Coronavirus Vaccine Launches Study in Australia and the USA
A late-stage biotechnology company based in Maryland announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373.
Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
Late on May 25, 2020, Novavax, Inc. issued a press statement saying “Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax.
“We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”
The Phase 1/2 clinical trial is being conducted in multiple parts.
The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted.
The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s 2-dose trial regimen assesses the dose sizes (5 and 25 micrograms) with Matrix‑M and without.
The Phase 2 portion is expected to be conducted in multiple countries, including the USA, and would assess immunity, safety, and COVID‑19 disease reduction in a broader age range.
This Phase 1/2 approach allows for the rapid advancement of NVX‑CoV2373 during the pandemic.
Novavax identified NVX‑CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies.
These results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID‑19 and thus helping to control the spread of this disease.
NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease.
NVX‑CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
In preclinical trials, NVX‑CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection.
The Coalition for Epidemic Preparedness Innovations (CEPI) previously announced it is investing up to $388 million of funding to advance the clinical development of NVX‑CoV2373.
Novavax’s 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 is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.
Precision Vaccinations publishes vaccine development news.