TB Vaccine Test on Covid-19 Expanding to Europe

Scanning electron microscope image of SARS-Cov-2 virus, in orange, emerging from cells (NIAID, Flickr)

5 May 2020. A clinical trial testing a current tuberculosis vaccine among health care workers in Australia is expanding in that country and to two European countries. Expansion of the Brace trial — short for BCG vaccination to Reduce the impact of Covid-19 in Australian health care workers following Coronavirus Exposure  — is funded by a $AU 10 million ($US 6.5 million) award from the Bill and Melinda Gates Foundation.

The Brace trial began on 27 March, testing the Bacille Calmette-Guerin, or BCG. vaccine among 4,170 health care staff in Australia treating patients with Covid-19 infections. The BCG vaccine, given to some 130 million infants per year, uses a live, weakened strain of Mycobacterium tuberculosis bacteria and is given mainly outside the U.S., where risk of the disease from that strain is much higher.

While not designed to protect against the SARS-CoV-2 virus, BCG vaccine can also increase immunity against other infections. Nonetheless, on 12 April, World Health Organization recommended against using BCG vaccines to immunize generally against Covid-19 infections, to avoid depleting stocks of the vaccine for protecting children.

The Brace clinical trial is conducted by Murdoch Children’s Research Institute, part of Royal Children’s Hospital in Parkville, Australia. The study team randomly assigns health care participants volunteering for the trial at various hospitals to receive a single dose of BCG vaccine, then are compared to other non-vaccinated volunteers. Researchers are looking primarily for cases of Covid-19 occurring among participants, particularly severe infections requiring hospitalization or leading to death, after six months. The team is also tracking Covid-19 infections, from asymptomatic to severe cases, hospitalizations, intensive care treatment, and related indicators such as absenteeism from work, over the next 12 months.

The Gates Foundation grant will enable the Murdoch Institute to increase the Brace trial sample to a total of 10,000 participants, adding more health care workers in Australia, and expand the trial to the Netherlands and Spain. Radboud University Medical Center in Nijmegen and UMC Utrecht, both in the Netherlands, expect to enroll some 4,000 health care staff at 13 sites in the two countries in the next few weeks.

Nigel Curtis, the Brace trial leader and director of Murdoch Institute’s Infectious Diseases and Microbiology Research Group, says in an institute statement, “It will be imperative to help our researchers show whether BCG vaccination improves innate immunity in front line health care workers, to buy crucial time to develop and importantly, validate, a specific anti-Covid-19 vaccine.”

“We have dealt with the pandemic extremely well in Australia with rapid and thorough physical distancing, contact tracing, and quarantine where appropriate,” notes Curtis. “This new funding from the Gates Foundation allows other countries to also test whether additional preventative measures may help protect health care workers. These sorts of trials normally take around eight to 12 months to start, but with the early support of philanthropy, we were able to start in record time, within three weeks.”

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• Oxford, AstraZeneca Partner on Covid-19 Vaccine
• Trial Okayed in Germany for Covid-19 Vaccine
• Moderna Gains $483M for Covid-19 Vaccine
• Five Covid-19 Vaccines in Clinical Trials
• Covid-19 Vaccine in Development, Trial Planned

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