Novavax launches trial of coronavirus vaccine candidate

Novavax has begun enrolling particpants in a Phase I/II trial assessing its coronavirus vaccine candidate NVX-CoV2373.

NVX-CoV2373 includes the US biotech's proprietary Matrix-M adjuvant to enhance immune responses and stimulate high levels of neutralising antibodies, it said.

Preliminary immunogenicity and safety results from the Phase I portion of the trial are expected in July 2020.

“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 Erck, president and chief executive of Novavax. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase II portion of the trial.”

The Phase I portion is a randomised, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX-CoV2373, both adjuvanted with Matrix-M and unadjuvanted, in around 130 healthy participants 18 to 59 years of age at two sites in Australia.

The Phase II arm is expected to be conducted in multiple countries and would assess immunity, safety and COVID-19 disease reduction in a broader age range.

The trial is being supported by a funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).