Dataset Information

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.

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).

SUBMITTER: Santos AP

PROVIDER: S-EPMC9972589 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

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.

Santos Ana Paula AP Werneck Guilherme Loureiro GL Dalvi Ana Paula Razal APR Dos Santos Carla Conceição CC Tierno Paulo Fernando Guimarães Morando Marzocchi PFGMM Condelo Hanna Silva HS Macedo Bruna B de Medeiros Leung Janaina Aparecida JA de Souza Nogueira Jeane J Malvão Ludmila L Galliez Rafael R Aguiar Roberta R Stefan Roberto R Knackfuss Sabrina Modena SM da Silva Elisangela Costa EC Castineiras Terezinha Marta Pereira Pinto TMPP de Andrade Medronho Roberto R E Silva José Roberto Lapa JRL Alves Rogério Lopes Rufino RLR de Moraes Sobrino Porto Luís Cristóvão LC Rodrigues Luciana Silva LS Kritski Afrânio Lineu AL de Queiroz Mello Fernanda Carvalho FC

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20230224

<h4>Objectives</h4>Evatuate if Bacillus Calmette-Guérin (BCG) vaccine could be used as a tool against SARS-CoV-2 based on the concept of trained immunity.<h4>Methods</h4>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 a ...[more]

PMID: 36841502

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Project description:BackgroundPopulation-based data on COVID-19 are essential for guiding policies. There are few such studies, particularly from low or middle-income countries. Brazil is currently a hotspot for COVID-19 globally. We aimed to investigate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody prevalence by city and according to sex, age, ethnicity group, and socioeconomic status, and compare seroprevalence estimates with official statistics on deaths and cases.MethodsIn this repeated cross-sectional study, we did two seroprevalence surveys in 133 sentinel cities in all Brazilian states. We randomly selected households and randomly selected one individual from all household members. We excluded children younger than 1 year. Presence of antibodies against SARS-CoV-2 was assessed using a lateral flow point-of-care test, the WONDFO SARS-CoV-2 Antibody Test (Wondfo Biotech, Guangzhou, China), using two drops of blood from finger prick samples. This lateral-flow assay detects IgG and IgM isotypes that are specific to the SARS-CoV-2 receptor binding domain of the spike protein. Participants also answered short questionnaires on sociodemographic information (sex, age, education, ethnicity, household size, and household assets) and compliance with physical distancing measures.FindingsWe included 25 025 participants in the first survey (May 14-21) and 31 165 in the second (June 4-7). For the 83 (62%) cities with sample sizes of more than 200 participants in both surveys, the pooled seroprevalence increased from 1·9% (95% CI 1·7-2·1) to 3·1% (2·8-3·4). City-level prevalence ranged from 0% to 25·4% in both surveys. 11 (69%) of 16 cities with prevalence above 2·0% in the first survey were located in a stretch along a 2000 km of the Amazon river in the northern region. In the second survey, we found 34 cities with prevalence above 2·0%, which included the same 11 Amazon cities plus 14 from the northeast region, where prevalence was increasing rapidly. Prevalence levels were lower in the south and centre-west, and intermediate in the southeast, where the highest level was found in Rio de Janeiro (7·5% [4·2-12·2]). In the second survey, prevalence was similar in men and women, but an increased prevalence was observed in participants aged 20-59 years and those living in crowded conditions (4·4% [3·5-5·6] for those living with households with six or more people). Prevalence among Indigenous people was 6·4% (4·1-9·4) compared with 1·4% (1·2-1·7) among White people. Prevalence in the poorest socioeconomic quintile was 3·7% (3·2-4·3) compared with 1·7% (1·4-2·2) in the wealthiest quintile.InterpretationAntibody prevalence was highly heterogeneous by country region, with rapid initial escalation in Brazil's north and northeast. Prevalence is strongly associated with Indigenous ancestry and low socioeconomic status. These population subgroups are unlikely to be protected if the policy response to the pandemic by the national government continues to downplay scientific evidence.FundingBrazilian Ministry of Health, Instituto Serrapilheira, Brazilian Collective Health Association, and the JBS Fazer o Bem Faz Bem.

Dataset Information

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.

Objectives

Methods

Results

Conclusion

Publications

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.

Similar Datasets

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