Doherty Clinical Trials Limited is proud to announce the commencement of the CHIVAS-M1 study (Controlled Human Infection for Vaccination Against Streptococcus pyogenes M1UK), which will help drive medical research and development of a vaccine against Streptococcus pyogenes, otherwise known as Strep A.
Strep A infections affect about 750 million people and kill more than 500,000 globally every year, more than influenza, typhoid or whooping cough. While many infections resolve without issue, some people develop life-threatening invasive disease, like toxic shock syndrome, flesh eating disease and post-infectious illnesses such as acute rheumatic fever, rheumatic heart disease and kidney disease. There is currently no vaccine against Strep A. A vaccine would be a global game changer and is the only plausible way to prevent Strep A infections on a global scale.
CHIVAS-M1 was developed by researchers at Murdoch Children’s Research Institute (MCRI) and is being conducted in Melbourne at Doherty Clinical Trials Ltd. The trial involves the controlled administration of the M1UK strain of Strep A to the throats of healthy adult volunteers in a safe, inpatient clinical setting with the aim of causing an infection (strep throat). Volunteers give blood, throat swab and saliva samples and are then cured of their infection with antibiotics.
The first modern Strep A controlled human infection model (CHIVAS-M75) was successfully established by the MCRI team in 2021 with a different strain of Strep A, the M75 strain. None of the volunteers in CHIVAS-M75 had any severe side effects. The same model was used in a penicillin dose-finding trial, also with no severe adverse events in any trial participants. The M1UK strain of Strep A is now being introduced into the model because it is one of the most common causes of non-invasive and invasive Strep A infections around the world. If a vaccine is going to prevent Strep A, it will have to target M1UK Strep A. The trial is funded by the Leducq Foundation as part of the international iSpy Network, a consortium of clinician-scientists and world-leading immunologists aiming to reduce the disease burden of Strep A.
Strep A research has traditionally focused primarily on animal models of infection, but Strep A only naturally causes infection in humans. The innovative research approach of the CHIVAS-M1 study allows scientists to analyse the course of human infection in real time and develop an experimental model of human infection that will eventually permit trials to be conducted on the effectiveness of candidate vaccines far more efficiently than traditional field trials.
Dr Josh Osowicki, lead study doctor at MCRI, said, “Our team at MCRI is excited to be working with Doherty Clinical Trials on CHIVAS-M1. The trial is a huge step forward for controlled human infection research, often called human challenge trials, in Australia. The samples we collect will drive so many important studies, here and around the world, to help us understand and prevent Strep A infections. This trial sets the stage for future human challenge trials we require to prove a vaccine can prevent Strep A disease.”
Dr Andrew Brockway, CEO of Doherty Clinical Trials Limited, said launching the CHIVAS-M1 study represents 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 now positions Australia among a select group of countries capable of conducting these complex, high-impact studies.”
Professor James McCarthy, Chief Medical Officer of Doherty Clinical Trials Limited, said that “Our facility was specifically designed so that we can safely conduct these important studies with a range of appropriate challenge models. As well, our staff are well trained to carefully expose participants to Strep A under close medical oversight. Doing these type of studies will accelerate the development of new vaccines and treatments that could save lives globally”
“Our team is passionate about enabling the discovery of better treatments for infectious diseases with significant global impact,” Dr Brockway said. “We are proud to lead this pioneering initiative with the MCRI team, and which will help fast-track the development of Strep A therapeutics and vaccines both in Australia and globally.”
Further details can be found here:
Doherty Clinical Trials Limited is proud to announce the commencement of the CHIVAS-M1 study (Controlled Human Infection for Vaccination Against Streptococcus pyogenes M1UK), which will help drive medical research and development of a vaccine against Streptococcus pyogenes, otherwise known as Strep A.
Senior Lab Manager, Vanessa Mollard represented Doherty Clinical Trials at the forum in Canberra
Dr Andrew Brockway's panel, 'Clinical Trials in Australia: Performance, Competitive Advantages, Challenges and Evolving Policy' at AusBiotech 2024
Highlighting the vital work of Doherty Clinical Trials and sharing why participants find it so rewarding.
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