Recruitment to the BRACE trial closed on 31st Jan 2021
Exeter Clinical Trial Unit,
St Luke’s Campus,
University of Exeter,
Exeter EX1 2LU
BCG vaccination to reduce the impact of COVID-19 in healthcare workers (The BRACE Trial)
What is BRACE?
Healthcare workers are at increased risk of contracting COVID-19, caused by SARS-CoV-2.
When healthcare workers are sick and unable to come to work, this puts extra pressure on the healthcare system.
In the BRACE trial, we aim to recruit 10,000 healthcare workers who work in a healthcare setting or have face-to-face contact with patients in the UK, Australia, the Netherlands, Spain, and Brazil.
Please be aware that the BRACE Trial is unable to organise or provide BCG vaccination to members of the public. The trial is no longer recruiting new participants and as such it is not possible to receive a BCG vaccine through the trial team.
The BRACE Trial aims to find out if the BCG vaccine offers any protection against COVID-19. The BRACE trial is ongoing and the answer to this question is unknown. We expect the results of the trial to be available in 2022. At this time the best way to protect yourself against COVID-19 is to take up your COVID-19 vaccination when offered it through the NHS.
Prof John Campbell
Professor of General Practice and Primary Care and BRACE Trial UK Regional Principal Investigator
Prof Adilia Warris
Professor in Paediatric Infectious Diseases and BRACE Trial UK Clinical Safety Lead
The results of this trial will help us find out whether, in current and future novel viral outbreaks, BCG vaccination could be used as an early intervention to protect healthcare workers and other high-risk groups.
In the UK, the trial is a collaboration between Exeter Medical School’s Clinical Trials Unit and the Murdoch Children’s Research Institute (MCRI) in Melbourne, Australia.
Professor Nigel Curtis of MCRI is the lead researcher of the BRACE trial. MCRI has received funding from several generous donors, including the Bill & Melinda Gates Foundation. MCRI, with support from the Gates Foundation, and the Peter Sowerby Foundation have provided critical funding to enable the expansion of the BRACE trial into the UK.
Professor John Campbell, Professor of General Practice and Primary Care here in University of Exeter is the principal investigator in the UK for the BRACE trial, with Professor Adilia Warris, Professor in Paediatric Infectious Diseases, as deputy principal investigator. The study is being run by the Exeter Clinical Trials Unit working in collaboration with the Exeter NIHR funded Clinical Research Facility. We are recruiting community based healthcare workers, including primary care based healthcare workers and care home staff who are able to attend our three recruitment centres in Exeter (initially), and in due course with planned recruitment taking place in and around Keele.
Who took part?
All healthcare workers who work in a health or social care setting or have face-to-face contact with patients were invited to check their eligibility to join the BRACE trial. Interested healthcare workers must have been willing to attend recruitment and follow-up at a central recruitment site.
Recruitment of participants closed on 31st January 2021.
What if participants had received a COVID-specific vaccine, this winter's flu vaccination, or the BCG vaccine?
Participants in the BRACE trial were eligible to receive COVID-specific vaccines as they become available. There was a gap of 7 days between participation in the BRACE trial and adminstration of the COVID vaccine.
Please note that, for scientific reasons related to the design of the BRACE study, people who had already received a COVID vaccine were not eligible to take part in the BRACE trial.
Healthcare workers who had recently received, or were about to receive, the flu vaccination, left at least 72 hours between the flu vaccination and attending the first BRACE research assessment visit.
People who had already received BCG were still eligible to take part in the BRACE Trial.
Why take part?
The Bacille Calmette-Guérin (BCG) vaccine is designed to protect against tuberculosis (TB). However it also boosts immunity to protect against other infections. We hope that the BCG vaccine will boost your immune system. It may provide you with non-specific protection against COVID-19 and other illnesses. (Note we cannot guarantee or promise you will receive any benefits from this trial.)
Information we collect in this trial will also help to inform how we respond to outbreaks of new viruses in the future.
What did participation involve?
- An initial blood test at first registration and further blood tests at 3, 6, 9 and 12 months.
- Random allocatation to receive the BGG vaccine, or a placebo vaccine.
- Downloading an app to easily record respiratory symptoms and fever.
- Completing online surveys at 3, 6, 9, and 12 months.
- Making sure you were tested for COVID-19 if you had suggestive symptoms.
Important Information, Risks and FAQs
- The Murdoch Institute and The Unversity of Exeter have created a list of FAQs for participants which you can find here.
- Occasionally some people experience adverse effects of the BCG vaccine. The majority of these are minor and local reactions around the injection site. These are outlined in detail in further information for you to read before taking part in the study.
- Having a blood sample collected may cause some discomfort or bruising. Having a throat swab can sometimes be uncomfortable but trained members of the research team will be collecting these samples.
- As with all clinical trials, you may decide later not to participate, up to and including at your vaccination appointment.
- We will not tell the healthcare provider where you work which of their staff members have consented to participate in this trial.
- There are no costs associated with participating in this trial, nor will you be paid. All medication, tests and medical care required as part of the trial will be provided to you free of charge.
COVID-specific vaccines – how does this affect participation in BRACE?
In light of the recent news regarding the successful development of COVID-specific vaccines, many people have already asked us about how this might affect the BRACE trial. Importantly, it is possible to participate in the BRACE Trial and to receive any new coronavirus vaccine when it becomes available.
A number of points are relevant:
- Participation in the BRACE trial does not act as a barrier to BRACE trial participants receiving approved COVID-19 vaccines as they become available. Current guidance is that there should be a 7-day interval between BRACE trial entry and receiving a COVID-19 vaccine.
- People who have already received a COVID-19 vaccine are not eligible to participate in the BRACE trial.
- There is evidence that BCG improves the response to some other vaccines. We cannot predict whether this will be the case for COVID-19 vaccines, but we will examine this as part of our BRACE trial analysis.
- Although new COVID-19 vaccines are becoming available, we anticipate that it may be some time before they are widely and routinely available.
- In the meantime, joining the BRACE trial provides the opportunity to help find out whether BCG protects against COVID-19 and other respiratory infections. This will also help us work out whether BCG might provide protection in any future pandemic until a specific vaccine can be developed.
For these reasons, we believe that the BRACE Trial remains very relevant to the current situation.
This is a developing situation and when we have any further relevant information we update this section.
Professor John Campbell: An Introduction to the BRACE trial
Professor Nigel Curtis: BCG Vaccine, COVID-19 and the BRACE Trial