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Led by the Murdoch Children’s Research Institute (MCRI) in Melbourne, the BRACE trial began in Australia on March 27. A grant of more than $ 10 million from the Bill & Melinda Gates Foundation has enabled its global expansion with added study centers in the Netherlands. Spain and Brazil. This week, the University of Exeter, which leads the British arm of the trial, announced that it would begin recruiting participants from the United Kingdom.
The trial aims to recruit 10,000 healthcare workers around the world. The results of the trial will help show whether the BCG vaccine could be used as an early intervention measure to protect healthcare workers and high-risk groups: both in the COVID-19 pandemic and in future new viral outbreaks.
BCG: increasing innate immunity?
The Bacillus Calmette-Guerin (BCG) vaccine protects against tuberculosis and is administered to more than 130 million babies worldwide each year. In the UK it is no longer used routinely (it was discontinued in 2005 due to low rates of TB in the general population), although it is sometimes given to adults who are at risk of TB because of their work.
While the BCG vaccine is designed to vaccinate against tuberculosis, it also stimulates the immune system to fight other infections. Previous studies suggest that the vaccine could reduce susceptibility to a variety of infections caused by viruses, including those similar to the new coronavirus that causes COVID-19.
Why is the BCG vaccine of interest?
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a single-stranded positive-sense RNA virus, and BCG vaccine has been shown to reduce the severity of infections from other viruses with that structure in controlled trials. For example, a 2018 study suggested that BCG vaccine reduced the viremia of yellow fever vaccine by 71% in volunteers in the Netherlands, while two studies in mice showed that it reduced the severity of mengovirus infection ( encephalomyocarditis virus).
However, the current WHO recommendation is that BCG vaccine be used for COVID-19 only in trials like this one. This is because the BCG vaccine is already in short supply and is necessary to protect children against tuberculosis in high-risk areas. Second, its effectiveness against COVID-19 is unknown.
The scientists also highlight that a BCG vaccine given in childhood decades ago, as was the case in the UK, is unlikely to work against COVID-19 today.
The BRACE trial focuses on healthcare workers, who are at increased risk of contracting the COVID-19 pandemic, in the hope that it can help boost innate immunity against subsequent infections – thus buying time in the race to develop an effective and safe vaccine against COVID. 19.
In the UK, the trial is initially recruiting 1,000 healthcare and healthcare workers in the southwest of England, who can attend clinics in Exeter. Researchers target 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. 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.
The trial plans to expand to other sites across the UK following the initial launch in Exeter.