Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial
Doesschate, Thijs Ten; van der Vaart, Thomas W; Debisarun, Priya A; Taks, Esther; Moorlag, Simone J C F M; Paternotte, Nienke; Boersma, Wim G; Kuiper, Vincent P; Roukens, Anna H E; Rijnders, Bart J A; Voss, Andreas; Veerman, Karin M; Kerckhoffs, Angele P M; Oever, Jaap Ten; van Crevel, Reinout; van Nieuwkoop, Cees; Lalmohamed, Arief; van de Wijgert, Janneke H H M; Netea, Mihai G; Bonten, Marc J M; van Werkhoven, Cornelis W
(2022) Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, volume 28, issue 9, pp. 1278 - 1285
(Article)
Abstract
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
... read more
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.
show less
Download/Full Text
Keywords: BCG, COVID-19, Health care workers, Randomized controlled trial, Trained immunity, Microbiology (medical), Infectious Diseases, Journal Article
ISSN: 1198-743X
Publisher: Elsevier Limited
Note: 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)
(Peer reviewed)
