We first chatted about ImmusanT’s vaccine to eliminate celiac disease, Nexvax2, in March of last year. That May we wrote again, with promising news from the vaccine’s first human trials. And then again in February of this year, when the company began producing several thousand doses for a new trial.
Well, that new trial is now underway, according to a press release. Hooray!
The trial is taking place in New Zealand, Australia, and the US (where ImmusanT is based). According to the release, the New Zealand / Australia study is a randomized, double-blind, placebo-controlled phase 1 b study. They hope to have 84 patients across four locations and to study the safety, tolerability, and pharacokinetics of the vaccine.
The American study is also randomized, double-blind, and placebo-controled, but is a phase 1 (not b) study. The plan is to collect data from 30 patients across four sites.
Both studies will be done on patients with celiac disease who are on a gluten-free diet. The patients will all carry the gene HLA-DQ2, which as many of 90% of celiac patients have (a genetic test is often the first step in establishing whether or not someone may have celiac disease, and in that test this is the gene they look for).
How does the vaccine work? I think the release says it more succinctly than I can:
Nexvax2 is a therapeutic vaccine that combines three proprietary peptides that elicit an immune response in patients with celiac disease who carry the immune recognition gene HLA-DQ2. In an approach similar to treatments for allergies to cats and dust mites, Nexvax2 is designed to reprogramme gluten-specific T cells triggered by the patient’s immune response to the protein. The goal is for Nexvax2 to restore celiac patients’ immune tolerance to gluten, reduce inflammation in the nutrient-absorbing villi that line the small intestine, return the intestine to a healthy state, and allow patients to eat a normal diet.
In our past posts on the vaccine, commenters have wondered whether or not the vaccine would work for people who have a gluten sensitivity but test negative for celiac disease, and whether it will only work for people with the HLA-DQ2 gene. Although the press release does not mention people with a sensitivity, it would seem to me (and I am NOT a medical professional) that the vaccine is really being developed with an eye towards celiac patients / towards those people whose immune systems are displaying clear signals of “attack!” — but that whichever gene is indicated, an immune response is an immune response is an immune response. As doctors and researchers learn more about non-celiac gluten sensitivity, I imagine we’ll know more about how many of the people on the gluten-free spectrum can potentially be helped by a vaccine.