The University of Queensland's re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved vaccine considered among the best in its class.
The pivotal proof-of-concept testing clears the way to progress the promising Clamp2 technology in a range of research programs.
Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an exciting reward for the team's continued dedication and the community's widespread support for the project.
"We compared second-generation clamp SARS-CoV-2 vaccine head-to-head with TGA-approved Nuvaxovid (Novavax), and the two were found to be functionally equivalent," Dr Chappell said.
"The Clamp2 trial group showed a 2.5-fold boost in neutralising 'titres' and it was 2.1 in the Novavax group.
"The two vaccines produced highly comparable results, however while there were no new COVID infections among the Clamp2 volunteers, there have been three covid cases detected amongst Nuvaxovid recipients so far."
The Coalition for Epidemic Preparedness Innovation (CEPI) has supported the team's rapid response vaccine research for five years and last year committed up to AU$8.5 million to continue development for use in the global response to future disease outbreaks.
Dr In-Kyu Yoon, Director Programmes and Innovative Technology at CEPI said advancing vaccine platforms - like UQs molecular clamp technology - would be crucial for developing vaccines against new emerging infectious threats.
"CEPI is striving towards vaccines being developed within 100 days of a new virus emerging: a goal known as the 100 Days Mission. I look forward to the continued progress of this cutting-edge technology," Dr Yoon said.
The technology is now entering a new phase with a company founded to develop the patented Molecular Clamp.
"UQ's commercialisation company UniQuest has licensed the technology to Vicebio, which is progressing its use against respiratory pathogens such as respiratory syncytial virus, human metapneumovirus and parainfluenza viruses," Dr Chappell said.
Progress to a proof-of-concept human trial for the re-engineered molecular clamp has also been supported by the Queensland and Australian Governments and philanthropic partners.
Queensland Deputy Premier Steven Miles said Queensland was leading the way in vaccine development and manufacturing.
"Advances in medical technology play a key role in bettering the health of Queenslanders throughout the state, and the Palaszczuk Government is committed to backing manufacturing here - made in Queensland by Queenslanders."
Participants in both clinical trial groups will be monitored regularly for a period of 6 months.
The trial was conducted with CSL Seqirus's proprietary MF59® adjuvant which was made available for inclusion with clamp2 vaccine.
Philanthropic partners include the Paul Ramsay Foundation, BHP Foundation, Newcrest, Glencore, RACQ and its members, A2 Milk, The Lott and Aurizon.
As part of UQ's partnering agreement with CEPI, and in line with CEPI's equitable access policy, UQ agrees that vaccine candidates produced using their platform technology will be available in an outbreak situation to populations at risk including in low-income and middle-income countries.