Efficacy and Safety of BCG Revaccination With M. bovis BCG Moscow to Prevent COVID-19 Infection in Health Care Workers: A Randomized Phase II Clinical Trial.

Autor:	Dos Anjos LRB; Laboratório de Bacteriologia Molecular, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil., da Costa AC; Departamento de Biomedicina, Faculdade Estácio de Sá de Goiás, Goiânia, Brazil., Cardoso ADRO; Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Brazil., Guimarães RA; Laboratório de Bacteriologia Molecular, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil.; Faculdade de Enfermagem, Universidade Federal de Goiás, Goiânia, Brazil., Rodrigues RL; Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Brazil., Ribeiro KM; Laboratório de Imunopatologia das Doenças Infecciosas, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil., Borges KCM; Laboratório de Imunopatologia das Doenças Infecciosas, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil.; Departamento de Áreas Acadêmicas, Instituto Federal de Goiás, Anápolis, Brazil., Carvalho ACO; Laboratório de Imunopatologia das Doenças Infecciosas, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil., Dias CIS; Departamento de Biomedicina, Faculdade Estácio de Sá de Goiás, Goiânia, Brazil., Rezende AO; Programa de Pós-graduação em Ciências da Saúde, Universidade Federal do Maranhão, São Luís, Brazil., Souza CC; Laboratório de Imunopatologia das Doenças Infecciosas, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil., Ferreira RRM; Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Brazil., Saraiva G; Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Brazil., Barbosa LCS; Laboratório de Bacteriologia Molecular, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil.; Laboratório de Imunopatologia das Doenças Infecciosas, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil., Vieira TDS; Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Brazil., Conte MB; Departamento de Pesquisa Clínica, Faculdade de Medicina de Petrópolis, Petrópolis, Brazil., Rabahi MF; Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Brazil., Kipnis A; Laboratório de Bacteriologia Molecular, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil., Junqueira-Kipnis AP; Laboratório de Imunopatologia das Doenças Infecciosas, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil.
Jazyk:	angličtina
Zdroj:	Frontiers in immunology [Front Immunol] 2022 Mar 22; Vol. 13, pp. 841868. Date of Electronic Publication: 2022 Mar 22 (Print Publication: 2022).
DOI:	10.3389/fimmu.2022.841868
Abstrakt:	The Bacillus Calmette-Guérin (BCG) vaccine, which is widely used to protect children against tuberculosis, can also improve immune response against viral infections. This unicentric, randomized-controlled clinical trial assessed the efficacy and safety of revaccination with BCG Moscow in reducing the positivity and symptoms of COVID-19 in health care workers (HCWs) during the COVID-19 pandemic. HCWs who had negative COVID-19 IgM and IgG and who dedicated at least eight hours per week in facilities that attended to individuals suspected of having COVID-19 were included in the study and were followed for 7, 15, 30, 60, and 180 days by telemedicine. The HCWs were randomly allocated to a revaccinated with BCG group, which received the BCG vaccine, or an unvaccinated group. Revaccination with BCG Moscow was found to be safe, and its efficacy ranged from 30.0% (95.0%CI -78.0 to 72.0%) to 31.0% (95.0%CI -74.0 to 74.0%). Mycobacterium bovis BCG Moscow did not induce NK cell activation at 15-20 days post-revaccination. As hypothesized, revaccination with BCG Moscow was associated with a lower incidence of COVID-19 positivity, though the results did not reach statistical significance. Further studies should be carried out to assess whether revaccination with BCG is able to protect HCWs against COVID-19. The protocol of this clinical trial was registered on August 5th, 2020, at REBEC (Registro Brasileiro de Ensaios Clínicos, RBR-4kjqtg - ensaiosclinicos.gov.br/rg/RBR-4kjqtg/1) and the WHO (# U1111-1256-3892). The clinical trial protocol was approved by the Comissão Nacional de ética de pesquisa- CONEP (CAAE 31783720.0.0000.5078). Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2022 dos Anjos, da Costa, Cardoso, Guimarães, Rodrigues, Ribeiro, Borges, Carvalho, Dias, Rezende, Souza, Ferreira, Saraiva, Barbosa, Vieira, Conte, Rabahi, Kipnis and Junqueira-Kipnis.)
Databáze:	MEDLINE
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