In May 2011 I reported on the Nexvax2, the Celiac Vaccine Slated for 2017, and voiced my skepticism. I wanted to provide an update. Per a recent press release, Trials Begin for Nexvax2 in New Zealand, Australia & US for Celiac Disease. One study will be performed in Australia and New Zealand on those who have the DQ2 genotype (genetic profile) for celiac disease, which majority have. They expect to have 84 subjects tested in 4 different test sites.
The vaccine is reportedly designed to re-establish a celiac’s tolerance to gluten. The randomized, double-blind, placebo-controlled phase I b study will be performed on those on a strict gluten-free diet who will receive multiple ascending doses of Nexvax2.
The second study, a randomized, double-blind, placebo-controlled phase I will be performed in the U.S. with 30 adult celiac subjects at approximately four sites. The study will evaluate the safety, tolerability and efficacy (effectiveness) of gluten in the test subjects.
Patrick H Griffin, MD, chief medical officer of ImmusanT stated in the press release, “Our clinical development programme will allow us to further examine the role of antigen-specific T cells in celiac disease activation and in the re-establishment of tolerance to gluten.”
The press release also states, “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.”
As reported in my earlier article (linked above), ImmusanT is the company conducting the study, and is funded by Nexpep, a biotechnology company which one of their focuses is to develop a treatment for celiac disease. Therefore, the funder has a vested interest in the results. I always like to see unbiased studies (I’m not saying that their study is unbiased, but it makes me leery), but at the same time, I believe if you are doing fine on a gluten-free diet, why mess success. And for those who are not doing well, note that there are usually medical/physical reasons why your symptoms are occurring: from dairy intolerance to additive sensitivities.
Dr. Vikki Petersen, who is an expert in the above intolerances, contributed an article last year on this subject. She has personally spoken to Dr. Robert Anderson, PhD (from Australia) and discussed the goals of his study.
The vaccine is derived from wheat and barley and contains 3 peptides (or protein fragments) that commonly create an immune reaction.
She explained that the vaccine is similar to a holistic approach, providing a little bit of what someone is sensitive to, as in allergy shots, to build up the immune system, in this case gluten along with the 3 peptides that commonly create an immune reaction. The vaccine’s purpose is to also create “an immune substance called gamma interferon, which is critical in developing a specific immunity.” Because “gamma interferon, when aberrant [departs from an accepted standard], is associated with autoimmune disease, meaning the immune system gets overstimulated to a point where it starts attacking the body itself instead of the foreign agent”, who knows what it will cause…additional autoimmune diseases?
See Dr. Vikki Petersen’s article: Celiac Disease News: A Vaccine is in Phase I Trials, which goes over the purpose of the study, what the vaccine contains, the side effects, and more.