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  • "Vaccine" for Celiac Disease

      The "vaccine" Nexvax 2 is designed to work similar to allergy shots.

    Caption: Image: CC--Steven Depolo

    An experimental "vaccine" called Nexvax 2 is being scheduled for human clinical trials to evaluate its effectiveness in celiac disease. Immusan T is a biotechnology company focusing on developing therapeutic vaccines and received $40 million in 2017 to fund Nexvax 2 to reduce the "suffering of those with celiac disease since it is a serious inflammatory autoimmune disease caused from gluten".

    Since there is no cure for celiac disease except following a strict gluten-free diet, symptoms can vary greatly based on age and diet content. Children with DQ2 and DQ8 genes may have a swollen belly, chronic diarrhea and poor appetite which can cause delayed growth. Adults often experience abdominal pain, fatigue, anemia and joint pain. 

    When grain products- containing gluten and gliadin- are consumed tissue transglutaminase in the small intestinal lining signals an immune response that produces antibodies which attack the lining of the small intestine. This leads to malabsorption of nutrients from food. Nutrient deficiencies cause liver, bone and neuron damage resulting in abnormal growth, poor tissue repair and numerous symptoms.

    Allergy vs Auto-Immune Disease

    It is important to understand that celiac disease and dermatitis herpetiformis (itchy, blistery skin rash) are auto-immune disorders NOT an allergy to gluten. Allergies occur when the immune system overreacts to a compound causing the release of histamines. An auto-immune disorder results when the body misidentifies a substance as dangerous and causes the immune system to attack the body's own tissue.

    Celiac Disease Epidemic

    Celiac disease and gluten enteropathies are a growing epidemic in the U.S. and across the world due to the increasing use of processed foods and food additives that use grain products for thickening, stability and dietary supplement fillers. Environmental factors may contribute to a person becoming gluten intolerant even after decades of consuming gluten without suffering serious health consequences.

    How "Vaccine" Works

    The "vaccine" Nexvax 2 is designed to work similar to allergy shots according to Live Science (Nov. 9, 2018). The treatment involves twice weekly injections administered over a 16 week (4 months) period to reprogram T cells to begin to tolerate gluten and suppress immune destruction of the villi in the small intestine. No available data is currently available on the ingredients used in Nexvax 2 so safety can not be assessed at this point.

    What is known is that vaccines DO NOT mean immunization whether through injection or oral dosing. Immunization is a process for developing tolerance and protection against infections. Dorland's Medical Dictionary states vaccination means to "inject a suspension of attenuated or killed microorganisms administered for prevention or treatment of infectious disease".

    The Center for Disease and Prevention Control (CDC) states that vaccination does NOT guarantee immunity. Natural immunity comes only after a person recovers from the actual disease, and not all who receive a vaccination will have immunity. No vaccine is 100% effective because everyone's immune system reacts differently.

    Before lining up to participate in the clinical trials, adapt a more educated approach to vaccination safety regarding a disease managed very effectively by a healthy gluten-free, lectin-free diet. It is a personal decision for adults with celiac disease whether or not they chose to vaccinate. 

    It will be many years before the safety of this celiac disease "vaccine" can be established.  On a personal note: I have been a celiac for more than 70 years and would never consider a "vaccine" just so I didn't have to worry about hidden gluten. 

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    I think this is one of several exciting research projects that I'm hopeful can improve the lives of those with celiac disease. I suspect if you had the choice of knowing you could take a vaccine that would improve your next 70 years with celiac than you would have a different perspective. 

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    I don’t believe you should be calling this a vaccine, with or without quotes. Celiac disease shots should suffice. Allergy shots are not called vaccines and neither should this. It is not a vaccine why complicate the message. 

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    You know. I have lost trust of anything I read on this site. The info given doesn't seem to be substantiated and it seems opinions override the content. I am so hopeful for this long-running website to get their facts and acts together. I am continually disappointed.

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    If they are using tiny amounts of gliadin twice a week for 4 months in the injections, I would imagine the person receiving this would feel very sick after weeks of this. Not a trial I would sign up for. I got allergy desensitization injections as a kid. My arm would swell like a baseball if the dose was too high. I wouldn't want a similar experience with gluten.

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    It would be more accurate to call Nexvax2 immunotherapy.  While I share your concern about the long term safety of Nexvax2, please distinguish between opinion and fact.  A significant subgroup of Celiac patients do not improve on a gluten free diet.  And, a significant subgroup of pediatric Celiac patients appear to respond to a gluten free diet (symptom resolution and negative antibodies) but still show evidence of active disease upon endoscopic evaluation.  Your experience is your experience.

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    From the article I can’t assess the purpose of the shots: are they to protect from incidental gluten exposure or can one eat normally, disregarding gluten?  

    Assuming that the shots are reasonably free from unacceptable side-effects and risk, I’d get them even if it only meant that once a month I could have pizza and beer or an Italian meal with bread and a gluten-containing entree.

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    I have been gluten free for 8 years. I applaud work in this field. I rely a lot on rice and I worry about the possible buildup of arsenic found in rice - especially American grown rice. Having the ability to eat gluten to vary my diet would be great.

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    I would try it if mean could eat fish and chip again and birthday cakes and Piza I dispoint can't have pasta on prescription now. I very disappointed it been noughting but row in my family

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    Perhaps it would be more accurate to say that vaccinations do not equal immunity since in the common parlance (CDC included) vaccine and immunization are used synonymously.  

    I was astonished by your comment that you would not consider a vaccine so you would not have to worry about hidden gluten.  Hidden gluten is becoming a huge issue and making many of our lives miserable as we try to stay on a gluten free diet.  The children and adults and their symptomology mentioned early in the article surely are well worth a vaccine/shot series should it be as safe as can be otherwise.

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    Guest SDPrairieCeone


    Guest Daisy - You are unnecessarily restricting yourself. There are tons of gluten-free flour mixes, cake mixes, pasta, and pizzas on the market. Yes, they are spendy, but many makers offer coupons online. Many recipes I use for quick breads and cakes adapt very well to substituting gluten-free flour blend for all-purpose flour. Experimentation with your own favorites is needed. Best hint ever to counteract the dryness/crumbles of baked goods from a chef I know who has experience with gluten-free food prep: add a big blob of sour cream. Made the best ever cobbler topping! You are limited only by your imagination. I have gifted cakes and cookies to friends and neighbors and they are always shocked when I tell them "It's gluten free." You don't have to wait for a medical treatment to enjoy your life now. I control my Celiac, it does not control me.

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  • About Me

    Betty Wedman-St Louis, PhD, RD is Assistant Professor, NY Chiropractic College, MS Clinical Nutrition Program Nutrition Assessment Course & Food Science Course.  She is author of the following books:

    • Fast and Simple Diabetes Menus, McGraw Hill Companies
    • Diabetes Meals on the Run, Contemporary Books
    • Living With Food Allergies, Contemporary Books
    • Diabetic Desserts, Contemporary Books
    • Quick & Easy Diabetes Menus Cookbook, Contemporary Books
    • American Diabetes Association Holiday Cookbook and Parties & Special Celebrations Cookbook, Prentice Hall Books


  • Related Articles

    Jefferson Adams
    Celiac.com 04/24/2014 - Though some celiacs will tell you they’re content to remain gluten-free for life, being able to freely consume gluten is the dream of many a person with celiac disease.
    ImmusanT is one of the few companies working on an actual vaccine for celiac disease. Over the next few months, ImmusanT is likely to begin reporting data from two separate early-stage clinical trials for NexVax2, a celiac disease vaccine.
    That data will offer the first glimpse into the potential for ImmusanT to treat celiac disease, and into the viability of the company’s peptide immunotherapy platform.
    The current two studies are Phase 1b trials, designed to confirm the safety of NexVax2, and to find a range of potential doses for the company’s next trials. Success at this stage still means a very long process for ImmusanT, as numerous clinical hurdles remain.
    Meanwhile, several other companies trying to find non-vaccine treatments for celiac disease.
    Both San Carlos, CA-based Alvine Pharmaceuticals and Baltimore, MD-based Alba Therapeutics, for instance, are developing drugs to supplement an existing gluten-free diet.
    Rather than being full-blown vaccines, these drugs are intended to reduce or eliminate adverse gluten-reactions due to simple gluten-contamination.
    Another company, Sitari Pharmaceuticals, fueled by $10 million in capital, and a joint venture with GlaxoSmithKline and Avalon Ventures, is also looking to pursue treatments for the digestive disorder.
    For its part, ImmusanT remains committed to its goal of developing a vaccine that will allow celiac patients to eat all the gluten they want.
    The company says its drug is currently the only treatment in development “focusing on disease modification so patients can resume an unrestricted diet.”

    Jefferson Adams
    Celiac.com 08/26/2016 - News that ImmusanT company is beginning full human trials for their celiac disease vaccine, NexVax 2, brought a number of comments from our readers.
    We first reported on their effort way back in 2002, with our story, Australian Researchers Begin Work on a Vaccine for Celiac Disease.
    We followed up over the years, with stories in 2009, First Ever Celiac Disease Vaccine Trials Underway in Australia and again in 2011, with articles reporting on the company's efforts to raise investment funds, titled ImmusanT Raises $20 Million in Series A Financing to Advance Immunotherapeutic and Diagnostic for Celiac Disease and on how ImmusanT's Celiac Vaccine Passed Phase I Clinical Trials and in 2012, with Is a Vaccine for Celiac Disease Just Around the Corner?
    Comments generally ran toward the affirmative side, with many people expressing excitement or interest in such a vaccine.
    From Jared M: I hope this research goes well. The bread, crackers and pizza I can live without. But I would really like to be able to drink a good IPA again. The sorghum beers are horrible. I am quickly growing tired of ciders. I would definitely pay for this treatment if it works.
    From Toni: I have celiac. That [a vaccine] would be wonderful.
    From Traci: I would like to be involved in a study for this immunization.
    From Linda Haas: Can't wait to hear more about the progress made on this vaccine...it sounds very promising!
    From Donda: I'm thrilled with the possibility of this coming to market.
    From Muriel Weadick: This is what all celiacs have been waiting for, and I am sure I am not alone in wishing the company success.
    From Suzanne: A vaccine like this would make it easier to eat out and go on vacation.
    Jeanne Burge wrote: I would gladly volunteer for the trials in the US. Hope this works!
    Still, a few comments ran toward the less than glowing side, with some people expressing trepidation, or outright distrust toward such a vaccine.
    From Cathi: My Question is, "What will be the side effects of this turning off the body's ability to fight Gluten?" Will there still be destruction some place else and maybe worse? So, many times a pill is created to help one thing only to find out that it created another problem some place else in the body. Frankly, I am worried.
    From Donna: Absolutely agree with you, Cathi. There is always a problem and side effects with ANY drug! My question is this - WHAT ELSE will be shut off? Will we be even MORE susceptible to other illnesses? I am worried as well!
    From Balm: Thanks but no thanks. I'll remain a celiac and continue to eat healthy. While trying to fix one problem, some will end up with far worse problems.
    From Jonnys: Stupid idea! Just another way to make more money off of people.
    Certainly, those who may have a weakened or compromised immune system should consult with a physician before receiving most vaccines. But, in adults with a healthy immune system, such a vaccine would likely present little or no danger to the recipient. Most people with celiac disease have healthy immune systems, so the likelihood of any adverse reaction will be slight.
    Of course, this is all theoretical, even at this point, as vaccine trials have so far not proven how well the vaccine actually works in preventing or curing celiac disease.
    So, the question is, if such a vaccine is proven safe and effective, would you be open to trying it, or not?

    Jefferson Adams
    Celiac.com 04/03/2017 - Massachusetts biotech firm ImmusanT has announced the successful completion of its first phase 1b trial of Nexvax2, an immunotherapy drug designed to protect celiac sufferers from the adverse effects of gluten exposure, including gastrointestinal symptoms, such as diarrhea, abdominal pain and bloating.
    Nexvax2 is a drug that relies on three peptides designed to promote T cells involved in the inflammatory reaction in celiac disease to become tolerant to gluten. The company hopes that an initial course will promote gluten-tolerance, which can then be maintained by periodic boosters of the vaccine.
    The phase 1b trial in 38 patients showed no issues with safety or tolerability, and indicated that the immunotherapy seemed to work as designed.  The study also helped ImmusanT to determine dosages for phase 2 trials to determine if Nexvax2 can protect patients on a gluten-free diet from inadvertent gluten exposure, which ImmusanT sees as the quickest route to approval.
    If Nexvax2 proves to be effective in preventing accidental gluten exposure in celiac patients, the company plans a follow-up program to see if immunotherapy with Nexvax2 can eliminate the need for a gluten-free diet in celiac patients; a step that represents a daunting challenge, and is somewhat of a Holy Grail for celiac researchers.
    ImmusanT is also developing diagnostic protocols for the vaccine, which are designed to guide its use and help improve diagnosis rates.
    Nexvax2 is just the latest in a large crop of auxiliary treatments aimed at celiac disease. Switzerland's Anokion teamed up with Japanese pharma Astellas in 2015 to form Kanyos, a company working on an immunotherapy for celiac disease along with type 1 diabetes. A company called Sanofi is also working with Selecta on a similar approach.
    Meanwhile, in 2013 AbbVie licensed rights to Alvine Pharmaceuticals AVL003, an oral therapy designed to break down gluten in the GI tract before it can cause damage.
    So, stay tuned celiac sufferers, the next few years could produce some very interesting new treatments for celiac disease, something considered impossible just ten years ago.
    Source: Fierce Biotech

    Jefferson Adams
    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.
    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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