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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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    5 hours ago, JazzyJake said:

    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.

    The latter, assuming it ends up working. That's what sets Nexvax2 apart from other therapeutic treatments; while most others (some of which are much further along in their development, incidentally) aim to protect against cross-contamination, Nexvax2 would in theory allow you to re-introduce a moderate amount of gluten into your diet. You probably wouldn't want to go to an all-you-can-eat wheat pizza buffet, but you could probably handle a beer or two. Maybe a sandwich with wheat bread. That sort of thing. More info from the official site: http://www.immusant.com/clinical-development/celiac-disease-programs.php 

    It's just now entering stage II clinical trials, though, so we're many years off from it becoming a reality. A different drug, INN-202 (more here: http://www.innovatebiopharma.com/inn-202.html), has proven both relatively safe and effective so far and is in stage III trials currently. It could be on the market within the next couple years. Unlike Nexvax2, it won't allow you to eat gluten freely, but it will protect against cross-contamination, so eating out with friends without having to worry if the kitchen knows how to properly prep for celiac disease could be a thing of the past. Speaking personally, that would be HUGE for me.

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    12 hours ago, Guest Kerk said:

    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. 

    It actually is a vaccine. Specifically, a therapeutic vaccine. I'm not sure why the author is putting it in quotes; this isn't some sort of dubious distinction.

    Edited by Magister Mundi
    Added link

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    2 hours ago, Ging said:

    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.

    Looking at the author's credentials, I suspect that comes from holding anti-vaccination sentiments. It's pretty common in chiropractic practice, unfortunately, and the ridiculousness of the "anti-vaxx" movement aside, it's disappointing that the word itself appears to be a significant hurdle to even considering the therapy. 

    Anyway, in this case, it's a therapeutic vaccine, so "immunization" isn't really the point to begin with, given that gluten isn't a virus or bacteria that the vaccine is training the body to fight against. Instead, the point of the vaccine is to "re-program" the immune system to treat gluten normally, rather than viewing it as a threat. You might already know that, but I suspect quite a few people don't, and the author of this article certainly didn't link to any sources (here and here, incidentally), so I figured I'd mention it.

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    24 minutes ago, Magister Mundi said:

    Looking at the author's credentials, I suspect that comes from holding anti-vaccination sentiments. It's pretty common in chiropractic practice, unfortunately, and the ridiculousness of the "anti-vaxx" movement aside, it's disappointing that the word itself appears to be a significant hurdle to even considering the therapy. 

    Anyway, in this case, it's a therapeutic vaccine, so "immunization" isn't really the point to begin with, given that gluten isn't a virus or bacteria that the vaccine is training the body to fight against. Instead, the point of the vaccine is to "re-program" the immune system to treat gluten normally, rather than viewing it as a threat. You might already know that, but I suspect quite a few people don't, and the author of this article certainly didn't link to any sources (here and here, incidentally), so I figured I'd mention it.

    Excellent points and I'm glad you made the clarification on the purported methodology of the injection/s.  I agree that the semantics are becoming an absurd sticking point. 

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    Celiac is not caused by gluten, but by genes.  The reactions are caused by gluten.  I could only imagine how I would react to this as I not only have Celiac but am allergic to gluten as well.  I cannot even touch it without getting painful welts.  Injecting it twice a week, um no thanks...  This is some seriously narrow thinking.

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    "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."

    For many of of this statement is not true at all. Many of us don't and have not indulged in fast food, processed food or foods with food additives. But, we can pinpoint our beginning of gut issues and other autoimmune issues when we reacted adversely to certain vaccines. And, that is the issue here; injected poisons and ingested poisons (pharma) along with poisons in our food, water and air.

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    Guest Michelle Morgan

    Posted

    Well they have gluten free pastas bread , chips cakes 🎂 and etc. found in wal mart mainly I’ve found it in Kroger .. also I’ve found out gluten free food higher in calories and sodium.. 

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    Celiac is a disease.  I have suffered for 30 years...as I have gotten older just small cross contamination sends me into a episode, that always ends at the hospital.  What needs to be addressed are products that claim to be gluten free, but are not.  Basically at this stage of the game, I do not eat anything I have not prepared.  I do not think a shot is going to help me.

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    Where do I sign up?  Im so uncomfortable and stressed  when I go out to eat because I try to relate to the waiter/waitress the importance of my Gluten & soy allergy.  I have to hope they are listening and relay the message to the chef to have my food made properly.  

    Also any weddings, parties, and holidays I feel like an outcast because I cant enjoy any of the same foods like everyone else.  Its not fun, its very depressing. 

    Keeping my fingers crossed for this shot/vaccine.  

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    Same here!!! I hv gluten setbacks all the time and most of the time I have no clue what happened. My body needs this vaccine so badly and my husband needs his wife back, my kids need their mom back. I need to go months and years between getting sick. Not days and weeks like now ....

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    A decade ago, the world-wide gluten intolerance was 1 in 2,500.  Today its 1 in 133.  Gluten and gliadin are toxic to "millions" of people! Yet, the food industry (manufacturers and restauranteurs) are not responding fast enough to the growing needs of celiac and non-celiac sensitivity diseases. 

    History: Hybridization began in 1938. However, extensive "repetitive back-crossing" and "crossings with foreign grass species" created the "dwarf super-hybridized wheat" that is responsible for the EPIDEMIC disease outbreak. Sadly, digestibility of the Modern Wheat was never examined!

    The method used to create the "dwarf super-hybridized wheat" is called "chemical mutagenesis" and is not classified as GMO engineering. The chemical is "highly toxic" sodium azide and gamma radiation. In 2003 "Clearfield" wheat ( tolerant to Beyond herbicide) was introduced. This "toxic" wheat is the preponderance of the wheat-type used in food stuffs/products.

    Despite the potential findings of a vaccine for celiac disease, do people want to put "mutated and highly toxic" modern wheat into their bodies?  The answer to that is an individual one.

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    I probably wouldn't go for the vaccine either if it became available. Most of the time I can navigate weddings, parties, restaurants and work lunches just fine.  It just took a little work.  More and more of my friends are becoming very allergy aware.  As a result of the food allergic and sensitive among us even at our church potlucks we label food for allergens or possible cross contamination.  

    Society has come a long way! These days my biggest problem is feeling obligated to eat the special (and often pricey) food people went out and purchased for 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.”
    Source:
    Xconomyc.com

    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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