Kühtreiber Willem M, Hostetter Emma R, Wolfe Grace E, Vaishnaw Maya S, Goldstein Rachel, Bulczynski Emily R, Hullavarad Neeshi S, Braley Joan E, Zheng Hui, Faustman Denise L
Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Massachusetts General Hospital, Boston, MA 02192, USA.
iScience. 2024 May 22;27(6):109881. doi: 10.1016/j.isci.2024.109881. eCollection 2024 Jun 21.
The Bacillus Calmette-Guérin vaccine has many off-target benefits, including protection from diverse infectious diseases. As SARS-CoV-2 evolved, COVID-19 disease became more transmissible and less lethal. In this Phase III double-blinded, placebo-controlled trial conducted late in the pandemic, we tested at-risk US adults with type 1 diabetes if multi-dose BCG protected against COVID-19 and other infectious disease, co-primary outcomes. From April 2021 to November 2022, Tokyo-strain BCG vaccines provided significant protection against COVID-19 disease ( = 0.023) and strong platform protection against all infectious diseases ( < 0.0001). Over the course of the study, commercial COVID-19 vaccines were rolled out, most of which were mRNA-based. In contrast to the protection afforded by BCG, as reported by others, COVID-19 mRNA vaccine alone provided no protection from COVID-19 disease ( = 0.43). BCG vaccination efficacy was unaffected by concurrent COVID-19 vaccinations; COVID-19 vaccines neither helped nor hindered BCG protection.
卡介苗有许多非靶向益处，包括预防多种传染病。随着严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的演变，冠状病毒病2019（COVID-19）的传播性增强而致死率降低。在大流行后期开展的这项III期双盲、安慰剂对照试验中，我们对患有1型糖尿病的美国高危成年人进行了测试，以确定多剂卡介苗是否能预防COVID-19及其他传染病，这是共同主要结局指标。从2021年4月至2022年11月，东京株卡介苗对COVID-19疾病提供了显著保护（P = 0.023），并对所有传染病提供了强大的平台保护（P < 0.0001）。在研究过程中，商用COVID-19疫苗开始推广，其中大多数是基于信使核糖核酸（mRNA）的。与其他人报告的卡介苗提供的保护相反，单独的COVID-19 mRNA疫苗对COVID-19疾病没有提供保护（P = 0.43）。卡介苗接种效果不受同时进行的COVID-19疫苗接种的影响；COVID-19疫苗既没有增强也没有阻碍卡介苗的保护作用。
