World-first human challenge trial to test efficacy of Strep A and rheumatic heart disease vaccine

Professor Michael Good

Griffith University’s Institute for Glycomics has received a $5 million philanthropic donation from the International Leducq Foundation to further the development of a vaccine to prevent Strep A infection and rheumatic heart disease in a world-first expanded clinical trial.

As part of the research program, and in collaboration with researchers at the Murdoch Children’s Research Institute, volunteers will be vaccinated and then given a deliberate Strep A infection to test the vaccine.

The research will lead to Phase II studies where hundreds of volunteers will be vaccinated and followed to test the efficacy of the vaccine in a real-world setting.

Griffith Vice Chancellor and President Professor Carolyn Evans.
Griffith Vice Chancellor and President Professor Carolyn Evans

Griffith University Vice Chancellor and President Professor Carolyn Evans said this generous funding from the Leducq Foundation is one of the largest philanthropic donations the university has ever received.

“As a university, we are incredibly proud of the work being done by the Institute for Glycomics and to test the vaccine through a controlled live dose of the bacteria will be ground-breaking for the medical world,” Professor Evans said.

“Leducq Foundation is a great partner to have on board as its mission is to improve human health through international efforts to combat cardiovascular disease and stroke.”

Lead researcher Professor Michael Good AO and Associate Professor Manisha Pandey, both from the Institute for Glycomics, discovered Strep A’s Achilles heel to help prevent not only Strep A infection but also rheumatic heart disease.

“A human clinical trial, which started in November, is currently underway in Canada at the University of Alberta where volunteers are receiving the vaccine to test for safety and immunogenicity,” Professor Good said.

“The vaccine, developed by Griffith University, is designed around key immune determinants, defined by the research team, which represent the organism’s Achilles heel.

“In pre-clinical research the vaccine has been shown to protect against all strains of Strep A that have been tested.

“There is currently no vaccine available for rheumatic heart disease and Strep A, and natural immunity takes years to develop.”

Strep A is responsible for rheumatic heart disease and many cases of deadly invasive disease and toxic shock.

In Australia, Aboriginal and Torres Strait Islander people suffer the highest rate of rheumatic heart disease in the world.

It is estimated that around 500,000 people die each year as a result of Strep A infection.

Associate Professor Manisha Pandey

Associate Professor Pandey said the funding from the Leducq Foundation will go a long way towards the continued development of the vaccine candidate through Phase I human clinical trials.

“This is ground-breaking medical research in which we will be able to test a Strep A vaccine in a human challenge trial,” she said.

“This next step will be crucial to test the efficacy of the vaccine in healthy participants.

“Following on from this, our research will then pave the way for a comprehensive testing strategy where we identify the optimal dose of the vaccine to take into a Phase II clinical trial.”

Dr David Milan, Leducq Chief Scientific Officer, said that supporting this effort to develop a Strep A vaccine falls squarely within the cardiovascular disease mission of the Leducq Foundation.

“Leducq is excited about the potential of a Strep A vaccine to reduce not only strep throat infections but downstream rheumatic heart disease, a major source of worldwide mortality, especially in low- and middle-income countries,” Dr Milan said.

Institute for Glycomics Director Professor Mark von Itzstein AO
Institute for Glycomics Director Professor Mark von Itzstein AO

Professor Mark von Itzstein AO, Director of the Institute for Glycomics was delighted the Leducq Foundation had identified the Institute’s vaccine candidate as an exciting opportunity.

“This significant financial support from the Leducq Foundation provides our researchers the capacity to progress the Institute’s most advanced vaccine candidate in human clinical trials,” Professor von Itzstein said.

“I am thrilled we will now undertake the next critical steps in our vision of producing a vaccine that will save many lives from the consequences of Strep A infection.”

Professor Andrew Steer, Director of the Infection, Immunity and Global Health at MCRI said: “MCRI is excited to co-lead the human infection trial of the Griffith vaccine in Melbourne, a major milestone for Strep A vaccines in Australia and indeed the world.”


Strep affects people of different ages and socio-economic levels.

It is a leading cause of infection-related death in the world.

Pathology due to Strep A include the relatively benign streptococcal tonsillitis and school sores, and the very serious conditions of rheumatic heart disease, necrotising fasciitis (‘flesh eating disease’), toxic shock syndrome, and kidney disease.