In an effort funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), Novavax, Inc. has begun enrolling volunteers for a phase three trial of NVX-CoV2373, a COVID-19 vaccine candidate.
Volunteers can be anyone 18 years of age or older, although they will be divided into two groups: those 18 through 64 and those aged 65 years or older. The trial will be randomized and placebo-controlled, gathering approximately 30,000 people and taking place at around 115 sites in the U.S. and Mexico. The candidate’s safety and efficacy will be the main focus of the trial, which Novavax will lead as the regulatory sponsor. The federal multi-agency effort known as Operation Warp Speed is also aiding the trial.
“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry, and the community,” NIAID Director Anthony Fauci said. “The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.”
Baseline nasopharyngeal and blood samples will be drawn from participants, after which they will be given either a vaccine or placebo at random. There will be two volunteers receiving an actual vaccine for every one given a placebo. A second injection will follow 21 days after the first, but participants will be studied for two years after.
Scientists will study the blood samples for immune responses to the COVID-19 causing virus, SARS-CoV-2. The trial’s primary endpoint is to determine whether the candidate can prevent symptomatic COVID-19 disease seven or more days after the second injection, compared to the placebo.
NVX-CoV2373 has already been animal tested, and in those studies produced antibodies that blocked the coronavirus spike protein from binding to cell surface receptors targeted by the virus, thereby preventing infection. It can also be stored, handled, and distributed at above-freezing temperatures, which gives it an edge over some of its competitors. Made from a stabilized form of the coronavirus spike protein with recombinant protein nanoparticle technology, the candidate was also shown to be well-tolerated in a phase one clinical trial. Phase 2b, 1/2, and another phase 3 trial are currently ongoing.