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      Frequently Asked Questions About Celiac Disease   04/07/2018

      This Celiac.com FAQ on celiac disease will guide you to all of the basic information you will need to know about the disease, its diagnosis, testing methods, a gluten-free diet, etc.   Subscribe to Celiac.com's FREE weekly eNewsletter   What are the major symptoms of celiac disease? Celiac Disease Symptoms What testing is available for celiac disease?  Celiac Disease Screening Interpretation of Celiac Disease Blood Test Results Can I be tested even though I am eating gluten free? How long must gluten be taken for the serological tests to be meaningful? The Gluten-Free Diet 101 - A Beginner's Guide to Going Gluten-Free Is celiac inherited? Should my children be tested? Ten Facts About Celiac Disease Genetic Testing Is there a link between celiac and other autoimmune diseases? Celiac Disease Research: Associated Diseases and Disorders Is there a list of gluten foods to avoid? Unsafe Gluten-Free Food List (Unsafe Ingredients) Is there a list of gluten free foods? Safe Gluten-Free Food List (Safe Ingredients) Gluten-Free Alcoholic Beverages Distilled Spirits (Grain Alcohols) and Vinegar: Are they Gluten-Free? Where does gluten hide? Additional Things to Beware of to Maintain a 100% Gluten-Free Diet What if my doctor won't listen to me? An Open Letter to Skeptical Health Care Practitioners Gluten-Free recipes: Gluten-Free Recipes
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    THIS VACCINE COULD BE A GAME-CHANGER FOR PEOPLE WITH CELIAC DISEASE


    Jefferson Adams


    • Can a vaccine for celiac diseasse change the way the disease is treated?


    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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    As part of their efforts to evaluate the vaccine, a team of researchers recently set out to investigate the efficacy of epitope-specific immunotherapy targeting CD4-positive T cells in celiac disease. Specifically, they assessed the safety and pharmacodynamics of the Nexvax2 vaccine in patients with celiac disease on a gluten-free diet.

    An article detailing the findings of their most recent effort, titled Epitope-specific immunotherapy targeting CD4-positive T cells in celiac disease: two randomized, double-blind, placebo-controlled phase 1 studies, appeared in the Lancet.

    The research team included Gautam Goel, PhD, Tim King, MBBChir, A James Daveson, MBBS, Jane M Andrews, MBBS, Janakan Krishnarajah, MBBS, Richard Krause, MD, Gregor J E Brown, MBBS, Ronald Fogel, MDCM, Charles F Barish, MD, Roger Epstein, MD, Timothy P Kinney, MD, Philip B Miner Jr, MD, Jason A Tye-Din, MBBS, Adam Girardin, BS, Juha Taavela, MD, Alina Popp, MD, John Sidney, BS, Prof Markku Mäki, MD, Kaela E Goldstein, BS, Patrick H Griffin, MD, Suyue Wang, PhD, John L Dzuris, PhD, Leslie J Williams, MBA, Prof Alessandro Sette, DrBiolSc, Prof Ramnik J Xavier, MD, Prof Ludvig M Sollid, MD, Prof Bana Jabri, MD, and Dr Robert P Anderson, MBChB.

    To assess the safety and pharmacodynamics of the vaccine in patients with celiac disease on a gluten-free diet, ImmusanT recently conducted two randomized, double-blind, placebo-controlled, phase 1 studies at 12 community sites in Australia, New Zealand, and the USA, in HLA-DQ2·5-positive patients aged 18–70 years who had celiac disease and were following a gluten-free diet.

    The goal of the study was to document the number and percentage of adverse events in the treatment period in an intention-to-treat analysis.

    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.

    Overall, 62 (57%) of 108 participants were randomly assigned after oral gluten challenge and 20 (71%) of 28 participants were randomly assigned after endoscopy.

    None of the study participants, investigators, or staff knew which patients received a given treatment; these details were known only by the study’s lead pharmacist.

    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.

    In the 16-dose study, participants received Nexvax2 150 μg or 300 μg or placebo twice weekly over 53 days; in a third biopsy cohort, patients also received either Nexvax2 at the MTD or a placebo. In both studies, about 5% of the participants reported were vomiting, nausea, and headache.

    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.

    In the 4-week post-treatment period, ascending dose cohorts underwent a further double-blind crossover, placebo-controlled oral gluten challenge, which had a fixed sequence. Meanwhile, biopsy cohorts received a gastroscopy with duodenal biopsies and quantitative histology within 2 weeks without oral gluten challenge. Of the participants who completed the post-treatment oral gluten challenge per protocol, interferon γ release assay to Nexvax2 peptides was negative in two (22%) of nine placebo-treated participants in the three-dose study.

    Compared with two (33%) of six who received Nexvax2 60 μg, five (63%) of eight who received Nexvax2 90 μg, and six (100%) of six who received Nexvax2 150 μg (p=0·007); in the 16-dose study, none (0%) of five placebo-treated participants had a negative assay versus six (75%) of eight who received Nexvax2 150 μg (p=0·021).

    The MTD of Nexvax2 was 150 μg for twice weekly intradermal administration over 8 weeks, which modified immune responsiveness to Nexvax2 peptides with no adverse impact on duodenal histology.

    Patients who received the intradermal administration of the vaccine reported gastrointestinal symptoms were not subtantially different to those seen with oral gluten challenge.

    While the commercial release of a viable vaccine is likely still some time away, early-phase trials have shown promise. Based on these results, ImmusanT will continue clinical development of this potentially therapeutic vaccine for celiac disease.

    Both trials were completed and closed before data analysis. Trials were registered with the Australian New Zealand Clinical Trials Registry, numbers ACTRN12612000355875 and ACTRN12613001331729.

    Source:

    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.


    Image Caption: Can a vaccine work against celiac disease? Photo: MilitaryHealth
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    Recommended Comments

    Guest Kristine Slager

    Posted

    Knowing the inefficacy and and numerous, horrific results of most vaccines, I can't even begin to imagine the nightmares this may cause. And all so you can eat a specific food?!? Following a gluten-free diet is 100% safe with 100% efficacy. Experiment on our family with a vaccine so we can eat a damn doughnut?? NO THANK YOU.

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    Guest Will

    Posted

    Another unreadable article. Tell us in plain English what the results were.

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    Guest margie

    Posted

    You have got to be kidding. With the toxic elements in vaccines and no long-term studies to judge the possible effects of vaccine ingredients, celiac sufferers have enough problems without adding vaccine complications to the list.

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    Guest Janet

    Posted

    When is it likely to be available in the US?? So hopeful!!

    I am 63 and I have celiac. I am gluten free and would love to take the vaccine but will not get my hopes up. I probably will be too old or not present at the time!

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    No way would I get vaccinated for something controllable through diet! The ingredients in vaccines are questionable at best.

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    Guest Marie LaRock

    Posted

    This would sure make my life a lot less complicated! Hope it will be available soon!

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    Guest Marie

    Posted

    When is it likely to be available in the US?? So hopeful!!

    I had read about a problem with this vaccine and it was only DQ2 who could take it. I do not think a vaccine is the answer, genetic manipulation before birth is.

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    Guest admin

    Posted

    Another unreadable article. Tell us in plain English what the results were.

    Some of the science just can't be easily simplified.

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    Guest admin

    Posted

    Knowing the inefficacy and and numerous, horrific results of most vaccines, I can't even begin to imagine the nightmares this may cause. And all so you can eat a specific food?!? Following a gluten-free diet is 100% safe with 100% efficacy. Experiment on our family with a vaccine so we can eat a damn doughnut?? NO THANK YOU.

    What horrific results are you talking about...no more small pox, or that you are not worried about polio?

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    Guest Jeff Adams

    Posted

    Knowing the inefficacy and and numerous, horrific results of most vaccines, I can't even begin to imagine the nightmares this may cause. And all so you can eat a specific food?!? Following a gluten-free diet is 100% safe with 100% efficacy. Experiment on our family with a vaccine so we can eat a damn doughnut?? NO THANK YOU.

    Most vaccines are, in fact, highly effective. In fact, I can't name a major vaccine that does not work as designed. Can you? So, far from causing "nightmare" scenarios, most vaccines actually reduce death and debilitation from preventable diseases. Also, I'm not sure the folks who are developing this vaccine are planning to "experiment on your family." I'm pretty sure they plan on testing it thoroughly in trials and then on human volunteers to make sure it is safe and effective before they make it commercially available. That is standard practice with all vaccines. Lastly, vaccines save lives. Vaccine hysteria promotes unnecessary suffering and, potentially, preventable deaths.

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    Guest Jeff Adams

    Posted

    You have got to be kidding. With the toxic elements in vaccines and no long-term studies to judge the possible effects of vaccine ingredients, celiac sufferers have enough problems without adding vaccine complications to the list.

    Toxic elements in vaccines? I'm not sure what you mean. Originally, many early vaccines contained small amounts of lead, then later mercury, then later aluminum. Again, we are talking micro-doses as a vaccine delivery vehicle. Literally hundreds of millions of people have received vaccines, and tolerated them perfectly fine. Lives have been saved. Unnecessary suffering, maiming and death have been prevented.

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    Guest Jeff Adams

    Posted

    Another unreadable article. Tell us in plain English what the results were.

    In an effort to assess how well the vaccine is tolerated in humans, it was tested on several groups at several doses. It seemed to work okay. Nothing horrible happened. Aside from a few mild side effects, things went well. Stay tuned for the results of the forthcoming trials.

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    Guest Hailey

    Posted

    I'm really hoping this vaccine will pass the next trials! I don't understand all the negativity with this. If you don't want to take it, fine. But don't ruin it for others. I am so excited about this.

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    Any updates on an expected release date? It would be such a burden off my shoulders to be able to eat out at a restaurant and not worry about cross contamination when I travel.

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  • Related Articles

    Jefferson Adams
    Celiac.com 02/04/2016 - BL-7010, a non-absorbable, orally available co-polymer for the treatment of celiac disease, has received designation as Class IIb medical device in the European Union, according to manufacturer BioLineRx Ltd.
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    The safety and efficacy of BL-7010 have been demonstrated in a number of pre-clinical studies, including a Phase 1/2 study completed in November 2014.
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    Read more at: PRNewswire.

    Jefferson Adams
    Celiac.com 08/05/2016 - Currently, a gluten free diet is the only option for treating celiac disease. Still, there are numerous patients who follow the diet, but do not respond fully clinically or histologically.
    What options do doctors have to treat celiac disease beyond a gluten-free diet? A team of researchers wanted to find out. The research team includes S. Kurada, A. Yadav, and DA Leffler of the Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, and the Celiac Research Program at Harvard Medical School, and the Department of Medicine at Boston Medical Center’s Boston University School of Medicine in Boston, Massachusetts.
    The team conducted a search of PubMed and clinicaltrials.gov to highlight celiac disease articles that use keywords including 'celiac disease' and 'refractory celiac disease' and focused on articles conducting pathophysiologic and therapeutic research in/ex-vivo models and human trials.
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    Expert Rev Clin Pharmacol. 2016 Jun 23:1-13.

    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.
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    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

  • Recent Articles

    Jefferson Adams
    Celiac.com 04/23/2018 - A team of researchers recently set out to learn whether celiac disease patients commonly suffer cognitive impairment at the time they are diagnosed, and to compare their cognitive performance with non-celiac subjects with similar chronic symptoms and to a group of healthy control subjects.
    The research team included G Longarini, P Richly, MP Temprano, AF Costa, H Vázquez, ML Moreno, S Niveloni, P López, E Smecuol, R Mazure, A González, E Mauriño, and JC Bai. They are variously associated with the Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital; Neurocience Cognitive and Traslational Institute (INECO), Favaloro Fundation, CONICET, Buenos Aires; the Brain Health Center (CESAL), Quilmes, Argentina; the Research Council, MSAL, CABA; and with the Research Institute, School of Medicine, Universidad del Salvador.
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    Source:
    J Clin Gastroenterol. 2018 Mar 1. doi: 10.1097/MCG.0000000000001018.

    Connie Sarros
    Celiac.com 04/21/2018 - Dear Friends and Readers,
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    Jefferson Adams
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    Jefferson Adams
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    Source:
    PLoS One. 2018; 13(3): e0193764. doi: & 10.1371/journal.pone.0193764

    Jefferson Adams
    Celiac.com 04/18/2018 - To the relief of many bewildered passengers and crew, no more comfort turkeys, geese, possums or other questionable pets will be flying on Delta or United without meeting the airlines' strict new requirements for service animals.
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    cnbc.com