A world-first vaccine is being tested which aims to end the need for gluten-free diets for coeliac disease.
Following global trials led by US-based pharmaceutical company ImmusanT Inc, the Australian trials will start at the Royal Melbourne Hospital Clinical Trials Centre in Melbourne and then roll out in Perth, Adelaide, Brisbane, Mackay and the Sunshine Coast.
It comes eight years after the Melbourne-designed injection was shown to be safe in the first patients with a potential treatment to reprogram the immune system's abnormal toxic response to gluten.
The only treatment for the 160,000 Australians with coeliac disease — most of them undiagnosed — is a strict lifelong gluten-free diet.
Coeliac disease is caused by an immune reaction to the gluten protein found in wheat, rye and barley.
Almost 150 patients across Australia, New Zealand and the US will be recruited in the phase two trial to receive injections of placebo or the active treatment, twice a week for four months. They will include patients from the Royal Adelaide Hospital, The Advertiser reported.
They will undergo three food challenges throughout the trial to test for symptomatic relief. Some patients will also have an intestinal biopsy to check for protective effect on gut lining.
The Nexvax2 vaccine is based on research at the Walter and Eliza Hall Institute of Medical Research (WEHI), which identified three peptides in gluten that trigger an immune response in 90 per cent of coeliacs who have the genetic form of the disease.
Lead researcher Dr Jason Tye-Din, from WEHI and Royal Melbourne Hospital, said the results from national and international Phase 1 trials showed that the therapy was safe and well tolerated even at the highest doses used.
"It also showed an intended biological effect on the immune system in patients with coeliac disease," Dr Tys-Din said. "The Phase 2 trials build on the data from earlier studies and it is great that Australia is still playing a pivotal role in this work."
The vaccine desensitised patients by targeting gluten-specific immune cells, so these T cells did not enter "attack mode" when gluten was present.
"The vaccine is designed to target the 90 per cent of coeliac disease patients with the HLA-DQ2 genetic form of disease," he said.
"A successful therapy that can restore normal gluten tolerance would revolutionise coeliac disease management."
The auto-immune disease is becoming increasingly prevalent, and is estimated to currently affect one in 70 Australians and 1.4 per cent of the global population, according to WEHI.
The vaccine is designed to restore what is lost in coeliac disease — the ability of the immune system to tolerate gluten.
Dr Tye-Din said the Phase 2 trial was important for "establishing clinical proof-of-concept for a treatment that could provide benefit beyond that of the gluten-free diet."
An analysis by Dr Tye-Din of almost 160 "gluten-free" meals from 127 businesses found that one in 10 contained gluten.