The pre-clinical trial work will take until at least June/July 2020 to complete. The pre-clinical trial work includes making sure the vaccine is safe to use in humans, determining the correct dosage.
The researchers intend to conduct Phase 1 clinical trials in Queensland and will put out a call for volunteers around May/June 2020 for screening.
The Phase 1 clinical trial will be used to determine the safe dosage range and identify any side effects. This will look at the safety of the vaccine.
The researchers said they will provide further details as to how people can get involved closer to the time.
There is a lot of pressure on making a safe and effective vaccine available globally. The UQ team are working with CEPI and regulatory authorities like Australia’s Therapeutics Goods Administration to fast-track the process to the extent that they can.
The Phase 1 clinical trials will wind up around August/September 2020.
All going well, they will move to expand the clinical studies to determine the vaccine works as intended. At this stage they will also start large-scale manufacturing.
If that stage is successful, they will increase manufacturing and begin distribution to where it’s needed.
Queensland’s strength in pre- and early-phase clinical trials
According to a 2015 MTP Connect that report looked at the value of clinical trials in Australia, clinical trials in Australia have been growing at about 5 percent per year since 2010, outpacing the United States of America, the United Kingdom and the overall global average growth rate.
The report said clinical trials supported almost 7000 highly skilled jobs in Australia and included $930 million in industry investment, most of which came from international medical device, biotechnology and pharmaceutical companies.
Queensland has strong capability around pre- and early-phase clinical trials.
What gives Queensland the edge is our two internationally renowned contract manufacturing facilities in Brisbane. Patheon Biologics (part of US biotech Thermo Fisher Scientific), and local company LuinaBio, specialising in manufacturing high-tech experimental drugs for clinical trials.
There are not many places in the world with this type of capability.
Queensland’s capability is further enhanced by the expertise and experience of specialist organisations, such as TetraQ and Nucleus Network/QPharm, medical experts of global standing, specialised and dedicated infrastructure, a world-class healthcare system, a strong intellectual property system, and Australia’s research and development tax incentive.
Pre-clinical trials are lab-based tests of a new drug or new medical device with the intention of gathering sufficient evidence to justify a clinical trial.
Early phase clinical trials test a potential new drug or medical device for the first time in a small group of people to evaluate safety and to see whether the drug or device works as intended.