A phase 2 randomised controlled study of the therapeutic vaccine Nexvax2^® is underway in Australian and New Zealand adults with HLA-DQ2·5 genotype positive coeliac disease.

The epitope-specific immunotherapy which ‘reprograms’ T cells, suppresses inflammation and aims to increase the threshold for clinical reactivity to gluten in patients with coeliac disease.

It offers patients the promise of freedom from a strict, life-long gluten free diet.

An earlier phase 1 study showed the vaccine could be safely administered to patients without immune activation if preceded by gradual dose escalation.

The current study will evaluate the efficacy of Nexvax2 administered subcutaneously over a 16-week treatment period and four-week follow-up.

Dr Jason Tye-Din, head of coeliac research at the Walter and Eliza Hall Institute of Medical Research said in a ImmunosanT statement that the trial was important in establishing clinical proof-of-concept for a potentially disease modifying treatment.

“The gluten-free diet is the only current treatment for coeliac disease, but it is onerous, complex and not always effective. 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 associated symptoms.”

President of Coeliac Australia Michael Bell said he was hopeful the trial was one step closer to an effective treatment for coeliac disease.