World-first vaccine trial may end gluten-free diets
A WORLD-first vaccine aiming to end the need for gluten-free diets for coeliac disease is being tested in an international trial.
Eight years after the Melbourne-designed injection was shown to be safe in the first patients, it is hoped the treatment will 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.
Even a few breadcrumbs can cause severe gastro symptoms and debilitating fatigue, as well as leading to damage to the small intestines, infertility, type 1 diabetes and osteoporosis.
The Nexvax2 vaccine is based on research at the Walter and Eliza Hall Institute of Medical Research, which identified the three peptides in gluten that trigger an immune response in the 90 per cent of coeliac patients that have the genetic form of the auto-immune disease.
Lead researcher and gastroenterologist Dr Jason Tye-Din, from WEHI and Royal Melbourne Hospital, said the vaccine desensitised patients by targeting gluten-specific immune cells, so these T cells did not enter "attack mode" when gluten was present.
"If you can give it in successive injections, you can retrain the immune system, so it learns to develop a tolerance," Dr Tye-Din said.
"If the trial is positive, it would suggest that having a normal diet is something people can aim for. That's the ultimate hope."
Jane Duyker and twin sister Eden, 22, were diagnosed after suffering severe gastro problems and fatigue in Year 12.
"I'm 100 per cent gluten-free, because the symptoms aren't worth it," Jane said.
"If I had a choice, I wouldn't have a gluten-free diet because going out with friends is hard. I'm often the one with the glass of water while everyone is eating."
Almost 150 patients across Australia, New Zealand and the US with be recruited in the phase II trial to receive injections of a placebo or the active treatment, twice a week for four months. 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.
Coeliac Australia president Michael Bell said that with one in 70 Australians living with coeliac disease, and four out of five undiagnosed, the holy grail was finding a treatment that allowed coeliacs to return to a normal diet given the difficulty of avoiding contaminated foods.
An analysis by Dr Tye-Din of almost 160 "gluten-free" meals from 127 Melbourne businesses, found that one in 10 contained gluten.