A TIA facility will play an important role in The University of Queensland’s research to take a second-generation molecular clamp vaccine to a proof-of-concept human trial.
The Coalition for Epidemic Preparedness Innovation (CEPI) will provide up to $8.5 million to support further development of the re-engineered technology for use in a global response to future disease outbreaks.
The clinical batch of the Clamp2 vaccine has been manufactured at the 50L scale at the Queensland node of TIA’s National Biologics Facility (NBF), housed at UQ’s Australian Institute for Bioengineering and Nanotechnology.
NBF Director of Strategic Development Ben Hughes said conducting such a human trial with material produced at UQ was a significant achievement.
“This will be a Phase I trial to assess the safety and efficacy of the Clamp2 platform in healthy volunteers,” Mr Hughes said.
“While we have selected a Clamp2 SARS-CoV-2 vaccine for the trial, this is to demonstrate the effectiveness and potential benefits of this platform compared to a currently licensed COVID-19 vaccine.
“It’s crucial in demonstrating that the platform of a combination of technology, team and NBF infrastructure can consistently deliver on future rapid-response needs.”
Associate Professor Keith Chappell, leader of UQ’s Rapid Response Vaccine Pipeline, said the human trial would involve 70 volunteers and was expected to start as early as March next year.
Half the volunteers would be given the Clamp2 COVID vaccine and half given Novavax, to compare the UQ technology against an already approved COVID-19 shot, Dr Chappell said.
“Putting our technology up against the best vaccines that are available and approved for use, we can tell with some certainty that our vaccine works,” he said.
“This technology could be used for making better vaccines for viruses we already know about or for viruses against which there is currently no vaccine available – and we’re actively pursuing both of those areas.”
Dr Chappell said pre-clinical testing had shown that Clamp2 met all expectations, produced stabilised antigens and induced strong neutralising immune responses.
“We have been able to validate the Clamp2 platform in the laboratory and show that it is equivalent to the original platform across multiple virus families including influenza virus, Nipah virus and SARS-CoV-2.
“Importantly, this re-engineered technology does not pose any issue with diagnostic interference as was encountered in 2020.”
A decision was made in 2020 not to proceed into later stage clinical studies for the first generation of the clamp technology following cross-reactivity in HIV diagnostics, with antibodies registering a low response on some highly sensitive tests.
UQ Associate Professor Dan Watterson, who headed the successful Clamp2 design, said it was important to understand the aim was not to bring a new COVID-19 vaccine to market.
“This is about the role this technology could play in safeguarding against future pandemics, ensuring we have an Australian-based rapid response vaccine pipeline, the team and the infrastructure ready to deliver clinical-grade material should it be needed in the future,” Dr Watterson said.