BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial.

OBJECTIVES: Bacille Calmette-Guérin (BCG) vaccine has immunomodulatory effects that may provide protection against unrelated infectious diseases. We aimed to determine whether BCG vaccination protects adults against COVID-19. DESIGN: Phase III double-blind randomised controlled trial. SETTING: Healthcare centres in Australia, Brazil, the Netherlands, Spain, and the United Kingdom during the COVID-19 pandemic. PARTICIPANTS: 3988 healthcare workers with no prior COVID-19 and no contraindication to BCG. INTERVENTION: Randomised 1:1 using a web-based procedure to receive a single 0.1 mL intradermal dose of BCG-Denmark (BCG group, n = 1999) or saline (placebo group, n = 1989). MAIN OUTCOME MEASURES: Difference in incidence of (i) symptomatic and (ii) severe COVID-19 during the 12 months following randomisation in the modified intention to treat (mITT) population (confirmed SARS-CoV-2 naïve at inclusion). RESULTS: Of the 3988 participants randomised, 3386 had a negative baseline SARS-CoV-2 test and were included in the mITT population. The 12-month adjusted estimated risk of symptomatic COVID-19 was higher in the BCG group (22.6%; 95% confidence interval [CI] 20.6 to 24.5%) compared with the placebo group (19.6%; 95% CI 17.6 to 21.5%); adjusted difference +3.0% points (95% CI 0.2 to 5.8%; p = 0.04). The 12-month adjusted estimated risk of severe COVID-19 (mainly comprising those reporting being unable to work for ≥3 consecutive days) was 11.0% in the BCG group (95% CI 9.5 to 12.4%) compared with 9.6% in the placebo group (95% CI 8.3 to 11.1%); adjusted difference +1.3% points (95% CI -0.7 to 3.3%, p = 0.2). Breakthrough COVID-19 (post COVID-19 vaccination) and asymptomatic SARS-CoV-2 infections were similar in the two groups. There were 18 hospitalisations due to COVID-19 (11 in BCG group, 7 in placebo group; adjusted hazard ratio 1.56, 95% CI 0.60 to 4.02, p = 0.4) and two deaths due to COVID-19, both in the placebo group. CONCLUSIONS: Compared to placebo, vaccination with BCG-Denmark increased the risk of symptomatic COVID-19 over 12 months among healthcare workers and did not decrease the risk of severe COVID-19 or post-vaccination breakthrough COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov NCT04327206.

Thirty-day readmission rates in a cohort of people living with HIV in southern Brazil, 2015 to 2017.

BACKGROUND: The intense use of antiretroviral therapy (ART) has reduced morbidity and mortality of HIV infection. In Brazil, the specific contribution of diseases related to HIV infection leading to hospital admission and readmission is not well known. AIMS: The study aimed to determine the clinico-epidemiological profile, 30-day readmission rate, and factors associated with this outcome in a cohort of adults with HIV infection in southern Brazil. METHODS: Unicentric retrospective cohort, with data collection through the review of medical records and databases. RESULTS: We analyzed 574 index hospitalizations and 451 individuals. Of these, 57.6% were men and the mean (±SD) age was 42.2 ± 12.3 years. Only 43.4% used ART regularly and low CD4 count and high frequency of detectable viral load were observed. HIV/AIDS-related diseases were identified in 55.2%, and tuberculosis was the most frequent etiology leading to index hospitalization. We found a 30-day readmission rate of 11.5% and hospitalization for HIV/AIDS-related illness was associated with a higher risk for the outcome. CONCLUSIONS: These findings highlight the need to expand resources for prevention, early diagnosis, retention, and treatment of people living with HIV in the region to reduce HIV/AIDS-associated diseases and possibly minimize consequent hospital readmission of these individuals.