BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary
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Open Access
BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial Ana Paula Junqueira-Kipnis1* , Laura Raniere Borges dos Anjos1, Lília Cristina de Souza Barbosa1, Adeliane Castro da Costa2, Kellen Christina Malheiros Borges1, Amanda da Rocha Oliveira Cardoso3, Kaio Mota Ribeiro1, Sarah Brena Aparecida Rosa1, Carine de Castro Souza1, Rogério Coutinho das Neves1, Guylherme Saraiva3, Sueli Meira da Silva1, Erika Aparecida da Silveira3, Marcelo Fouad Rabahi3, Marcus Barreto Conte4 and André Kipnis1
Abstract Objectives: The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial for the antiviral immune response. Therefore, strategies to prevent COVID-19 in health workers (HW) should be carried out to prevent them becoming unwell so that they can continue to work during the pandemic. The hypothesis is that BCG will improve the innate immune response and prevent symptomatic infection or COVID-19 severity. The primary objective is to verify the effectiveness and safety of the BCG vaccine to prevent or reduce incidence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with BCG and also its severity and mortality during the pandemic of the disease. Secondary objectives are to estimate the incidence of COVID-19 among these professionals and the innate immune response elicited to BCG. Trial design: This a phase II trial for repositioning BCG as a preventive strategy against COVID-19. The trial is an open-label, parallel-group randomised clinical trial, comparing HW vaccinated with BCG and HW not vaccinated. Participants: The trial will recruit 800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation. Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for (Continued on next page)
* Correspondence: [email protected] 1 Institute of Tropical Pathology and Public Health, Federal University of Goiás, Goiânia, Goiás, Brazil Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not p
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