Cape Town trial begins next week - can BCG shot prevent Covid-19 infection?
If successful the experiment, using a cheap 100-year-old TB vaccine, will transform a small band of unknown Cape Town researchers into superheroes.
Conducted by TASK, a Bellville-based Clinical Research Centre, the aim of the study is to determine if a booster shot of BCG (Bacille Calmette-Guérin) reduces the probability of Covid-19 infection and the severity of the symptoms.
Primarily a vaccine against TB in children, BCG also protects against other respiratory tract infections in children and adults.
Success in the “state-of-the-art” year-long study of at least 500 health workers would save lives and financial ruin not just in South Africa but across the world where the raging pandemic has so far claimed 190000 lives, crippled economies, overwhelmed healthcare systems and sowed global uncertainty.
The study could start showing its first positive outcomes in July. Keith Cloete, the provincial head of health, said: “We wholeheartedly support the trial and eagerly await positive outcomes. This could be a major boost with huge national and global ramifications.”
TASK’s trial follows headlines about an anecdotal study that revealed a vast reduction in Covid-19 respiratory infections, and up to six times less deaths in countries that have universal BCG vaccination policies. One of those is South Africa, which has been vaccinating all newborns with BCG since the 1970s.
“The more BCG done in a country the better the Covid outcomes,” said TASK chief executive and study leader Andreas Diacon, who also lectures in medicine at Stellenbosch University.
“It might just be coincidence. But we know that when you expose natural defence cells to BCG they appear to be learning something about how to fight infections. They seem to change their behaviour slightly, not just to fight TB but other infections as well. This is just one of the indicators that BCG might provide a suit of armour against Covid-19.”
Diacon said this observation has been made many times worldwide.
“A few years ago, while testing a new TB vaccine, they compared it to BCG. Because of the rigorous follow-up, they found per chance that those who had a BCG booster had less frequent upper respiratory tract infections like pneumonia.
“This evidence was never pursued urgently. For me, it was a ‘post it on my desk to get around to someday when I had the time’. Now with Covid, it’s moved up to priority number one. And I have a good hunch that we could be on to a game-changer.”
Several similar trials are due to start in the Netherlands and Australia, but TASK’s study is first out of the blocks.
“We can do this kind of research quicker than anyone else because we have all the systems and protocols in place from our TB research where we are trailblazers,” said Diacon.
“Okay, Covid is a new disease but that’s no problem because the process is routine for us. We have highly trained staff who work quickly and effectively.”
TASK has a reputable track record in the field of TB research where it’s a leading global player in early-phase TB medicine evaluation. TASK trials from 2005 to 2012 led to the registration of Bedaquiline, the first new TB drug in decades, for TB patients with resistance to conventional antibiotics. Diacon received an international award for this achievement.
TASK also has a head start because it raced through the regulatory process in less than a week instead of the usual three to four months.
“The regulators have been fantastic,” said Diacon. “The ethics committee responded over the weekend, which is unheard of, and with constructive collaborative feedback which is very encouraging. Tygerberg have also given us a head start with quick access to their staff to recruit participants while we complete the regulatory process which means we can hit the ground running.”
TASK’s placebo-controlled adaptive randomised controlled trial kicks off next week with the first vaccination of 500 health-care workers in a facility adjacent to Tygerberg Hospital’s Ward D-10, one of the country’s officially designated Covid-19 treatment centres.