoculated at two, four, and six months of age. In infants receiving DTaP a significantly lower rate of local reactions, crying and fever was o...

  7. Flu Vaccination

    CERN Multimedia

    2006-01-01

    People working on the CERN site who wish to be vaccinated against influenza may go to the Medical Service (ground floor, Bldg. 57) without an appointment (preferably between 14:00 and 16:00), PROVIDED THAT THEY BRING THEIR OWN VACCINE WITH THEM. Ideally, vaccination should take place between 1st October and 30th November 2006. The influenza vaccine is recommended for CERN staff aged 50 and over. Vaccination is particularly important for those suffering from chronic lung, cardio-vascular or kidney problems, for diabetics and for those convalescing from serious medical problems or major surgery. The Medical Service will not administer vaccines to family members or retired staff members, who must contact their family doctor. CERN Medical Service

  8. FLU VACCINATION

    CERN Multimedia

    2006-01-01

    People working on the CERN site who wish to be vaccinated against influenza may go to the Medical Service (ground floor, Bldg. 57) without an appointment (preferably between 14:00 and 16:00), PROVIDED THAT THEY BRING THEIR OWN VACCINE WITH THEM. Ideally, vaccination should take place between 1st October and 30th November 2006. The influenza vaccine is recommended for CERN staff aged 50 and over. Vaccination is particularly important for those suffering from chronic lung, cardio-vascular or kidney problems, for diabetics and for those convalescing from serious medical problems or major surgery. The Medical Service will not administer vaccines to family members or retired staff members, who must contact their family doctor. CERN Medical Service

  9. Flu vaccination

    CERN Multimedia

    CERN Medical Service

    2006-01-01

    People working on the CERN site who wish to be vaccinated against influenza may go to the Medical Service (ground floor, Bldg. 57) without an appointment (preferably between 14:00 and 16:00), PROVIDED THAT THEY BRING THEIR OWN VACCINE WITH THEM. Ideally, vaccination should take place between 1st October and 30th November 2006. The influenza vaccine is recommended for CERN staff aged 50 and over. Vaccination is particularly important for those suffering from chronic lung, cardio-vascular or kidney problems, for diabetics and for those convalescing from serious medical problems or major surgery. The Medical Service will not administer vaccines to family members or retired staff members, who must contact their family doctor.CERN Medical Service

  10. Flu Vaccination

    CERN Multimedia

    2006-01-01

    People working on the CERN site who wish to be vaccinated against influenza may go to the Medical Service (ground floor, Bldg. 57) without an appointment (preferably between 14:00 and 16:00), PROVIDED THAT THEY BRING THEIR OWN VACCINE WITH THEM. Ideally, vaccination should take place between 1st October and 30th November 2006. The influenza vaccine is recommended for CERN staff aged 50 and over. Vaccination is particularly important for those suffering from chronic lung, cardio-vascular or kidney problems, for diabetics and for those convalescing from serious medical problems or major surgery. The Medical Service will not administer vaccines to family members or retired staff members, who must contact their family doctor. CERN Medical service

  11. The March Toward Malaria Vaccines.

    Science.gov (United States)

    Hoffman, Stephen L; Vekemans, Johan; Richie, Thomas L; Duffy, Patrick E

    2015-12-01

    malaria. Progress during the last few years has been significant, and a first generation malaria candidate vaccine, RTS,S/AS01, is under review by the European Medicines Agency (EMA) for its quality, safety and efficacy under article 58, which allows the EMA to give a scientific opinion about products intended exclusively for markets outside of the European Union. However, much work is in progress to optimize malaria vaccines in regard to magnitude and durability of protective efficacy and the financing and practicality of delivery. Thus, we are hopeful that anti-malaria vaccines will soon be important tools in the battle against malaria. PMID:26590432

  12. Leptospirosis vaccines

    OpenAIRE

    Jin Li; Wang Zhijun; Węgrzyn Alicja

    2007-01-01

    Abstract Leptospirosis is a serious infection disease caused by pathogenic strains of the Leptospira spirochetes, which affects not only humans but also animals. It has long been expected to find an effective vaccine to prevent leptospirosis through immunization of high risk humans or animals. Although some leptospirosis vaccines have been obtained, the vaccination is relatively unsuccessful in clinical application despite decades of research and millions of dollars spent. In this review, the...

  13. Anthrax Vaccine: A Dilemma for Homeland Security

    OpenAIRE

    Rempfer, Thomas L.

    2009-01-01

    This article appeared in Homeland Security Affairs (May 2009), v.5 no.2 Past problems with the Department of Defense anthrax vaccine currently impact Department of Homeland Security and the Department of Health and Human Services policy. Following the 2001 anthrax letter attacks, those departments included the old anthrax vaccine in the Strategic National Stockpile. This article explores the Department of Defense'۪s experience with the vaccine, enumerating past safety, efficacy, regulatory...

  14. Flu vaccination in pregnancy

    OpenAIRE

    Maria Siettou; Maria Saridi

    2012-01-01

    In periods of seasonal influenza, during pandemic flu in the past and from recent experience that we have the emergence of influenza A (H1N1), pregnant compared with non-pregnant women are at increased risk to get sick and to develop serious complications up to mortality. Purpose: This paper examines the risks that arise for pregnant from contamination with the flu virus and the safety of influenza vaccination in pregnancy. Method: The method involves searching review and research studies in ...

  15. Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience

    Directory of Open Access Journals (Sweden)

    Jacqueline M. Miller

    2011-01-01

    Full Text Available Meningococcal diseases are serious threats to global health, and new vaccines specifically tailored to meet the age-related needs of various geographical areas are required. This paper focuses on the meningococcal conjugate vaccines developed by GSK Biologicals. Two combined conjugate vaccines were developed to help protect infants and young children in countries where the incidence of meningococcal serogroup C or serogroup C and Y disease is important: Hib-MenC-TT vaccine, which offers protection against Haemophilus influenzae type b and Neisseria meningitidis serogroup C diseases, is approved in several countries; and Hib-MenCY-TT vaccine, which adds N. meningitidis serogroup Y antigen, is currently in the final stages of development. Additionally, a tetravalent conjugate vaccine (MenACWY-TT designed to help protect against four meningococcal serogroups is presently being evaluated for global use in all age groups. All of these vaccines were shown to be highly immunogenic and to have clinically acceptable safety profiles.

  16. Vaccinating captive chimpanzees to save wild chimpanzees.

    Science.gov (United States)

    Warfield, Kelly L; Goetzmann, Jason E; Biggins, Julia E; Kasda, Mary Beth; Unfer, Robert C; Vu, Hong; Aman, M Javad; Olinger, Gene Gerrard; Walsh, Peter D

    2014-06-17

    Infectious disease has only recently been recognized as a major threat to the survival of Endangered chimpanzees and Critically Endangered gorillas in the wild. One potentially powerful tool, vaccination, has not been deployed in fighting this disease threat, in good part because of fears about vaccine safety. Here we report on what is, to our knowledge, the first trial in which captive chimpanzees were used to test a vaccine intended for use on wild apes rather than humans. We tested a virus-like particle vaccine against Ebola virus, a leading source of death in wild gorillas and chimpanzees. The vaccine was safe and immunogenic. Captive trials of other vaccines and of methods for vaccine delivery hold great potential as weapons in the fight against wild ape extinction. PMID:24912183

  17. Safety and Immunogenicity of the Mycobacterium tuberculosis {Delta}lysA {Delta}panCD Vaccine in Domestic Cats Infected with Feline Immunodeficiency Virus

    Science.gov (United States)

    Feline immunodeficiency virus (FIV)+ and FIV- cats (n = 4/group) received 2 x 10**6 cfu Mycobacterium tuberculosis Delta-lysA Delta-panCD intramuscularly. Vaccination elicited antibody responses; albeit, at lower levels in FIV+ cats as compared to FIV- cats. Delayed-type hypersensitivity responses ...

  18. A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine

    NARCIS (Netherlands)

    Mehendale, Sanjay; van Lunzen, Jan; Clumeck, Nathan; Rockstroh, Jurgen; Vets, Eva; Johnson, Philip R.; Anklesaria, Pervin; Barin, Burc; Boaz, Mark; Kochhar, Sonali; Lehrman, Jennifer; Schmidt, Claudia; Peeters, Mathieu; Schwarze-Zander, Carolynne; Kabamba, Kabeya; Glaunsinger, Tobias; Sahay, Seema; Thakar, Madhuri; Paranjape, Ramesh; Gilmour, Jill; Excler, Jean-Louis; Fast, Patricia; Heald, A1lison E.

    2008-01-01

    A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman prim

  19. Safety, immunogencity, and efficacy of a cold-adapted A/Ann Arbor/6/60 (H2N2) vaccine in mice and ferrets

    International Nuclear Information System (INIS)

    We studied the attenuation, immunogenicity and efficacy of the cold-adapted A/Ann Arbor/6/60 (AA ca) (H2N2) virus in mice and ferrets to evaluate its use in the event of an H2 influenza pandemic. The AA ca virus was restricted in replication in the respiratory tract of mice and ferrets. In mice, 2 doses of vaccine elicited a > 4-fold rise in hemagglutination-inhibition (HAI) titer and resulted in complete inhibition of viral replication following lethal homologous wild-type virus challenge. In ferrets, a single dose of the vaccine elicited a > 4-fold rise in HAI titer and conferred complete protection against homologous wild-type virus challenge in the upper respiratory tract. In both mice and ferrets, the AA ca virus provided significant protection from challenge with heterologous H2 virus challenge in the respiratory tract. The AA ca vaccine is safe, immunogenic, and efficacious against homologous and heterologous challenge in mice and ferrets, supporting the evaluation of this vaccine in clinical trials.

  20. Safety and immunogenicity of the RIVM hexavalent meningococcal B vesicle vaccine for Rotterdam children aged 2-3 and 7-8

    NARCIS (Netherlands)

    Labadie J; de Kleijn ED; Lafeber AB; Mees MMM; Booy K; de Groot R; van Omme GW; van Dijken H; Kuipers AJ; van den Dobbelsteen G; Juttmann RE; Wala M; van Alphen AJW; Rumke HC; LVO

    2000-01-01

    In dit rapport wordt verslag gedaan van een gerandomiseerde gecontroleerd fase-II klinische studie naar de veiligheid en immunogeniciteit van het RIVM hexavalente MenB vesicle vaccin in 189 kinderen van 2-3 jaar en 168 kinderen van 7-8 jaar in de stad Rotterdam. Twee concentraties van het MenB vesi

  1. Research on immunological safety of 20 micrograms dose of recombinant hepatitis B vaccine in adults%20微克重组乙型肝炎疫苗对成人免疫安全性的研究

    Institute of Scientific and Technical Information of China (English)

    王萍; 李艳萍; 韦琳; 农艺; 谢昌平; 杨兵华; 蓝剑

    2013-01-01

    [Objective] To observe the safety of different doses of recombinant hepatitis B vaccine (Hansenula polymorpha) in adults.[Methods] 1600 students who were over 15 years old,without hepatitis B vaccination history and contraindications to vaccination,were selected as the object of observation,while all of their hepatitis B markers,including HBsAg,anti-HBs and anti-HBc,were negative by laboratory screening,as well as ALT level were normal.By using random,double blind and the control principle,the students were divided into the experiment group and the control group,800 people in each group.According to 0,1,6 months schedule,the experiment group was given 20 μg of recombinant hepatitis B vaccine (Hansenula polymorpha) and the control group was given 10 μg of recombinant hepatitis B vaccine (Hansenula polymorpha).The venous blood samples were collected before immunization and the 4th weeks after whole course vaccination,to evaluate the immunogenicity by serum anti-HBs detection.[Results] There were 463 and 437 cases of adverse reactions in the experimental group and the control group,which the incidence rate was 57.88% and 54.63% respectively.The incidence rate of moderate and over adverse reactions was 9.25% and 8.25% respectively.The incidence rate of local reactions was 42.50% and 36.007% respectively,while the rate of local reactions over Grade 2 was 5.00% and 3.25% respectively.The incidence rate of general reactions was 37.38% and 35.50% respectively,while the rate of general reactions over Grade 2 was 4.63% and 5.63% respectively.There was no significant difference in total incidence rate of adverse reactions,incidence rate of general reactions and incidence rate of local reactions over Grade 2 between two groups.The main local adverse reactions included pain and redness,and the general reaction was mainly fever.The severe adverse reactions related to vaccination were not reported.20 micrograms dose of recombinant hepatitis B vaccine was

  2. Preventive vaccination against cervical cancer: Korean Society of Gynecologic Oncology Guideline

    OpenAIRE

    Min, Kyung-Jin; Kwon, Sang-Hoon; Kim, Sunghoon; Kim, Hyun Jung; Seong, Seok Ju; Song, Yong Jung; Shin, Jin Woo; Lee, Keun Ho; Lim, Myong Cheol; Chung, Hyun Hoon; Ju, Woong; Hong, Jin Hwa; Lee, Jeong-Won; Kim, Jae-Weon; Bae, Duk-Soo

    2016-01-01

    After human papillomavirus (HPV) vaccine guidelines published by Korean Society of Gynecologic Oncology (KSGO) in 2011, new studies have been published, leading to additional data regarding efficacy, safety, number of vaccination rounds, and ideal age of vaccine administration. We searched and reviewed the literatures focused on the efficacy of 2-dose schedule vaccination, the efficacy of 3-dose schedule vaccination in middle-aged women, the ideal age of 3-dose schedule vaccination, the safet...

  3. Adjuvants and immunostimulants in fish vaccines: Current knowledge and future perspectives.

    OpenAIRE

    Tafalla, C.; Bøgwald, Jarl; Dalmo, Roy Ambli

    2013-01-01

    Vaccination is the most adequate method to control infectious diseases that threaten the aquaculture industry worldwide. Unfortunately, vaccines are usually not able to confer protection on their own; especially those vaccines based on recombinant antigens or inactivated pathogens. Therefore, the use of adjuvants or immunostimulants is often necessary to increase the vaccine efficacy. Traditional adjuvants such as mineral oils are routinely used in different commercial bacterial vaccines avai...

  4. Safety and immunogenicity of a mutagenized, live attenuated Rift Valley fever vaccine, MP-12, in a Phase 1 dose escalation and route comparison study in humans.

    Science.gov (United States)

    Pittman, Phillip R; McClain, David; Quinn, Xiaofei; Coonan, Kevin M; Mangiafico, Joseph; Makuch, Richard S; Morrill, John; Peters, Clarence J

    2016-01-20

    Rift Valley fever (RVF) poses a risk as a potential agent in bioterrorism or agroterrorism. A live attenuated RVF vaccine (RVF MP-12) has been shown to be safe and protective in animals and showed promise in two initial clinical trials. In the present study, healthy adult human volunteers (N=56) received a single injection of (a) RVF MP-12, administered subcutaneously (SQ) at a concentration of 10(4.7) plaque-forming units (pfu) (SQ Group); (b) RVF MP-12, administered intramuscularly (IM) at 10(3.4)pfu (IM Group 1); (c) RVF MP-12, administered IM at 10(4.4)pfu (IM Group 2); or (d) saline (Placebo Group). The vaccine was well tolerated by volunteers in all dose and route groups. Infrequent and minor adverse events were seen among recipients of both placebo and RVF MP-12. One subject had viremia detectable by direct plaque assay, and six subjects from IM Group 2 had transient low-titer viremia detectable only by nucleic acid amplification. Of the 43 vaccine recipients, 40 (93%) achieved neutralizing antibodies (measured as an 80% plaque reduction neutralization titer [PRNT80]) as well as RVF-specific IgM and IgG. The highest peak geometric mean PRNT80 titers were observed in IM Group 2. Of 34 RVF MP-12 recipients available for testing 1 year following inoculation, 28 (82%) remained seropositive (PRNT80≥1:20); this included 20 of 23 vaccinees (87%) from IM Group 2. The live attenuated RVF MP-12 vaccine was safe and immunogenic at the doses and routes studied. Given the need for an effective vaccine against RVF virus, further evaluation in humans is warranted. PMID:26718688

  5. Safety and immunogenicity of hepatitis B vaccine ButaNG in adults Inocuidade e imunogenicidade da vacina contra a hepatite B, ButaNG, em adultos

    Directory of Open Access Journals (Sweden)

    Luzia M. IOSHIMOTO

    1999-05-01

    Full Text Available Recombinant yeast-derived hepatitis B vaccine manufactured by Instituto Butantan was administered in two groups of adult volunteers (I, II following two different schedules of immunization. In the first trial (10 mg doses and 0, 1, 3 months vaccination schedule 106 individuals completed the full immunization program. The results of seroconversion by age group varied from 70 to 100% and the GMT from 46.5 to 124.9 mIU mL-1. In the second trial with 68 individuals (for dosage comparison and 0, 1, 6 months vaccination schedule indicated that the vaccine formulated in 20 mg was more effective than in 10 mg. The adverse reactions observed in the vaccinees were less frequent than the ones previously found since the introduction of similar vaccines.Vacina contra a hepatite B, produzida no Instituto Butantan em levedura recombinante, foi administrada em dois grupos de voluntários adultos (I e II seguindo dois esquemas diferentes de imunização. No primeiro ensaio (doses de 10 mg e esquema de vacinação de 0, 1, 3 meses, 106 indivíduos completaram o programa de imunização proposto. Os resultados de soroconversão agrupados por faixa etária variaram de 70 a 100%, enquanto que o TGM foi de 46,5 a 124 mUI mL-1. No segundo ensaio com 68 indivíduos (comparação de doses e esquema de vacinação de 0, 1, 6 meses os resultados indicaram que a vacina formulada em dose de 20 mg foi mais eficaz que em dose de 10 mg. Os efeitos adversos observados nos vacinados foram menores do que os relatados por outros autores, desde o início da aplicação de vacinas similares.

  6. 四价HPV疫苗预防尖锐湿疣的meta分析%Efficacy and safety of quadrivalent human papillomavirus vaccine for preventing condyloma acuminatum: a meta analysis

    Institute of Scientific and Technical Information of China (English)

    周自广; 宋云焕

    2011-01-01

    Objective To assess the effieacy and safety of prophylactiC quadrivalent human papillomavirus( HPV) vaccine in the prevention of condyloma acuminatum. Methods By aearching Cochrane library , MEDLINE , EMBASE , CBM , the randomized controlled trials ( RCTs) about prophylactic quadrivalent HPV vaccine were included. Two researchers independently reviewed the data and assessed the quality. The data were inputted and analyzed by RevMan 4. 2 software. Resuks Three randomized controlled trials ( RCT) involving 11 450 women met the inclusion criteria. The meta analysis showed that the incidence of condyloma acuminaLum was significantly lower in quadrivalent HPV vaccine group than in control group. The majority of adverse events were minor. The incidence of serious adverse events was balanced between vaccine group and cantrol group. ConcLusion Quadrivalent HPV vaccine is effective and safe in preventing condyloma acuminatum.%目的 评价四价HPV疫苗预防尖锐湿疣的有效性及安全性. 方法 计算机检索Cochrane图书馆、MEDLINE,EMBASE和CBM,纳入所有关于四价HPV疫苗的随机对照试验,由两名研究者独立提取资料并进行方法学质量评估,试验数据的统计分析采用Cochrane协作网提供的RevMan 4.2软件. 结果 共纳入3项随机对照试验(RCT),包括11 450例女性,meta分析结果显示:疫苗接种组尖锐湿疣的发病率明显低于对照组,差异有统计学意义.主要不良反应较轻微,严重不良反应在疫苗组和对照组保持均衡. 结论 四价HPV疫苗预防尖锐湿疣安全有效.

  7. Hepatitis B vaccination in preterm infants

    OpenAIRE

    Huang, F.; Lee, P; Lee, C.; Huang, L.; Chang, L; Liu, S.

    1997-01-01

    AIM—To investigate the immunogenicity and safety of existing recommendations for hepatitis B vaccination in preterm infants.
METHODS—Recombinant hepatitis B vaccine (H-B-VAX II, 5 µg per dose) was given to 85 preterm infants divided into two groups, using two different schedules. Forty four group A infants with birthweights of 

  8. Hepatitis B vaccination in United Kingdom accident and emergency departments.

    OpenAIRE

    Heyworth, J

    1988-01-01

    Hepatitis B vaccination is not widespread amongst staff in accident and emergency departments in the United Kingdom. The results of a survey of departments training senior registrars reveal that unfounded fears concerning the safety of the vaccine are responsible for the low uptake. The need for vaccination, cost, medicolegal aspects and future developments are discussed.

  9. Virulence, immunogenicity and vaccine properties of a novel chimeric pestivirus

    DEFF Research Database (Denmark)

    Rasmussen, Thomas Bruun; Uttenthal, Åse; Reimann, Ilona;

    2007-01-01

    avirulent and neither chimeric virus nor viral RNA was detected in serum after vaccination. The safety of the vaccine was tested by horizontal transmission to sentinel pigs, which remained uninfected. The vaccine efficacy was examined by challenge infection with classical swine fever virus (CSFV) Eystrup...

  10. Typhoid vaccines.

    Science.gov (United States)

    Aggarwal, A; Dutta, A K

    2001-08-01

    Typhoid fever continues to be a major public health problem in developing countries with about 33 million cases per year. Protective efficacy of traditional acetone/phenol killed vaccines is similar to newer typhoid vaccines (Ty21A and Vi antigen vaccine) but side effects of these newer vaccines are considerably less. Though the mortality is low, typhoid fever causes considerable morbidity and loss of working days. Problems during treatment are increasing due to emergence and spread of multidrug resistant S. typhi. Hence to decrease the incidence of typhoid fever in addition to ensuring safe water supply and excreta disposal a typhoid vaccine needs to be introduced in the National Immunization Schedule. PMID:11563251

  11. DNA vaccines: a review of developments.

    Science.gov (United States)

    Webster, R G; Robinson, H L

    1997-10-01

    Immunisation with purified DNA is a powerful technique for inducing immune responses. The concept is very simple, involving insertion of the gene encoding the antigen of choice into a bacterial plasmid, and injection of the plasmid into the host where the antigen is expressed and induces humoral and cellular immunity. This technology can induce immunity to all antigens that can be encoded by DNA; this includes all protein, but not carbohydrate, antigens. DNA immunisation appears to result in presentation of antigens to the host's immune system in a natural form, similar to that achieved with live attenuated vaccines. The most efficacious routes for DNA immunisation are bombardment with particles coated with DNA (gene-gun), followed by intramuscular and intradermal administration. The efficiency of transfection of host cells is low, but sufficient to induce immunological responsiveness. The DNA plasmid is retained in the transfected cells in an unintegrated form for the life of the cell. The majority of transfected cells are eliminated, but residual expression has been detected for longer periods. In animal model systems, DNA immunisation has been shown to induce protective immunity to influenza, herpes, rabies, hepatitis B and lymphocytic choriomeningitis viruses, and to malaria and mycobacteria. However, strategies to induce protective immunity to HIV and other disease agents remain to be developed. DNA vaccines permit modulation of the immune response by altering the route or method of DNA administration, by including immunostimulatory sequences in the plasmid, and by co-administration of cytokine genes with the gene encoding the antigen of interest. A T helper 1 response provides cell-mediated immune killing of infected cells and neutralising antibody production, while a T helper 2 response induces IgE and allergic responses. The advantages of DNA immunisation are: similarity to live attenuated vaccination but without the possibility of contamination with

  12. Factors contributing to suboptimal rates of childhood vaccinations in Vermont.

    Science.gov (United States)

    Kelley, Catherine A; Velazco, Cristine S; Delaney, Thomas V; Bensimhon, Adam; Huang, Kuang-Ning; Jarvis, Paul R; Jolin, Jonathan S; Schaberg, Kurt B; Burke, Marianne; Finley, Christine; Carney, Jan K

    2015-12-01

    Childhood immunizations are invaluable in preventing contagious diseases. Nonetheless, vaccines have become increasingly controversial with growing numbers of caregivers refusing to vaccinate their children. The percentage of fully vaccinated children in Vermont is one of the lowest nationally. This study set out to determine Vermont caregivers' attitudes toward immunizations to better explain why the percentage of fully vaccinated children has fallen in Vermont. A survey regarding caregivers' health care knowledge about children, their vaccination concerns, and their children's vaccination status was sent to participants in the Vermont Women, Infants and Children's Program from two districts. In total, 83% (n = 379) of respondents reported their children received all recommended vaccinations for their age. Respondents who considered themselves highly knowledgeable regarding their children's health care and confident about the safety of vaccinations were significantly associated with reporting their children as being current on vaccinations and with their intent to continue vaccinations. Respondents indicated highest concern regarding the safety and number of vaccinations administered during one visit. Primary care providers were indicated as important resources for addressing concerns about vaccinations and health care knowledge of children. The results help to understand low vaccination rates in Vermont and can be used for targeting health campaigns to improve vaccination rates. PMID:24821076

  13. Vaccination of 1-Day-Old Turkey Poults with Fowlpox Vaccine by Subcutaneous Route.

    Science.gov (United States)

    Sarma, Girish; Kersting, Barry A; Spina, Gary

    2015-09-01

    In high-challenge areas, 1-day-old chicks are often vaccinated with fowlpox vaccine to provide early protection against the disease. However, we were unable to find any information in the published literature on the safety and efficacy of live fowlpox virus vaccine in 1-day-old turkeys. In this study, we evaluated a freeze-dried chicken-embryo-origin live fowlpox virus vaccine for its safety and efficacy in 1-day-old turkey poults by administering the vaccine subcutaneously in the upper back of the neck. Following vaccination, the turkeys were observed for 3 wk for vaccine-associated mortality and adverse reactions. Efficacy was evaluated by challenging the turkeys against a standard challenge strain of fowlpox virus. The results of this study indicated that the vaccine was safe and efficacious for subcutaneous administration in 1-day-old turkeys. None of the vaccinated turkeys revealed any adverse reactions or mortality associated with the vaccine. The vaccine protected more than 98% of the turkeys against fowlpox virus challenge. PMID:26478161

  14. PRODUCTION AND QUALITY CONTROL OF VACCINES

    OpenAIRE

    Manish kumar; Kunal; M. B.Anusha; P. Udhayaraja

    2014-01-01

    Health specialists are not always aware of the need to apply different purchasing approaches.There are many companies producing vaccines but only a few meet internationally- recognized standards of safety and efficacy. The safety and efficacy of the vaccines cannot Biological E. Limited determined through laboratory testing.From the chemical testing we concluded that the amount of Adjuvant and preservative were exactly equal and was not found to violet the limits set and r...

  15. Dengue vaccine: hypotheses to understand CYD-TDV-induced protection.

    Science.gov (United States)

    Guy, Bruno; Jackson, Nicholas

    2016-01-01

    Dengue virus (DENV) is a human pathogen with a large impact on public health. Although no vaccine against DENV is currently licensed, a recombinant vaccine - chimeric yellow fever virus-DENV tetravalent dengue vaccine (CYD-TDV) - has shown efficacy against symptomatic dengue disease in two recent Phase III clinical trials. Safety observations were also recently reported for these trials. In this Opinion article, we review the data from recent vaccine clinical trials and discuss the putative mechanisms behind the observed efficacy of the vaccine against different forms of the disease, focusing on the interactions between the infecting virus, pre-existing host immunity and vaccine-induced immune responses. PMID:26639777

  16. Superior Efficacy and Safety of a Nonemulsive Variant of the NGcGM3/VSSP Vaccine in Advanced Breast Cancer Patients.

    Science.gov (United States)

    de la Torre, Ana; Pérez, Kirenia; Vega, Aliz M; Santiesteban, Eduardo; Ruiz, Raiza; Hernández, Leonardo; Durrutí, Dayamí; Viada, Carmen E; Sánchez, Liset; Álvarez, Mabel; Durán, Yunier; Moreno, Yoisbel G; Arencibia, Maylén; Cepeda, Meylán; Domecq, Milagros; Cabrera, Leticia; Sánchez, Jorge L; Hernández, José J; Valls, Ana R; Fernández, Luis E

    2016-01-01

    NGcGM3 ganglioside is a tumor-specific antigen expressed in human breast tumors. The NGcGM3/VSSP vaccine, consisting in very small-sized proteoliposomes (VSSP) obtained by the incorporation of NGcGM3 into the outer membrane protein complex of Neisseria meningitidis, has been previously tested in a Phase II trial in patients with metastatic breast cancer (MBC) but emulsified with Montanide ISA 51. An Expanded Access study was carried out in MBC patients aiming to find if a nonemulsive formulation of NGcGM3/VSSP, without Montanide ISA 51, could be more safe and effective. A total of 104 patients were vaccinated with the nonemulsive formulation (900 μg), subcutaneously (SC), or with the emulsive formulation (200 μg), intramuscularly (IM). An intent-to-treat analysis of efficacy was performed with all patients, and 93 patients were split off according to the site of metastases (visceral/nonvisceral). Of note, SC-treated patients exhibited a superior median overall survival (OS) than IM-treated patients (23.6 vs. 8.2 months; log rank P = 0.001). Even though in the subset of patients with nonvisceral metastases SC vaccination duplicated the median OS compared to the alternative option (31.6 vs. 16.5 months), this difference did not reach statistical significance (log rank P = 0.118). Curiously, in patients with visceral metastases, the advantage of the nonemulsive formulation was more apparent (median OS 21.0 vs. 6.2 months; log rank P = 0.005). The vaccine was safe for both formulations. PMID:26917965

  17. Safety and Colonization of Two Novel virG(icsA)-based Live Shigella sonnei Vaccine Strains in Rhesus Macaques (Macaca mulatta)

    OpenAIRE

    Collins, Todd A; Barnoy, Shoshana; Baqar, Shahida; Ranallo, Ryan T.; Nemelka, Kevin W; Venkatesan, Malabi M.

    2008-01-01

    Shigella are gram-negative bacterium that cause bacillary dysentery (shigellosis). Symptoms include diarrhea and discharge of bloody mucoid stools, accompanied by severe abdominal pain, nausea, vomiting, malaise, and fever. Persons traveling to regions with poor sanitation and crowded conditions become particularly susceptible to shigellosis. Currently a vaccine for Shigella has not been licensed in the United States, and the organism quickly becomes resistant to medications. During the past ...

  18. 76 FR 50221 - International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing...

    Science.gov (United States)

    2011-08-12

    ... safety testing of rabies vaccines requires large numbers of laboratory animals and involves significant... Rabies Vaccine Potency Testing WHO World Organisation for Animal Health (OIE) Incorporating Reduction... Vaccine Potency Testing Breakout Session 2: Non-Animal Approaches to Rabies Vaccine Potency...

  19. Vaccine Hesitancy: Causes, Consequences, and a Call to Action.

    Science.gov (United States)

    Salmon, Daniel A; Dudley, Matthew Z; Glanz, Jason M; Omer, Saad B

    2015-12-01

    Vaccine hesitancy reflects concerns about the decision to vaccinate oneself or one's children. There is a broad range of factors contributing to vaccine hesitancy, including the compulsory nature of vaccines, their coincidental temporal relationships to adverse health outcomes, unfamiliarity with vaccine-preventable diseases, and lack of trust in corporations and public health agencies. Although vaccination is a norm in the U.S. and the majority of parents vaccinate their children, many do so amid concerns. The proportion of parents claiming non-medical exemptions to school immunization requirements has been increasing over the past decade. Vaccine refusal has been associated with outbreaks of invasive Haemophilus influenzae type b disease, varicella, pneumococcal disease, measles, and pertussis, resulting in the unnecessary suffering of young children and waste of limited public health resources. Vaccine hesitancy is an extremely important issue that needs to be addressed because effective control of vaccine-preventable diseases generally requires indefinite maintenance of extremely high rates of timely vaccination. The multifactorial and complex causes of vaccine hesitancy require a broad range of approaches on the individual, provider, health system, and national levels. These include standardized measurement tools to quantify and locate clustering of vaccine hesitancy and better understand issues of trust; rapid, independent, and transparent review of an enhanced and appropriately funded vaccine safety system; adequate reimbursement for vaccine risk communication in doctors' offices; and individually tailored messages for parents who have vaccine concerns, especially first-time pregnant women. The potential of vaccines to prevent illness and save lives has never been greater. Yet, that potential is directly dependent on parental acceptance of vaccines, which requires confidence in vaccines, healthcare providers who recommend and administer vaccines, and the

  20. Sustaining Vaccine Confidence in the 21st Century

    OpenAIRE

    Karin Hardt; Ruprecht Schmidt-Ott; Steffen Glismann; Adegbola, Richard A.; François P. Meurice

    2013-01-01

    Vaccination provides many health and economic benefits to individuals and society, and public support for immunization programs is generally high. However, the benefits of vaccines are often not fully valued when public discussions on vaccine safety, quality or efficacy arise, and the spread of misinformation via the internet and other media has the potential to undermine immunization programs. Factors associated with improved public confidence in vaccines include evidence-based decision-maki...

  1. Controversies and challenges of vaccination: an interview with Elizabeth Miller.

    Science.gov (United States)

    Miller, Elizabeth

    2015-01-01

    Although strong evidence exists that the benefits of vaccination by far outweigh potential adverse events, controversy still exists. This has led opponents of vaccination to question its safety, efficacy and necessity. In an interview with Professor Elizabeth Miller, we discuss the continuum of beliefs held by vaccine refusers and hesitators, the resulting health consequences, and ways in which health professionals and industry regulators can help promote transparency to better convey the substantial health benefits of vaccination. PMID:26472230

  2. Tumor vaccines

    International Nuclear Information System (INIS)

    Tumor vaccines have several potential advantages over standard anticancer regiments. They represent highly specific anticancer therapy. Inducing tumor-specific memory T-lymphocytes, they have potential for long-lived antitumor effects. However, clinical trials, in which cancer patients were vaccinated with tumor vaccines, have been so far mainly disappointing. There are many reasons for the inefficiency of tumor vaccines. Most cancer antigens are normal self-molecules to which immune tolerance exists. That is why the population of tumor-specific lymphocytes is represented by a small number of low-affinity T-lymphocytes that induce weak antitumor immune response. Simultaneously, tumors evolve many mechanisms to actively evade immune system, what makes them poorly immunogenic or even tolerogenic. Novel immunotherapeutic strategies are directed toward breaking immune tolerance to tumor antigens, enhancing immunogenicity of tumor vaccines and overcoming mechanisms of tumor escape. There are several approaches, unfortunately, all of them still far away from an ideal tumor vaccine that would reject a tumor. Difficulties in the activation of antitumor immune response by tumor vaccines have led to the development of alternative immunotherapeutic strategies that directly focus on effector mechanisms of immune system (adoptive tumor- specific T-lymphocyte transfer and tumor specific monoclonal antibodies). (author)

  3. Cervical cancer in India and HPV vaccination.

    Science.gov (United States)

    Kaarthigeyan, K

    2012-01-01

    Cervical cancer, mainly caused by Human Papillomavirus infection, is the leading cancer in Indian women and the second most common cancer in women worldwide. Though there are several methods of prevention of cervical cancer, prevention by vaccination is emerging as the most effective option, with the availability of two vaccines. Several studies have been published examining the vaccine's efficacy, immunogenicity and safety. Questions and controversy remain regarding mandatory vaccination, need for booster doses and cost-effectiveness, particularly in the Indian context. PMID:22754202

  4. Pertussis Vaccine Trials in the 1990s

    OpenAIRE

    Lambert, Linda C.

    2014-01-01

    The significant burden of disease due to pertussis, which predominantly affects newborns during their first few months of life, was substantially decreased following the introduction of inactivated whole-bacterial-cell vaccines in the middle of the 20th century. Although these vaccines were effective in reducing the incidence of pertussis in the countries that implemented their widespread use, increasing concerns about pertussis vaccine–associated adverse events led the development of acellul...

  5. Modern Vaccines/Adjuvants Formulation Session 6: Vaccine & Adjuvant Formulation & Production 15-17 May 2013, Lausanne, Switzerland

    OpenAIRE

    Fox, Christopher B.

    2013-01-01

    The Modern Vaccines/Adjuvants Formulation meeting aims to fill a critical gap in current vaccine development efforts by bringing together formulation scientists and immunologists to emphasize the importance of rational formulation design in order to optimize vaccine and adjuvant bioactivity, safety, and manufacturability. Session 6 on Vaccine and Adjuvant Formulation and Production provided three examples of this theme, with speakers emphasizing the need for extensive physicochemical characte...

  6. Sequential Phase 1 and Phase 2 randomized, controlled trials of the safety, immunogenicity and efficacy of combined pre-erythrocytic vaccine antigens RTS,S and TRAP formulated with AS02 Adjuvant System in healthy, malaria naïve adults.

    Science.gov (United States)

    Kester, Kent E; Gray Heppner, D; Moris, Philippe; Ofori-Anyinam, Opokua; Krzych, Urszula; Tornieporth, Nadia; McKinney, Denise; Delchambre, Martine; Ockenhouse, Christian F; Voss, Gerald; Holland, Carolyn; Beckey, Jolie Palensky; Ballou, W Ripley; Cohen, Joe

    2014-11-20

    In an attempt to improve the efficacy of the candidate malaria vaccine RTS,S/AS02, two studies were conducted in 1999 in healthy volunteers of RTS,S/AS02 in combination with recombinant Plasmodium falciparum thrombospondin-related anonymous protein (TRAP). In a Phase 1 safety and immunogenicity study, volunteers were randomized to receive TRAP/AS02 (N=10), RTS,S/AS02 (N=10), or RTS,S+TRAP/AS02 (N=20) at 0, 1 and 6-months. In a Phase 2 challenge study, subjects were randomized to receive either RTS,S+TRAP/AS02 (N=25) or TRAP/AS02 (N=10) at 0 and 1-month, or to a challenge control group (N=8). In both studies, the combination vaccine had an acceptable safety profile and was acceptably tolerated. Antigen-specific antibodies, lymphoproliferative responses, and IFN-γ production by ELISPOT assay elicited with the combination vaccine were qualitatively similar to those generated by the single component vaccines. However, post-dose 2 anti-CS antibodies in the RTS,S+TRAP/AS02 vaccine recipients were lower than in the RTS,S/AS02 vaccine recipients. After challenge, 10 of 11 RTS,S+TRAP/AS02 vaccinees, 5 of 5 TRAP/AS02 vaccinees, and 8 of 8 infectivity controls developed parasitemia, with median pre-patent periods of 13.0, 11.0, and 12.0 days, respectively. The absence of any prevention or delay of parasitemia by TRAP/AS02 suggests no apparent added value of TRAP/AS02 as a candidate vaccine. The absence of significant protection or delay of parasitemia in the 11 RTS,S+TRAP/AS02 vaccine recipients contrasts with previous 2 dose studies of RTS,S/AS02. The small sample size did not permit identifying statistically significant differences between the study arms. However, we speculate, within the constraints of the challenge study, that the presence of the TRAP antigen may have interfered with the vaccine efficacy previously observed with this regimen of RTS,S/AS02, and that any future TRAP-based vaccines should consider employing alternative vaccine platforms. PMID:24950358

  7. The efficacy and safety of a nicotine conjugate vaccine (NicVAX® or placebo co-administered with varenicline (Champix® for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Hoogsteder Philippe HJ

    2012-12-01

    Full Text Available Abstract Background A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood–brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix® and intensive counseling as an aid in smoking cessation and relapse prevention. Methods/design Two centers will include a total of 600 smokers who are motivated to quit smoking. At week −2 these smokers will be randomized, in a 1:1 ratio, to either 6 injections of NicVAX® or placebo, both co-administered with 12-weeks of varenicline treatment, starting at week 0. The target quit day will be set after 7 days of varenicline treatment at week 1. Smokers will be followed up for 54 weeks. The primary outcome is defined as biochemically validated prolonged smoking abstinence from week 9 to 52. Secondary outcomes include safety, immunogenicity, smoking abstinence from week 37 to 52, abstinence from week 9 to 24, abstinence in the subset of subjects with the highest antibody response, and lapse/relapse rate. Discussion This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain

  8. Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases.

    Science.gov (United States)

    Narayana, Ashwath; Manoharan, Aravind; Narayan, Madhusudana Shampur; Kalappa, Sudarshan Mysore; Biligumba, Gangaboraiah; Haradanahalli, Ravish; Anand, Ashwini Manoor

    2015-01-01

    The currently advocated rabies post-exposure prophylaxis regimens are of one month duration with reduced patient compliance. WHO recommended research on shortened vaccination regimens which have a practical and economic advantage over the existing regimens. Hence, the present study was undertaken to assess the safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases. This study was a comparative, open label, phase III, randomized clinical trial conducted at Anti rabies clinic, KIMS Hospital, Bangalore, India. The study was registered in Clinical Trials Registry of India (CTRI) bearing the registration number CTRI/2012/12/003230. Ninety subjects with category II/III animal bites/exposures were enrolled. Equine rabies immunoglobulin was administered to all category III exposures. 0.1 mL of either purified chick embryo cell vaccine (Rabipur) or purified verocell rabies vaccine (Verorab) was administered intradermally into 4 sites on days 0, 3 and 7 to all the study subjects. Serum of subjects collected on day 0, 14, 90 and 365 were analyzed for rabies virus neutralizing antibody (RVNA) concentration. The incidence of ADR in Rabipur and Verorab group was 2.96% and 1.14% respectively. In Rabipur group, geometric mean concentration (95% confidence interval) of RVNA was 14.5 (13.50, 15.57), 11.78 (11.27, 12.31) and 5.95 (5.50, 6.44) IU/mL on days 14, 90 and 365 respectively; In Verorab group geometric mean concentration (95% confidence interval) of RVNA was 14.43 (13.41, 15.53), 11.93 (11.47, 12.40) and 5.67 (5.29, 6.08) IU/mL on days 14, 90 and 365 respectively. In conclusion, Rabipur and Verorab were found to be safe, immunogenic and comparable with each other, when administered using one week, 4 site intradermal regimen (4-4-4-0-0) in animal bite cases. PMID:26083005

  9. Arthropod vaccines.

    Science.gov (United States)

    Lee, R; Opdebeeck, J P

    1999-03-01

    Antigens located in the midgut of the tick are hidden from the host's immune system. Egg production of ticks can be reduced when ticks are fed on animals vaccinated with midgut antigens of the tick, and a subunit vaccine formulated with the recombinant antigen Bm86 is now available that can reduce the number of ticks infesting cattle grazing on pasture. Midgut antigens used in vaccines against insects that transmit pathogenic organisms to humans have not been as effective in reducing insect fecundity and an alternative approach may be necessary. Transmission-blocking vaccines directed at interfering with the vector-pathogen interaction could result in loss of vector competence and block the spread of disease-causing organisms. PMID:10198800

  10. Influenza vaccination

    DEFF Research Database (Denmark)

    Østerhus, Sven Frederick

    2015-01-01

    The Cochrane Library was systematically searched for meta-analyses regarding influenza vaccination of various populations, both healthy and sick. An effect in reducing the number of cases of influenza, influenza-like illness or complications to influenza was found in some studies, but, generally......, the quality of the studies was low, and several studies lacked hard clinical endpoints. Data on adverse effects were scarce. More randomised controlled trials investigating the effects of influenza vaccination are warranted....

  11. BVDV vaccination in North America: risks versus benefits.

    Science.gov (United States)

    Griebel, Philip J

    2015-06-01

    The control and prevention of bovine viral diarrhea virus (BVDV) infections has provided substantial challenges. Viral genetic variation, persistent infections, and viral tropism for immune cells have complicated disease control strategies. Vaccination has, however, provided an effective tool to prevent acute systemic infections and increase reproductive efficiency through fetal protection. There has been substantial controversy about the safety and efficacy of BVDV vaccines, especially when comparing killed versus modified-live viral (MLV) vaccines. Furthermore, numerous vaccination protocols have been proposed to protect the fetus and ensure maternal antibody transfer to the calf. These issues have been further complicated by reports of immune suppression during natural infections and following vaccination. While killed BVDV vaccines provide the greatest safety, their limited immunogenicity makes multiple vaccinations necessary. In contrast, MLV BVDV vaccines induce a broader range of immune responses with a longer duration of immunity, but require strategic vaccination to minimize potential risks. Vaccination strategies for breeding females and young calves, in the face of maternal antibody, are discussed. With intranasal vaccination of young calves it is possible to avoid maternal antibody interference and induce immune memory that persists for 6-8 months. Thus, with an integrated vaccination protocol for both breeding cows and calves it is possible to maximize disease protection while minimizing vaccine risks. PMID:26050569

  12. Antipneumococcal vaccination

    Directory of Open Access Journals (Sweden)

    Gian Vincenzo Zuccotti

    2013-06-01

    Full Text Available Streptococcus pneumoniae (SP is a gram-positive bacterium with more than 90 known serotypes causing around 11% of all deaths worldwide in children aged 1-59 months. A new era in prevention of SP-related diseases started in at the beginning of 2000s when a 7-valent pneumococcal conjugate vaccine (PCV7 was recommended as the vaccine of choice in pediatric age. PCV7 dramatically reduced invasive pneumococcal diseases (IPD among children with indirect effects noted among other age groups as well. However, thanks to a strict surveillance network, an increase in non-vaccine serotypes (NVTs causing IPD was noted worldwide and in late 2000s a new second generation vaccine (13-valent pneumococcal conjugate vaccine-PCV13 with an expanded serotype coverage was licensed. Due to the lack of solid effectiveness data, up to know it is difficult to predict how the composition of NVTs will change after the large-scale introduction of PCV13 or whether the characteristics of the serotypes will change. Long-term surveillance of both IPD, pneumonia, acute otitis media and carriage will be crucial to ascertain whether these second generation vaccines are having the desired effect of reducing the incidence of diseases in the long term. Proceedings of the 9th International Workshop on Neonatology · Cagliari (Italy · October 23rd-26th, 2013 · Learned lessons, changing practice and cutting-edge research

  13. Vaccines Against Malaria

    OpenAIRE

    Ouattara, Amed; Laurens, Matthew B.

    2014-01-01

    No licensed malaria vaccine currently exists; however, final phase 3 testing results of a leading candidate vaccine are forthcoming. Continued challenges to malaria vaccine developers include genetically diverse strains found in nature and establishment of a vaccine correlate of protection.

  14. HPV Vaccine and Pregnancy

    Science.gov (United States)

    ... recurrent respiratory papillomatosis (JORRP). What is the HPV vaccine? The HPV vaccine provides protection against some types of HPV. ... I am pregnant. Should I get the HPV vaccine? The HPV vaccine is not recommended for pregnant women because ...

  15. Ear Infection and Vaccines

    Science.gov (United States)

    ... an ENT Doctor Near You Ear Infection and Vaccines Ear Infection and Vaccines Patient Health Information News ... or may need reinsertion over time. What about vaccines? A vaccine is a preparation administered to stimulate ...

  16. Live Virus Smallpox Vaccine

    Science.gov (United States)

    ... A - Z Index SMALLPOX FACT SHEET The Live Virus Smallpox Vaccine The vaccinia virus is the "live ... it cannot cause smallpox. What is a "live virus" vaccine? A "live virus" vaccine is a vaccine ...

  17. Principles of malaria vaccine trials: Memorandum from a WHO Meeting*

    OpenAIRE

    1986-01-01

    The Scientific Working Groups on Immunology of Malaria and on Applied Field Research in Malaria of the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases held a joint meeting at WHO headquarters in Geneva, Switzerland, on 4-8 February 1985 to consider the current status of malaria vaccine research. Although experience with vaccines against bacterial and viral infections provides valuable information, the advanced stages of development of malaria vaccines pose...

  18. 9 CFR 113.65 - Brucella Abortus Vaccine.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Brucella Abortus Vaccine. 113.65 Section 113.65 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS STANDARD REQUIREMENTS Live Bacterial Vaccines § 113.65 Brucella...

  19. VIROSOMES: A NOVEL VACCINATION TECHNOLOGY

    Directory of Open Access Journals (Sweden)

    Priyanka Rathore et al

    2012-01-01

    Full Text Available Vaccine development has continuously shifted away from live attenuated or inactivated whole organisms. Although this approach having good efficacy but for improvement on comparison of risk/benefit ratio which needs improvement due to their highly complex compositions which result in safety concerns. As a consequence, a number of indications remained unadressed. The next generation vaccines represented as subunit vaccines, whereby the only pathogens fragments used which are relevant in inducing protective immunity. For the successful subunit vaccination two major key requirements are safe carrier and adjuvant system, since the small, isolated pathogen fragments themselves are generally weak immunogens. Pevion’s virus-like particle (VLP vaccine technology, called virosomes, and their design is specifically for the development of safe and effective subunit vaccines. Virosomes based vaccination has already been approved in more than 40 countries, including for elderly and infants. It is successful in solid regulatory & safety track record as well as the feasibility of production upscaling. The outstanding profile with combined efficacy and safety of virosomes-based vaccines are known for its origin in the unique mode of action of these multifunctional particles. It leads to a comprehensive induction of a complete immune response, in contrast to single-sided triggers. Virosomes are reconstituted viral envelopes that can serve as vaccines and as vehicles for cellular delivery of macromolecules. The prospect of drug delivery and targeting using virosomes is an interesting field of research and development. As virosomes are biocompatible, biodegradable, nontoxic, and non-autoimmunogenic, and various attempts have been made to use them as vaccines or adjuvants as well as delivery system for drugs, nuleic acids, nucleic acids, or genes for therapeutic purposes. The virus of choice is influenza virus. Virosomal drug delivery depends on the methods used

  20. Human Vaccines & Immunotherapeutics: News

    OpenAIRE

    Riedmann, Eva M.

    2013-01-01

    Long-term effectiveness shown for Merck’s chickenpox vaccine Again—no link between vaccines and autism Experimental ovarian cancer vaccine successful in phase 1 Sinovac’s HFMD vaccine meets phase 3 study goal A vaccine for long-suffering cat allergy patients Vaccines are key to breaking infectious disease-malnutrition cycle Cancer vaccine failures due to the adjuvant IFA? Novartis’ typhoid vaccine make good progress

  1. [Vaccinations in patients with autoimmune diseases].

    Science.gov (United States)

    Bühler, Silja; Hatz, Christoph

    2016-01-01

    The number of individuals with autoimmune diseases treated with immunosuppressive drugs is increasing steadily. The variety of immunosuppressive drugs and in particular biological therapies is also rising. The autoimmune disease itself as well as the immunosuppressive therapy increases the risk of infection in this population. Particularly the risk of vaccine-preventable infections is elevated. Thus, preventing infections by the means of vaccination is of utmost importance. The Division of Infectious Diseases of the Epidemiology, Biostatistics and Prevention Institute, University of Zurich, performed a literature search on the topic of vaccinations in patients with autoimmune diseases upon request by the Swiss Federal Commission for Vaccination Issues. Overall, data are scarce. The following main points were retrieved from the literature: Inactivated vaccines are safe, but their immunogenicity may be reduced under immunosuppressive therapy. In addition to the generally recommended basic vaccinations, specific vaccinations, such as influenza and pneumococcal vaccination are indicated in these patient groups. Live vaccines are generally contraindicated under immunosuppressive therapy due to safety concerns. However, specific exceptions apply. Furthermore, certain time intervals for the administration of live vaccines after pausing or ceasing an immunosuppressive therapy should be respected. PMID:27268452

  2. Immunization by a bacterial aerosol.

    Science.gov (United States)

    Garcia-Contreras, Lucila; Wong, Yun-Ling; Muttil, Pavan; Padilla, Danielle; Sadoff, Jerry; Derousse, Jessica; Germishuizen, Willem Andreas; Goonesekera, Sunali; Elbert, Katharina; Bloom, Barry R; Miller, Rich; Fourie, P Bernard; Hickey, Anthony; Edwards, David

    2008-03-25

    By manufacturing a single-particle system in two particulate forms (i.e., micrometer size and nanometer size), we have designed a bacterial vaccine form that exhibits improved efficacy of immunization. Microstructural properties are adapted to alter dispersive and aerosol properties independently. Dried "nanomicroparticle" vaccines possess two axes of nanoscale dimensions and a third axis of micrometer dimension; the last one permits effective micrometer-like physical dispersion, and the former provides alignment of the principal nanodimension particle axes with the direction of airflow. Particles formed with this combination of nano- and micrometer-scale dimensions possess a greater ability to aerosolize than particles of standard spherical isotropic shape and of similar geometric diameter. Here, we demonstrate effective application of this biomaterial by using the live attenuated tuberculosis vaccine bacille Calmette-Guérin (BCG). Prepared as a spray-dried nanomicroparticle aerosol, BCG vaccine exhibited high-efficiency delivery and peripheral lung targeting capacity from a low-cost and technically simple delivery system. Aerosol delivery of the BCG nanomicroparticle to normal guinea pigs subsequently challenged with virulent Mycobacterium tuberculosis significantly reduced bacterial burden and lung pathology both relative to untreated animals and to control animals immunized with the standard parenteral BCG. PMID:18344320

  3. Characteristics of Memory B Cells Elicited by a Highly Efficacious HPV Vaccine in Subjects with No Pre-existing Immunity

    OpenAIRE

    Scherer, Erin M.; Smith, Robin A; Simonich, Cassandra A.; Niyonzima, Nixon; Carter, Joseph J.; Galloway, Denise A.

    2014-01-01

    Author Summary There is an urgent need to better understand how to reliably generate effective vaccines, particularly subunit vaccines, as certain pathogens are considered to pose too great of a safety risk to be developed as live, attenuated or killed vaccines (e.g., HIV-1). The human papillomavirus (HPV) vaccines are two of the most effective subunit vaccines ever developed and have continued to show protection against HPV associated disease up to and beyond five years post-vaccination. Mor...

  4. Efficacy of HVT-IBD vector vaccine compared to attenuated live vaccine using in-ovo vaccination against a Korean very virulent IBDV in commercial broiler chickens.

    Science.gov (United States)

    Roh, J-H; Kang, M; Wei, B; Yoon, R-H; Seo, H-S; Bahng, J-Y; Kwon, J-T; Cha, S-Y; Jang, H-K

    2016-05-01

    The production performance, efficacy, and safety of two types of vaccines for infectious bursal disease virus (IBDV) were compared with in-ovo vaccination of Cobb 500 broiler chickens for gross and microscopic examination of the bursa of Fabricius, bursa/body weight (b/B) ratio, flow cytometry, and serologic response to Newcastle disease virus (NDV) vaccination. One vaccine was a recombinant HVT-IBD vector vaccine (HVT as for herpesvirus of turkeys) and the other was an intermediate plus live IBDV vaccine. A significant difference was detected at 21 d. Eight of 10 chickens that received the IBDV live vaccine had severe bursal lesions and a relatively low b/B ratio of 0.95, and an inhibited NDV vaccine response. On the other hand, the HVT-IBD vector vaccine resulted in mild bursal lesions and a b/B ratio of 1.89. Therefore, the live vaccine had lower safety than that of the HVT-IBD vector vaccine. To determine the protective efficacy, chickens were intraocularly challenged at 24 d. Eight of 10 chickens in the IBDV live vaccination group showed gross and histological lesions characterized by hemorrhage, cyst formation, lymphocytic depletion, and a decreased b/B ratio. In contrast, the HVT-IBD vector vaccinated chickens showed mild gross and histological lesions in three of 10 chickens with a b/B ratio of 1.36, which was similar to that of the unchallenged controls. Vaccinated chickens showed a significant increase in IBDV antibody titers, regardless of the type of vaccine used. In addition, significantly better broiler flock performance was observed with the HVT-IBD vector vaccine compared to that of the live vaccine. Our results revealed that the HVT-IBD vector vaccine could be used as an alternative vaccine to increase efficacy, and to have an improved safety profile compared with the IBDV live vaccine using in-ovo vaccination against the Korean very virulent IBDV in commercial broiler chickens. PMID:26944964

  5. Tuberculosis: looking beyond BCG vaccines.

    Directory of Open Access Journals (Sweden)

    Mustafa Abu S

    2003-01-01

    Full Text Available Tuberculosis (TB is an infectious disease of international importance and ranks among the top 10 causes of death in the World. About one-third of the world′s population is infected with Mycobacterium tuberculosis. Every year, approximately eight million people develop active disease and two million die of TB. The currently used BCG vaccines have shown variable protective efficacies against TB in different parts of the world. Moreover, being a live vaccine, BCG can be pathogenic in immunocompromised recipients. Therefore, there is an urgent need to develop new vaccines against TB. The comparative genome analysis has revealed the existence of several M. tuberculosis-specific regions that are deleted in BCG. The work carried out to determine the immunological reactivity of proteins encoded by genes located in these regions revealed several major antigens of M. tuberculosis, including the 6 kDa early secreted antigen target (ESAT6. Immunization with ESAT6 and its peptide (aa51-70 protects mice challenged with M. tuberculosis. The protective efficacy of immunization further improves when ESAT6 is recombinantly fused with M. tuberculosis antigen 85B. In addition, ESAT6 delivered as a DNA vaccine is also protective in mice. Whether these vaccines would be safe or not cannot be speculated. The answer regarding the safety and efficacy of these vaccines has to await human trials in different parts of the world.

  6. Vaccinations for Adult Solid-Organ Transplant Recipients: Current Recommendations and Protocols

    OpenAIRE

    Duchini, Andrea; Goss, John A.; Karpen, Saul; Pockros, Paul J.

    2003-01-01

    Recipients of solid-organ transplantation are at risk of severe infections due to their life-long immunosuppression. Despite emerging evidence that vaccinations are safe and effective among immunosuppressed patients, most vaccines are still underutilized in these patients. The efficacy, safety, and protocols of several vaccines in this patient population are poorly understood. Timing of vaccination appears to be critical because response to vaccinations is decreased in patients with end-stage...

  7. Virus-like particles as a vaccine against porcine reproductive and respiratory syndrome virus

    OpenAIRE

    Venkatesh Murthy, Ambika Mosale

    2013-01-01

    Porcine reproductive and respiratory syndrome (PRRS) is the most significant infectious disease currently affecting the swine industry worldwide. Several inactivated and modified live vaccines (MLV) have been developed to curb PRRSV infections. The unsatisfactory efficacy and safety of these vaccines, drives for the development of new generation PRRS universal vaccines. Virus like particles (VLPs) based vaccines are gaining increasing acceptance compared to subunit vaccines, as they present t...

  8. Beyond antigens and adjuvants: formulating future vaccines.

    Science.gov (United States)

    Moyer, Tyson J; Zmolek, Andrew C; Irvine, Darrell J

    2016-03-01

    The need to optimize vaccine potency while minimizing toxicity in healthy recipients has motivated studies of the formulation of vaccines to control how, when, and where antigens and adjuvants encounter immune cells and other cells/tissues following administration. An effective subunit vaccine must traffic to lymph nodes (LNs), activate both the innate and adaptive arms of the immune system, and persist for a sufficient time to promote a mature immune response. Here, we review approaches to tailor these three aspects of vaccine function through optimized formulations. Traditional vaccine adjuvants activate innate immune cells, promote cell-mediated transport of antigen to lymphoid tissues, and promote antigen retention in LNs. Recent studies using nanoparticles and other lymphatic-targeting strategies suggest that direct targeting of antigens and adjuvant compounds to LNs can also enhance vaccine potency without sacrificing safety. The use of formulations to regulate biodistribution and promote antigen and inflammatory cue co-uptake in immune cells may be important for next-generation molecular adjuvants. Finally, strategies to program vaccine kinetics through novel formulation and delivery strategies provide another means to enhance immune responses independent of the choice of adjuvant. These technologies offer the prospect of enhanced efficacy while maintaining high safety profiles necessary for successful vaccines. PMID:26928033

  9. Vaccination against ticks and the control of ticks and tick-borne disease

    International Nuclear Information System (INIS)

    Full text: Ticks and tick-borne disease are a major constraint to livestock production in developing countries. The control of ticks is of particular importance given that a major component of the control of tick-borne disease is, in fact, via the control of the vector. Problems with the control of ticks through pesticide application continue to increase, explaining the continued interest in vaccine and biological control strategies as alternatives. The feasibility of vaccination was demonstrated conclusively with the release, in 1994, of a recombinant commercial vaccine against Boophilus microplus. Nevertheless, since then the field has languished commercially, despite ongoing scientific progress. This paper will address the hurdles to further development and some ways in which they might be overcome. Efficacy and the development of prototype vaccines Recombinant vaccines have a number of potential advantages over chemical control. These include safety, specificity and freedom from environmental contamination. They are potentially low cost and stable, either minimising or eliminating the need for a cold chain for distribution. Another advantage is less well recognised. Many of the problems with pesticides derive from inaccurate or inappropriate application. In this regard, vaccines are more robust technology, being less dependent on volume or timing of application. The problem with vaccines is their perceived and real lack of efficacy. The current commercial vaccine against B. microplus is a single antigen vaccine that, at best, gives 90% protection. Used in a sustained way, this is adequate in many production situations. In other situations, efficacy may be less and hence inadequate. Efficacy can be increased through the addition of other antigens to a vaccine. Over the last decade a number of possibilities have been identified, though none have been thoroughly evaluated. A reliable evaluation of the existing portfolio of antigens in a field situation would be

  10. Vaxvec: The first web-based recombinant vaccine vector database and its data analysis.

    Science.gov (United States)

    Deng, Shunzhou; Martin, Carly; Patil, Rasika; Zhu, Felix; Zhao, Bin; Xiang, Zuoshuang; He, Yongqun

    2015-11-27

    A recombinant vector vaccine uses an attenuated virus, bacterium, or parasite as the carrier to express a heterologous antigen(s). Many recombinant vaccine vectors and related vaccines have been developed and extensively investigated. To compare and better understand recombinant vectors and vaccines, we have generated Vaxvec (http://www.violinet.org/vaxvec), the first web-based database that stores various recombinant vaccine vectors and those experimentally verified vaccines that use these vectors. Vaxvec has now included 59 vaccine vectors that have been used in 196 recombinant vector vaccines against 66 pathogens and cancers. These vectors are classified to 41 viral vectors, 15 bacterial vectors, 1 parasitic vector, and 1 fungal vector. The most commonly used viral vaccine vectors are double-stranded DNA viruses, including herpesviruses, adenoviruses, and poxviruses. For example, Vaxvec includes 63 poxvirus-based recombinant vaccines for over 20 pathogens and cancers. Vaxvec collects 30 recombinant vector influenza vaccines that use 17 recombinant vectors and were experimentally tested in 7 animal models. In addition, over 60 protective antigens used in recombinant vector vaccines are annotated and analyzed. User-friendly web-interfaces are available for querying various data in Vaxvec. To support data exchange, the information of vaccine vectors, vaccines, and related information is stored in the Vaccine Ontology (VO). Vaxvec is a timely and vital source of vaccine vector database and facilitates efficient vaccine vector research and development. PMID:26403370

  11. Biodistribution and Toxicological Safety of Adenovirus Type 5 and Type 35 Vectored Vaccines Against Human Immunodeficiency Virus-1 (HIV-1), Ebola, or Marburg Are Similar Despite Differing Adenovirus Serotype Vector, Manufacturer's Construct, or Gene Inserts

    OpenAIRE

    Sheets, Rebecca L.; Stein, Judith; Bailer, Robert T.; Koup, Richard A.; Andrews, Charla; Nason, Martha; He, Bin; Koo, Edward; Trotter, Holly; Duffy, Chris; Manetz, T. Scott; Gomez, Phillip

    2008-01-01

    The Vaccine Research Center has developed vaccine candidates for different diseases/infectious agents (including HIV-1, Ebola, and Marburg viruses) built on an adenovirus vector platform, based on adenovirus type 5 or 35. To support clinical development of each vaccine candidate, pre-clinical studies were performed in rabbits to determine where in the body they biodistribute and how rapidly they clear, and to screen for potential toxicities (intrinsic and immunotoxicities). The vaccines biodi...

  12. Toxicological Safety Evaluation of DNA Plasmid Vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile Virus Is Similar Despite Differing Plasmid Backbones or Gene-Inserts

    OpenAIRE

    Sheets, Rebecca L.; Stein, Judith; Manetz, T. Scott; Andrews, Charla; Bailer, Robert; Rathmann, John; Gomez, Phillip L.

    2006-01-01

    The Vaccine Research Center has developed a number of vaccine candidates for different diseases/infectious agents (HIV-1, Severe Acute Respiratory Syndrome virus, West Nile virus, and Ebola virus, plus a plasmid cytokine adjuvant—IL-2/Ig) based on a DNA plasmid vaccine platform. To support the clinical development of each of these vaccine candidates, preclinical studies were performed to screen for potential toxicities (intrinsic and immunotoxicities). All treatment-related toxicities identif...

  13. Ten years of HPV vaccines: State of art and controversies.

    Science.gov (United States)

    Angioli, Roberto; Lopez, Salvatore; Aloisi, Alessia; Terranova, Corrado; De Cicco, Carlo; Scaletta, Giuseppe; Capriglione, Stella; Miranda, Andrea; Luvero, Daniela; Ricciardi, Roberto; Montera, Roberto; Plotti, Francesco

    2016-06-01

    The human papillomavirus (HPV) represents one of the most common sexually transmitted infections and it has been related to cervical cancer. The HPV vaccines prevent infection with certain species of HPV associated with the development of cervical cancer or genital warts. We carried out a PubMed search up to 2015 evaluating all randomized studies published in literature. This review discusses the current status of HPVs vaccines on the global market, efficacy, safety profiles, controversies and future vaccine developments. Three HPVs vaccines are currently on the global market: bivalent, quadrivalent and ninevalent. Bivalent and quadrivalent vaccines can protect against almost 70% of cervical HPV-related cancerous and precancerous conditions and the ninevalent vaccine, instead, provides a protection against almost 90%. The use of vaccinations raised several controversies in the last years and, currently, is not possible to establish which type of vaccine is most effective, however all of them are safe. PMID:27066937

  14. Need for a safe vaccine against respiratory syncytial virus infection

    Directory of Open Access Journals (Sweden)

    Joo-Young Kim

    2012-09-01

    Full Text Available Human respiratory syncytial virus (HRSV is a major cause of severe respiratory tract illnesses in infants and young children worldwide. Despite its importance as a respiratory pathogen, there is currently no licensed vaccine for HRSV. Following failure of the initial trial of formalin-inactivated virus particle vaccine, continuous efforts have been made for the development of safe and efficacious vaccines against HRSV. However, several obstacles persist that delay the development of HRSV vaccine, such as the immature immune system of newborn infants and the possible Th2-biased immune responses leading to subsequent vaccine-enhanced diseases. Many HRSV vaccine strategies are currently being developed and evaluated, including live-attenuated viruses, subunit-based, and vector-based candidates. In this review, the current HRSV vaccines are overviewed and the safety issues regarding asthma and vaccine-induced pathology are discussed.

  15. Vaccine Vexes

    Institute of Scientific and Technical Information of China (English)

    Maya; Reid

    2011-01-01

    IT’S always nice when expectations are exceeded by half a billion dollars.This was the case for the Global Alliance for Vaccines and Immunization(GAVI) at its fundraising conference in June.A public-private initiative,GAVI,which works to ensure children in developing countries receive crucial vaccinations,had gone into the meeting hoping to net $3.7 billion.They came away with $4.3 billion,"despite the fact that donors everywhere are coping with budget crises," as Bill Gates

  16. Pre-existing immunity against vaccine vectors – friend or foe?

    OpenAIRE

    Saxena, Manvendra; Van, Thi Thu Hao; Baird, Fiona J.; Coloe, Peter J; Smooker, Peter M.

    2013-01-01

    Over the last century, the successful attenuation of multiple bacterial and viral pathogens has led to an effective, robust and safe form of vaccination. Recently, these vaccines have been evaluated as delivery vectors for heterologous antigens, as a means of simultaneous vaccination against two pathogens. The general consensus from published studies is that these vaccine vectors have the potential to be both safe and efficacious. However, some of the commonly employed vectors, for example Sa...

  17. Vaccination of turkeys in the wattles (dewlap) with turkey meningo-encephalitis live vaccine and Pasteurella multocida killed-in-oil vaccine.

    Science.gov (United States)

    Samina, I; Khinich, Y; Peleg, B A

    1999-10-01

    Vaccination of turkeys via the wattle has been introduced as a novel route of vaccination using attenuated live viral turkey meningo-encephalitis (TME) and killed-in-oil bacterial (Pasteurella multocida) vaccines. The efficacy of the immunization was evaluated by the haemagglutination-inhibition test for TME and by challenge for TME and P. multocida. Immunization via the wattle route was comparable or better as compared with the conventional routes, intramuscular and subcutaneous, for P. multocida and TME, respectively. These results were obtained by wattle vaccination administered either by injection, punching with a needle as used for fowl pox vaccination or by topical application. The advantages of wattle vaccination are: no local untoward reactions (P. multocida), which might frequently occur in the muscles following improper subcutaneous mass vaccination, less time and labour consuming, and less stress for the turkeys. It is suggested to test the wattle route of vaccination with other viral and bacterial vaccines in turkeys and other avian species. PMID:26911605

  18. Human Vaccines & Immunotherapeutics: News

    OpenAIRE

    Riedmann, Eva M

    2013-01-01

    Vaccinating boys against HPV to reduce cancer rates across the sexes New melanoma vaccine contains natural product from marine sponges Impact of Hib conjugate vaccines in developing countries Electronic Health Records to keep track of immunization status Pregnant women urged to get whooping cough vaccination New nano-coating developed to preserve vaccines Alternative approach to creating a universal flu vaccine New modular vaccine design: MAPS technology

  19. Vaccination in Renal Transplant Patients (VcRtp study)

    LENUS (Irish Health Repository)

    Rathore, F

    2016-02-01

    Adverse outcomes of influenza & pneumococcal infections in solid organ transplant recipients have been well documented. Vaccinations are therefore recommended by multiple guidelines. Despite emerging evidence of the safety & effectiveness among immunosuppressed patients, most vaccines are still underutilized, we conducted a survey among the renal transplant patients in Beaumont Hospital to determine the awareness and uptake of vaccinations. Questionnaires were handed to patients during a clinic visit over a span of 2 weeks and 250 questionnaires were posted out to randomly selected transplant patients, The Questionnaire addressed various aspects including the awareness of importance of vaccinations, source of information, if they were up to date with the vaccines & where did they receive it?

  20. Review: New Vaccine Against Tuberculosis: Current Developments and Future Challenges

    Science.gov (United States)

    Liu, Jun

    2009-04-01

    Tuberculosis (TB) continues to be a global health threat. BCG was developed as an attenuated live vaccine for tuberculosis control nearly a century ago. Despite being the most widely used vaccine in human history, BCG is not an ideal vaccine and has two major limitations: its poor efficacy against adult pulmonary TB and its disconcerting safety in immunocompromised individuals. A safer and more effective TB vaccine is urgently needed. This review article discusses current strategies to develop the next generation of TB vaccines to replace BCG. While some progresses have been made in the past decade, significant challenges lie ahead.