World-first coeliac disease vaccine enters Phase 2 trials

October 31, 2018, Walter and Eliza Hall Institute of Medical Research
World-first coeliac disease vaccine enters Phase 2 trials
Head of coeliac research at the Institute Dr Jason Tye-Din is leading the Melbourne Phase 2 trial of immune therapy Nexvax2. Credit: Walter and Eliza Hall Institute of Medical Research

A coeliac disease vaccine that aims to protect patients from the harmful effects of gluten has entered Phase 2 clinical trials in Melbourne.

Following the commencement of global led by US-based pharmaceutical company ImmusanT Inc., the Australian trials will commence at the Royal Melbourne Hospital Clinical Trials Centre in Melbourne and then roll out in Perth, Adelaide, Brisbane, Mackay and the Sunshine Coast.

Led by the Walter and Eliza Hall Institute's head of coeliac research and gastroenterologist at the Royal Melbourne Hospital Dr. Jason Tye-Din, the Melbourne trial of Nexvax2 (RESET CeD) is now recruiting for patients with coeliac .

Coeliac disease is caused by an immune reaction to the gluten protein found in wheat, rye and barley. The autoimmune disease is becoming increasingly prevalent, and is estimated to currently affect one in 70 Australians and 1.4 per cent of the global population.

Dr. Tye-Din said volunteer participation was crucial to the success of the trials. "The vaccine is designed to target the 90 per cent of coeliac disease patients with the HLA-DQ2 genetic form of disease," he said.

Dr. Tye-Din said he was very excited about the commencement of Phase 2 trials because of the therapy's potential for one day enabling patients to safely have gluten in their diet. "A successful therapy that can restore normal gluten tolerance would revolutionise coeliac disease management.

Nexvax2 is designed to restore what is lost in coeliac disease – the ability of the immune system to tolerate gluten.

President of Coeliac Australia Mr Michael Bell said the organisation's members and many thousands of Australians with coeliac disease had been looking forward to the announcement of Phase 2 trials.

"Many have been following the development of Nexvax2 for more than a decade and are hopeful the trials will take us one step closer to an effective treatment for coeliac disease," Mr Bell said.

Building on Institute research

Dr. Tye-Din has been leading the way in understanding what triggers coeliac disease in a combined effort involving patients, clinicians and scientists for more than a decade.

Initiated by Dr. Bob Anderson, now chief scientific officer for ImmusanT Inc., and Dr. Tye-Din in 2003, the Institute's coeliac research program identified the toxic parts – or peptides – of gluten that led to the design of the targeted immune treatment and subsequent Phase I trials undertaken in Melbourne.

"The results from national and international Phase 1 trials showed that the therapy was safe and well tolerated even at the highest doses used, and also showed an intended biological effect on the immune system in patients with coeliac disease. 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," Dr. Tye-Din said.

Patients who are interested in partaking in the Melbourne-based Phase 2 trial of Nexvax2 (RESET CeD) for the treatment of are invited to visit the Royal Melbourne Hospital website or contact the Walter and Eliza Hall Institute's coeliac team at

For a list of sites offering the trial in Australia pleae visit the Coeliac Australia website.

Explore further: Celiac disease vaccine shows promising results in Phase I trial

Related Stories

Celiac disease vaccine shows promising results in Phase I trial

May 9, 2011
The world's first potential vaccine for coeliac disease has shown promising results for treating coeliac disease in a Phase I clinical trial and is expected to move to Phase II trials within the next year.

Childhood coeliac disease discovery opens door for potential treatments

September 3, 2015
A new study has revealed childhood coeliac disease mirrors the condition in adults, increasing the possibility a coeliac disease therapy that could enable patients to eat gluten again will work in children.

Study puts 'gluten-free' claims to the test

May 28, 2018
A first of its kind study led by Institute researchers has detected potentially harmful levels of gluten in foods sold and served as 'gluten-free' across Melbourne.

New clue in celiac disease puzzle: Cause of oat toxicity explained

November 18, 2014
Melbourne researchers have identified why some people with coeliac disease show an immune response after eating oats.

Research gives new insight into coeliac disease

October 11, 2012
For the first time, scientists have visualised an interaction between gluten and T-cells of the immune system, providing insight into how coeliac disease, which affects approximately 1 in 133 people, is triggered.

Recommended for you

Patchy distribution of joint inflammation resolved

November 16, 2018
Chronic inflammatory rheumatic diseases such as rheumatoid arthritis (RA) and spondylo-arthritis (SpA) are chronic, disabling diseases with a poor outcome for loco-motoric function if left untreated. RA and SpA each affect ...

A low-gluten, high-fiber diet may be healthier than gluten-free

November 16, 2018
When healthy people eat a low-gluten and fibre-rich diet compared with a high-gluten diet, they experience less intestinal discomfort including less bloating. Researchers at University of Copenhagen show that this is due ...

Youth dating violence shaped by parents' conflict-handling views, study finds

November 16, 2018
Parents who talk to their children about nonviolent ways of resolving conflict may reduce children's likelihood of physically or psychologically abusing their dating partners later—even when parents give contradictory messages ...

Why we shouldn't like coffee, but we do

November 15, 2018
Why do we like the bitter taste of coffee? Bitterness evolved as a natural warning system to protect the body from harmful substances. By evolutionary logic, we should want to spit it out.

Dietary fat is good? Dietary fat is bad? Coming to consensus

November 15, 2018
Which is better, a low-fat/high-carbohydrate diet or a high-fat/low-carbohydrate diet—or is it the type of fat that matters? In a new paper featured on the cover of Science magazine's special issue on nutrition, researchers ...

Low-carb diets cause people to burn more calories

November 14, 2018
Most people regain the weight they lose from dieting within one or two years, in part because the body adapts by slowing metabolism and burning fewer calories. A meticulous study led by Boston Children's Hospital, in partnership ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.