- In an announcement in February this year, the University of Cape Town had revealed that its researchers are expected to start a Phase I clinical trial of an experimental COVID-19 vaccine produced by the US Company ImmunityBio.
- The Phase I trial started in March at the Wellcome Centre for Infectious Diseases Research in Africa’s (CIDRI-Africa) Khayelitsha clinical research site and is still going on.
In an announcement in February this year, the University of Cape Town had revealed that its researchers are expected to start a Phase I clinical trial of an experimental COVID-19 vaccine produced by the US Company ImmunityBio. The said vaccine was reported to be more robust against the emergence of new variants. Since then the trial has progressed. The Phase I trial started in March at the Wellcome Centre for Infectious Diseases Research in Africa’s (CIDRI-Africa) Khayelitsha clinical research site and is still going on.
The second chair in the Department of Medicine at UCT and a co-investigator on the trial, Prof Graeme Meintjes said that the purpose of the trial was to assess safety, and participants were monitored closely for side effects and for reactions to the vaccine.
The review did not raise any major safety concerns and he added that the Phase I trial design has since been adapted to include more cohorts. This has been approved by the South African Health Products Regulatory Authority (SAHPRA). The UCT ethics committee approval is still awaited.
The four additional cohorts include people who have had COVID-19 to facilitate the researchers to look at the effect the vaccine on boosting existing immunity against COVID-19. Vaccines are approved only after findings from phase III trials have been published. Meintjes has confirmed that plans are underway for a larger Phase II and Phase III trial in South Africa, led by the South African Medical Research Council (SAMRC).
Details of the trial design will however only are made public once SAHPRA has given the green light for the trial to proceed. It for example remains to be seen to which vaccines the ImmunityBio vaccine will be compared – we think it is unlikely that placebos will be used in future trials given that we already have vaccines that work very well.
