Cape Town trial begins next week



[ad_1]

By Mike Behr Time of published article9h ago

Share this article:

Cape Town: An “armor” against Covid-19 is the target of an innovative clinical trial in South Africa that will vaccinate its first participant at Tygerberg Hospital early next week.

If the experiment is successful, the use of a cheap 100-year-old tuberculosis vaccine will transform a small band of unknown Cape Town researchers into superheroes.

Conducted by TASK, a Bellville-based Clinical Research Center, the goal of the study is to determine whether a boost injection of BCG (Bacille Calmette-Guérin) reduces the likelihood of Covid-19 infection and the severity of symptoms.

Primarily a childhood TB vaccine, BCG also protects against other respiratory tract infections in children and adults.

Success in the year-long “cutting-edge” study of at least 500 health workers would save lives and financial ruin not just in South Africa but worldwide, where the raging pandemic has so far claimed 20,000 lives, economies Paralyzed, they overwhelmed health systems and spread global uncertainty.

The study could start showing its first positive results in July. Keith Cloete, the provincial health chief, said: “We wholeheartedly support the trial and look forward to positive results.” This could be a huge boost with huge national and global ramifications. “

The TASK trial follows the headlines about an anecdotal study that revealed a large reduction in Covid-19 respiratory infections and up to six times fewer deaths in countries that have universal BCG vaccination policies. One of them is South Africa, which has vaccinated all newborns with BCG since the 1970s.

“The more BCG is done in a country, the better Covid’s results will be,” said TASK executive director and study leader Andreas Diacon, who also teaches medicine at Stellenbosch University.

“It could just be a coincidence. But we know that when you expose natural defense cells to BCG, they seem to be learning something about how to fight infection. They seem to slightly change their behavior, not only to fight tuberculosis but also for other infections. This is just one of the indicators that BCG could provide armor against Covid-19 “.

Diacon said this observation has been made many times around the world.

“A few years ago, while testing a new tuberculosis vaccine, they compared it to BCG. Due to rigorous monitoring, they found by chance that those who had a BCG booster had less frequent upper respiratory tract infections such as pneumonia.

“This evidence was never urgently pursued. For me, it was a “post it to my desk to arrive someday when I had time”. Now with Covid, he moved to priority number one. And I have a feeling we could change the game. “

Several similar trials are expected to start in the Netherlands and Australia, but the TASK study is the first to come out.

“We can do this type of research faster than anyone else because we have all the established systems and protocols of our TB research where we are pioneers,” Diacon said.

“Well, Covid is a new disease, but that is not a problem because the process is routine for us. We have highly trained personnel who work quickly and effectively.”

TASK has a reputable track record in the field of tuberculosis research, where it is a leading global player in the evaluation of early-stage TB medications. TASK trials from 2005 to 2012 led to the registration of Bedaquiline, the first new tuberculosis drug in decades, for patients with resistance to conventional antibiotics. Diacon received an international award for this achievement.

TASK also has an initial advantage because it went through the regulatory process in less than a week instead of the usual three or four months.

“Regulators have been fantastic,” said Diacon. “The ethics committee responded over the weekend, which is unheard of and with constructive collaborative comments that is very encouraging. Tygerberg has also given us a head start with quick access to its staff to recruit participants as we complete the regulatory process, which means we can start executing. ”

The TASK placebo-controlled adaptive randomized controlled trial begins next week with the first vaccination of 500 healthcare workers at a facility adjacent to Room D-10 at Tygerberg Hospital, one of the officially designated Covid-19 treatment centers in the country.

Weekend Argus



[ad_2]