Schaper C, Fleming T R, Self S G, Rida W N
Department of Biostatistics, University of Washington, Seattle 98195, USA.
Annu Rev Public Health. 1995;16:1-22. doi: 10.1146/annurev.pu.16.050195.000245.
HIV vaccine trials present significant challenges related to trial endpoints, vaccine efficacy measurement, and the role of nonvaccine interventions. Infection is a valid endpoint for detecting sterilizing immunity. But if the vaccine prevents AIDS without preventing infection, infection may be a misleading surrogate. Appropriate endpoints must be defined for other mechanisms of vaccine action. Direct, indirect, behavioral, and biological effects all determine vaccine efficacy. False security among HIV-vaccine recipients may make negative behavioral effects an important component of vaccine performance. Both biological potency and a more comprehensive program effectiveness should be measured. These goals may require unblinded designs or community randomization. Nonvaccine interventions are currently the only HIV-prevention strategy. Support for larger scale implementation requires more rigorous evaluation that is less dependent on self-reported behavioral changes. The vaccine trial cohorts provide a unique opportunity to cost-effectively evaluate behavioral interventions.
HIV疫苗试验在试验终点、疫苗效力测量以及非疫苗干预措施的作用方面面临重大挑战。感染是检测灭菌免疫的有效终点。但如果疫苗能预防艾滋病却不能预防感染，那么感染可能是一个具有误导性的替代指标。必须为疫苗作用的其他机制定义适当的终点。直接、间接、行为和生物学效应都会决定疫苗效力。HIV疫苗接种者中的虚假安全感可能会使负面行为效应成为疫苗效果的一个重要组成部分。应同时衡量生物学效力和更全面的项目效果。这些目标可能需要非盲法设计或社区随机化。非疫苗干预措施目前是唯一的HIV预防策略。对更大规模实施的支持需要更严格的评估，且这种评估较少依赖自我报告的行为变化。疫苗试验队列提供了一个以具有成本效益的方式评估行为干预措施的独特机会。
