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20-September-2008 09:55:52 - trial A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. Methodology A basic vaccine trial might involve forming two groups from a random sample of the target population. One group receives the vaccine while the control group receives a placebo, an adjuvant-containing cocktail, or a different vaccine which might be intended to protect against a different pathogen. Data on antibody production and immunity to the disease in question is collected from both groups some time after the administration of the vaccine or placebo, and a statistical test is performed on these two sets of data to determine whether or not there is any statistically significant difference between them. If the vaccine produces no statistically significant results, then it is rejected. Side effects of the vaccine are also noted, and these too contribute to the decision on whether to license it. Methodological issues and problems Vaccine trials may take months or years to complete, since a sufficient time period must elapse for the subjects to react to the vaccine and develop the required antibodies. Antibody production is regarded as sufficient to prove the vaccine's effectiveness, and it is rare for subjects to be exposed directly to the biological agent usually a virus or bacteria the vaccine is supposed to provide immunity against. Assessing the severity of vaccine injuries and the likelihood of such side effects in the target population is extremely difficult, both because of the diversity of patients and due to the vast number of possible interactions with other medicines and environmental factors.citation needed In many trials, adverse effects of vaccines are actively monitored only for a short time, e.g. two weeks.citation needed In many trials, the vaccine efficacy and safety research is not done by comparing to a group not receiving the vaccine, but to a group receiving a different vaccine for a different disease or a cocktail of vaccine additives e.g., aluminum adjuvants - thus the research is not designed to show, and can not demonstrate, either real vaccine efficacy or safety.citation needed Often the vaccine trial group gets the same injection placebo, adjuvant cocktail, a different vaccine a certain time period after the control group and vice versa, making it impossible for anyone to study the long term effects of the vaccine which is studied.citation needed v d e Vaccines, Vaccination, Immunization, and Inoculation see also artificial induction of immunity Development Adjuvants Cancer vaccines DNA vaccination HIV Live vector vaccine Models Timeline Trial Administration Global: GAVI Policy Schedule Vaccine injury USA: ACIP VAERS VSD Vaccine court Vaccines live Anthrax BCG tuberculosis Flu MMR MMRV PolioOPV Rotavirus Smallpox Varicella Yellow fever Inactivated/toxoid inactivated virus: Flu HAV PolioIPV inactivated bacteria/toxoid: DTwP conjugate: Hib PCV Other subunit: Anthrax DTaP HPV recombinant DNA: HBV other: Anthrax PPV Controversy General A-CHAMP MMR NCVIA Pox party Safe Minds Thiomersal See also List of vaccine topics Epidemiology Eradication of infectious diseases Retrieved from http://en..org/wiki/Vaccine_trial Categories: Virology | Microbiology | ImmunologyHidden categories: All articles with statements | Articles with statements since January 2008 Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page Languages Deutsch This page was last modified on 1 April 2008, at 00:24
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