The South African clinical trial, run by a Bellville-based clinical research centre, may result in a vaccine that could potentially decrease the morbidity and mortality rate resulting from Covid-19.
This is according to dr Caryn Upton, principal investigator of the Bacille Calmette-Guérin (BCG) trial at TASK Clinical Research Centre. The trial commenced on 4 May at Tygerberg Hospital.
A BCG vaccine or placebo will be received by 500 healthcare workers within the next few weeks, said dr Upton. The trial participants will be monitored for up to a year thereafter, she said.
On the left, pulmonology specialist, prof Diacon stands with dr Caryn Upton, principal investigator, watching as a nurse administers the Bacille Calmette-Guérin vaccine on the first participant in the trial.
PHOTO: Duncan McDonald
The aim is to determine whether or not BCG vaccinations can reduce the probability of Covid-19 infections or a symptom severity thereof, said Duncan McDonald, head of business development and marketing at TASK.
According to McDonald, the BCG vaccines protect against respiratory tract infections and are used against tuberculosis (TB) in children.
It is said that revaccinating adults with BCG could aid in decreasing the consequences of the pandemic, according to dr Upton.
The placebo-controlled, adaptive and randomized trial will be led by prof Andreas Diacon, a pulmonology specialist at Tygerberg Hospital and medical professor at Stellenbosch University.
TASK’s chief opperational officer, dr Naadira Vanker, came across a trial in the Netherlands called BCG Corona. TASK has subsequently received and modified their protocol.
Principal investigator, dr Caryn Upton explains the significance of the Bacille Calmette-Guérin trial
Principal investigator, dr Caryn Upton stands on the right in front of TASK staff as she trains the team leading up to the commencement of the trial.
PHOTO: Duncan McDonald
Time frame
According to Upton, the trial should be rigorous and evidence-based.
The requisite protocols are already in place, due to extensive TB research in South Africa, enables TASK to do the research quicker, said Upton.
The ideal outcome, according to Upton, would be that a significant difference between the two different arms are identified in the early stages, enabling the doctors to make recommendations as soon as possible during the pandemic.
“We need it to be fast enough that we’re able to see something quickly, but also not so fast that it overwhelms the healthcare system and that we have a lot of healthcare workers who are sick,” said Upton.
As soon as evidence of statistically significant data emerges, or if a futility is identified, the evidence will be provided to the relevant regulatory bodies, Upton said.
Principal investigator, dr Caryn Upton, discusses the additional challenges the Bacille Calmette-Guérin trial is faced with.
Promising outcome
No evidence currently exists that the trial has any effect in terms of preventing Covid-19, said Upton. A statistician will therefore regularly analyse the data from the trial and a data safety monitoring board will also be looking at the unblinded data, Upton added.
In comparison to countries who have also implemented BCG trials, such as Australia and the Netherlands, South Africa is in a unique position, according to Diacon. This is due to the high prevalence of TB in South Africa and renders TASK familiar with BCG trials for other respiratory tract infections, said Diacon.
The outcome of this BCG trial could be a potential game changer, he said.
TASK’s information sheet on the clinical trial currently underway at Tygerberg Hospital.