Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study
- Category: Vaccines
- Published on Wednesday, 22 December 2021 10:15
- Hits: 1768
- PREVENT-19 trial participants receive heterologous or homologous third dose of NVX-CoV2373
- Continuation of Phase 3 trial will evaluate safety and efficacy
GAITHERSBURG, MD, USA I December 21, 2021 I Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the first 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.
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 (5 micrograms of recombinant Spike protein plus 50 micrograms of Matrix-M™ adjuvant) 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.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain 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 formulated with Novavax' patented saponin-based Matrix-M™ adjuvant 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.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
PREVENT-19, a trial in the U.S. and Mexico, with 25,452 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response in both studies.
Full results from the PREVENT-19 pivotal Phase 3 clinical trial of NVX-CoV2373 have been published in the New England Journal of Medicine.
About Matrix-M™ Adjuvant
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.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization in Indonesia and the Philippines, and has been submitted for regulatory authorization in multiple markets globally. NanoFlu™, the company's quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company's NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.