Volunteers needed for 'Clamp2' vaccine testing

University of Queensland

Recruitment is underway for a pivotal proof-of-concept human trial of The University of Queensland's second-generation molecular clamp vaccine.

Seventy healthy volunteers are needed for the study at Nucleus Network in Brisbane, to demonstrate the potential benefits of the re-engineered vaccine platform.

Project leader, Associate Professor Keith Chappell, said the safety and immunogenicity of a second generation clamp SARS-CoV-2 vaccine would be compared to a currently licenced COVID-19 vaccine, after meeting all expectations in pre-clinical testing.

"Half of the study participants will receive one dose of the UQ vaccine and the other group will receive the TGA-approved Novavax vaccine.

"After receiving the vaccines, participants in both groups will be monitored regularly for a period of 6 months, with appointments at the Nucleus Network clinic."

Dr Chappell said there had been continued community support for UQ's vaccine efforts and the team hoped this would be reflected in recruitment for the important proof-of-concept trial.

"We need healthy volunteers aged 18 to 50 to put up their hands and by participating they will be making a genuine difference helping us to be ready for the next pandemic.

"There will be an assessment to ensure the trial is right for them, there are no overnight stays required, and participants will be reimbursed for their time."

The 'Clamp2' platform has produced stabilised antigens and induced strong neutralising immune response in pre-clinical testing and does not pose any of the diagnostic interference issues encountered in 2020.

The Coalition for Epidemic Preparedness Innovation (CEPI) is providing up to AU$8.5 million to support further development of the platform for use in the global response to future disease outbreaks.

Progress to a proof-of-concept human trial has also been supported by the Queensland and Australian Governments.

Queensland's Deputy Premier and Minister for State Development Steven Miles said this next stage of the Clamp2 journey was a shot in the arm for manufacturing confidence in Queensland.

"UQ's Rapid Response Vaccine Pipeline team has demonstrated that the Clamp2 vaccine induces an equivalent immune response to a number of viruses, which is a fantastic step forward," Dr Miles said.

"The fact it was made right here in Queensland is hugely significant.

"The Palaszczuk Government is always proud to invest in game-changing programs like this."

NBF Queensland Node Director, Ben Hughes, said the goal was not to rush a new COVID-19 vaccine to market.

"This is about testing the technology that can help to safeguard against future pandemics, and ensuring Australia has the capability to develop and deliver clinical-grade vaccines should they be needed," he said.

Nucleus Network Chief Medical Officer Jason Lickliter said the company was excited to partner with UQ on the clinical trial of this promising new vaccine platform.

"It is a great opportunity for Queenslanders to participate in a study of a vaccine that was developed in Queensland," he said.

"Should there be a future global disease outbreak, this will potentially allow us to respond faster."

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 made available in an outbreak situation to populations at risk including low-income and middle-income countries.

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