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).
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.
In March 2020, COVID-19 was declared a pandemic by the WHO. Since then, efforts have been made to increase our knowledge of the disease. The convalescent plasma (CP) donation involves a series of criteria for donor eligibility, such as pre-donation and serological tests. Currently, the antibody response against SARS-CoV-2 remains poorly understood and the usefulness of serological tests is unclear (Long, et al. Nature Medicine, 2020). Based on donor eligibility, one can better assess the antibody response to SARS-CoV-2 from post-infection candidates. This is an observational, prospective study, without intervention. From 06/26/2020 to 07/31/2020, serological data of candidates for CP donation were collected. Recovered COVID-19 patients who had been previously tested were interviewed. RT-PCR and serological test (chemiluminescence immunoassays) for SARS-CoV-2 were carried out to verify their eligibility for CP collection. The data were related to the time of the onset of symptoms and the collection of the material. Subjects with non-detectable RT-PCR and reagent IgG were considered eligible. Reference values were IgM > 1.2 AU/mL and IgG > 1.4 AU/mL. The characteristics of the candidates are summarized in Table 1. Of 234 interviewed subjects, 70 were screened for pre-collection tests, 49 were male. The average age was 36 (20 - 57). After serological screening, 44/70 (62.8%) were considered eligible for CP donation. The reasons for ineligibility were: 17/70 (24.3%) non-reagent IgG, 4/70 (5.7%) with detectable RT-PCR and 5/70 (7.1%) due to reasons in clinical screening. The median between the onset of symptoms and the serology sample collection was 32.5 (21 - 77) days, (IQR 28.75 to 37.25). Those who were more likely to be eligible to donate were the subjects who had a longer time interval between the symptoms onset and the sample collection (p <0.012). Although viral clearance in the upper airways is expected from the 10th day of symptom onset, only 50% of patients will have an undetectable test (Özçürümez, et al. J Allergy Clin Immunol. 2020). In our sample, 5.7% (4/70) of the subjects had detectable RT-PCR, which can represent residual viral genome and not active infection. We observed that 20% of the subjects samples were non-reagent. Those who were tested up to the 21st of the onset of symptoms might not have had seroconversion yet. For those tested after the 28th day, we can infer that the antibodies had already been cleared. Some authors state that patients who had mild infections may react with less antibodies (Özçürümez, et al. J Allergy Clin Immunol. 2020), which could explain this fact. Likewise, it was not possible to relate serological titers to the severity of the disease, as this was not one of the selection criteria.In 40/70 donors (57.2%) IgM remained above 1.2 AU / mL after the 21st day of symptom onset. Interestingly, 2 of these had only reagent IgM after the 36th day of symptom onset. Most subjects who had reagent IgM after the 21st of symptoms also had reagent IgG. We inferred that they were in a vigorous convalescence phase. In addition, 75.7% of the subjects presented reagent IgG regardless of the date of onset of symptoms. Most of them had both reagent IgM and IgG. Only one donor's (1.4%) IgM and IgG were non-reagent 21 days after the onset of symptoms. As we did not collect serial samples, we could not verify the average amount of days for seroconversion to take place. Some authors recommend that the single collection should occur at least 21 days after the onset of symptoms, so seroconversion is observed (Deeks, et al., Cochrane Database Syst Rev. 2020). In our sample, 4 donors (5%) collected the samples on the 21st day after the symptom onset. Of these, 3 had seroconversion, 2 with IgM and IgG, 1 with IgG and 1 with reagent IgM. The values suggest that the subjects who could donate CP were those that presented a longer time interval between the onset of symptoms and the blood sample collection, in comparison to those who could not (p=0,012 and 0,409, respectively). The median of days between symptom onset and serology testing was also higher in the non-eligible group. Besides, the eligible group had a higher average concentration of IgM and IgG compared to the non-eligible one. In conclusion, regarding the serological criteria, about 25% of the studied population could not donate CP. Although a single serology sample collection after the 21st day of symptom onset is recommended, only 1 candidate did not show seroconversion. Disclosures No relevant conflicts of interest to declare.
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