A new human challenge trial under way in Melbourne aims to advance research into Strep A, accelerating efforts towards the development of a vaccine.
The trial, a collaboration between Murdoch Children's Research Institute (MCRI) and Doherty Clinical Trials Limited, will infect healthy adult volunteers with a particular strain of Strep A in a safe, clinical setting, to better understand and prevent diseases caused by the common bacteria.
Human challenge trials allow researchers to study the course of infection in real time and develop a model of infection that would allow drug and vaccine candidates to be tested far more rapidly and efficiently than traditional trials.
The collaboration follows the development of a human challenge model, led by MCRI, which was found to be safe and could be used to test Strep A vaccines.
Strep A infections affect about 750 million people and kill more than 500,000 globally every year, more than influenza, typhoid or whooping cough. They typically cause sore throat, but can also lead to scarlet fever, skin sores and life-threatening infections.
Most Strep A infections resolve, but some patients develop life-threatening invasive diseases like toxic shock syndrome and necrotising fasciitis (flesh eating disease), and serious post-infectious illnesses such as acute rheumatic fever, rheumatic heart disease and kidney disease.
MCRI's Dr Josh Osowicki said developing a vaccine for Strep A would be a global game changer and was the only plausible way to prevent these infections.
"A Strep A vaccine would not only prevent Strep A infections but also prevent invasive Strep A disease, which can be devastating for adults and children, like Asi who has been left with major communication and mobility issues," he said.
Doherty Clinical Trials Limited CEO Dr Andrew Brockway said launching the study represented a major step forward for Australian medical research.
"Human challenge trials are an essential part of the global infectious disease toolkit, and the ability to conduct a study such as this positions Australia among a select group of countries capable of conducting these complex, high-impact studies," he said.
Doherty Clinical Trials Limited Chief Medical Officer Professor James McCarthy said, "Our facility was specifically designed so that we can safely conduct these important studies with a range of appropriate challenge models. Our staff are well trained to carefully expose participants to Strep A under close medical oversight.
"Doing these types of studies will accelerate the development of new vaccines and treatments that could save lives globally. We are proud to lead this pioneering initiative with the MCRI team, which will help fast-track the development of Strep A therapeutics and vaccines both in Australia and overseas," he said.
The trial is funded by the Leducq Foundation as part of the iSpy Network, a consortium of clinician-scientists and immunologists aiming to reduce the disease burden of Strep A.
