Rapaka Rekha R, Hammershaimb Elizabeth A, Neuzil Kathleen M
University of Maryland Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Clin Infect Dis. 2022 Jan 29;74(2):352-358. doi: 10.1093/cid/ciab213.
Coronavirus disease 2019 (COVID-19) vaccine trials provide valuable insight into the safety and efficacy of vaccines, with individually randomized, placebo-controlled trials being the gold standard in trial design. However, a myriad of variables must be considered as clinical trial data are interpreted and used to guide policy decisions. These variables include factors such as the characteristics of the study population and circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains, the force of infection, the definition and ascertainment of endpoints, the timing of vaccine efficacy assessment, and the potential for performance bias. In this Viewpoints article, we discuss critical variables to consider when comparing efficacy measurements across current and future COVID-19 vaccine trials.
2019冠状病毒病(COVID-19)疫苗试验为疫苗的安全性和有效性提供了宝贵见解,个体随机、安慰剂对照试验是试验设计的金标准。然而,在解释临床试验数据并将其用于指导政策决策时,必须考虑无数变量。这些变量包括研究人群的特征、正在传播的严重急性呼吸综合征冠状病毒2(SARS-CoV-2)毒株、感染强度、终点的定义和确定、疫苗效力评估的时间以及表现偏倚的可能性等因素。在这篇观点文章中,我们讨论在比较当前和未来COVID-19疫苗试验的效力测量结果时需要考虑的关键变量。