TY - JOUR
T1 - Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial
AU - Doesschate, Thijs Ten
AU - van der Vaart, Thomas W
AU - Debisarun, Priya A
AU - Taks, Esther
AU - Moorlag, Simone J C F M
AU - Paternotte, Nienke
AU - Boersma, Wim G
AU - Kuiper, Vincent P
AU - Roukens, Anna H E
AU - Rijnders, Bart J A
AU - Voss, Andreas
AU - Veerman, Karin M
AU - Kerckhoffs, Angele P M
AU - Oever, Jaap Ten
AU - van Crevel, Reinout
AU - van Nieuwkoop, Cees
AU - Lalmohamed, Arief
AU - van de Wijgert, Janneke H H M
AU - Netea, Mihai G
AU - Bonten, Marc J M
AU - van Werkhoven, Cornelis W
N1 - Funding Information:
We would like to thank the health care workers for their participation. We gratefully acknowledge the help of all colleagues in the participating hospitals who helped carry out this randomized trial under difficult circumstances. A special thanks goes out to project manager Katina Kardamanidis, the data managers Frank Leus and Roxanne Schaakx, the members of the Data Safety Management Board, infectious diseases specialist dr. Jan-Jelrik Oosterheert, medical microbiologist dr. Miquel Ekkelenkamp and medical statistician Dr. Maarten van Smeden and to the independent expert of the trial, infectious disease specialist Prof. Dr. Andy Hoepelman.
Funding Information:
BCG-CORONA was a parallel, double-blind, placebo-controlled randomized trial conducted in nine hospitals in the Netherlands. The study protocol was approved by the institutional review board of the University Medical Centre (UMC) Utrecht, registered at clinicaltrials.gov (Identifier: NCT04328441), and published [ 5 ]. All participants provided written informed consent. The trial was investigator-initiated and funded by the UMC Utrecht and Radboud UMC Nijmegen, the Netherlands.
Publisher Copyright:
© 2022 The Author(s)
PY - 2022/9
Y1 - 2022/9
N2 - Objectives: The COVID-19 pandemic increases healthcare worker (HCW) absenteeism. The bacillus Calmette-Guérin (BCG) vaccine may provide non-specific protection against respiratory infections through enhancement of trained immunity. We investigated the impact of BCG vaccination on HCW absenteeism during the COVID-19 pandemic. Methods: HCWs exposed to COVID-19 patients in nine Dutch hospitals were randomized to BCG vaccine or placebo in a 1:1 ratio, and followed for one year using a mobile phone application. The primary endpoint was the self-reported number of days of unplanned absenteeism for any reason. Secondary endpoints included documented COVID-19, acute respiratory symptoms or fever. This was an investigator-funded study, registered at ClinicalTrials.gov (NCT03987919). Results: In March/April 2020, 1511 HCWs were enrolled. The median duration of follow-up was 357 person-days (interquartile range [IQR], 351 to 361). Unplanned absenteeism for any reason was observed in 2.8% of planned working days in the BCG group and 2.7% in the placebo group (adjusted relative risk 0.94; 95% credible interval, 0.78–1.15). Cumulative incidences of documented COVID-19 were 14.2% in the BCG and 15.2% in the placebo group (adjusted hazard ratio (aHR) 0.94; 95% confidence interval (CI), 0.72–1.24). First episodes of self-reported acute respiratory symptoms or fever occurred in 490 (66.2%) and 443 (60.2%) participants, respectively (aHR: 1.13; 95% CI, 0.99–1.28). Thirty-one serious adverse events were reported (13 after BCG, 18 after placebo), none considered related to study medication. Conclusions: During the COVID-19 pandemic, BCG-vaccination of HCW exposed to COVID-19 patients did not reduce unplanned absenteeism nor documented COVID-19.
AB - Objectives: The COVID-19 pandemic increases healthcare worker (HCW) absenteeism. The bacillus Calmette-Guérin (BCG) vaccine may provide non-specific protection against respiratory infections through enhancement of trained immunity. We investigated the impact of BCG vaccination on HCW absenteeism during the COVID-19 pandemic. Methods: HCWs exposed to COVID-19 patients in nine Dutch hospitals were randomized to BCG vaccine or placebo in a 1:1 ratio, and followed for one year using a mobile phone application. The primary endpoint was the self-reported number of days of unplanned absenteeism for any reason. Secondary endpoints included documented COVID-19, acute respiratory symptoms or fever. This was an investigator-funded study, registered at ClinicalTrials.gov (NCT03987919). Results: In March/April 2020, 1511 HCWs were enrolled. The median duration of follow-up was 357 person-days (interquartile range [IQR], 351 to 361). Unplanned absenteeism for any reason was observed in 2.8% of planned working days in the BCG group and 2.7% in the placebo group (adjusted relative risk 0.94; 95% credible interval, 0.78–1.15). Cumulative incidences of documented COVID-19 were 14.2% in the BCG and 15.2% in the placebo group (adjusted hazard ratio (aHR) 0.94; 95% confidence interval (CI), 0.72–1.24). First episodes of self-reported acute respiratory symptoms or fever occurred in 490 (66.2%) and 443 (60.2%) participants, respectively (aHR: 1.13; 95% CI, 0.99–1.28). Thirty-one serious adverse events were reported (13 after BCG, 18 after placebo), none considered related to study medication. Conclusions: During the COVID-19 pandemic, BCG-vaccination of HCW exposed to COVID-19 patients did not reduce unplanned absenteeism nor documented COVID-19.
KW - BCG
KW - COVID-19
KW - Health care workers
KW - Randomized controlled trial
KW - Trained immunity
UR - https://www.scopus.com/pages/publications/85130805747
U2 - 10.1016/j.cmi.2022.04.009
DO - 10.1016/j.cmi.2022.04.009
M3 - Article
C2 - 35489606
SN - 1198-743X
VL - 28
SP - 1278
EP - 1285
JO - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
IS - 9
ER -