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  • Jefferson Adams
    Jefferson Adams

    Would You Try a Vaccine for Celiac Disease?

    Reviewed and edited by a celiac disease expert.
    Would You Try a Vaccine for Celiac Disease? - Photo: CC--Frank Balsinger
    Caption: Photo: CC--Frank Balsinger

    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.



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    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?



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    My son is only 5 and was diagnosed at 15 months old. He is still so young so yes I would be very happy if there was something in the future he could do pending it had been proven safe and all that. So many things I worry about for his future like his teen years, dating, restrictions on employment for ex military if he wanted to.. Just so many "what ifs".. As a mom I would love to make things as easy as possible for him. I feel terrible when he asks me why God made him different and how gluten just looks so good.. I can usually cheer him up and everything will be ok, but it comes up every once in awhile and just breaks my heart. Will continue to follow the research to see where it goes.

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    I think the IDEA is terrific, but I have my doubts concerning the effectiveness of a vaccine for my problem (celiac disease) as well as possible side effects. I am in my 60s and already deal with side effects of a blood pressure medication. Because my pediatrician told my mother that I had "outgrown" celiac when i was 10 years old, I ate a normal diet for about 50 years and then suddenly faced CONSEQUENCES. I feel very lucky to be alive with normal digestion - and strict adherence to a gluten free diet, which I spice up with lots of fruit, veggies, herbs, meats, dairy, good recipes, etc. Another doubt I have about a vaccine is this: celiac disease is not caused by viruses or bacteria. What are we inoculating/what are we inoculating against?

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    My son is only 5 and was diagnosed at 15 months old. He is still so young so yes I would be very happy if there was something in the future he could do pending it had been proven safe and all that. So many things I worry about for his future like his teen years, dating, restrictions on employment for ex military if he wanted to.. Just so many "what ifs".. As a mom I would love to make things as easy as possible for him. I feel terrible when he asks me why God made him different and how gluten just looks so good.. I can usually cheer him up and everything will be ok, but it comes up every once in awhile and just breaks my heart. Will continue to follow the research to see where it goes.

    I agree with you wholeheartedly, Ashley. My son is 9, and was diagnosed when he was 3. I worry about his future as well. Sometimes he'll look at and smell my food, and say that he wishes that he could eat it, and it kills me. He also made me promise that if they do come out with a vaccine, I'll buy him all the gluten foods that he hasn't been able to eat, like Twix and Kit-Kats.

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    I would try it even if only so I could eat gluten free out at restaurants without fear of cross contamination. I get violently ill with the least amount of gluten and so I don't eat out at all. Waiting and waiting for an entirely gluten free restaurant to come to my area. Please...

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    Hello,

    It hasn't been intentional, but many of my travels in the recent years have been to coastal towns or towns very low in elevation. I have found that drinking or eating any products with gluten/wheat in them has caused no adverse reaction to my GI. So long as I do not travel back to higher elevation cities inside of 24 hours of having had gluten, I have no adverse reactions back at home either. I do not know if my cilia feel the same way at the lower elevations when I have ate or drank products containing gluten, but thought it was interesting to note.

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  • About Me

    Jefferson Adams

    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 2,500 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. 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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  • Related Articles

    Jefferson Adams
    Celiac.com 03/30/2012 - A company called Microtest Laboratories is manufacturing doses of what they claim may be the first effective vaccine treatment for celiac disease. At this point, the only treatment for celiac disease is to avoid gluten in the diet.
    Other companies are working on vaccines for celiac disease, and several working trials are underway. However, this new drug's creator, ImmusanT, based in Cambridge says that, unlike other vaccines, which prevent an infection, their drug, Nexvax2 works by changing the immune system so it no longer attacks gluten.
    Production on Nexvax2, began last week, Steven G. Richter, Microtest’s president and science director, told a local reporter. So far, ImmusanT has raised $20 million in investor capital to bring the vaccine to market.
    Regarding the path from concept to manufacturing for Nexvax2, Richter says that the process has been anything but straightforward. "It's arty process," he told a local reporter, "you have to develop protocols for all the manufacturing and plans to do all of the work aseptically. You have to get all those protocols and plans approved through the regulatory process. Then you have to do the work.”
    Microtest is initially manufacturing 9,000 vials for ImmusanT: two 3,000-dose batches of vaccine and a 3,000-dose batch of inert placebo to be used in the clinical trial. Richter says that the control group contains everything except the active vaccine.
    ImmusanT is looking to start the first clinical trials in the second quarter of this year by testing the doses on people with celiac disease. The full article, in Massliveonline.com quotes Leslie J. Williams, president and CEO of ImmusanT, as saying that “The test will be if it [the vaccine] induces a tolerance for gluten in the diet."
    The report says that Williams and the company hope to get the vaccine commercially available by 2017. Will the company succeed? Will they have a successful vaccine available in just five short years? Let us know what you think.



    Jefferson Adams
    Celiac.com 04/10/2015 - Of course, a strict gluten free diet is still the only safe and effective treatment for celiac disease. However, new drugs in development, some of which are currently being tested on humans, might allow people with celiac disease to safely eat gluten again, at least in small amounts.
    To be fair, even if all goes smoothly, it will be a few years at least before we see such treatments on the market. Moreover, even though many early results have been encouraging, none have yet entered safety trials, the final step before Food and Drug Administration approval and commercial availability.
    Drugs currently under trial include an enzyme that splits the protein in wheat that triggers adverse reactions, into smaller harmless products, and another which promises to make the gut less leaky, and thus block potentially toxic substances from triggering inflammation.
    There are several other drugs in earlier stages of development aimed at suppressing the immune response to gluten and preventing intestinal inflammation:
    ALV003, which will protect people with celiac disease against gut damage from small amounts of gluten. BL-7010 is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten. ImmusanT’s therapeutic vaccine Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2. Larazotide acetate (AT-1001) is Alba Therapeutics Corporation’s investigational product, a first-in-class tight junction regulator, intended for the treatment of patients with celiac disease. AVX176, from Avaxia Biologics, is an investigational oral antibody drug that is the subject of U.S. composition of matter patent 8,071,101, “Antibody Therapy for Treatment of Diseases Associated with Gluten Intolerance.” The patent, which expires on May 27 2029, provides broad coverage for treating celiac disease using orally administered antibodies produced by Avaxia’s proprietary platform technology [32]. ActoGenX is carrying out discovery research in celiac disease with its range of ActoBiotics™, which use Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc. Chemocentryx’s CCR9, is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn’s disease. It has completed one Phase 2 trial in 67 patients with celiac disease. Meanwhile, in Europe, Dr. Falk Pharma and Zedira recently announced the start of phase I clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. The small molecule targets the dysregulated transglutaminase within the small intestine in order to dampen the immune response to gluten which drives the disease process.
    Some of these drugs may be taken right before eating gluten, while others might be more effective when taken on a regular schedule. If approved for use as intended, these drugs will likely allow people with celiac disease to eat gluten in small amounts. To my knowledge, there is no drug in current trial phases that is designed to permit unrestricted gluten consumption.
    So, the good news is that the next few years may see commercially available treatments that might actual help people manage celiac disease. The downside for people with celiac disease, at least for now, is that there is no treatment on the horizon that will allow safe, unlimited gluten-consumption. Moreover, there is no hint that a cure is coming anytime soon.
    Still, it’s good to know that researchers are working on providing helpful tools for treating celiac disease.
    Are you looking forward to seeing new treatment options for celiac disease? What kind of benefits should such treatments offer?
    Source:
    Gastroenterology Report


    Jefferson Adams
    Celiac.com 07/25/2016 - Celiac disease is one of the most common immune-mediated diseases. Often, a gluten-free diet does not fully control celiac symptoms and disease activity.
    Even though no new therapies have been approved, a growing effort, coupled with a rapidly expanding knowledge of the regulatory pathway could soon lead to new breakthroughs.
    A team of researchers recently reviewed the epidemiology, pathophysiology, and current treatment paradigm for celiac disease. The researchers were M Wungjiranirun, CP Kelly, and DA Leffler, both of the Division of Gastroenterology at the Celiac Center of Beth Israel Deaconess Medical Center in Boston, Massachusetts, USA.
    They also reviewed the major types of therapies being proposed for celiac treatment, and expounded broadly upon what is known, and what can be predicted concerning the regulatory pathway for approval of a new celiac disease treatment. In the near future, increasingly numerous and diverse therapy options will enter clinical trials. The desired result will be the first approved agents targeting celiac disease treatment outside of a gluten-free diet.
    The team notes that, though things like biopsies and blood tests will always be important in therapeutic clinical trials, there is not currently enough evidence to link them with improved patient outcomes, which is required as a baseline for drug approval. This means that patient-reported outcomes will likely be primary end points in Phase III celiac disease trials for some time to come.
    Source:
    Am J Gastroenterol. 2016 Jun;111(6):779-86. doi: 10.1038/ajg.2016.105. Epub 2016 Mar 29.


    Jefferson Adams
    Celiac.com 07/19/2016 - The world's first vaccine aimed at curing celiac disease is slated to begin full trials later this year, and residents of the Australian state of Victoria will be among the first humans to give it a try against celiac disease.
    The vaccine, called Nexvax2, was developed by Australian scientist Dr Bob Anderson, and is aimed at giving celiac patients a chance to overcome their immune reaction to the gluten found in products containing wheat, rye and barley. Nexvax2 aims to de-sensitise patients to three peptides contained in gluten that trigger a damaging reaction in their immune system.
    Previous trials on 150 patients from Melbourne, Perth, Adelaide, Brisbane and Auckland were aimed at finding a safe dosage rather than assessing its ability to beat celiac disease. Results from those favorable earlier trials were released in May, and Dr Anderson says that the larger phase II study, also being undertaken in the US and Europe, will assess how well the vaccine works against celiac disease.
    Dr Anderson first identified the peptides triggering coeliac disease and began developing the vaccine while working at Melbourne's Walter and Eliza Hall Institute, before travelling to Boston for six weeks as part of a sister city arrangement through the City of Melbourne, where he made contact with ImmusanT to further the discovery.
    This is certainly exciting news for people with celiac disease, many of whom may benefit from such treatment.
    Stay tuned for news on the progress of these trials.
    Source:
    dailysecrets.press


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