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  • Jefferson Adams
    Jefferson Adams

    Promising Celiac Vaccine Nexvax2 Begins Phase Two Trials

    Reviewed and edited by a celiac disease expert.

      Carriers of HLA-DQ2.5 account for approximately 90% of people with disease, and Nexvax2 is designed to protect these patients from the effects of gluten exposure.


    Caption: Image: CC--Dawn Huczek

    Celiac.com 11/05/2018 - ImmusanT, Inc. is a clinical stage company looking to deliver innovative peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, initiated enrollment in Australia and New Zealand for its celiac disease vaccine. Along with Nexvax2, ImmusanT is working to develop vaccines for other HLA-associated autoimmune diseases, including type 1 diabetes.

    The Phase 2 trials will assess the safety, tolerability and efficacy of its celiac vaccine, Nexvax2, on celiac patients who carry the immune recognition genes for HLA-DQ2.5.  Carriers of HLA-DQ2.5 account for approximately 90% of people with disease, and Nexvax2 is designed to protect these patients from the effects of gluten exposure.


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    Nexvax2 is currently the only disease-modifying therapeutic candidate in clinical development for patients with celiac disease. Injections of Nexvax2 are designed to reprogram T cells that trigger an inflammatory response to gluten, thereby suppressing inflammation in patients with celiac disease. Phase 1 studies showed Nexvax2 to be safe and well-tolerated at even its highest dose levels. 

    In Phase 2 clinical trials, ImmusanT hopes to confirm clinical efficacy of Nexvax2 administered by injection into the skin for treatment of celiac disease. The study plan consists of an initial screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.

    The trials will be conducted at sites in Melbourne, Perth, Adelaide and Brisbane, in addition to sites in New Zealand. For the U.S. study researchers will enroll approximately 150 patients across the U.S., Australia and New Zealand. 

    Phase 2 is a randomized, double-blind, placebo-controlled clinical study of Nexvax2 in adults with confirmed celiac disease who have followed a gluten-free diet for at least a year prior to screening. 

    “This trial is important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet,” and will “test if Nexvax2 can specifically target the immune response to gluten in people with celiac disease and modify associated symptoms,” said Jason Tye-Din, MBBS, Ph.D., principal investigator at the Royal Melbourne Hospital and head of celiac research at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia. 

    For more information about RESET CeD, including inclusion and exclusion criteria, please visit www.clinicaltrials.gov (Identifier: NCT03644069). 


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    i'm glad to hear of a progress toward a cure, or a block.

    as a dh sufferer on dapsone, I look forward to the results.

    I take a flue shot, might as well try a proven celiac shot.

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    I am #4 in my family with Celiacs.  The problem of getting waiters to believe that you're not on a fad diet is the biggest problem.  I prefer to eat at home.  If the vaccine is tested as well as the shingles (zoster vaccine), I would take it.  I also have sorjenes and that is autoimmune disease also.  It's not an easy life but I doubt it would be available in my lifetime.  I appreciate all the help I receive from the Celiacs site on line.  If they could find a cure before my children come down with it, I would be thankful.  What's interesting to me is that two of four have gastrointestinal issues (female) and the other two (male) have rashes in the mouth and body when they happen to get gluten. It's a strange, life altering disease.  Just thankful it is not life threatening if you watch very carefully what goes in your mouth and on your body.  Thankfully,  it is a choice we each can make for what we feel is best for our bodies.

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    "Since the pathogens are not a threat to cause an immune system reaction, vaccines contain something called an adjuvant, which is placed in a vaccine to cause a strong immune response. Most vaccines use aluminum as an adjuvant, which is a neurotoxin that triggers the necessary heightened immune system response."

    Note how geneticists are "scrambling" to remove the "bad" gluten from "wheat" through new processes of hybridization.  Over the decades since 1900's scientists cross-bred plants in order to increase the amount of gluten.  In the decades to follow, the effort to make wheat drought and insect resistant led to genetic modification of the "dwarf" stalk hybrid.  The scientist got their wish in the 1990's when the percentage increase in gluten rose 17% above the 1960's wheat version.  In the late 90's it was discovered that "modern" wheat resulted in an increase in gluten-related diseases and sensitivities.  The Cooperating Parties for ICD-10 Disease code set "created" new disease codes for reporting the "new" gluten-sensitivity disorders and expanded the coding descriptions for  these disease.  Growing up in the 1950's I remember seeing the 15-foot amber waves of grain and the sweet smell of baked breads on the grocery shelves.  Now I have to hold my nose when passing the bread isle in order to avoid the "stench" that resembles that of a "putrification" of food.  The American agronomist, Norman Borlaug led initiatives worldwide that contributed to the extensive increases in agricultural production later termed the Green Revolution with its study of "plant pathology" that later evolved into a Global Farming mission to "Transfer rice immunity to cereals (wheat, maize, sorghum and barley) and transfer bread- wheat proteins (gliadin and glutenin) to other cereals."  

    Set aside the gluten issue and there is the wheat "GLIADIN" content which is now being reported as responsible for many other disease processes.  gluten-free oats for example do not contain more than 10ppm of gluten, but are high in gliadin.  Gliadin is responsible for increasing IgE- antibodies. 

    Vaccines are designed in an attempt to ease the populace mindset in order to regain confidence in ingesting wheat, barley and rye that are 'literally" laying in mountain-high piles in open soccer fields.  As the hybridization process continues it is ever more becoming an economic disaster for the wheat, barley and rye industries.  What once began with the ideology of "food security in the nations", the principles have been altered to reflect "economics" and "control".  

     

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    This vaccine is all very well and may stop vili destruction but I have significant nerve damage from gluten. I would wonder whether such a vaccine would stop the nerve damaging effects as effectively as a gluten-free diet... the gut reactions are the least of my problems.

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    A biologist friend from a major research university attempted to clarify what he meant when he stated that what this article proffers is NOT A VACCINE. He clarifies using my own example of taking small, daily doses of wildflower honey to help acclimate the body to the local pollens: 

    "Vaccines purposely cause an immune response so you only really need the shot in a longgg while for a particular pathogen (assuming it will not mutate often like the flu!). A vaccine is given to train the immune system to have a proper, fast response to a pathogen. The daily-dose of local wildflower honey is small to avoid a strong allergenic response, which is a more specific type of immune response triggered by the production of too much IgE (allergy and parasite specific antibody). This is not a vaccine but is called immunotherapy instead because certain T cells are trained to help lower the amount of IgE present in response to an allergen.

    "The Celiac 'vaccine' is more akin to immunotherapy in allergies because you are avoiding the immune response and are instead trying to get the immune system to better regulate itself so it does not attack your gut when you are exposed to glutin. If it were a vaccine then it would be training your immune system to have a stronger response to gluten, which would be bad."

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    Thanks. I think? 

    Given that rampant T cell response to ~20ppm gluten appears likely to cause nerve damage for some weeks to months after, I'm still not convinced. I have too much permanent damage to the long nerves already to be an experiment. 

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    I was recently kicked out of the Phase 2 clinical trial, because I didn't have a severe enough reaction when I did the food challenge. Since when is Celiac just about the immediate reaction? Sounds more like they are trying to put bandaids on symptoms, not protect you from intestinal damage. 

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    On 11/16/2018 at 2:29 AM, sc'Que? said:

    A biologist friend from a major research university attempted to clarify what he meant when he stated that what this article proffers is NOT A VACCINE. He clarifies using my own example of taking small, daily doses of wildflower honey to help acclimate the body to the local pollens: 

    "Vaccines purposely cause an immune response so you only really need the shot in a longgg while for a particular pathogen (assuming it will not mutate often like the flu!). A vaccine is given to train the immune system to have a proper, fast response to a pathogen. The daily-dose of local wildflower honey is small to avoid a strong allergenic response, which is a more specific type of immune response triggered by the production of too much IgE (allergy and parasite specific antibody). This is not a vaccine but is called immunotherapy instead because certain T cells are trained to help lower the amount of IgE present in response to an allergen.

    "The Celiac 'vaccine' is more akin to immunotherapy in allergies because you are avoiding the immune response and are instead trying to get the immune system to better regulate itself so it does not attack your gut when you are exposed to glutin. If it were a vaccine then it would be training your immune system to have a stronger response to gluten, which would be bad."

    At almost 70 years of age, I have no trust in the medical establishment or pharmaceuticals. I have suffered enough from vaccines and autoimmune issues since the age of 13 (1963) and so called desensitizing shots in 1980. 

     

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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