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A large-scale global trial designed to test the theory that the widely used BCG vaccine could help protect against COVID-19 will soon recruit healthcare staff and home workers in the UK.
The University of Exeter leads the UK branch of the trial, dubbed the BCG Vaccination Trial to Reduce the Impact of COVID-19 on Healthcare Workers (BRACE).
The BRACE trial is coordinated by the Murdoch Children’s Research Institute (MCRI) in Melbourne, Australia. The test has received more than $ 10 million from the Bill and Melinda Gates Foundation to enable its global expansion. The Peter Sowerby Foundation has contributed funds to support the Exeter test site.
The UK joins study centers in Australia, the Netherlands, Spain and Brazil in the largest trial of its kind. Together, the trial will recruit more than 10,000 healthcare staff. Participants will receive the BCG vaccine (currently administered to more than 100 million babies worldwide each year to protect them against tuberculosis (TB)) or a placebo injection. In the UK, routine BCG vaccination was discontinued in 2005 due to low rates of tuberculosis in the general population.
Professor John Campbell, from Exeter University School of Medicine, is the leader of the BRACE study in the UK. He said: “COVID-19 has killed more than a million people worldwide, and more than 33 million people contract the disease, sometimes in its most serious forms. BCG has been shown to boost immunity in a generalized way, which may offer some protection against COVID-19. We are excited to contribute to the large-scale international BRACE study in which we seek to establish whether the BCG vaccine could help protect people at risk of contracting COVID-19. If it does, we could save lives by administering or completing this available and cost-effective vaccine. “
Previous studies suggest that the Bacillus Calmette-Guerin (BCG) vaccine could reduce susceptibility to a variety of infections caused by viruses, including those similar to the new coronavirus that causes COVID-19. Examining the mechanism by which this may work is part of the trial the BRACE researchers are conducting.
The BCG vaccine increases immunity by “training” the immune system to respond to subsequent infections with greater intensity.
The researchers hope that this enhanced “innate immunity” will buy crucial time to develop an effective and safe vaccine against COVID-19.
Initially, the BRACE trial is recruiting healthcare and sanitation workers in the South West of England, who can attend clinics in Exeter. The trial is aimed at these professionals because they work in fields with high exposure to COVID-19. The trial specifically looks at whether the BCG vaccine reduces coronavirus infection or the severity of COVID-19 symptoms.
Professor Campbell added: “People on the front lines of COVID-19, including healthcare workers and workers in nursing homes, are particularly vulnerable to coronavirus infection. Until now, most research has overlooked nursing home workers. The BRACE trial provides us with a great opportunity to offer potential help to this important group of individuals who provide health care to some of our most vulnerable citizens in important community settings. I would really encourage the nursing home staff to join us in helping us find out if the BCG vaccine could provide a safe, widely available and cost-effective way to reduce the risk of COVID-19. “
In the UK, the trial will be conducted by the Exeter Clinical Trials Unit and will be supported by the Center for Clinical Research funded by the local National Institute for Health Research. Lynne Quinn, Exeter CTU’s director of operations, said the trial initially seeks to recruit 1,000 participants who work in nursing homes and other community healthcare settings. She said: “The first wave of recruiting will take place in and around Exeter, and we have exciting plans to expand to other sites across the UK so we hope to expand our recruiting figures at a later stage.”
Professor Nigel Curtis, global leader of the BRACE trial at MCRI, said: “We are delighted that the UK is joining this international trial to help determine if we can reuse an existing safe vaccine to reduce the impact of COVID-19 in health workers, including those working in nursing homes who are at special risk. “
Participants will be asked to fill out a daily symptom diary through an app, get tested for COVID-19 whenever they have symptoms, complete regular questionnaires and provide blood samples. These samples will allow scientists to understand how blood cells respond differently to exposure to COVID-19 and other viruses, with and without the BCG vaccine.
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