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.

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).

Antibody response against SARS-CoV-2 in convalescent plasma donors: Can we predict subjects' eligibility?

Abstract Introduction As the Coronavirus Disease 2019 (COVID-19) pandemic unfolds around the world; answers related to the antibody response against the virus are necessary to develop treatment and prophylactic strategies. We attempted to understand part of the immune response of convalescent plasma donation candidates. Method We carried out a cross-sectional, observational, non-intervention study, testing 102 convalescent plasma donation candidates for antibodies against the virus, relating these data to the time interval between symptom onset and sample collection, age, disease severity, and gender. Results In our sample, the individuals who developed a greater antibody response were the ones who had a longer time interval between symptom onset and sample collection, the ones who had been hospitalized and the subjects above 35 years old. Moreover, 17 individuals did not present any reactive antibodies. Conclusion These results are important in that they raise questions about the role of the humoral response against the virus, as some individuals do not develop antibodies to fight it. In addition, they help develop recruitment strategies for convalescent plasma donors, who should be asymptomatic for at least 21 days and are possibly more likely to have reactive antibodies after 35 days without symptoms.

Antibody response against SARS-CoV-2 in convalescent plasma donors: Can we predict subjects' eligibility?

INTRODUCTION: As the Coronavirus Disease 2019 (COVID-19) pandemic unfolds around the world; answers related to the antibody response against the virus are necessary to develop treatment and prophylactic strategies. We attempted to understand part of the immune response of convalescent plasma donation candidates. METHOD: We carried out a cross-sectional, observational, non-intervention study, testing 102 convalescent plasma donation candidates for antibodies against the virus, relating these data to the time interval between symptom onset and sample collection, age, disease severity, and gender. RESULTS: In our sample, the individuals who developed a greater antibody response were the ones who had a longer time interval between symptom onset and sample collection, the ones who had been hospitalized and the subjects above 35 years old. Moreover, 17 individuals did not present any reactive antibodies. CONCLUSION: These results are important in that they raise questions about the role of the humoral response against the virus, as some individuals do not develop antibodies to fight it. In addition, they help develop recruitment strategies for convalescent plasma donors, who should be asymptomatic for at least 21 days and are possibly more likely to have reactive antibodies after 35 days without symptoms.

[High-risk clusters and temporal trends in congenital syphilis infection in Brazil]. / Aglomerados de alto risco e tendência temporal da sífilis congênita no Brasil.

OBJECTIVE: To determine the occurrence of high-risk clusters for congenital syphilis (CS) in Brazil and describe the temporal trends in the CS infection in the country, comparing children whose mothers received vs. those whose mothers did not receive prenatal care. METHOD: This ecological study used data from the National Disease Notification System (Sistema de Informação de Agravos de Notificação, SINAN) and the Live Birth Information System (Sistema de Informações sobre Nascidos Vivos, SINASC). For cluster analysis, the Kulldorff scan statistic was applied to the population at risk. Statistical significance was determined by the log-likelihood ratio based on Poisson discrete distribution. To analyze the temporal trends of disease detection rates, Prais-Winsten regression was used. The analysis was performed with SatScan 9.4 and Stata 14.0 software. RESULTS: Clusters with detection rates of 41.3, 44.4 and 188.1 CS cases/10 000 live births were identified in 2001, 2009 and 2017 respectively. In 2001, the rates were 8 times higher in the clusters than in the remaining country; in 2009, the rates were 3.3 times higher; and in 2017, 2.5 times higher. An increasing trend in CS infection was detected in all regions and federation units. The rates were 8.53 times higher in the children of mothers without prenatal care (243.3 cases/1 000 live births vs. 28.3 cases/1 000 live births in the children of mothers with prenatal care). CONCLUSIONS: The identification of municipality clusters at high risk for CS and of increasing trends in CS infection across the country, even in the presence of prenatal care, suggests the need for improvement of public health actions to fight this disease.

Aglomerados de alto risco e tendência temporal da sífilis congênita no Brasil

[RESUMO]. Objetivo. Determinar a existência de aglomerados de municípios (clusters) com alto risco para sífilis congênita (SC) no Brasil e descrever a tendência temporal da doença no país, comparando a população de crianças cujas mães realizaram o pré-natal com aquelas cujas mães não realizaram esse controle. Métodos. Este estudo ecológico utilizou dados do Sistema de Informação de Agravos de Notificação (SINAN) e do Sistema de Informações sobre Nascidos Vivos (SINASC). Para a análise de aglomerados, a estatística de varredura Kulldorff foi aplicada à população de risco. A significância estatística foi determinada pelo logaritmo da razão de verossimilhança utilizando a distribuição discreta de Poisson. Para a análise das tendências das taxas de detecção do agravo, utilizou-se a regressão de Prais-Winsten. A análise foi realizada com os programas SatScan 9.4 e Stata 14.0. Resultados. Clusters com taxas de detecção de 41,3, 44,4 e 188,1 casos/10 000 nascidos vivos foram identificados em 2001, 2009 e 2017, respectivamente. Em 2001, as taxas foram 8 vezes maiores nos clusters do que no restante do país; em 2009, foram 3,3 vezes maiores; e, em 2017, 2,5. Detectou-se uma tendência crescente na infecção por SC em todas as regiões e unidades da federação. As taxas foram 8,53 vezes maiores nos neonatos cujas mães não realizaram pré-natal (243,3 casos/1 000 nascidos vivos vs. 28,4 casos/1 000 nascidos vivos em mães com pré-natal). Conclusões. A identificação de aglomerados de municípios com alto risco para SC e de tendências crescentes de infecção por SC em todo o país, mesmo na presença de pré-natal, indicam a necessidade de melhoria nas ações de saúde pública para o combate dessa doença.

[ABSTRACT]. Objective. To determine the occurrence of high-risk clusters for congenital syphilis (CS) in Brazil and describe the temporal trends in the CS infection in the country, comparing children whose mothers received vs. those whose mothers did not receive prenatal care. Method. This ecological study used data from the National Disease Notification System (Sistema de Informação de Agravos de Notificação, SINAN) and the Live Birth Information System (Sistema de Informações sobre Nascidos Vivos, SINASC). For cluster analysis, the Kulldorff scan statistic was applied to the population at risk. Statistical significance was determined by the log-likelihood ratio based on Poisson discrete distribution. To analyze the temporal trends of disease detection rates, Prais-Winsten regression was used. The analysis was performed with SatScan 9.4 and Stata 14.0 software. Results. Clusters with detection rates of 41.3, 44.4 and 188.1 CS cases/10 000 live births were identified in 2001, 2009 and 2017 respectively. In 2001, the rates were 8 times higher in the clusters than in the remaining country; in 2009, the rates were 3.3 times higher; and in 2017, 2.5 times higher. An increasing trend in CS infection was detected in all regions and federation units. The rates were 8.53 times higher in the children of mothers without prenatal care (243.3 cases/1 000 live births vs. 28.3 cases/1 000 live births in the children of mothers with prenatal care). Conclusions. The identification of municipality clusters at high risk for CS and of increasing trends in CS infection across the country, even in the presence of prenatal care, suggests the need for improvement of public health actions to fight this disease.