Celiac disease vaccine appears promising way to restore immune system

Though currently there is no cure for celiac disease (following a strict gluten-free diet is the only treatment), that may change in our lifetime, as a potential celiac disease vaccine is being developed and has entered phase two of its trial and is anticipated to finish the trial this year.

The vaccine, Nexvax2, is being developed by ImmusanT and is the only disease-modifying approach for celiac in clinical development right now. The vaccine is designed to reprogram the T cells that are trigged by a person’s immune response to gluten. Nexvax2 aims to restore immune tolerance to gluten, reduce inflammation in the small intestine and ultimately, allow those with celiac disease to resume eating a diet with gluten in it.

Phase 2 of this trial enrolled 150 patients in Australia, New Zealand and the U.S.

“Inadvertent gluten exposures can cause significant and long-term negative impacts on patient health,” said Leslie Williams, chief executive officer of ImmusanT. “At ImmusanT, we are deeply committed to advancing Nexvax2 to protect celiac patients from the effects of inevitable gluten exposure.”

The vaccination, which is given subcutaneously, is given in small doses at first, then gradually increased so the body builds a resistance to the gluten protein over several months. A malfunctioning TG2 enzyme causes the immune system to attack the lining of the small intestine. This mistaken immune response leads to a host of issues as the body attempts to rid itself of what it considers a poison.


Phase one was considered successful, as the vaccine was shown to be safe and well-tolerated, even when given at its highest doses. Phase two will aim to confirm the effectiveness of the vaccine and broaden ImmusanT’s understanding of the impact of immunotherapies.

In addition to building a person’s tolerance for gluten, this vaccine could prevent serious health complications that are caused over time by untreated celiac disease, such as some types of cancers. Celiac affects as many as 1 in 100 people worldwide and causes inflammation of the small intestine, leading to bloating, joint pain, and inability to absorb nutrients.

ImmusanT also uses its platform to develop peptide-based immune therapies for people with other autoimmune diseases, including Type-1 diabetes. The company also focuses on developing highly specific diagnostics and are developing their first diagnostic which diagnoses celiac disease through an in vitro blood test that measures T-cell markers. An estimated 83 percent of Americans with celiac disease are undiagnosed or misdiagnosed, according to Beyond Celiac, so this diagnostic could be beneficial to many.

Click here for more information on celiac disease and its symptoms.


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