Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico
- PREVENT-19 enrolls 30,000 volunteers across 118 sites in the
“The full enrollment of PREVENT-19 is another important step in building a body of evidence to demonstrate that NVX-CoV2373 will be safe and effective across diverse, representative populations,” said
PREVENT-19 was planned with specific recruitment diversity and representation goals and enrolled 30,000 volunteers. Location of trial sites emphasized communities and demographic groups most impacted by the disease, including those living with co-morbid conditions that place them at higher risk of complications from COVID-19. The trial largely reached its demographic goals amid the concurrent rollout of vaccines authorized for emergency use.
The trial enrolled diverse participants as follows:
- LatinX: 20%
African American: 13%
- Native American: 6%
- Asian American: 5%
- Older adults (65 years and older): 13%
PREVENT-19 is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. Two thirds of the participants are assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants receive placebo. Trial sites were also selected in locations where transmission rates were high to accelerate the accumulation of positive cases that could show efficacy.
PREVENT-19 is being conducted with support from the
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of the spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
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Source: Novavax, Inc.