New Melbourne-based facility to deliver human challenge trials

Australia’s first facility specifically commissioned to deliver human challenge trials, Doherty Clinical Trials, was launched today in Melbourne by Minister for Medical Research Ben Carroll and Professor Sharon Lewin, Director of The Peter Doherty Institute for Infection and Immunity. As a not-for-profit registered charity and subsidiary of The University of Melbourne, Doherty Clinical Trials has been established by the Doherty Institute to accelerate the development of novel medicines and vaccines through bespoke early-phase clinical trials solutions, including human challenge trials.

A human challenge trial allows researchers to test the effectiveness of vaccines and therapeutics for infectious diseases by administering a well-characterised infectious agent to healthy volunteer participants, with the aim of speeding up drug development. Professor James McCarthy, Chief Medical Officer of Doherty Clinical Trials, said human challenge trials are one of the most efficient ways to evaluate the efficacy of novel vaccines and therapeutics.

“By providing early and rapid efficacy data using small cohorts of participants, human challenge trials can produce more reliable and reproducible results than studies in affected patients where variables are less controlled,” McCarthy said.

“With these type of studies, vital information about the efficacy of vaccines and potential treatments can be received very quickly and at a significantly lower cost.

“As most drugs and vaccines fail along the clinical development pathway, it is advantageous to rapidly determine if development of a candidate vaccine or treatment should continue, or if the researchers should pivot to an alternative candidate with a higher chance of success.”

The establishment of Doherty Clinical Trials was made possible by generous contributions from the Victorian Government and philanthropic funding via the Doherty Institute. The 25-bed facility is currently located in the former Peter Mac building in East Melbourne, but in the future it will be housed in the Australian Institute for Infectious Disease (AIID) — set to be completed in 2027 — alongside Foundation Partners the Doherty Institute, The University of Melbourne and the Burnet Institute.

“While human challenge trials have been used to develop new medicines and vaccines globally for decades, our purpose-built facility is the first of its kind in the Southern Hemisphere, and will build capabilities right here in Victoria enabling rapid research translation,” Lewin said.

“The COVID-19 pandemic highlighted the need to accelerate how new vaccines and treatments are developed. This will help us all to get lifesaving medicines more rapidly in future pandemics.”

Upcoming human challenge trials will include influenza, Streptococcus pyogenes (Strep A), gonorrhoea and malaria, and will be conducted in partnership with Australian and global research teams. People can register their interest to participate in future trials at https://www.dohertyclinicaltrials.com/contact-us.

Image caption: The Australian Institute for Infectious Disease is set to be the future home of Doherty Clinical Trials. Artist impression by Wardle.