BRACE [COVID-19]
Research type
Research Study
Full title
BCG vaccination to Reduce the impact of COVID-19 in healthcare workers following Coronavirus Exposure (BRACE) Trial
IRAS ID
286410
Contact name
John Campbell
Contact email
Sponsor organisation
Murdoch Children’s Research Institute (MCRI)
Eudract number
2020-002503-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Human Research Ethics Committee (HREC), 62586
Duration of Study in the UK
1 years, 4 months, 11 days
Research summary
Research Summary
BRACE is an Australian study, sponsored by the Murdoch Institute for Children’s Research (MCRI), and the University of Exeter is the lead UK site.
This trial is testing whether the Bacille Calmette-Guerin (BCG) vaccine can reduce the severity of COVID-19 in healthcare workers. For around 80% of people, the virus causes mild to moderate disease with symptoms similar to respiratory diseases such as influenza (fever, cough, and fatigue). Around 14% of people experience severe disease requiring hospitalisation. The remaining 6% are critical cases that have respiratory failure, septic shock and/or organ failure.
This trial focuses on healthcare workers as they are at the frontline of the COVID-19 pandemic. Because healthcare workers work closely with patients they have greater exposure and risk of contracting the virus. There is currently no vaccine for COVID-19; protection of healthcare workers relies on the use of personal protective equipment. All healthcare staff, including doctors, nurses, care-home staff, cleaners and administrative staff are vital to ensuring the health system can function during such a pandemic.
The tuberculosis (TB) vaccine, BCG, has been shown to protect against non-TB infections by boosting the immune system. Studies show that it can decrease mortality of those infected by half, protects against other infections and improves the response to other vaccines. The mechanism by which BCG influences immunity is not completely understood. We want to find out whether the BCG vaccine might protect against COVID-19. We are interested in whether the vaccine can reduce the number of cases of COVID-19, and the severity of the illness, compared to a placebo. The trial results will help us find out whether, in future disease outbreaks, BCG vaccination could be used as an early intervention to protect healthcare workers and high-risk groups.
Summary of Results
The BRACE trial aimed to test whether the BCG vaccine could protect healthcare workers against COVID-19 in the first six months after vaccination.
We found that BCG vaccination did not reduce the risk of developing COVID-19 in the first 6 months of the trial. The risk of symptomatic COVID-19 was 14.7% in the BCG group and 12.3% in the placebo group during the first six months after joining the trial. This difference was not statistically significant. The trial could not determine if the vaccine reduced hospitalisations or death due to the low numbers of participants with severe COVID-19.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0240
Date of REC Opinion
11 Sep 2020
REC opinion
Further Information Favourable Opinion