US-based biotechnology company Novavax initiated patients in an Australian-based phase one trial of its investigational COVID-19 vaccine this week with the support of clinical research organisation, Nucleus Network.
Nucleus is running the trial of Novavax's recombinant spike protein nanoparticle vaccine, NVX-CoV2373.
“As Australia’s largest phase 1 clinical trials specialist, we have a rich history of delivering phase 1 vaccine trials, and a long-standing track record with Novavax,” said Nucleus Network infectious diseases physician and microbiologist Paul Griffin. “This trial offers the first critical step into creating a potential vaccine that is safe and able to be accelerated into the next phase of development.”
“The urgent global race to develop a vaccine against the COVID-19 pandemic drove our rapid identification and selection of an optimal, highly immunogenic vaccine candidate,” said Stanley C. Erck, President and CEO of Novavax. “We are pleased that Nucleus, our long-time partner, was able to accommodate our accelerated timeline.”
The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia (Melbourne and Brisbane). The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.
The trial is expected to deliver preliminary immunogenicity and safety results in July.
According to US-based BIO, there are now over 500 vaccines and treatments in development targeting COVID-19. Several vaccines, including from Novavax, have entered early phase clinical trials.