The clinical trials of a candidate coronavirus vaccine being tested in Australia were scrapped after participants in the research returned false-positive HIV test results, the developers announced on Friday. The Covid-19 vaccine, which was developed by the University of Queensland (UQ) and the biotech company CSL, was scrapped, the company said in a statement released to the Australian Stock
The vaccine was one of four candidates Australia had undertaken to purchase and arrangements were made to secure 51 million doses of the vaccine accordingly.
In a statement, CSL confirmed that the 216 participants in the study had not reported any significant adverse effects, and the vaccine was shown to have a "strong safety profile."
However, study data showed that the vaccine-generated antibodies interfered with the diagnosis of HIV and led to false positives in some HIV studies, CSL said.
If the vaccine was carried out nationwide, CSL said that by triggering a surge of false-positive HIV tests in the population, it could undermine public health in Australia.
"Follow up tests confirmed that there is no HIV virus present, just a false positive on certain HIV tests. There is no possibility the vaccine causes infection," the statement said.
Before the trial began, CSL also said participants were advised that the vaccine could interfere with some diagnostic tests for HIV.
Human experiments of 120 volunteers in Brisbane have been performed since July this year.
The vaccine, manufactured at CSL's biologics facility in Victoria, was produced using the so-called 'molecular clamp' existing UQ technology, a proprietary device designed to induce an immune response and protect against people who develop Covid-19.
Australian Prime Minister Scott Morrison, responding to the CSL news, said dropping the trial should show Australians that the government and researchers we're proceeding carefully.
"The government is not surprised by what happened today. We are moving quickly, but not with any undue haste," he said, adding that the system works as it should and, as always, Australians are safe.
In July 2020, the University of Queensland started a Phase 1 trial of its COVID-19 vaccine candidate-v451 to test protection and immunogenicity in healthy volunteers.
Upon completion of successful trials, CSL worked towards taking responsibility for the Phase 2/3 clinical trial and large-scale development of the vaccine.
Although the result was disappointing, UQ Vice-Chancellor Deborah Terry said she was incredibly proud of the UQ team, which had shouldered a heavy burden of responsibility while the world was watching.
I would also like to thank our many supporters, our sponsors, including the Federal and Queensland governments, and of course, the 216 Queenslanders who volunteered so enthusiastically for the Phase 1 trials," said Terry."
UQ vaccine co-lead Paul Young said that while it was possible to re-engineer the vaccine, the team did not have the luxury of time required.
"Doing so would set back development by another 12 months or so, and while this is a tough decision to take, the urgent need for a vaccine must be a priority for everyone," Young said.
According to Johns Hopkins University, Australia has so far recorded 28,011 coronavirus cases and 908 related deaths.