1. 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.
- Author
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Dos Anjos LRB, da Costa AC, Cardoso ADRO, Guimarães RA, Rodrigues RL, Ribeiro KM, Borges KCM, Carvalho ACO, Dias CIS, Rezende AO, Souza CC, Ferreira RRM, Saraiva G, Barbosa LCS, Vieira TDS, Conte MB, Rabahi MF, Kipnis A, and Junqueira-Kipnis AP
- Subjects
- BCG Vaccine, Child, Health Personnel, Humans, Immunization, Secondary methods, Moscow, Pandemics prevention & control, COVID-19 prevention & control, Mycobacterium bovis
- Abstract
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.)
- Published
- 2022
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