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    Could a New Vaccine Mean Safe Gluten Consumption for Celiac Disease Sufferers?


    Jefferson Adams


    • An Australian university is beginning trials on a vaccine that could change the face of celiac disease treatment by allowing celiacs to safely eat gluten.


    Celiac.com 06/20/2018 - Currently, the only way to manage celiac disease is to eliminate gluten from the diet. That could be set to change as clinical trials begin in Australia for a new vaccine that aims to switch off the immune response to gluten. 


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    The trials are set to begin at Australia’s University of the Sunshine Coast Clinical Trials Centre. The vaccine is designed to allow people with celiac disease to consume gluten with no adverse effects. A successful vaccine could be the beginning of the end for the gluten-free diet as the only currently viable treatment for celiac disease. That could be a massive breakthrough for people with celiac disease.

    USC’s Clinical Trials Centre Director Lucas Litewka said trial participants would receive an injection of the vaccine twice a week for seven weeks. The trials will be conducted alongside gastroenterologist Dr. James Daveson, who called the vaccine “a very exciting potential new therapy that has been undergoing clinical trials for several years now.”

    Dr. Daveson said the investigational vaccine might potentially restore gluten tolerance to people with celiac disease.The trial is open to adults between the ages of 18 and 70 who have clinically diagnosed celiac disease, and have followed a strict gluten-free diet for at least 12 months. Anyone interested in participating can go to www.joinourtrials.com.

    Read more at the website for Australia’s University of the Sunshine Coast Clinical Trials Centre.

    Source:

    1 1


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    Guest Laura

    Posted

    I wonder if the vaccine would negate the gluten cross-reactor symptoms.  It is not difficult to find foods free of gluten, but processed foods, breads, pretzels, broth, dips, etc. are loaded with yeast and/or milk & egg.  

    It's been 9 years since I last ate these things. I would have no issues staying on a gluten-free diet, but would cherish being able to consume the cross-reactors without a GI reaction.  That in and of itself would be a "miracle".  Time will tell.  At any rate, it has been many years of non-stop food insecurity.  Generally speaking,  I wish food consumption were not a necessary part of living. 

    Why, oh why, did the scientists engineer wheat to contain 17 times the gluten content of the 1960's version?  Why, oh why, did the FDA approve the high-gluten hybrid plant without testing it in a controlled population?  Every year the ICD-10 classification for celiac & non-celiac gluten sensitivity diseases has expanded.  Where will it end?

    Good News:  I found 2 new products (crackers) & 1 older product (humus) that do not contain the toxic oils: canola, sunflower, safflower, grape seed or cotton seed oils, no egg, no yeast.  Just had my first cracker after 9 years.  I tried them & had no reactions.  

     

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    Is there a timeline for completion of the study and will this potentially meet US FDA standards for approval for use here in the U.S.

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    Guest EA1985

    Posted

    Any timeline?

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  • About Me

    Jefferson Adams is a freelance writer living in San Francisco. He has covered Health News for Examiner.com, and provided health and medical content for Sharecare.com. His work has appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate, among others.

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  • 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.
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    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 05/29/2017 - Currently, a gluten-free diet is the only way to manage celiac disease. Can a celiac vaccine change that? One company thinks so. ImmusanT corporation has developed a therapeutic vaccine, Nexvax2, that is specifically designed to treat celiac disease. The vaccine is an adjuvant-free mix of three peptides that include immunodominant epitopes for gluten-specific CD4-positive T cells. The vaccine is designed to neutralize gluten-specific CD4-positive T cells to further antigenic stimulation.
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    The study enrolled a total of 108 participants from Nov 28, 2012, to Aug 14, 2014, in the three-dose study, and from Aug 3, 2012, to Sept 10, 2013, in the 16-dose study.
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    In the three-dose study, participants received either Nexvax2 60 μg, 90 μg, or 150 μg weekly, or placebo over 15 days; in a fourth biopsy cohort, patients received either Nexvax2 at the maximum tolerated dose (MTD) or a placebo.
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    Among participants given the MTD, four of eight subjects in the third cohort experienced adverse gastrointestinal treatment-emergent events; zero of three participants had adverse events in the biopsy cohort in the three-dose study, while five events occurred in five (63%) of eight participants in the first cohort, and three events in two (29%) of seven participants in the biopsy cohort of the 16-dose study.
    Those who received the vaccine at the MTD on either schedule showed no significant difference between average villous height to crypt depth ratio in distal duodenal biopsies, as compared with those who received placebo.
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    Source:
    The Lancet Affiliations:
    The researchers are variously affiliated with the Division of Gastroenterology and Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA, USA, the Broad Institute of Harvard and Massachusetts Institute of Technology, Cambridge, MA, USA; the Department of Gastroenterology, Auckland City Hospital, Auckland, New Zealand; the School of Medicine, University of Queensland, Brisbane, QLD, Australia; the Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, SA, Australia; the Linear Clinical Research, Nedlands, WA, Australia; the Department of Gastroenterology, Alfred Hospital, Prahran, VIC, Australia; the Clinical Research Institute of Michigan, Chesterfield, MI, USA; the University of North Carolina School of Medicine, Chapel Hill, NC, USA; Wake Gastroenterology and Wake Research Associates, Raleigh, NC, USA; Atlantic Digestive Specialists, Portsmouth, NH, USA; Ridgeview Medical Center, Waconia, MN, USA; Oklahoma Foundation for Digestive Research, Oklahoma City, OK, USA; ClinSearch, Chattanooga, TN, USA; the Immunology Division, Walter and Eliza Hall Institute of Medical Research, Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia; the Murdoch Children's Research Institute and Department of Gastroenterology, Royal Melbourne Hospital, Parkville, VIC, Australia; the Immunology Division, Walter and Eliza Hall Institute of Medical Research, Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Alfred Rusescu Institute for Mother and Child Care and Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, La Jolla, CA, USA; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Centre for Immune Regulation, KG Jebsen celiac Disease Research Centre, and Department of Immunology, University of Oslo, Oslo, Norway; the Oslo University Hospital-Rikshospitalet, Oslo, Norway; Department of Pediatrics, Department of Medicine, University of Chicago, Chicago, IL, USA; and ImmusanT in Cambridge, MA, USA.

    Jefferson Adams
    Celiac.com 12/22/2017 - Venture capital firms Arch Venture, and Vatera are betting big on biotech startup ImmusanT, the makers of potential celiac disease vaccine Nexvax2.
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    Read more at: endpts.com

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    Celiac.com 07/16/2018 - Did weak public oversight leave Arizonans ripe for Theranos’ faulty blood tests scam? Scandal-plagued blood-testing company Theranos deceived Arizona officials and patients by selling unproven, unreliable products that produced faulty medical results, according to a new book by Wall Street Journal reporter, whose in-depth, comprehensive investigation of the company uncovered deceit, abuse, and potential fraud.
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    Celiac.com 07/14/2018 - If you’re looking for a simple, nutritious and exciting alternative to standard spaghetti and tomato sauce, look no further than this delicious version that blends ripe plum tomatoes, garlic, olive oil, basil, and firm sliced ricotta to deliver a tasty, memorable dish.
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    Jean Duane
    Celiac.com 07/13/2018 - I went to a friend’s home for dinner.  A few days before, she called and asked me what I could eat.  I asked her what she was planning to make, and she said she was grilling meats with side dishes.  I said, “Great.  Please just grill a piece of chicken for me with salt and pepper, and I’ll be happy to bring a side.” She said, “No need to bring a side.  I’ve got this.” When I arrived, she greeted me and said, “I spent all day cooking tonight’s dinner so you can eat it. Hey would you just check this salad dressing to see if it is OK for you?” I looked at the ingredients and it contained gluten and dairy, both of which I cannot eat.  Then I glanced around the kitchen and saw evidence of wheat cross-contamination, including buns being toasted on the grill, and gluten-containing barbeque sauce spilling on the grill where my “clean” chicken was cooking. She had other guests to tend to, and I couldn’t offer instruction or read the ingredients of everything she used in the meal. 
    At social gatherings, I’ve been challenged too by those who ask if I am really “allergic,” or just eating gluten free as a “fad.” I’ve been told many times by hosts and hostesses that, “a little won’t hurt you,” or “everything in moderation,” or “if it is made with loving hands, it is good for you to eat.”  Of course, all of this is bunk for those with food allergies or celiac disease.  A little bit may kill us, and whether made with loving hands or not, it will certainly make us sick. 
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    This column will present a scenario such as the one above, and ask that you comment on how you would navigate it. Let’s talk about it. Let’s share ideas.  Using the example above, here’s the scenario for this issue:
    What would you do?
    Your kind-hearted friend invites you to dinner and insists on cooking for you.  You arrive and the first thing she says is, “I’ve spent all day making this for you. Oh, I bought this salad dressing for you, but you might want to read the ingredients first.”  You do, and it contains malt vinegar.  You look around the kitchen and notice evidence of cross-contamination in the rest of the meal.  What do you do? 
    Please comment below and feel free to share the tricky scenarios that you’ve encountered too.  Let’s discuss how to surmount these social situations.  What would you do?

    Jefferson Adams
    Celiac.com 07/12/2018 - Previous research has shown that the oral administration of Bifidobacterium infantis Natren Life Start super strain (NLS-SS) reduces of gastro-intestinal symptoms in untreated celiac disease patients. The reduction of symptoms was not connected with changes in intestinal permeability or serum levels of cytokines, chemokines, or growth factors. Therefore, researchers suspected that the reduction of symptoms might be related to the modulation of innate immunity.
    To test that hypothesis, a team of researchers set out to assess the potential mechanisms of a probiotic B.infantis Natren Life Start super strain on the mucosal expression of innate immune markers in adult patients with active untreated celiac disease compared with those treated with B. infantis 6 weeks and after 1 year of gluten-free diet.
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    Their results showed that a gluten-free diet lowers duodenal macrophage counts in celiac disease patients more effectively than B. infantis, while B. infantis lowers Paneth cell counts and reduces expression of a-defensin-5.
    This study documents the differential innate immune effects of treatment with B. infantis compared with 1 year of gluten-free diet. The team calls for further study to better understand the synergistic effects of gluten-free diet and B. infantis supplementation in celiac disease.
    Source:
    J Clin Gastroenterol

    Jefferson Adams
    Celiac.com 07/11/2018 - For people with celiac disease, finding decent gluten-free bread is like searching gold. Many have given up on bread entirely and others begrudgingly relate themselves to the ignominious frozen aisle at their supermarket and content themselves with one of the many dry, shriveled, flavorless loaves that proudly tout the gluten-free label. 
    For these people, the idea of freshly baked bread is a distant, if comforting, memory. The idea of going to Paris and marching into a boulangerie and walking out with a warm, tasty, gluten-free baguette that was freshly baked on the premises that morning, is like a dream. Now, in some Parisian bakeries, that dream is becoming a reality. And the tear of joy from the thankful gluten-free masses are sure to follow.
    These days, a single sign on the awning speaks to hungry customers who peruse the tarts and chou buns, and the loaves that fill the cooling on racks behind a glass pane at Chambelland boulangerie and café in Paris’ 11th arrondissement. The sign lettered in French translates: “artisan baker; flour producer; naturally gluten free.” That’s right. Naturally gluten-free. At a bakery. In Paris. 
    Only the flat, focaccia-style loaves, and the absence of baguettes, tells customers that this bakery is something different. Chambelland opened its doors in 2014 and continues to do a brisk business in delicious, freshly baked gluten-free breads and other goods.
    The boulangerie is the work of Narhaniel Doboin and his business partner, Thomas Teffri-Chambelland. They use flour made of grains including rice, buckwheat and sorghum to make delicious gluten-free baked goods. Doboin says that customers queued in the rain on the first day, hardly believing their eyes, some began to cry. 
    For gluten-free Parisians, there was a time before Chambelland, and the time after. If you find yourself in Paris, be sure to search them out for what is sure to be a gluten-free delight.
    Or maybe book your ticket now.
    Read more at: Independent.co.uk