Two Alliance members, Nucleus Network and 360biolabs, are facilitating the first human trial of a COVID-19 vaccine developed by US biotech company Novavax.
The first human trial of the Novavax COVID-19 vaccine began on the Alfred Research Alliance precinct today.
In the race to find treatments and solutions for the COVID-19 pandemic, there are currently more than 100 coronavirus vaccines in development around the world – but only 10 have made it to human trials so far.
One of those is Novavax’s NVX-CoV2373 vaccine, which was developed at the company’s headquarters in Baltimore and began dosing at Nucleus Network’s Melbourne clinic today. The Phase I trial is the first of its kind in the Southern Hemisphere.
“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,” said Dr Paul Griffin, infectious diseases physician and microbiologist at Nucleus Network.
The trial has a total of 131 participants across Nucleus Network’s sites in Melbourne and Brisbane, with the first six people to begin treatment on the Alliance precinct today.
The participants are all healthy adults aged between 18 and 59, and will be injected with a virus substitute before receiving the vaccine.
In the fight against COVID-19, there are several different strategies begin utilised by companies around the globe to develop a vaccine. Novavax’s is a SARS-CoV-2 recombinant spike protein nanoparticle vaccine, meaning it uses the ‘spike protein’ in the virus to create antibodies.
As an additional endorsement of the Alfred Research Alliance’s expertise in clinical trials, another member organisation, 360biolabs, was selected by Novavax to conduct the sample analysis for the vaccine.
Due to the nature and sensitivities of certain assays used in this clinical trial, a specialist biosecurity facility was required. With its highly experienced scientists working in state-of-the-art Biosafety Level 2 and 3 laboratories, 360biolabs was identified as having the ideal resources and environment to conduct these crucial studies.
The results of the Phase I trial are expected in July. If successful, it will then be able to proceed to a Phase II trial where it will be administered to a larger group of people to determine efficacy and further evaluate its safety.
Although lockdown restrictions are beginning to lift in Victoria, the social distancing requirements of the COVID-19 pandemic have presented some unique challenges for Nucleus Network in administering the trial.
CEO Cameron Johnson said the clinical trials organisation would be taking strict precautions to ensure the integrity of the trial and improve safety for clinic staff and trial participants.
“These staff are assigned to work only in functional designated areas and there is no cross-pollination of these teams,” he said. “We still have a long way to go, but we’re proud to be a part of the team to deliver a safe, effective and globally accessible vaccine as quickly as possible.”
This vaccine trial is one of more than 30 COVID-19 projects currently underway at the Alfred Research Alliance.
As one of Australia’s leading biomedical precincts, the Alliance is home to some of the country’s top infectious diseases researchers and clinicians, who have played an active role in the COVID-19 response so far and in ongoing research into the virus and its impacts.
Researchers across all eight member organisations have been involved in several ways, including vaccine and antiviral development, serology testing, laboratory services and public health research.