The effect of BCG vaccination on infection and antibody levels against SARS-CoV-2-The results of ProBCG: a multicenter randomized clinical trial in Brazil.

Autor:	Santos AP; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; Pedro Ernesto University Hospital, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Werneck GL; Collective Health Studies Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Dalvi APR; Collective Health Studies Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Dos Santos CC; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Tierno PFGMM; Barueri County Hospital, São Paulo Association for Medicine Development, São Paulo, Brazil., Condelo HS; Histocompatibility Laboratory, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Macedo B; Pedro Ernesto University Hospital, State University of Rio de Janeiro, Rio de Janeiro, Brazil., de Medeiros Leung JA; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; Pedro Ernesto University Hospital, State University of Rio de Janeiro, Rio de Janeiro, Brazil., de Souza Nogueira J; Histocompatibility Laboratory, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Malvão L; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Galliez R; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Aguiar R; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Stefan R; Medical Sciences School, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Knackfuss SM; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., da Silva EC; Molecular Micobacteriology Laboratory, Medical School and Hospital Complex HUCFF-IDT - Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Castineiras TMPP; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., de Andrade Medronho R; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., E Silva JRL; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Alves RLR; Pedro Ernesto University Hospital, State University of Rio de Janeiro, Rio de Janeiro, Brazil., de Moraes Sobrino Porto LC; Histocompatibility Laboratory, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Rodrigues LS; Medical Sciences School, State University of Rio de Janeiro, Rio de Janeiro, Brazil., Kritski AL; Molecular Micobacteriology Laboratory, Medical School and Hospital Complex HUCFF-IDT - Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., de Queiroz Mello FC; Thorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. Electronic address: fcqmello@idt.ufrj.br.
Jazyk:	angličtina
Zdroj:	International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2023 May; Vol. 130, pp. 8-16. Date of Electronic Publication: 2023 Feb 24.
DOI:	10.1016/j.ijid.2023.02.014
Abstrakt:	Objectives: Evatuate if Bacillus Calmette-Guérin (BCG) vaccine could be used as a tool against SARS-CoV-2 based on the concept of trained immunity. Methods: A multicenter, double-blinded, randomized clinical trial recruited health care workers (HCWs) in Brazil. The incidence rates of COVID-19, clinical manifestations, absenteeism, and adverse events among HCWs receiving BCG vaccine (Moreau or Moscow strains) or placebo were compared. BCG vaccine-mediated immune response before and after implementing specific vaccines for COVID-19 (CoronaVac or COVISHIELD) was analyzed. Cox proportional hazard and linear mixed effect modeling were used. Results: A total of 264 volunteers were included for analysis (BCG = 134 and placebo = 130). The placebo group presented a COVID-19 cumulative incidence of 0.75% vs 0.52% of BCG. The Moreau strain also presented a higher incidence rate (1.60% × 0.22%). BCG did not show a protective hazard ratio against COVID-19. In addition, the log (immunoglobulin G) level against SARS-CoV-2 presented a higher increase in the BCG group, whether or not participants had COVID-19, but also without statistical significance. Conclusion: Our results suggest that BCG has a tendency of protection against SARS-CoV-2 and higher immunoglobulin G levels than placebo. The clinical trial was registered at https://clinicaltrials.gov/ (NCT04659941). Competing Interests: Declaration Of Competing Interest The authors have no competing interests to declare. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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