Clinical Trials Begin for Celiac Vaccine Nexvax2

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.

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The vaccine is reportedly designed to re-establish a celiac’s tolerance to gluten. The randomized, double-blind, placebo-controlled phase I b┬ástudy will be performed on those on a strict gluten-free diet who will receive┬ámultiple ascending doses of Nexvax2.

Image: Syringe Vaccine

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,┬áÔÇťOur 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.ÔÇŁ

The press release also states, “The goal is for Nexvax2 to restore celiac patientsÔÇÖ 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),┬áImmusanT is the company conducting the study, and is funded by┬áNexpep, a┬ábiotechnology 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,┬áwhen 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:┬áCeliac 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.

17 Replies to “Clinical Trials Begin for Celiac Vaccine Nexvax2”

  1. Eu tenho v├írias doen├žas associadas e acredito estar dentro de uma dieta sem glutem mas n├úo tem como garantir que realmente estamos seguros lendo rotulos dos fabridcantes que na grande maioria aqui no Brasil n├úo sabem o que ├ę Glutem.
    E sabemos que o glutem danifica o intestino causando v├írias perdas ao organismo e isto causa uma serie de doen├žas. Ent├úo diante destas informa├ž├Áes ├ę que eu espero a vacina NEXVAX2 para corrigir o sistema imunol├│gico e acho tamb├ęm que este estudo pode avan├žar e corrigir o sistema para outras doen├žas auto imune

    Portuguese to English translation:

    I have several associated diseases and believe to be within a gluten free diet but have no guarantee that we are really reading labels of insurance fabridcantes that the vast majority here in Brazil do not know what gluten is.
    And we know that gluten damages the intestines causing severe losses to the body and this causes a number of diseases. So before this information is that I hope the vaccine NEXVAX2 to correct the immune system and also think that this study can proceed to fix the system for other autoimmune diseases

  2. Hi,

    My name is Luana from Brazil. I would like to Know more information about Celiac Vaccine? When this vaccine came to Brazil. I┬┤m celiac and a woul like to much to use this. Please let me down about this.

    Tks

    Luana.

  3. I know that they use this method to deal with IGE reactions, true allergies, but not sure how the mechanism would work with IGA reactions. They must have a basis for their suppositions or they wouldn’t have got this far I dont think but I’m not convinced by it, I’d need to do more reading around it. I wouldn’t be willing to take the risk that I’d end up with more autoimmune problems.

  4. It IS crazy! They are (our government) is doing this to us, using GM wheat. Now they want to “fix” people with Celiac disease or other issues with a vaccine of all things? This is insane, crazy! Right now doctors do not care for Celiac patients. If you don’t believe me I suggest reading Gluten Dude’s FB page or blog. My husband was diagnosed and because 3 out of 5 of us have autoimmune issues, we avoid it. I don’t even want to understand the “science.” It sounds like another Big Pharma money maker. How about labeling GMO’s and giving us our REAL wheat back in our fields. This “vaccine” is disgusting to me and I’m pretty sure my husband will not have any interest in it. It is what it is…you can’t reverse it just like you can’t reverse Autism or Cancer. You have it, you find a way to live with it. I’m just tired of everything being about money vs good health care! Sorry for the rant Carla… BTW I love, love, love your page! I made my husband your GF cheesecake with chocolate gnache for his birthday, 1 month after he was diagnosed. It was wonderful and he was happy to have something to eat on his birthday. : )

    1. Hi Cara,

      Thanks for the clarification. You rant? Never! LOL! But seriously, I hear you! I never assume that a clinical trial is rigged, etc., but surely there aren’t black box warnings on so many drugs nowadays for nothing. I was surprised to see one on an antibiotic a couple of years ago. Meanwhile, the subject of Big Pharma can fill an entire blog on its own. I’m not sure if our earlier generation was fortunate or just in the dark about such things.

      Thank you for the kudos! And I’m so glad to hear that your hubby had a great birthday back when he first started his GF diet. I love that graham cracker crust! You just have to add enough butter. I rarely measure mine. I just go by the texture. When was he diagnosed?

      Take care, and don’t hesitate to email me with any special requests for recipes.

      Carla

    2. “Right now doctors do not care about celiac patients.” Maybe YOUR doctor doesn’t care, but I know tons of doctors who DO care about celiac patients. I have 2 excellent physicians who have helped me tremendously! Please stop demonizing things that you don’t have all the info. on – it could actually be a good thing. Educate yourself before forming an opinion.

  5. I would submit my son, if he qualified. I still don’t see the correlation between Trisomy 21 and Celiac-Sprue. I have a special needs child that also has to be on a special expensive diet. Why wouldn’t I try? He even just gets a simple tummy virus it’s like I’m dealing with the pre-diagnosis on top of the virus. I have to be like (excuse the pun) a Nazi when it comes to food,utensils, food prep areas, etc to be sure that there is no cross contamination. He is sensitive to the highest degree according to his blood test. So, for myself, why not? I’d however prefer to do this over summer break. In his school if he has diarrhea he has to be home 24 hrs. But this is just my opinion, I don’t need bashed or belittled for exercising my opinion

    1. Hi Heather,

      Who has been bashing or belittling you for your beliefs? I’ll go hunt them down for you myself.

      I understand that you must be at your wits end. If I were in your shoes with a child with downs, I just may do the same. All you can do is what is best for your son. Does your son have celiac and downs? Or are you saying your son has downs and you don’t understand why he needs to be on a gluten free diet? If it’s the latter, I’ve only read that the gluten-free diet seems to work on downs, ADHD, etc.

      I wish you all the luck!

      Carla

      FYI for others: Trisomy 21 = Down Syndrome.

  6. I thought the Dr. Peter Green book said that celiacs express the gene in such a way that they are missing the enzyme or enzymes that help to digest wheat.
    If we are missing the enzymes, the wheat will still get in and go undigested. So even if the autoimmune reaction stops, isn’t there likely to be continued damage in some way to the gastrointestinal system?
    I suppose in the case of accidental ingestion, I’d be happy to mitigate the damage by having it be limited to “just” GI damage as opposed to GI damage PLUS the autoimmune response.

    1. Hi FHMom,

      Thanks for your feedback.

      They are trying to change the immune system so that it does not cause an autoimmune reaction. I believe that Dr. Petersen’s concern is that if the gamma interferon they are trying the get the body to create becomes aberrant (reacts in an unusual manner) that it may cause an autoimmune reaction. I’m not certain whether it may cause the celiac systems to get worse or if it could cause other autoimmune diseases to develop. Either way, it’s a chance most are probably not willing to take.

      My concern is that if the trial is successful in the time allotted, that an additional autoimmune disease may develop in the future. I have autoimmune disease, transverse myelitis (inflammation of the spinal cord), which is sometimes known to develop into multiple sclerosis which is also an autoimmune disease. My doc said that it takes years for MS to develop. Therefore, if an autoimmune disease takes years to develop, no one knows what will happen to them years down the road, even if the celiac vaccine helps them in the short run.

      Any thoughts, anyone?

      Carla

  7. I just don’t see how this is feasible. They say they introduce it a little at a time to build immunity, but it’s not like celiacs become immune when they consume gluten over time. I’m not sure, I guess I just don’t understand the science behind it.

    1. Spenser, it doesn’t involve just a bit of gluten, but 3 peptides (or protein fragments) which commonly create an immune reaction. The peptides are supposed to cause the immune reaction. I suppose they need the gluten for the immune system to react.

      I hope this makes it clearer.

      Carla

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