Novavax has announced the beginning of a phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of Vaccinology at University of the Witwatersrand, will lead the clinical trial, which is supported in part by a US$ 15 million grant from the Bill & Melinda Gates Foundation.
According to Dr. Shabir, 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.
“I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax’s COVID-19 vaccine’s positive phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults,” he further stated.
The Phase 2 trials which will evaluate the vaccine candidate’s safety, immunogenicity, and efficacy, will see as many as 2,900 volunteers, aged 18 to 64, participate. The randomized, observer-blinded, placebo-controlled Phase 2 study will have two cohorts.
One cohort will investigate efficacy, safety and immunogenicity in around 2,665 healthy adults while the second cohort will assess safety and immunogenicity in nearly 240 medically stable, HIV-positive adults.
If approved in South Africa, Novavax intends to supply the vaccine to the country through its alliance with the Serum Institute of India.
The South African study is part of a larger, global clinical programme to evaluate NVX-CoV2373, including larger Phase 3 studies with approximately 30,000 participants, to be launched throughout the world.
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Article by Jedidah Mwangi