Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.
“With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley C. Erck, president and chief executive officer, Novavax. “We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program.”
Novavax PREVENT-19 Phase 3 Study
PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-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. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.
Two thirds of the participants will be assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants will receive placebo. Trial sites were selected in locations where transmission rates are currently high, to accelerate the accumulation of positive cases that could show efficacy.
NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.
Enrollment And Study Population
Novavax plans to recruit, enroll, and study a diverse population with an emphasis on communities and demographic groups most impacted by the disease as well as to maximize participation of older adults and those living with co-morbid conditions (e.g., obesity, hypertension and diabetes) that place them at higher risk of complications from COVID-19. Enrollment goals are:
- ≥ 25 percent of the study population is intended to be in the 65 years of age or older group
- ≥ 15 percent black/African American
- 10-20 percent LatinX
- 1-2 percent American Indian
“We are encouraged by the data generated to-date on NVX-CoV2373 and are optimistic about our ability to positively build on the body of evidence with this trial,” said Gregory M. Glenn, M.D, president of research and development, Novavax.
“We recognize that volunteers considering our trial may have questions about the potential impact on their ability to receive an authorized vaccine when it becomes available to them. We wish to reassure participants that we are working to ensure that their involvement in our trial does not negatively impact their ability to be vaccinated at the appropriate time.”