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  • 1 1

    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.
    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 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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    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.
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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.
    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.
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    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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    She will then look to an expanded set of programs as well as the data to determine the best direction for the company. Williams says that all options are currently open, including another funding round, an IPO or even a strategic deal.
    Read more at: endpts.com

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    Jefferson Adams
    Celiac.com 07/21/2018 - These easy-to-make tortilla wraps make a great addition to your lunchtime menu. Simply grab your favorite gluten-free tortillas, a bit of cream cheese, some charred fresh sweet corn, creamy avocado and ripe summer tomato. Add a bit of sliced roast beef and some mayonnaise and hot sauce, and you’re in business. And it's all ready in about half an hour. If you cook the corn the night before, they can be ready in just a few minutes.
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    Jefferson Adams
    Celiac.com 07/19/2018 - Maintaining a gluten-free diet can be an on-going challenge, especially when you factor in all the hidden or obscure gluten that can trip you up. In many cases, foods that are naturally gluten-free end up contain added gluten. Sometimes this can slip by us, and that when the suffering begins. To avoid suffering needlessly, be sure to keep a sharp eye on labels, and beware of added or hidden gluten, even in food labeled gluten-free.  Use Celiac.com's SAFE Gluten-Free Food List and UNSAFE Gluten-free Food List as a guide.
    Also, beware of these common mistakes that can ruin your gluten-free diet. Watch out for:
    Watch out for naturally gluten-free foods like rice and soy, that use gluten-based ingredients in processing. For example, many rice and soy beverages are made using barley enzymes, which can cause immune reactions in people with celiac disease. Be careful of bad advice from food store employees, who may be misinformed themselves. For example, many folks mistakenly believe that wheat-based grains like spelt or kamut are safe for celiacs. Be careful when taking advice. Beware of cross-contamination between food store bins selling raw flours and grains, often via the food scoops. Be careful to avoid wheat-bread crumbs in butter, jams, toaster, counter surface, etc. Watch out for hidden gluten in prescription drugs. Ask your pharmacist for help about anything you’re not sure about, or suspect might contain unwanted gluten. Watch out for hidden gluten in lotions, conditioners, shampoos, deodorants, creams and cosmetics, (primarily for those with dermatitis herpetaformis). Be mindful of stamps, envelopes or other gummed labels, as these can often contain wheat paste. Use a sponge to moisten such surfaces. Be careful about hidden gluten in toothpaste and mouthwash. Be careful about common cereal ingredients, such as malt flavoring, or other non-gluten-free ingredient. Be extra careful when considering packaged mixes and sauces, including soy sauce, fish sauce, catsup, mustard, mayonnaise, etc., as many of these can contain wheat or wheat by-product in their manufacture. Be especially careful about gravy mixes, packets & canned soups. Even some brands of rice paper can contain gluten, so be careful. Lastly, watch out for foods like ice cream and yogurt, which are often gluten-free, but can also often contain added ingredients that can make them unsuitable for anyone on a gluten-free diet. Eating Out? If you eat out, consider that many restaurants use a shared grill or shared cooking oil for regular and gluten-free foods, so be careful. Also, watch for flour in otherwise gluten-free spices, as per above. Ask questions, and stay vigilant.

    Jefferson Adams
    Celiac.com 07/18/2018 - Despite many studies on immune development in children, there still isn’t much good data on how a mother’s diet during pregnancy and infancy influences a child’s immune development.  A team of researchers recently set out to assess whether changes in maternal or infant diet might influence the risk of allergies or autoimmune disease.
    The team included Vanessa Garcia-Larsen, Despo Ierodiakonou, Katharine Jarrold, Sergio Cunha,  Jennifer Chivinge, Zoe Robinson, Natalie Geoghegan, Alisha Ruparelia, Pooja Devani, Marialena Trivella, Jo Leonardi-Bee, and Robert J. Boyle.
    They are variously associated with the Department of Undiagnosed Celiac Disease More Common in Women and Girls International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, United States of America; the Respiratory Epidemiology, Occupational Medicine and Public Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom; the Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom; the Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; the Division of Epidemiology and Public Health, University of Nottingham, Nottingham, United Kingdom; the Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom; and Stanford University in the USA.
    Team members searched MEDLINE, Excerpta Medica dataBASE (EMBASE), Web of Science, Central Register of Controlled Trials (CENTRAL), and Literatura Latino Americana em Ciências da Saúde (LILACS) for observational studies conducted between January 1946 and July 2013, and interventional studies conducted through December 2017, that evaluated the relationship between diet during pregnancy, lactation, or the first year of life, and future risk of allergic or autoimmune disease. 
    They then selected studies, extracted data, and assessed bias risk. They evaluated data using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). They found 260 original studies, covering 964,143 participants, of milk feeding, including 1 intervention trial of breastfeeding promotion, and 173 original studies, covering 542,672 participants, of other maternal or infant dietary exposures, including 80 trials of 26 maternal, 32 infant, or 22 combined interventions. 
    They found a high bias risk in nearly half of the more than 250 milk feeding studies and in about one-quarter of studies of other dietary exposures. Evidence from 19 intervention trials suggests that oral supplementation with probiotics during late pregnancy and lactation may reduce risk of eczema. 44 cases per 1,000; 95% CI 20–64), and 6 trials, suggest that fish oil supplementation during pregnancy and lactation may reduce risk of allergic sensitization to egg. GRADE certainty of these findings was moderate. 
    The team found less evidence, and low GRADE certainty, for claims that breastfeeding reduces eczema risk during infancy, that longer exclusive breastfeeding is associated with reduced type 1 diabetes mellitus, and that probiotics reduce risk of infants developing allergies to cow’s milk. 
    They found no evidence that dietary exposure to other factors, including prebiotic supplements, maternal allergenic food avoidance, and vitamin, mineral, fruit, and vegetable intake, influence risk of allergic or autoimmune disease. 
    Overall, the team’s findings support a connection between the mother’s diet and risk of immune-mediated diseases in the child. Maternal probiotic and fish oil supplementation may reduce risk of eczema and allergic sensitization to food, respectively.
    Stay tuned for more on diet during pregnancy and its role in celiac disease.
    Source:
    PLoS Med. 2018 Feb; 15(2): e1002507. doi:  10.1371/journal.pmed.1002507

    Jefferson Adams
    Celiac.com 07/17/2018 - What can fat soluble vitamin levels in newly diagnosed children tell us about celiac disease? A team of researchers recently assessed fat soluble vitamin levels in children diagnosed with newly celiac disease to determine whether vitamin levels needed to be assessed routinely in these patients during diagnosis.
    The researchers evaluated the symptoms of celiac patients in a newly diagnosed pediatric group and evaluated their fat soluble vitamin levels and intestinal biopsies, and then compared their vitamin levels with those of a healthy control group.
    The research team included Yavuz Tokgöz, Semiha Terlemez and Aslıhan Karul. They are variously affiliated with the Department of Pediatric Gastroenterology, Hepatology and Nutrition, the Department of Pediatrics, and the Department of Biochemistry at Adnan Menderes University Medical Faculty in Aydın, Turkey.
    The team evaluated 27 female, 25 male celiac patients, and an evenly divided group of 50 healthy control subjects. Patients averaged 9 years, and weighed 16.2 kg. The most common symptom in celiac patients was growth retardation, which was seen in 61.5%, with  abdominal pain next at 51.9%, and diarrhea, seen in 11.5%. Histological examination showed nearly half of the patients at grade Marsh 3B. 
    Vitamin A and vitamin D levels for celiac patients were significantly lower than the control group. Vitamin A and vitamin D deficiencies were significantly more common compared to healthy subjects. Nearly all of the celiac patients showed vitamin D insufficiency, while nearly 62% showed vitamin D deficiency. Nearly 33% of celiac patients showed vitamin A deficiency. 
    The team saw no deficiencies in vitamin E or vitamin K1 among celiac patients. In the healthy control group, vitamin D deficiency was seen in 2 (4%) patients, vitamin D insufficiency was determined in 9 (18%) patients. The team found normal levels of all other vitamins in the healthy group.
    Children with newly diagnosed celiac disease showed significantly reduced levels of vitamin D and A. The team recommends screening of vitamin A and D levels during diagnosis of these patients.
    Source:
    BMC Pediatrics