TY - JOUR
T1 - Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic
T2 - a randomized controlled trial
AU - Madsen, Anne Marie Rosendahl
AU - Schaltz-Buchholzer, Frederik
AU - Nielsen, Sebastian
AU - Benfield, Thomas
AU - Bjerregaard-Andersen, Morten
AU - Dalgaard, Lars Skov
AU - Dam, Christine
AU - Ditlev, Sisse Bolm
AU - Faizi, Gulia
AU - Azizi, Mihnaz
AU - Hameed, Zainab Nadhim
AU - Johansen, Isik Somuncu
AU - Kofoed, Poul-Erik
AU - Krause, Tyra Grove
AU - Kristensen, Gitte Schultz
AU - Loekkegaard, Ellen Christine Leth
AU - Mogensen, Christian Backer
AU - Mohamed, Libin
AU - Oedegaard, Emilie Sundhaugen
AU - Ostenfeld, Anne
AU - Soerensen, Marcus Kjaer
AU - Wejse, Christian
AU - Netea, Mihai G
AU - Aaby, Peter
AU - Benn, Christine Stabell
N1 - © 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: [email protected].
PY - 2024
Y1 - 2024
N2 - BACKGROUND: 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.METHODS: 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.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 (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).CONCLUSIONS: In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes.CLINICAL TRIALS REGISTRATION: NCT0437329 and EU Clinical Trials Register (EudraCT number 2020-001888-90).
AB - BACKGROUND: 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.METHODS: 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.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 (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).CONCLUSIONS: In this relatively healthy cohort of HCWs, there was no overall effect of BCG on any of the study outcomes.CLINICAL TRIALS REGISTRATION: NCT0437329 and EU Clinical Trials Register (EudraCT number 2020-001888-90).
KW - BCG Vaccine
KW - COVID-19/epidemiology
KW - Communicable Diseases
KW - Health Personnel
KW - Humans
KW - Pandemics/prevention & control
KW - SARS-CoV-2
KW - health care worker
KW - epidemic
KW - BCG vaccination
KW - randomized controlled trial
KW - COVID-19
KW - nonspecific effects of vaccines
UR - http://www.scopus.com/inward/record.url?scp=85183823612&partnerID=8YFLogxK
U2 - 10.1093/infdis/jiad422
DO - 10.1093/infdis/jiad422
M3 - Journal article
C2 - 37774494
SN - 0022-1899
VL - 229
SP - 384
EP - 393
JO - The Journal of infectious diseases
JF - The Journal of infectious diseases
IS - 2
ER -