The new trial, ‘RESET CeD’ will evaluate the safety, tolerability and efficacy of the vaccine in adults with coeliac disease who have the common HLA-DQ2.5 gene, seen in approximately 90% of people with coeliac disease.
Nexvax2 is administered as a series of injections and is designed to target and reprogram the T cells that trigger an inflammatory response to gluten. By suppressing this inflammation it aims to prevent the adverse clinical effects caused by gluten ingestion in people with coeliac disease.
The new RESET CeD trial is a randomised, double-blind, placebo-controlled clinical study of Nexvax2 in adults with medically confirmed coeliac disease, who have been following a gluten free diet for at least 12 months. The study plan consists of a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment follow-up period. Participants must be willing to consume a moderate amount of gluten.
Who can take part:
• Adults 18 to 70 years of age with biopsy-proven coeliac disease and following a gluten-free diet
• Willingness to consume a moderate amount of gluten
• Worsening of gastrointestinal symptoms in response to an oral gluten challenge
• Coeliac gene HLA-DQ 2.5 positive (if not known, this will be tested)
• Unwilling or unable to perform self-injections
• History of inflammatory bowel disease and/or microscopic colitis
• Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
• Use of oral or parenteral corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable
• Females who are lactating or pregnant.
What is involved:
• Twice weekly injections during treatment phase (16 weeks)
• Blood samples
• Vital signs (blood pressure and pulse)
• Completion of questionnaires
• Daily electronic diary
• Gastroscopy and biopsy (in a proportion of participants)
Next Steps for Potential Trial Participants
If you’re comfortable with the commitment required, and you feel you satisfy the inclusion and exclusion criteria, please assist us in further screening qualification and upload your test results for the following:
- Diagnostic biopsy results
- Serology results
- Gene testing results
Once we’ve received these documents, we will be phoning eligible participants as we reach the next phase of screening in January – February 2019. Please make sure your contact details below are accurate so we can contact you.