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    Promising Celiac Vaccine Nexvax2 Begins Phase Two Trials

    Jefferson Adams
    • 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.

    Promising Celiac Vaccine Nexvax2 Begins Phase Two Trials
    Caption: Image: CC--Dawn Huczek

    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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    I've read this article my comment to Celiac.com when I sent a review of this article is that if this injection is successful, because gluten-free has become a huge money maker they are going to be up against big business, factories have been opened, specialty bakeries, etc etc and of course all the other gluten-free product makers they will fight it all the way, mainly because Hollywood put us in the spotlight with all,these stars etc going on a Gluten Free "Diet" they should,check out the calories etc in our diets they don't have a clue. 

    I sincerely hope, but I've had it too long since 1989, and it probably won't work for me, but I do hope that they are allowed to market this injection at the end of (if successful) trials because we deserve to have some kind of "normal" back in our lives.  It is a terribly restrictive disease most people refer to it as an allergy 🤦🏼‍♀️ if only it was.🙏🏽

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    Guest Gavin Ayling

    Posted

    Is Joan H's concern a genuine one? Is there an example of a successful treatment for an illness that has been stopped from being sold by other business interests, or is this a conspiracy theory / unfounded concern?

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    I don't think that should be a major concern. Two reasons: One, I doubt making gluten-free products is really that great of a money making venture, it's a very niche market. Sure companies are going into it to make money but it's not like they're Apple. Two, Celiacs are only a small portion of the people who eat gluten free. This vaccine is intended to help those with autoimmune disorders and there is a much greater portion of people who are gluten free for other reasons. According to the Gluten Free Agency, 9 million people (out of population of 36 million) in Canada are eating gluten free now, which is comprised include 1% who are celiac, 6% of the population with gluten sensitivity, and 22% who are gluten avoiders for non-medical reasons. 

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    Gluten free is fully entrenched as a lifestyle and evergreen fad (apart from any proven health issue). Vaccinating celiacs will in no way dent the industry, nor even eliminate many individual's sensitivity to gluten.

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    I wouldn't touch this with a ten foot pole. Celiac is an autoimmune disorder and no one with autoimmune issues should be getting any vaccines, and vaccines are notorious for causing gut issues. Our guts are already ruined enough without adding insult to injury. 

    Edited by CATRYNA

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    Do I have Celiac?  I dont know,  I went gluten-free while on Adkins diet.  After staying   gluten-free for 3months, my TGG test was negative.  But all my previous rheumaroid factors (  I do have APLS -a lupus related lood disease)  fell from high  to  what one hematologist called " boring."  Every doc who has compared my before and after blood work has told me to stay off gluten, despite a lack of clear Celiac dx.  Since that life changing event, I have dived deeply into the dark, Functional Med side of health care, and I now know that gluten, as well as other grains and sugars and chemicals cause other, only newly discovered hormone cascades and gut biome destrunctions which are not all dependent upon the immune system.  No vaccine is going to change those cascade trajectories.  So yes, I miss croissants being able to eat at church pot lucks without having to find and grill the cooks about  ingredients, but I will never, EVER go  back to eating a delightful poison! gluten-free is not a fad diet.  Now that we have computers that speed our processing of complex biologic data it becoming more and more evident that our current " name it and blame it" medical approach is waaaay too simplistic! 

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    8 hours ago, Guest Dee said:

    Do I have Celiac?  I dont know,  I went gluten-free while on Adkins diet.  After staying   gluten-free for 3months, my TGG test was negative.  But all my previous rheumaroid factors (  I do have APLS -a lupus related lood disease)  fell from high  to  what one hematologist called " boring."  Every doc who has compared my before and after blood work has told me to stay off gluten, despite a lack of clear Celiac dx.  Since that life changing event, I have dived deeply into the dark, Functional Med side of health care, and I now know that gluten, as well as other grains and sugars and chemicals cause other, only newly discovered hormone cascades and gut biome destrunctions which are not all dependent upon the immune system.  No vaccine is going to change those cascade trajectories.  So yes, I miss croissants being able to eat at church pot lucks without having to find and grill the cooks about  ingredients, but I will never, EVER go  back to eating a delightful poison! gluten-free is not a fad diet.  Now that we have computers that speed our processing of complex biologic data it becoming more and more evident that our current " name it and blame it" medical approach is waaaay too simplistic! 

    Guest Dee    You nailed it, girl! I agree whole heartedly to everything you said. I have Hashimotos, Celiac and DH. As far as I'm concerned, anyone with an autoimmune issue, should not eat gluten nor ever get a vaccine. Aside, from the nasty ingredients in vaccines, the very fact that vaccines are noted to stimulate the immune system would be detrimental to anyone who has an immune system that is already out of control. Kudos to you, for getting to the bottom of your problems and moving ahead proactively. 

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    Time will tell if a celiac vaccine is safe and effective. I'm old enough (79) that I may not live to see the day that a reliable vaccine is available. In the meantime, I'm going to continue to get vaccines to try to avoid pneumonia, shingles, and influenza. We all have to make our own judgements about these things, and that's mine.

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    I am from the UK and I have been suffering from Refactory type two celiac disease for the past 4years. I have been on trials in Holland for 5 months for Refactory type two and have never heard any results from the trials. I have suffered from undiagnosed celiac disease for overy 55 year's until 6 year's ago and then I found I had  Refactory type two celiac disease. 

    However without these trials we would never progress to finding any sort of cure for any  disease which can or could be  fatal. My hat goes off to these Proffessionals who are doing their utmost to helping people like us.  Good luck with the next upcoming trials 

    .

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    Guest Twojay

    Posted

    I have just been diagnosed as a celiac six month ago and spent 76 years eating whatever I have fancied, and I am a good cook too and love cooking. If there is a miracle in a form of a vaccine, no side effects, (and wish the best to the fellow Aussies for getting there) I'll take it, will be happy to eat fresh bread instead of just getting high on the aroma and have some chips or real doughnut, have an Asian takeaway or a pasta, and buy anything without first looking at the ingredients for the word "wheat". Having said that, while I would never go on a gluten-free diet for a fad, it is possible to have a rich and varied gluten-free free regime, and if you name a dish it can be done. 

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  • About Me

    Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, and science. He previously served as Health News Examiner for Examiner.com, and provided 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 Dangerous Grains by James Braly, MD and Ron Hoggan, MA.

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