Watch: An exclusive look at South Africa’s COVID-19 BCG vaccine trial
The aim of the study is to determine if the BCG vaccine will reduce the probability of contracting the virus or lessen the severity of symptoms associated with COVID-19.
Cape Town-based clinical research organisation TASK has recently begun work on the practical application of a BCG (Bacillus Calmette–Guérin) vaccine trial and its potential ability to halt COVID-19.
Led by Professor Andreas Diacon and Dr Caryn Upton, the aim of the study is to determine if BCG (re)vaccination reduces the probability of infection with the SARS-CoV-2 virus and/or the severity of symptoms associated with COVID-19.
Over the last 15 years, TASK has completed 65 research projects, many of which hold global significance and have contributed to progressing the scientific field of (tuberculosis) TB drug and vaccine development — most notably with early bactericidal activity (EBA) studies and clinical trials. This, in part, led to the registration of the medication known as Bedaquiline.
TASK CEO Diacon is a professor of medicine and principal specialist in pulmonology at Stellenbosch University and Tygerberg Academic Hospital in Cape Town.
Watch: COVID-19 BCG VACCINE TRIAL
The Severe Acute Respiratory Syndrome Coronavirus-2 — also known as SARS-CoV-2 or COVID-19 — has spread rapidly throughout the world. Locally, the pandemic threatens to overpower South Africa’s already-strained public healthcare system.
“Strategies to prevent staff absenteeism in an overrun healthcare system are, therefore, desperately needed to safeguard continuous patient care,” said TASK.
BCG is primarily used as a vaccine against TB in children, but also has non-specific protective effects against other respiratory tract infections in both children and adults.
BCG vaccinations are administered to newborns in South Africa. TASK, however, contends it may be possible that (re)vaccinating adults could help reduce the severe acute symptoms associated with the coronavirus and, in doing so, lessen the burden on the country’s healthcare system.
“The primary objective of this trial is to find out if BCG revaccination reduces disease severity, hospital admissions and death in frontline workers with direct patient contact during the pandemic phase of COVID-19,” said TASK.
TASK business development and marketing head Duncan McDonald said the concept of trained immunity due to vaccines has been around for decades, but has not been well researched.
“We decided this research was definitely worth doing. We have a unique take on the project as we are revaccinating. South Africa has had a universal BCG vaccination policy since the 1970s. It will be interesting to compare the results across different geographic areas and with vaccination vs revaccination in the coming months,” said McDonald.
Call for healthcare workers to participate
TASK says a minimum of 500 healthcare workers will be invited to participate in the BCG-coronavirus vaccine trial.
“After vaccination, we will follow up regularly with telephonic or electronic interviews to capture events, such as SARS-CoV-2 virus infection, respiratory tract infection or hospitalisation,” it said.
The study team will regularly run statistical tests to see whether the benefits of BCG (re)vaccination can be shown. There will be an independent committee looking at the results.
“If there is a robust enough positive signal the results will be made public,” it said.
The study is currently funded by TASK and limited to 500 participants. External funding, however, would allow for an increase in the number of participants.
“This would, in turn, detect a protective effect of BCG revaccination more quickly. Thus we are calling on all appropriate entities, internal sponsors and funders and local government to make further funds available,” it added.
McDonald said it would most likely take around two months to recruit the 500 healthcare workers.
“We are estimating it will take two months to recruit 500 HCWs, but of course the sooner the better and we are working as hard and fast as resources allow,” he said.
McDonald said TASK will start recruiting on Monday 11 May. He said there are currently 40 to 50 people on trial thus far. The volunteers will be monitored and evaluated for a year.
When asked what the hope is for the BCG vaccine, McDonald said:
“We hope that we see a significant reduction in the severity of COVID-19 in the volunteers who receive the BCG vaccine. If we do see a significant benefit, this might be able to be used as one of many tools in the prevention and treatment of COVID-19 while awaiting an effective vaccine,” he said.
To participate as a sponsor or funder, one may contact Duncan McDonald at firstname.lastname@example.org or at 021-100-3606. To join the study as a participant, one may call or WhatsApp 079-050-2775 or e-mail email@example.com.