Laboratório de Bacteriologia Molecular, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Brazil.
Departamento de Biomedicina, Faculdade Estácio de Sá de Goiás, Goiânia, Brazil.
Front Immunol. 2022 Mar 22;13:841868. doi: 10.3389/fimmu.2022.841868. eCollection 2022.
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%). 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).
卡介苗(BCG)疫苗被广泛用于预防儿童结核病,也可以改善对病毒感染的免疫反应。这项单中心、随机对照临床试验评估了在 COVID-19 大流行期间,用卡介苗莫斯科重新接种疫苗是否能降低卫生保健工作者(HCWs) COVID-19 阳性和症状的发生率。该研究纳入了 COVID-19 IgM 和 IgG 均为阴性、每周至少 8 小时在为疑似 COVID-19 患者提供服务的设施中工作的 HCWs,并通过远程医疗对他们进行了 7、15、30、60 和 180 天的随访。HCWs 被随机分配到接受卡介苗组或未接种组。结果发现,卡介苗莫斯科重新接种是安全的,其疗效在 30.0%(95.0%CI -78.0 至 72.0%)至 31.0%(95.0%CI -74.0 至 74.0%)之间。卡介苗莫斯科在重新接种后 15-20 天不会诱导 NK 细胞激活。正如假设的那样,卡介苗莫斯科重新接种与 COVID-19 阳性率降低相关,但结果未达到统计学意义。应开展进一步研究,以评估卡介苗重新接种是否能保护 HCWs 免受 COVID-19 感染。该临床试验方案于 2020 年 8 月 5 日在 REBEC(巴西临床试验注册处,REBEC 注册编号:RBR-4kjqtg - ensaiosclinicos.gov.br/rg/RBR-4kjqtg/1)和世界卫生组织(WHO)(# U1111-1256-3892)注册。该临床试验方案已获得国家伦理委员会(CONEP)的批准(CAAE 31783720.0.0000.5078)。