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Encyclopedia > Vaccine trial
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Methodology

A basic 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. 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. Jump to: navigation, search A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or ameliorate the effects of infection by any natural or wild strain of the organism. ... From Latin ex- + -periri (akin to periculum attempt). ... A placebo, from the Latin for I will please, is a medical treatment (operation, therapy, chemical solution, pill, etc. ... Jump to: navigation, search Schematic of antibody binding to an antigen An antibody is a protein used by the immune system to identify and neutralize foreign objects like bacteria and viruses. ... In a medical sense, immunity is a state of having sufficient biological defenses to avoid infection, disease, or other unwanted biological invasion. ... One may be faced with the problem of making a definite decision with respect to an uncertain hypothesis which is known only through its observable consequences. ... In statistics, a result is significant if it is unlikely to have occurred by chance, given that a presumed null hypothesis is true, but is not improbable if the null hypothesis is false. ... A side-effect is any effect other than an intended primary effect. ...


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 and likelihood of side affects in the target population is extremely difficult because of the diversity of patients and the vast number of possible interactions with other medicines and environmental factors. In Egyptian mythology, Month is an alternate spelling for Menthu. ... Jump to: navigation, search A year is the time between two recurrences of an event related to the orbit of the Earth around the Sun. ... Jump to: navigation, search A virus is a microscopic nonliving parasite that infects cells in biological organisms. ... Phyla/Divisions Actinobacteria Aquificae Bacteroidetes/Chlorobi Chlamydiae/Verrucomicrobia Chloroflexi Chrysiogenetes Cyanobacteria Deferribacteres Deinococcus-Thermus Dictyoglomi Fibrobacteres/Acidobacteria Firmicutes Fusobacteria Gemmatimonadetes Nitrospirae Omnibacteria Planctomycetes Proteobacteria Spirochaetes Thermodesulfobacteria Thermomicrobia Thermotogae Bacteria (singular, bacterium) are a major group of living organisms. ...


  Results from FactBites:
 
HIV Vaccine Trials Unit (2505 words)
A vaccine trial is a standard way to test a specific study vaccine so that researchers can prove that the study vaccine is safe, and can find out more about whether it might work to prevent or fight disease.
Volunteers for vaccine trials should be HIV negative and planning to stay in the Seattle area for the duration of the study (at least 12-24 months).
Trial participants play a very important role in the search for an HIV vaccine, and the safety and rights of participants are given the highest priority.
  More results at FactBites »


 

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