South Africa will launch clinical trials of a US-developed coronavirus vaccine with 2,900 volunteers this week, the second such study, lead investigator Shabir Madhi said.
Known as NVX-CoV2373, the vaccine was developed by US biotech company Novavax from the genetic sequence of SARS‑CoV‑2, the virus that causes the COVID-19 disease.
It will be administered to the first volunteer in the randomised, observer-blinded trial on Wednesday.
"It's a two-dose schedule, and they get two either vaccines or placebos… spaced three weeks apart," professor Madhi of the Johannesburg-based University of the Witwatersrand (Wits), told AFP.
Since the country also accounts for 20 percent of global HIV infections according to UNAIDS 2020 data, 240 medically stable, HIV-positive adults will also participate in the clinical trial.
Dr Shabir Madhi, professor of Vaccinology at Wits University, will lead the clinical trial which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation, the company said in a statement on Monday (17 August).
“Because South Africa is experiencing a winter surge of Covid-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373,” said Gregory M. Glenn, president of Research and Development at Novavax.
“We appreciate the continued support of the Bill & Melinda Gates Foundation and CEPI, and our strong ongoing collaboration with Wits University, all of whom are united with us in our commitment to produce and deliver a safe, effective vaccine across the globe.”
Novavax said that the trial will consist of two cohorts. The first cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults.
The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allows for evaluation of the vaccine across a diverse, representative study population, it said.
Novavax expects that, if approved in South Africa, its Covid-19 vaccine will ultimately be supplied to in the country through a recently announced collaboration with the Serum Institute of India.
“The major motivation for the Covid-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own,” said Madhi.
“I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax’ Covid-19 vaccine’s positive Phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults.”