Using BCG Vaccine to Enhance Nonspecific Protection of Health Care Workers During the COVID-19 Pandemic: A Randomized Controlled Trial.

Autor:	Madsen AMR; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Schaltz-Buchholzer F; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Nielsen S; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Benfield T; Department of Infectious Diseases, Center of Research and Disruption of Infectious Diseases, Amager and Hvidovre Hospital, Copenhagen University Hospital, Hvidovre, Denmark., Bjerregaard-Andersen M; Department of Endocrinology, University Hospital Southwest Jutland, Esbjerg, Denmark., Dalgaard LS; Department of Medicine, Goedstrup Hospital, Herning, Denmark., Dam C; Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen, Denmark., Ditlev SB; Copenhagen Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen, Denmark., Faizi G; Department of Endocrinology, University Hospital Southwest Jutland, Esbjerg, Denmark., Azizi M; Department of Endocrinology, University Hospital Southwest Jutland, Esbjerg, Denmark., Hameed ZN; Department of Orthopaedic Surgery, Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospital, Copenhagen, Denmark., Johansen IS; Department of Infectious Diseases, Odense University Hospital, Odense, Denmark., Kofoed PE; Department of Pediatrics and Adolescent Medicine, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark., Krause TG; Statens Serum Institut, Copenhagen, Denmark., Kristensen GS; Department of Emergency Medicine, Hospital Soenderjylland, University Hospital of Southern Denmark, Aabenraa, Denmark., Loekkegaard ECL; Department of Gynecology and Obstetrics, Nordsjaelland Hospital, Copenhagen University Hospital, Hilleroed, Denmark., Mogensen CB; Department of Emergency Medicine, Hospital Soenderjylland, University Hospital of Southern Denmark, Aabenraa, Denmark., Mohamed L; Department of Pediatrics and Adolescent Medicine, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Denmark., Oedegaard ES; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Ostenfeld A; Department of Gynecology and Obstetrics, Nordsjaelland Hospital, Copenhagen University Hospital, Hilleroed, Denmark., Soerensen MK; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Wejse C; Department of Infectious Diseases, Aarhus University Hospital, Skejby, Denmark., Netea MG; Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands.; Department for Genomics and Immunoregulation, Life and Medical Sciences Institute, University of Bonn, Bonn, Germany., Aaby P; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Benn CS; Bandim Health Project, Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Danish Institute for Advanced Study, University of Southern Denmark, Odense, Denmark.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2024 Feb 14; Vol. 229 (2), pp. 384-393.
DOI:	10.1093/infdis/jiad422
Abstrakt:	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). Competing Interests: Potential conflicts of interests . T. B. reports grants or contracts from Novo Nordisk, Simonsen, Lundbeck, Kai, Erik and Susanna Olesen's Charitable Found, GSK, Pfizer, Boehringer Ingelheim, Gilead Sciences, MSD, Pentabase, Roche, Novartis, Kancera AB, Janssen, and Astra Zeneca; consulting fees from GSK and Pfizer; honoraria for lectures from GSK, Pfizer, Gilead Sciences, Boehringer Ingelheim, Abbvie, and Astra Zeneca; and donation of trial medication from Eli Lilly. P. E. K. reports participation on Data Safety Monitoring Board or Advisory Board on trials “Specific and non-specific effects of measles and BCG vaccines for mother and child (MATVAC)”, “Evaluating the effectiveness of different BCG strains in Guinea-Bissau: A randomized trial of the impact on neonatal hospital admissions”, and “BCG vaccine to reduce unplanned absenteeism due to COVID-19 illness of health care workers in Guinea-Bissau and Mozambique. A multi-center single-blinded randomized controlled trial (BCG-COVID-RCT)”, and “A randomized trial of providing BCG vaccination immediately to neonates admitted to the intensive care unit in Guinea-Bissau: Effect on mortality”. C. W. reports honoraria for a lecture from Novartis; and participation on the Advisory Board on COVID-19 Treatments, Danish government. I. S. J. reports honoraria from Pfizer for being chairman for the European Congress of Clinical Microbiology and Infectious Diseases 2023 COVID-19 symposium. M. G. N. reports to be scientific founder and have stock in TTxD and Lemba. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. (© 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: journals.permissions@oup.com.)
Databáze:	MEDLINE
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