Human trials begin today on the University of Queensland’s COVID-19 vaccine.
Innovation Minister, Kate Jones said volunteers would receive the first vaccine dose this morning in Herston, in a trial run by early phase clinical trial specialist Nucleus Network.
“This research is putting Queensland on the map,” Ms Jones said.
“We invested millions into this research because we know a vaccine is crucial to defeating COVID-19.
“But the success of our research has the eyes of the world on Queensland.
“Today makes me proud to be a Queenslander. Our vaccine – made in Queensland by Queenslanders could save millions of lives throughout the world.”
Today’s announcement comes after the Queensland Government announced $10 million in March to fast-track the development of the vaccine by six months, to make it available as early as early 2021.
Ms Jones said Queensland now joined a small group of vaccine developers around the world who are moving out of the lab and into human trials.
“Queensland boasts one of the most promising vaccine candidates on the planet,” she said.
“We asked Queenslanders to roll up their sleeves to save lives – and they’ve answered the call in droves.
“We needed up to 120 volunteers for the first stage. More than 4000 people have put up their hands to volunteer.”
One of the University’s COVID-19 vaccine research leaders, Professor Paul Young said the first human trial was about evaluating the safety and immune response of the vaccine in a group of healthy volunteers.
“The green light to move into this human trial follows extensive pre-clinical testing that the team has been conducting since first selecting the lead vaccine candidate on 14 February,” Prof Young said.
“This testing showed that the vaccine was effective in the lab in neutralising the virus and safe to give to humans.”
He said once human testing was under way, researchers expect to have preliminary results after about three months.
“We’ll hold a collective breath while we wait to see how the trial goes.”
“But if all goes well, we can move to the next stage in the vaccine’s development – a larger trial with a much bigger group of people from a range of ages to see if the vaccine works across the board.”
Associate Professor Keith Chappell, co-lead on the University’s project, said it was “a fantastic achievement to move so quickly into clinical trials”.
“We have reached this important stage with help from our collaborators at the Australian National University, the Doherty Institute and CSIRO,” Prof Chappell said.
The clinical batch of vaccine for use in the trial was a manufactured by a close partnership between UQ and CSIRO with technical assistance by Australian biotech company CSL, Brisbane based Thermo Fisher and Swedish company Cytiva.
Project Director Professor Trent Munro said the team had known from the beginning that they would need to advance the manufacturing component of the development pipeline to run alongside clinical trials.
“We recently also announced a manufacturing partnership 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.
“It’s great to see this Queensland program underpin such a strong Australian connection.”
Nucleus Network Principal Investigator and infectious diseases expert Associate Professor Paul Griffin said as Australia’s largest Phase 1 clinical trials provider, the company had a distinct advantage for accelerating vaccine trials.
“We have a rich history as a company in Phase 1 vaccine trials and are well-positioned to implement rapid testing with first-in human trials of UQ’s potential vaccine,” Associate Prof Griffin said.
“Our Brisbane clinic location in the renowned Herston health precinct, with access to some of the best clinical expertise and facilities in Australia, allows us to conduct highly specialised clinical trials. From vaccines and infectious diseases, through to biosimilars and malaria studies, we are putting Queensland on the global map of gold standard clinical trials.”
The University of Queensland was tasked by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine against the novel coronavirus in January, supported by an initial investment of up to US$4.5 million.
University of Queensland and CEPI entered into a partnership in June with CSL to take the rapid response ‘molecular clamp’ enabled vaccine through clinical development and manufacture, if it proves successful.