A framework for assessing immunological correlates of protection in vaccine trials
A framework for assessing immunological correlates of protection in vaccine trials
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DOI：
10.1086/522428
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发表时间：
2007-11-01
影响因子：
6.4
通讯作者：
Self, Steven G.
中科院分区：
文献类型：
--
作者：
Qin, Li;Gilbert, Peter B.;Self, Steven G.
疫苗研究的一个中心目标是确定疫苗诱导的免疫反应，预测对感染或疾病的保护。“保护的相关物”一词被用来指至少3个不同的概念，这导致了围绕这一主题的混乱。我们提出了这些不同概念的免疫相关物的精确定义，使用命名法“风险相关物”，“1级保护替代物”和“2级保护替代物”。“我们提出了一个总体框架，用于评估疫苗有效性试验中这3种免疫相关性水平。为了证明所提出的原则，我们分析了来自1943年流感疫苗田间试验的数据，支持韦斯毒株A特异性抗体滴度作为1级保护替代物。文中还讨论了其它真实的和模拟的例子。
A central goal of vaccine research is to identify a vaccine-induced immune response that predicts protection from infection or disease. The term "correlate of protection" has been used to refer to at least 3 distinct concepts, which has resulted in confusion surrounding this topic. We propose precise definitions of these different concepts of immune correlates, using the nomenclature "correlate of risk," " level 1 surrogate of protection," and "level 2 surrogate of protection." We suggest a general framework for assessing these 3 levels of immune correlates in vaccine efficacy trials. To demonstrate the proposed principles, we analyze data from a 1943 influenza vaccine field trial, supporting Weiss strain A - specific antibody titers as a level 1 surrogate of protection. Other real and simulated examples are also discussed.