American vaccine development company Novavax says it has begun a Phase 2b clinical trial in South Africa to evaluate the efficacy of a Covid-19 vaccine candidate.
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.”