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A WORLD-FIRST vaccine is being tested with the goal of ending gluten-free diets for celiac disease.
Following global trials led by US pharmaceutical company ImmusanT Inc., Australian trials will begin at the Royal Melbourne Hospital's Clinical Trial Center in Melbourne, followed by Perth, Adelaide, Brisbane, Mackay and the Sunshine Coast.
It comes eight years after the injection designed by Melbourne proved safe for the first patients with potential treatment to reprogram the abnormal toxic response of the immune system to gluten.
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The only treatment for the 160,000 Australians with celiac disease – mostly undiagnosed – is a strict gluten-free diet that lasts a lifetime.
Celiac disease is caused by an immune reaction to the gluten protein found in wheat, rye and barley.
Nearly 150 patients in Australia, New Zealand and the United States will be enrolled in the Phase 2 trial to receive placebo injections or active treatment, twice a week for four months. They will include patients from the Royal Adelaide Hospital, L & # 39; advertiser reported.
Throughout the trial, they will face three dietary challenges to determine symptomatic relief. Some patients will also undergo an intestinal biopsy to check their protective effect on the intestinal mucosa.
The Nexvax2 vaccine is based on research from the Walter and Eliza Hall Medical Research Institute (WEHI), who identified three gluten peptides that trigger an immune response in 90% of celiacs carrying the genetic form of the disease .
Lead researcher Dr. Jason Tye-Din of WEHI and Royal Melbourne Hospital said the results of the national and international Phase 1 trials showed that the treatment was safe and well tolerated, even at the highest doses used. .
"It has also shown a desired biological effect on the immune system in patients with celiac disease," said Dr. Tys-Din. "Phase 2 trials are backing up on previous study data and it is good that Australia still plays a central role in this work."
The vaccine desensitized patients by targeting gluten-specific immune cells, so these T cells did not enter "attack mode" in the presence of gluten.
"The vaccine is designed to target 90% of patients with celiac disease who have the genetic form of HLA-DQ2," he said.
"Effective treatment that could restore normal gluten tolerance would revolutionize the management of celiac disease."
Autoimmune disease is becoming more prevalent and is estimated to affect one in every 70 Australians and 1.4% of the world's population, according to WEHI.
The vaccine is designed to restore what is lost in celiac disease – the ability of the immune system to tolerate gluten.
Dr. Tye-Din stated that the Phase 2 trial was important for "the establishment of a clinical proof of concept of a treatment likely to provide benefits going beyond those of a gluten-free diet ".
An analysis by Dr. Tye-Din of nearly 160 "gluten-free" meals from 127 companies found that one in ten contained gluten.
For a list of hospitals performing the test, visit www.coeliac.org.au.
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