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MELBOURNE: Clinical trials of a coronavirus vaccine candidate being developed in Australia were scrapped after trial participants yielded false-positive results for HIV, developers announced Friday.
The COVID-19 vaccine, which was being developed by the University of Queensland (UQ) and biotech company CSL, has been scrapped, the company said in a statement issued to the Australian Stock Exchange, CSL said it would halt trials. additional.
The vaccine was one of four candidates that Australia had committed to purchasing, and consequently deals were made to secure 51 million doses of the vaccine.
Emphasizing that the vaccine has a “strong safety profile,” CSL said, “The potential for this cross-reaction had been anticipated prior to the start of the trial.”
In a statement, CSL said that no serious adverse effects had been reported in the 216 trial participants and that the vaccine was shown to have a “robust safety profile.”
However, the trial data revealed that the antibodies generated by the vaccine interfered with the diagnosis of HIV and resulted in false positives in some HIV tests, CSL said.
If the vaccine is rolled out nationally, CSL said it could undermine public health in Australia by causing a wave of false positive HIV tests in the community.
“Follow-up tests confirmed that there is no presence of the HIV virus, only a false positive in certain HIV tests. There is no possibility that the vaccine causes infection,” the statement added.
CSL also said that participants were told before the trial began that the vaccine could interfere with certain HIV diagnostic tests.
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Human trials have been conducted since July this year with 120 volunteers in Brisbane.
The vaccine, manufactured at CSL’s biological facility in Victoria, was developed using an existing UQ technology called a “molecular clamp,” a proprietary system that is designed to stimulate an immune response and protect against people who develop COVID-19.
Reacting to the CSL news, Australian Prime Minister Scott Morrison said abandoning the trial should show Australians that the government and investigators were proceeding carefully.
“What happened today is not a surprise to the government. We are moving fast, but not too fast,” he said, adding that the system is working as it should and that Australians are protected, as always.
The University of Queensland began a phase 1 trial of its COVID-19 vaccine candidate, v451 in July 2020 to assess safety and immunogenicity in healthy volunteers.
CSL was working to take over responsibility for the phase 2/3 clinical trial and large-scale manufacturing of the vaccine after the trials were successfully completed.
UQ Vice Chancellor Deborah Terry said that while the result was disappointing, she was immensely proud of the UQ team that had taken on great responsibility as the world watched.
“I also want to thank our many partners, our donors, including the federal and Queensland government, and of course the 216 Queenslanders who volunteered for Phase 1 trials,” Terry said.
UQ vaccine co-director Paul Young said that while the vaccine could be redesigned, the team couldn’t afford the time needed.
“Doing so would delay development by another 12 months, and while it is a difficult decision to make, the urgent need for a vaccine should be everyone’s priority,” Young said.
Australia has so far reported 28,011 coronavirus cases and 908 coronavirus-related deaths, according to Johns Hopkins University.
Clinical trials of a coronavirus vaccine candidate being developed in Australia have been ruled out after trial participants yielded false positive results for HIV, developers announced Friday.
The COVID-19 vaccine, which was being developed by the University of Queensland (UQ) and biotechnology firm CSL, has been scrapped, the company said in a statement issued to the Australian Stock Exchange, CSL said it would halt trials. additional.
READ ALSO | Pfizer COVID-19 Vaccine Gets US Expert Approval for Emergency Use
The vaccine was one of four candidates that Australia had committed to purchasing, and consequently deals were made to secure 51 million doses of the vaccine.
Emphasizing that the vaccine has a “strong safety profile,” CSL said, “The potential for this cross-reaction had been anticipated prior to the start of the trial.”
In a statement, CSL said that no serious adverse effects had been reported in the 216 trial participants and that the vaccine was shown to have a “robust safety profile.”
However, the trial data revealed that the antibodies generated by the vaccine interfered with the diagnosis of HIV and resulted in false positives in some HIV tests, CSL said.
If the vaccine is rolled out nationally, CSL said it could undermine public health in Australia by causing a wave of false positive HIV tests in the community.
“Follow-up tests confirmed that there is no presence of the HIV virus, only a false positive in certain HIV tests.
There is no possibility that the vaccine will cause infection, “the statement added.
CSL also said that participants were told before the trial began that the vaccine could interfere with certain HIV diagnostic tests.
Human trials have been conducted since July this year with 120 volunteers in Brisbane.
The vaccine, manufactured at CSL’s biological facility in Victoria, was developed using an existing UQ technology called a “molecular clamp,” a proprietary system that is designed to stimulate an immune response and protect against people who develop COVID-19.
Reacting to the CSL news, Australian Prime Minister Scott Morrison said abandoning the trial should show Australians that the government and investigators were proceeding carefully.
“What happened today is not a surprise to the government.
We are moving fast, but not too fast, ” he said, adding that the system is working as it should and Australians are protected, as always.
Did the University of Queensland initiate a phase 1 trial of its COVID-19 vaccine candidate? v451 in July 2020 to assess safety and immunogenicity in healthy volunteers.
CSL was working to assume responsibility for the phase 2/3 clinical trial and large-scale manufacturing of the vaccine after the trials were successfully completed.
UQ Vice Chancellor Deborah Terry said that while the result was disappointing, she was immensely proud of the UQ team that had taken on great responsibility as the world watched.
“I also want to thank our many partners, our donors, including the Queensland and federal government, and of course the 216 Queenslanders who volunteered for Phase 1 trials,” Terry said.
UQ vaccine co-director Paul Young said that while the vaccine could be redesigned, the team couldn’t afford the time needed.
“Doing so would delay development for another 12 months or more, and while it’s a difficult decision to make, the urgent need for a vaccine should be everyone’s priority,” Young said.
Australia has so far reported 28,011 coronavirus cases and 908 coronavirus-related deaths, according to Johns Hopkins University.
