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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.

    Thank you Barb for this smart comment. It shows your ability for critical thinking and common sense. Please just brush off these rude comments from ignorant people. It is staggering how most Americans are so out of touch with food. Anybody well traveled who can compare knows that the food supply in America is the worst in the world. And for the vaccines and the drugs, you are absolutely right. And I am a physician. I see many aging celiacs getting sicker and sicker. The main reasons are: gluten-free junk food and too many environmental toxins, including heavy metals. Mercury in vaccine IS a heavy metal furthermore damaging the immune system and is not safe. Overseas studies have proven this many times over and over. As for eating "normal", most of what Americans see as "normal" food is considered in the rest of the word as pure garbage.

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    The test for obtaining gluten-free products in the country that I live in, not the US, is to eat 5 or six slices of bread a day to test positive. I refused to eat more gluten as the damage to the villi is irreparable. If the allergy is severe then one can be extremely ill fainting vomiting etc. Gluten-free products are imported and very expensive, and they also taste like cardboard. To eat normal food would be a joy. There are no restaurants I can attend or public functions where I can eat, which cuts out a social life. I was undiagnosed until the age of 67, by which time I had other ailments. People who are celiac need dietary help and financial to obtain gluten-free products, not readily forthcoming in a small country where there are about 400 diagnosed as celiac, with a possibility of 4,000 undiagnosed celiacs. One third of our population are diabetic so it is a problem of lifestyle and the wrong food. People in UK and the US even Australia have more food choices than a very small country which has a dense population. We need a vaccine or the choice of one or the correct food at an affordable cost.

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    I mean, it's not just "eating all the goodies you want." It would be really nice to go out to a restaurant, or go on a regular vacation or not have to bring my own food to a wedding and not have to worry about anything... just saying.

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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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