301. Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial
- Author
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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, 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, and van Werkhoven, Cornelis H
- 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.
- Published
- 2022