April 15, 2020
An Australian-based company has announced it will begin Phase I testing of a possible COVID-19 vaccine in Brisbane and Melbourne within weeks.
Nucleus Network says this will be the first COVID-19 vaccine to be tested outside the United States, and only the third such clinical trial in the world.
Phase I clinical trials test a possible vaccine for the first time in a small group of people to evaluate safety, eg. to determine a safe dose and any possible side-effects.
They are the first step in the process that must occur before a new vaccine is released into the marketplace.
The Nucleus Network trials will test a possible vaccine developed by US-based biotechnology company Novavax.
A media release from Nucleus on Wednesday announced it was due to begin Phase I testing for the Novavax SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine, NVX-CoV2373.
“Nucleus has a rich history of Phase I vaccine trials, and a long-standing track-record with Novavax; we are well-positioned to implement rapid testing with first-in-human trials over the coming weeks,” Nucleus CEO Cameron Johnson said.
“With the capacity to conduct this trial across both our Melbourne and Brisbane clinics, we will be assisting Novavax to undertake Phase 1 trials and fast track NVX-CoV2373 to potential subsequent development as soon as possible.”
Novavax president and CEO Stanley Erck said the urgent global race to develop a vaccine against the COVID-19 pandemic had driven the company’s rapid identification of a vaccine candidate.
“We are pleased that Nucleus, our long-time partner, was able to accommodate our accelerated timeline,” Mr Erck said.
The Phase 1 trial of NVX-CoV2373 is expected to begin in mid-May with preliminary immunogenicity and safety results in July.
“We own 150 of the total 250 dedicated Phase 1 beds available in Australia over two sites in Melbourne and Brisbane, located within major medical precincts. Supported by our workforce of over 400 specialists, we are in the unique position of offering sponsors a multi-site pathway to conduct their clinical trials,” Mr Johnson said.
