Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
J Infect Dis. 2023 Nov 11;228(10):1467-1478. doi: 10.1093/infdis/jiad316.
BCG vaccination has beneficial off-target ("nonspecific") effects on nonmycobacterial infections. On this premise, trials set out to investigate whether BCG provides off-target protection against coronavirus disease 2019 (COVID-19). A literature search identified 11 randomized "BCG COVID-19" trials, with conflicting results. These trials and the differences in their study design are discussed using the PICOT (participants, intervention, control, outcome, and timing) framework to highlight the factors that likely explain their inconsistent findings. These include participant age, sex and comorbid conditions, BCG vaccination strain and dose, outcome measure and duration of follow-up. Understanding how to control these factors to best exploit BCG's off-target effects will be important in designing future trials and intervention strategies.
BCG 疫苗接种对非分枝杆菌感染具有有益的非靶向（“非特异性”）作用。基于这一前提，人们开展了临床试验，旨在研究 BCG 是否对 2019 年冠状病毒病（COVID-19）提供非靶向保护。文献检索确定了 11 项随机“BCG COVID-19”试验，但结果存在差异。本文使用 PICOT（参与者、干预、对照、结局和时间）框架讨论了这些试验及其设计差异，以突出可能解释其不一致发现的因素。这些因素包括参与者的年龄、性别和合并症、BCG 疫苗接种菌株和剂量、结局指标以及随访时间。了解如何控制这些因素以最大程度地利用 BCG 的非靶向作用，对于设计未来的试验和干预策略非常重要。
