Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial. (September 2022)

• Record Type: Journal Article
• Authors: ten Doesschate, Thijs; 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 H.
• Is Part Of: Clinical microbiology and infection. Volume 28:Number 9(2022)
• Page Start: 1278
• Page End: 1285
• Publication Date: 2022-09
• Subjects: BCG -- COVID-19 -- Health care workers -- Randomized controlled trial -- Trained immunity; Medical microbiology -- Periodicals; Diagnostic microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.01
• DOI: 10.1016/j.cmi.2022.04.009
• Languages: English
• ISSNs: 1198-743X

Abstract

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 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.