Coeliac disease vaccine trial enters second phase

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Coeliac disease vaccine trial enters second phase


19 February 2019

USC’s Clinical Trials Centre is about to begin stage two of research into an experimental vaccine that aims to improve the lives of those with coeliac disease by ‘switching off’ the immune response to gluten.

Coeliac disease is a serious chronic medical condition in which the ingestion of gluten, even in small amounts, leads to an immune response that causes damage to the small intestine.

Sufferers struggle with various gastrointestinal symptoms and, if untreated, face potentially serious complications. Currently, the only way to manage the disease is by the strict avoidance of gluten in the diet.

USC’s Clinical Trials Centre Director Lucas Litewka said phase one of the trial last year showed the vaccine was well tolerated by patients, and phase two would see the vaccine trialled over a longer timeframe of six months, requiring approximately 20 clinic visits.

He said the trial would be conducted alongside Dr Sue Thackwray at the Clinical Trial Centre on Sippy Downs Drive, Sippy Downs.

Dr Thackwray said a gluten-free diet was demanding for patients, expensive, and difficult to maintain as gluten was used extensively in modern food production.

“There is a real unmet need for therapies other than the gluten-free diet for some people with coeliac disease,” she said. “This is a very exciting potential experimental therapy that has been undergoing clinical trials for several years now.”

Dr Thackwray said that with further research, a vaccine might be developed that could potentially restore gluten tolerance in coeliac disease sufferers.

The company developing the vaccine is ImmusanT, which recently gained fast track designation by the United States Food and Drug Administration (FDA) – a status awarded to some investigational drugs that have potential to fulfil unmet needs of patients with serious or life-threatening conditions.

Adults between the ages of 18 and 70 can take part in this trial if they have medically diagnosed coeliac disease and have been following a strict gluten-free diet for 12 months or more.

Those who meet the criteria and are enrolled in the study will be compensated for their time. Patients interested in participating can go here or call (07) 5456 3797.

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