Statistical evaluation of HIV vaccines in early clinical trials.
Statistical evaluation of HIV vaccines in early clinical trials.
复制标题
早期临床试验中艾滋病毒疫苗的统计评估。
DOI：
10.1016/j.cct.2005.11.008
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发表时间：
2006
期刊：
影响因子：
--
通讯作者：
Russell,NinaD
中科院分区：
文献类型：
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作者：
Moodie,Zoe;Rossini,AJ;Hudgens,MichaelG;Gilbert,PeterB;Self,StevenG;Russell,NinaD
艾滋病毒大流行是对全球公共卫生的紧迫威胁；艾滋病毒疫苗的开发至关重要。对候选艾滋病毒疫苗的临床评估不同于标准的治疗学试验框架，主要是因为研究的是健康的个人。我们提出了一个为HIV疫苗试验网络(HVTN)开发的早期评估计划，该计划受到疫苗设置的独特特征的激励。该计划包括3个典型阶段(第一阶段、第二阶段、第二阶段)，为不同疫苗方案的安全性和免疫原性评估提供了一种统一而灵活的方法。这些早期试验的目标是将候选疫苗的数量缩小到最有希望的候选疫苗，这些候选疫苗值得在疗效试验中进一步研究。
The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed for the HIV Vaccine Trials Network (HVTN) motivated by characteristics unique to the vaccine setting. The program consists of 3 prototypical stages (Phase I, Ib, II) that provide a unified yet flexible approach to the safety and immunogenicity evaluation of diverse vaccine regimens. The goal of these early trials is to narrow the number of candidate vaccines to the most promising candidates worthy of further study in efficacy trials.