COVID-19 Vaccine: Novavax initiates Phase IIb trial in South Africa
Gaithersburg: Novavax, Inc. , a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax' 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 NVXCoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.
"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, M.D., President, 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."
The randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373 will include two cohorts. One 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. Novavax expects that, if approved in South Africa, its COVID-19 vaccine would ultimately be supplied to South Africa through Novavax' 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 Shabir Madhi, M.B.B.C.H., FCPaeds, Ph.D. "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."
In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted to the U.S. Food and Drug Administration(FDA) and an independent safety monitoring committee, and have also been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org. Novavax to initiate the Phase 2 portion of this trial in the and Australia in the near future. This trial will include approximately 1,500 subjects and will include older adults.
The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.