Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: a randomized controlled trial.
BCG vaccination
COVID-19
SARS-CoV-2
epidemic
health care worker
non-specific effects of vaccines
randomised controlled trial
Journal
The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675
Informations de publication
Date de publication:
29 Sep 2023
29 Sep 2023
Historique:
received:
19
04
2023
revised:
27
08
2023
accepted:
26
09
2023
medline:
30
9
2023
pubmed:
30
9
2023
entrez:
29
9
2023
Statut:
aheadofprint
Résumé
The BCG (Bacillus Calmette-Guérin) vaccine can induce non-specific protection against unrelated infections. We aimed to test the effect of BCG on absenteeism and health of Danish health care workers (HCWs) during the COVID-19 pandemic. A single-blinded randomized controlled trial including 1,221 HCWs from nine 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 (RR 1.23, 95% credibility interval: 0.98 to 1.53). BCG had no effect on incidence of COVID-19 or all-cause hospitalization overall. In secondary analyses BCG re-vaccination was associated with higher COVID-19 incidence (HR 2.47, 95% confidence interval (CI): 1.07 to 5.71), but also reduced risk of hospitalization (HR 0.28, CI: 0.09 to 0.86). The incidence of infectious disease episodes was similar between randomization groups (HR 1.09, CI: 0.96 to 1.24). In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes.
Sections du résumé
BACKGROUND
BACKGROUND
The BCG (Bacillus Calmette-Guérin) vaccine can induce non-specific protection against unrelated infections. We aimed to test the effect of BCG on absenteeism and health of Danish health care workers (HCWs) during the COVID-19 pandemic.
METHODS
METHODS
A single-blinded randomized controlled trial including 1,221 HCWs from nine 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.
RESULTS
RESULTS
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 (RR 1.23, 95% credibility interval: 0.98 to 1.53). BCG had no effect on incidence of COVID-19 or all-cause hospitalization overall. In secondary analyses BCG re-vaccination was associated with higher COVID-19 incidence (HR 2.47, 95% confidence interval (CI): 1.07 to 5.71), but also reduced risk of hospitalization (HR 0.28, CI: 0.09 to 0.86). The incidence of infectious disease episodes was similar between randomization groups (HR 1.09, CI: 0.96 to 1.24).
CONCLUSIONS
CONCLUSIONS
In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes.
Identifiants
pubmed: 37774494
pii: 7286586
doi: 10.1093/infdis/jiad422
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.