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. (May 2023)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: International journal of infectious diseases. Volume 130(2023)
• Page Start: 8
• Page End: 16
• Publication Date: 2023-05
• Subjects: COVID-19 -- BCG -- Vaccine; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2023.02.014
• Languages: English
• ISSNs: 1201-9712

Abstract

HIGHLIGHTS: Bacillus Calmette-Guérin (BCG) could be effective against SARS-CoV-2 based on the concept of trained immunity. COVID-19 vaccines and BCG can enhance the immune response represented by immunoglobulin G levels. The cumulative incidence of COVID-19 was smaller in BCG-vaccinated participants. Immunoglobulin G levels tend to be higher and longer in the group submitted to BCG vaccination. ABSTRACT: 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).