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Vaccine trial
A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.〔
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==Methodology==
A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and selecting the proper antigen to invoke an immune response. The preclinical stages are also necessary to determine approximate dose ranges and proper drug formulations (i.e., tablet, injection etc…) This is also the stage in which the drug candidate may be first tested in laboratory animals prior to moving to the phase one trials. Vaccines such as the oral polio vaccine have been first tested for adverse effects and immunogenicity in monkeys as well as non-human primates〔World Health Organization. (2012). Standard Operating Procedure: Neurovirulence test of types 1, 2, or 3 live attenuated poliomyelitis vaccines (oral) in transgenic mice susceptible to poliovirus. Retrieved November 10, 2015, from http://www.who.int/biologicals/vaccines/TgmNVT_SOPv6_Final_09112012.pdf〕. Recent scientific advances have helped to use transgenic animals as a part of vaccine preclinical protocol in hopes to more accurately determine drug reactions in humans〔. Understanding vaccine safety and the immunological response to the drug, such as toxicity, are necessary components of the preclinical stage. Other drug trials focus on the pharmacodynamics and pharmacokinetics; however, in vaccine studies it is essential to understand toxic effects at all possible dosage levels and the interactions with the immune system.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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