EXPERT REACTION: UQ COVID vaccine abandoned after HIV antibody positives

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UQ and CSL have this morning confirmed they are abandoning their trials of an Australian COVID-19 vaccine after recipients generated HIV antibodies during phase 1 tests. This means the antibodies produced by the vaccine can interfere with HIV diagnostic tests. However there was no possibility the vaccine caused infection, and routine follow-up tests confirmed no HIV virus was present. In a statement to the Australian Stock Exchange, CSL said in order for the vaccine to be released, it would require "significant changes" to HIV testing procedures, and the UQ vaccine co-lead Paul Young said fixing the vaccine would set development back another year.

Organisation/s: CSL Innovation Pty Ltd, The University of Queensland

Funder: UQ and CSL acknowledge the support of the Coalition for Epidemic Preparedness Innovations (CEPI) in partnering to enable the rapid development of the vaccine candidate through clinical trials.

Media release

From: CSL Innovation Pty Ltd

For Immediate Release: Update on The University of Queensland COVID-19 vaccine

Friday, 11th December, 2020: The University of Queensland (UQ) and CSL today announce that the Phase 1 trial of the UQ-CSL v451 COVID-19 vaccine has shown that it elicits a robust response towards the virus and has a strong safety profile. There were no serious adverse events or safety concerns reported in the 216 trial participants. However, following consultation with the Australian Government, CSL will not progress the vaccine candidate to Phase 2/3 clinical trials.

The University of Queensland commenced a Phase 1 trial of their COVID-19 vaccine candidate – v451 – 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 also showed the generation of antibodies directed towards fragments of a protein (gp41), which is a component used to stabilise 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.

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 rollout of this vaccine. Therefore, CSL and the Australian Government have agreed vaccine development will not proceed to Phase 2/3 trials.

The Phase 1 trial will continue, where further analysis of the data will show how long the antibodies persist, with studies so far showing that levels are already falling. The University of Queensland plans to submit the full data for peer review publication.

UQ Vice-Chancellor, Professor Deborah Terry, said 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, said 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-neutralising 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 said “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 organisations, and many others, over the last 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 (CEPI) in partnering to enable the rapid development of the vaccine candidate through clinical trials.

-ENDS –

Expert Reaction

These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.

Associate Professor Sanjaya Senanayake is a specialist in Infectious Diseases and Associate Professor of Medicine at The Australian National University

While it is disappointing that an Australian vaccine candidate has been taken off the table, it is not surprising that one of the many COVID-19 vaccines has failed.

In general, about 90 per cent of vaccines never make it to market. As a global community, we have been spoilt with the unprecedented swiftness and success with which the development of COVID-19 vaccines have taken place.

This is a reminder of the stark reality of vaccine development. The issue was an unusual one, not related to efficacy or even to safety in the usual sense. The problem was that the innovative molecular clamp technology of the UQ vaccine had needed a protein from the HIV virus: the gp41 protein. There was never any risk of participants in the trial getting HIV - think of it as using a body part rather than a whole person - but it did mean that some participants were testing positive to HIV even though they didn't have HIV.

Given that millions of people in Australia and around the world might have received the vaccine, this could have led to confusion and anxiety as people tested positive to HIV without actually having the infection. There are still over 50 candidate vaccines in different stages of human trials on top of the three vaccines that our government has already made deals with; therefore, vaccine supply in the absence of the UQ vaccine should not be an issue, assuming some of them are successful in their Phase 3 trials.

Despite this news, we should be proud of UQ’s efforts, which will give them the experience and platform for more important vaccination work in the future.

Last updated: 11 Dec 2020 1:14pm