Novavax Inc has announced enrolment of the first participants in a phase 1/2 clinical trial of its coronavirus vaccine candidate, NVXCoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. 
NVXCoV2373 includes Novavax’ proprietary MatrixM adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases,
“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 COVID19 pandemic,” said Mr Stanley C. Erck, President and CEO 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 two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVXCoV2373, both adjuvanted with MatrixM and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with MatrixM and without.
The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVXCoV2373 during the pandemic. 
The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).
Novavax identified NVXCoV2373 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 COVID19 and thus helping to control the spread of this disease.
Dr. Richard Hatchett, CEO of CEPI said, “Entering clinical trials is an important step on the path to delivering a safe, effective and globally accessible vaccine against COVID-19. Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’ vaccine candidate. CEPI’s priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.”

Novavax has identified NVXCoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies.