A phase 3 trial evaluating the vaccine candidate NVX-CoV2373 (Novavax) against coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers.
NVX-CoV2373 is engineered from the genetic sequence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine candidate contains the Company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses.
The randomized, observer-blinded, placebo-controlled trial will assess the efficacy and safety of NVX-CoV2373 in approximately 30,000 adults in the US and Mexico, including a goal of enrolling at least 25% of individuals aged 65 years and older. The study will also focus on enrolling individuals at higher risk of severe COVID-19 disease, including those who are Black (including African Americans), Native American, or of Latino or Hispanic ethnicity, and those who have underlying health conditions (eg, obesity, chronic kidney disease, diabetes).
Participants will be randomized 2:1 to receive 2 intramuscular injections of either NVX-CoV2373 or placebo administered 21 days apart. The primary end point is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease (7 or more days after the second vaccination).
An independent data and safety monitoring board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study. The study is being funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
In November 2020, the FDA granted Fast Track designation to NVX-CoV2373 based on data from a phase 1/2 trial as well as preclinical studies. Findings from the phase 1 portion showed that NVX-CoV2373 was well tolerated and elicited antibody responses numerically superior to that seen in human convalescent sera. The vaccine was also found to induce polyfunctional CD4+ T cell responses.
Adults interested in participating in the trial can visit coronaviruspreventionnetwork.org.
Phase 3 trial of Novavax investigational COVID-19 vaccine opens. [press release]. Bethesda, MD: National Institutes of Health; December 28, 2020.