A world-first coeliac disease vaccine is being tested in Australia and could spark the end of gluten-free diets that many people abide by to manage their condition.
Coeliac disease can impact both men and women and people of all ages, although 80 per cent of all people with coeliac disease are undiagnosed. It occurs when there is an immune reaction to the gluten found in wheat, rye and barley.
Around one in 70 Australians and 1.4 per cent of the world’s population are impacted by the disease. The new vaccine that protects patients against the harmful impacts of gluten is now in the second phase of clinical trials. At present, there is no cure for coeliac disease and the only recognised treatment is following a strict gluten-free diet for life.
The RESET CeD trial by US-based pharmaceutical company ImmusanT Inc. will evaluate the safety, tolerability and efficacy of the new vaccine in adults carrying the HLA-DQ2.5 gene – found in 90 per cent of patients with coeliac disease. The Nexvax2 therapeutic treatment works as a series of injections that target and reprogram the T Cells that trigger an inflammatory response to gluten.
The injections helps prevent inflammation and it’s hoped it will stop serious side effects caused when those with coeliac disease consume gluten. The trial has been welcomed by many in the health community, including Coeliac Australia.
“Our members and many thousands of Australians with coeliac disease have been looking forward to the announcement of the Phase 2 trial,” President of Coeliac Australia Michael Bell said in a statement. “Many have been following the development of Nexvax2 for more than a decade and are hoping the results will take us one step closer to an effective treatment of coeliac disease.”
The RESET CeD trial will be conducted in Melbourne, Brisbane, Mackay, the Sunshine Coast, Adelaide and Perth, as well as in sites across New Zealand and the United States. Researchers are seeking adults aged between 18 and 70 with biopsy-proven coeliac disease who are following a gluten-free diet to participate in the randomised, double-blind, placebo-controlled clinical study.
It will include a screening period of six weeks, 16 weeks of treatment and a four-week post-treatment follow-up period. Part of the trial will see participants consume moderate amounts of gluten, while injections, blood samples, completion of questionaries and daily electronic completion of diaries will be some of the other requirements of participation.
“This trial is important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet,” Dr Jason Tye-Din, Chair of Coeliac Australia Medical Advisory Committee, said. “Even the most diligent patients can suffer the adverse effects of accidental exposure. This study will test if Nexvax2 can specifically target the immune response to gluten in people with coeliac disease and modify associated symptoms.”
Phase 1 trials showed Nexvax2 was safe and well-tolerated when administered at the highest dosage levels.
ImmusanT said in a statement that the purpose of the trial is to develop Nexvax2 as a treatment that would allow patients to return to an unrestricted diet.
A complete list of Australian trial criteria can be viewed here at coeliac.org.au.