Australian Covid-19 vaccine trials ended after test subjects return ‘false positive’ HIV results

An Australian produced coronavirus vaccine candidate has been scrapped after trial participants returned false positive test results for HIV, developers announced Friday.

The inoculation, which had yet to progress beyond Phase 1 trials, was being jointly developed by the University of Queensland and Australian biotech company CSL. Australia had hoped the vaccine would be available by mid-2021.

In a statement, CSL said that no serious adverse effects had been reported in the 216 trial participants, and the vaccine was shown to have a “strong safety profile.” However trial data revealed that antibodies generated by the vaccine interfered with HIV diagnosis and led to false positives on some HIV tests, CSL said.

If the vaccine was 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 HIV virus present, just a false positive on certain HIV tests. There is no possibility the vaccine causes infection,” the statement added.

Australian Prime Minister Scott Morrison told reporters on Friday morning that the vaccine “will no longer feature as part of the country’s vaccine plan.” Australia had pre-emptively ordered 51 million doses of the CSL vaccine in October.

Morrison said that Australia had backed four vaccines that showed promise but “at no stage … believed that all four of those vaccines would likely get through that process.”

“So that’s why we spread our risk. That’s why we backed important projects. And that’s why we pre-prepared to ensure that we could deal with any issues along the way,” he said.

In addition to the University of Queensland vaccine, Australia had previously ordered a combined 73.8 million doses of the AstraZeneca and the Novavax vaccines.

Australian Minister for Health Greg Hunt said that following the announcement, Australia would be ordering an extra 20 million units from AstraZeneca and 11 million from Novovax.

A vaccine has to pass through three stages of trials before it can then be considered for approval for public use. Australia has yet to grant approval to a coronavirus vaccine candidate.

Adam Taylor, early career research leader in emerging viruses at Griffith University’s Menzies Health Institute, said in an emailed statement that the false positive HIV results were a result of the technology used to create the vaccine.

“The (vaccine’s) molecular clamp is made from a HIV protein, which on its own is harmless. The molecular clamp stabilizes the coronavirus spike protein and presents it to the body in a way that promotes a good immune response. This is why the clamp technology is so vital,” Taylor said.

He added that the clamp model vaccine had shown “good safety and immune response” against the coronavirus in early clinical trials, and the possibility for generating an HIV positive result had been thought to be low.

Some Australian health experts have praised the University of Queensland researchers for ending the trial when they did. “Although it might seem counter-intuitive, from a research ethics viewpoint, this is a success,” said Diego Silva, an health ethics expert at the University of Sydney School of Public Health, in an emailed statement.