Author Interviews, Gastrointestinal Disease, Lancet, Vaccine Studies / 13.05.2017
First Report Of A Therapeutic Vaccine For Gluten Sensitive Celiac Disease
MedicalResearch.com Interview with:
Leslie Williams, BS, RN, MBA
Director, Founder, President and
Chief Executive Officer and
Dr Robert P Anderson MBChB BMedSc PhD FRACP
Chief Scientific Officer
ImmusanT, Cambridge, MA
MedicalResearch.com: What is the background for this study?
Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period.
(more…)
![Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MA](https://medicalresearch.com/wp-content/uploads/ImmusanT-200x44.png)