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

AbstractObjectivesThe 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 Goi ânia (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 designThis 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.ParticipantsThe trial will recruit 800 HW of Goi ânia - 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 ...
Source: Trials - Category: Research Source Type: clinical trials