Johannesburg - Researchers at the University of Cape Town (UCT) had to put the brakes on a Covid-19 trial that was supposed to start this week after a participant in the international study got sick.
The international Johnson & Johnson Ad26.Cov2-S phase three study has been paused after a participant fell ill with an unexplained illness. This is the second Covid-19 trial to be paused because of a sick participant. Last month, the AstraZeneca trial was paused after a participant in the UK leg of the study fell ill, also from a mysterious illness. After investigations, the trial was reinstated.
Locally, the Johnson & Johnson study is being done in partnership with UCT. Professor Glenda Gray, president and chief executive of the SA Medical Research Council and the protocol chairperson of this trial, said they were hoping to get between 10 000 and 12 000 participants in 31 sites across the country. Internationally, it has about 60 000 participants, in the US, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
“They paused it at a global level. The important thing to realise is that participants’ safety is paramount. While they are investigating it (the illness), it is safer to pause the global study until we know what is going on. It is hard to justify continuing,” Gray said.
In a statement announcing the pause, Johnson & Johnson said: “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies. We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
Gray said the study team was still trying to investigate whether the participant was on the placebo or the vaccine. Once the illness was evaluated, a decision whether to continue or not would be made.
Gray said what the team discovered would influence whether the local study, which was supposed to start this week, would continue or not.
She said it was important to protect participants.
“We now need to know if this illness is related to the vaccine.”
The Star