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.
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Santos Ana Paula, Werneck Guilherme Loureiro, Dalvi Ana Paula Razal, Dos Santos Carla Conceição, Tierno Paulo Fernando Guimarães Morando Marzocchi, Condelo Hanna Silva, Macedo Bruna, de Medeiros Leung Janaina Aparecida, de Souza Nogueira Jeane, Malvão Ludmila, Galliez Rafael, Aguiar Roberta, Stefan Roberto, Knackfuss Sabrina Modena, da Silva Elisangela Costa, Castineiras Terezinha Marta Pereira Pinto, de Andrade Medronho Roberto, E Silva José Roberto Lapa, Alves Rogério Lopes Rufino, de Moraes Sobrino Porto Luís Cristóvão, Rodrigues Luciana Silva, Kritski Afrânio Lineu, de Queiroz Mello Fernanda Carvalho
Аннотация
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).