The facility will aid in expediting the development of innovative therapies and vaccines by offering customised early-phase clinical trial solutions. Credit: Alexander Raths / Shutterstock.com.

Australia’s first-of-its-kind clinical trial facility dedicated to delivering human challenge trials, Doherty Clinical Trials, launched in East Melbourne.

Victoria Government Medical Research Minister Ben Carroll and Peter Doherty Institute for Infection and Immunity (Doherty Institute) director and professor Sharon Lewin AO opened the facility.

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Established by the Doherty Institute, Doherty Clinical Trials is a not-for-profit registered charity and the University of Melbourne subsidiary.

The facility is dedicated to expediting the development of innovative therapies and vaccines by offering customised early-phase clinical trial solutions, including human challenge trials.

With a capacity of 25 beds, the unit is housed in the former Peter Mac building in East Melbourne.

Human challenge trial is a specialised form of early-phase clinical research designed to evaluate the effectiveness of vaccines and treatments for infectious diseases.

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These trials involve the deliberate exposure of healthy subjects to a controlled dose of an infectious agent in a secure environment to assess the performance of a drug or vaccine.

Plans are in place for it to relocate the facility to the Australian Institute for Infectious Disease (AIID), where it will join foundation partners such as the Doherty Institute, the University of Melbourne, and the Burnet Institute.

Doherty Clinical Trials is set to conduct upcoming human challenge trials targeting diseases such as influenza, Streptococcus pyogenes (Strep A), gonorrhoea, and malaria. These trials will be carried out in collaboration with research teams from both Australia and around the world.

The establishment of the Doherty Clinical Trials facility has been supported by significant contributions from the Victorian state government and philanthropic donations through the Doherty Institute.

Doherty Clinical Trials chief medical officer professor James McCarthy said: “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.

“With these types 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 the 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.”