Assessment of Immune Correlates of Protection via Controlled Vaccine Efficacy and Controlled Risk
通过受控疫苗效力与受控风险评估免疫保护相关指标
Immune correlates of protection (CoPs) are immunologic biomarkers accepted as a surrogate for an infectious disease clinical endpoint and thus can be used for traditional or provisional vaccine approval. To study CoPs in randomized, placebo-controlled trials, correlates of risk (CoRs) are first assessed in vaccine recipients. This analysis does not assess causation, as a CoR may fail to be a CoP. We propose a causal CoP analysis that estimates the controlled vaccine efficacy…