A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—Evaluation of Antibody Concentrations

Abstract

Tuberculosis (TB) was the predominant cause of death from a single infectious agent worldwide before the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic. Although TB vaccines have been successfully used for about 100 years, their full effect is still unknown. In previous studies, a reduced incidence and mortality from a coronavirus disease in TB-vaccinated populations were reported. In this article, we present the secondary analysis of a randomised controlled trial, reporting the results of a serological assessment evaluating the effect of the Bacillus Calmette–Guérin (BCG) vaccine on SARS-CoV-2. Participants—healthcare workers—were assessed 1–2 and 8 months after the second dose of the coronavirus disease 2019 (COVID-19) vaccine. We found no associations between antibody concentration, BCG revaccination, and additional characteristics, such as age, gender, or Body Mass Index. The effect of BCG vaccination on the immunological response against SARS-CoV-2 requires further research.

Keywords

• COVID-19
• BCG
• vaccines
• clinical trial
• SARS-CoV-2
• health care