Human trials of Australian Covid vaccine begin today

Australian scientists are on track to deliver a COVID-19 vaccine this year, with the start on Monday of human trials of the prototype drug.

Researchers predict a working drug to be available as early as September. Picture: AFP

Australian scientists are on track to deliver a COVID-19 vaccine this year, with the start on Monday of human trials of the prototype drug.

Only a handful of the 180-odd vaccines in development around the world have reached this critical stage of testing, putting the promising University of Queensland immuniser in the top tier of contenders from the US, Britain and China.

UQ’s “molecular clamp” technology has the added advantage of being a platform vaccine that could be recalibrated to address future pandemics.

Volunteers will receive the drug for the first time in Brisbane on Monday to confirm it is safe for people and capable of generating a base-level immune response.

The scientists had sought 120 volunteers for the phase-1 clinical trial, but were stunned when more than 4000 came forward.

One of the lead researchers, Paul Young, said the human testing followed extensive evaluation of the candidate drug in laboratory animals in Australia and the Netherlands.

“The green light to move into this human trial follows extensive preclinical testing that the

UQ researcher Paul Young. Picture: Annette Dew

team has been conducting since first selecting the lead vaccine candidate on 14 February,” Professor Young said. “This testing showed that the vaccine was effective in the lab in neutralising the virus and safe to give to humans.”

Painstaking work that would normally take years has been telescoped into the months since COVID-19 erupted in China and spread across the globe, infecting nearly 13 million people and killing more than 567,000 to date. Australia has 9562 confirmed cases and 108 deaths.

But the alarming second wave of infections in Victoria has underlined warnings that life wouldn’t return to normal until a vaccine was rolled out.

“We hope for a vaccine to come as soon as possible but it may not come for many months,” deputy chief medical health officer Nick Coatsworth said on Sunday, emphasising that social distancing, handwashing and face masks remained the only defence for now.

The UQ team was confident from the outset that their formulation would work. So far, they have hit their targets to sift the candidate vaccine, S-Spike, from 250 possible variations and take it to human trials.

“In terms of getting a vaccine that we think will work, we think we are already there,”

Dr Keith Chappell.

another key researcher, Keith Chappell, told The Australian recently.

“But getting a vaccine that’s available for seven billion people of the planet … means we have to move to scale and that’s a very different proposition.”

Project leader Trent Munro said the process to create, test and bring the vaccine to market had been dramatically fast-tracked.

Normally, planning to make and distribute a new drug would wait until regulators had signed off on it. But in this case, clinical trials would overlap with the manufacturing development phase to save time. No corners would be cut on safety or efficacy, Professor Munro said.

“We recently … announced a manufacturing deal with CSL, so if things go to plan they’ll rapidly advance production of millions of doses and move the program into later stage clinical testing, regulatory approval, large-scale manufacture and distribution,” he said on Sunday.

In April, preclinical testing in lab animals showed the molecular clamp vaccine delivered better immunity levels than those in people who had recovered from COVID-19. The technology targets spike proteins that bristle on the surface of the coronavirus, effectively pinning them before the pathogen can activate. An adjuvant, or boosting agent, is added to the vaccine to trigger a powerful immune response.

While it is entering human trials later than some of the pacesetters overseas, the UQ scientists said their research had been “frontloaded” by the prior application of the molecular clamp technology to the influenza virus and MERS, a coronavirus closely related to the SARS-CoV2 pathogen that causes COVID-19. This would accelerate end-stage development of the vaccine.

Professor Munro predicts a working drug could be available in September — though final approvals and the capacity to mass-produce doses could take longer. “That’s the goal we have … but, yes, I think that is a possibility if everything went to plan,” he said.