The trial is underway in the UK, in partnership with the UK government’s Vaccines Taskforce. Gaithersburg, Md.-based Novavax said it expects to enroll up to 10,000 individuals between 18 and 84 years of age, with and without relevant comorbidities, over the next four to six weeks and to make its UK study protocol public “in the coming days.”
NVX-CoV2373 is a stable, prefusion protein made using the company’s recombinant protein nanoparticle technology that includes its proprietary MatrixM adjuvant, according to the company. Half of the Phase 3 trial participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive a placebo, the company said.
The trial is designed to enroll at least 25% of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.