Novavax has expanded its Phase 3 clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19, to include adolescents, the company said in a news release.
The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents 12-17 years old.
Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will be monitored for safety for up to two years following the final dose.
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials. The first arm is a trial in the United Kingdom that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall. The second arm is the PREVENT-19 trial in the United States and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the United States and Australia.
