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  • Gryphon Myers
    Gryphon Myers

    Celiac Disease Vaccine Enters Phase 1 Clinical Trials in U.S.

    Reviewed and edited by a celiac disease expert.

    Caption: Photo: CC--Daniel Paquet

    Celiac.com 09/10/2012 - Last year, ImmusanT's Nexvax2 celiac disease vaccine passed its phase 1 clinical trials in Australia and New Zealand, causing a stir of hope and anticipation within the celiac disease community. It will still be a while before the vaccine is available to the public, but yesterday ImmusanT announced that it commenced phase 1b clinical trials in New Zealand and Australia and phase 1 clinical trials in the U.S.

    Photo: CC--Daniel PaquetNew Zealand and Australia's phase 1b randomized, placebo-controlled, double-blind study will follow on the prior phase 1 trials and involve approximately 84 celiac disease patients on gluten-free diet at four study sites throughout the two countries. The focus of the study will be on evaluating safety, tolerability and pharmacokinetics (what the body does to the drug), as well as determining appropriate doses for subsequent studies.

    In the U.S., the phase 1 randomized, placebo-controlled, double-blind study will involve 30 celiac disease patients on gluten-free diet at approximately four test sites throughout the country. This preliminary study will evaluate safety, tolerability, and pharmacokinetics of the drug for American subjects.

    Patients in both studies will have confirmed diagnosis of celiac disease, as well as the HLA-DQ2 gene (which approximately 90% of celiac disease sufferers carry). Blood tests for gluten-reactive T cells will also be used to select suitable test subjects.

    The studies will employ an intradermal injection vaccine delivery solution by BD.

    The Nexvax2 vaccine is intended to restore the body's ability to tolerate gluten. It is hoped that antigen-specific T cells will be the key to allowing patients to consume gluten freely with no adverse effects. If all goes well during this and subsequent clinical trials, we could have a cure for celiac disease in the not-too-distant future.

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    Like the Gardisil vaccine that is now killing children or the vaccine that created a new virus by combining the DNA so people are getting sick. With mercury and other stuff in Vaccines, I don't think many will line up for it except those who want to eat all the goodies that humans are not supposed to eat anyhow.

     

    It is better to eat like a human should instead of becoming a test subject so the pharm industry can make more profit. Dr. Osborne is against this and so am I. I refuse to take drugs that may fix one thing and then cause something worse.

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    Wow Barb, way to put out the misinformation. The mercury used in vaccines has been proven to be safe, mainly because it was not an organic mercury compound. And people are not supposed to eat wheat? It was one of the staples of early civilizations. And, outside of some fringe people, Gardisil is generally considered safe.

     

    As a person with celiac disease, I would love something like this so I could be normal again and not be in fear when I eat.

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    Like the Gardisil vaccine that is now killing children or the vaccine that created a new virus by combining the DNA so people are getting sick. With mercury and other stuff in Vaccines, I don't think many will line up for it except those who want to eat all the goodies that humans are not supposed to eat anyhow.

     

    It is better to eat like a human should instead of becoming a test subject so the pharm industry can make more profit. Dr. Osborne is against this and so am I. I refuse to take drugs that may fix one thing and then cause something worse.

    You're an idiot.

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    Barb,

     

    Most coeliacs would like to eat normally. Yes, wheat shouldn't be in loads of products but until the manufacturers stop adding this, then there will be a need. Quite frankly, the damage done from being listened accidental far out weighs any vaccine risk for me.

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    Living gluten-free is not as horrific as it was when I was diagnosed 11 years ago, but it still stinks! Yes, there are many more choices out there, but the expense is huge, you can't trust every label, or that every waitperson has been properly trained. I will be in line for the vaccine once I know the results of the trial, and keeping my fingers crossed!

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    Hummmm... The wheat we grow now is not at all like that grown and eaten by our grandparents' generation and gluten intolerance is now so common that eating gluten-free is the new fad. Of course big pharma is now interested in developing a vaccine that they can make money from. After learning about all the horrible things they put in vaccines to preserve them and make them more "active", I am not at all interested in being vaccinated and being their guinea pig. There is no thing like "healthful mercury". Big pharma wants to vaccinate BOYS with Gardisil as well as the girls. Why? What is the agenda here other than a new revenue source?

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    I, too, am leary of drugs that may help in one area, but cause adverse reactions in another. However, I will wait for more information on this approach. I have been living gluten-free for about seventeen years and am doing fine except for foods that are not, as yet, available in a gluten-free form.

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    How wonderful if this vaccine works! And, hey, stop dissing Barb! If I had the choice of not ingesting gluten or having the vaccine, I'd opt for no gluten in my diet, but that's me (and Barb).

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  • About Me

    Gryphon Myers recently graduated from UC Berkeley with a degree in interdisciplinary studies, research emphasis in art, society and technology. He is a lifelong vegetarian, an organic, local and GMO-free food enthusiast and a high fructose corn syrup abstainer. He currently lives in Northern California. He also writes about and designs video games at Homunkulus.

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