Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Department of Infectious Diseases, Center of Research and Disruption of Infectious Diseases, Amager and Hvidovre Hospital, Copenhagen University Hospital, Hvidovre, Denmark.
J Infect Dis. 2024 Feb 14;229(2):384-393. doi: 10.1093/infdis/jiad422.
The BCG (Bacillus Calmette-Guérin) vaccine can induce nonspecific protection against unrelated infections. We aimed to test the effect of BCG on absenteeism and health of Danish health care workers (HCWs) during the coronavirus disease 2019 (COVID-19) pandemic.
A single-blinded randomized controlled trial included 1221 HCWs from 9 Danish hospitals. Participants were randomized 1:1 to standard dose BCG or placebo. Primary outcome was days of unplanned absenteeism. Main secondary outcomes were incidence of COVID-19, all-cause hospitalization, and infectious disease episodes.
There was no significant effect of BCG on unplanned absenteeism. Mean number of days absent per 1000 workdays was 20 in the BCG group and 17 in the placebo group (risk ratio, 1.23; 95% credibility interval, 0.98-1.53). BCG had no effect on incidence of COVID-19 or all-cause hospitalization overall. In secondary analyses BCG revaccination was associated with higher COVID-19 incidence (hazard ratio [HR], 2.47; 95% confidence interval [CI], 1.07-5.71), but also reduced risk of hospitalization (HR, 0.28; 95% CI, .09-.86). The incidence of infectious disease episodes was similar between randomization groups (HR, 1.09; 95% CI, .96-1.24).
In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes.
NCT0437329 and EU Clinical Trials Register (EudraCT number 2020-001888-90).
卡介苗（BCG）疫苗可诱导针对无关感染的非特异性保护。我们旨在检验 BCG 对丹麦医护人员（HCWs）在 2019 年冠状病毒病（COVID-19）大流行期间缺勤和健康的影响。
一项单盲随机对照试验纳入了来自丹麦 9 家医院的 1221 名 HCWs。参与者以 1:1 的比例随机分为标准剂量 BCG 或安慰剂组。主要结局为计划外缺勤天数。主要次要结局为 COVID-19 发病率、全因住院率和传染病发作。
BCG 对计划外缺勤无显著影响。BCG 组每 1000 个工作日缺勤天数为 20 天，安慰剂组为 17 天（风险比，1.23；95%置信区间，0.98-1.53）。BCG 对 COVID-19 或全因住院率无影响。在二次分析中，BCG 再接种与 COVID-19 发病率升高相关（风险比 [HR]，2.47；95%置信区间 [CI]，1.07-5.71），但也降低了住院风险（HR，0.28；95% CI，0.09-0.86）。随机分组之间传染病发作的发生率相似（HR，1.09；95% CI，0.96-1.24）。
在这组相对健康的 HCWs 中，BCG 对任何研究结局均无总体影响。
NCT0437329 和欧盟临床试验注册（EudraCT 编号 2020-001888-90）。
