Novavax Inc. (NVAX) announced initiation of PREVENT-19 COVID-19 vaccine phase 3 trial booster study.
The company noted that booster doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, have been administered in an extension of the company's PREVENT-19 pivotal Phase 3 clinical trial.
The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373.
According to the company, all PREVENT-19 trial participants are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen and may be administered at least six months after receipt of active vaccine.
The primary endpoint is the first occurrence of polymerase chain reaction (PCR)-confirmed mild, moderate or severe COVID-19 with onset at least seven days after the third (booster) vaccine dose.
Two additional groups will be evaluated in this portion of the trial. Trial participants who initially received placebo and subsequently received a different COVID-19 vaccine are also eligible for a booster dose of NVX-CoV2373.
Participants who were unblinded after initially receiving active vaccine and did not subsequently receive another vaccine will also be eligible to be boosted with NVX-CoV2373.
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