Australian COVID-19 Vaccine Candidate Cancels Clinical Trial
The University of Queensland announced that following consultation with the Australian Government, CSL will not progress the UQ-CSL v451 COVID-19 vaccine candidate to Phase 2/3 clinical trials.
The University of Queensland said in a press release issued on December 11, 2020, it commenced a Phase 1 trial of their COVID-19 vaccine candidate in July 2020, to assess safety and immunogenicity in healthy volunteers. CSL was working towards taking responsibility for the Phase 2/3 clinical trial and large-scale manufacture of the vaccine, upon completion of successful trials.
The Phase 1 data showed the generation of antibodies directed towards fragments of a protein (gp41), which is a component used to stabilize the vaccine. Trial participants were fully informed of the possibility of a partial immune response to this component.
But, it was unexpected that the levels induced would interfere with certain HIV tests.
There is no possibility the vaccine causes infection, and routine follow-up tests confirmed there is no HIV virus present, said the University.
With advice from experts, CSL and UQ have worked through the implications that this issue presents to rolling out the vaccine into broad populations.
It is generally agreed that significant changes would need to be made to well-established HIV testing procedures in the healthcare setting to accommodate the rollout of this experimental vaccine.
Therefore, CSL and the Australian Government have agreed vaccine development will not proceed to Phase 2/3 trials, confirmed the University.
The University of Queensland plans to submit the full data for peer-review publication.
UQ Vice-Chancellor, Professor Deborah Terry, said in a press statement, ‘while the outcome was disappointing, she was immensely proud of the UQ team who had shouldered a heavy burden of responsibility while the world watched on.’
‘I also want to thank our many partners, our donors – including the Federal and Queensland Government – and of course the 216 Queenslanders who so willingly volunteered for the Phase 1 trials.’
UQ vaccine co-lead, Professor Paul Young, added that although it was possible to re-engineer the vaccine, the team did not have the luxury of time needed.
“Doing so would set back development by another 12 or so months, and while this is a tough decision to take, the urgent need for a vaccine has to be everyone’s priority.”
“I said at the start of vaccine development that there were no guarantees, but what is really encouraging is that the core technology approach we used has passed the major clinical test. It is a safe and well-tolerated vaccine, producing the strong virus-neutralizing effect that we were hoping to see.”
“So we will continue to push forward and we are confident that with further work the Molecular Clamp technology will be a robust platform for future vaccine development here in Australia and to meet future biosecurity needs.”
Dr. Andrew Nash, Chief Scientific Officer for CSL, commented: ‘this outcome highlights the risk of failure associated with early vaccine development, and the rigorous assessment involved in making decisions as to what discoveries advance.’
“This project has only been made possible by the innovative science developed by world-class scientists at The University of Queensland and the strong collaboration between our organizations, and many others, over the past 10 months.”
“CSL and Seqirus are committed to continuing our work to protect the Australian population against COVID-19. Manufacture of approximately 30 million doses of the Oxford/AstraZeneca vaccine candidate is underway, with first doses planned for release to Australia early next year.”
“In addition, CSL has agreed at the request of the Australian Government to manufacture an additional 20 million doses.”
UQ and CSL acknowledge the support of the Coalition for Epidemic Preparedness Innovations is partnering to enable the rapid development of the vaccine candidate through clinical trials.
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