Jump to content

Important Information

This site places cookies on your device (Cookie settings). Continued use is acceptance of our Terms of Use, and Privacy Policy.

  • Sign Up
  • Join our community!

    Do you have questions about celiac disease or the gluten-free diet?

  • Member Statistics

    84,896
    Total Members
    4,125
    Most Online
    Silvicen
    Newest Member
    Silvicen
    Joined
  • 0

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


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

    Source:

    0


    User Feedback

    Recommended Comments



    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.

    Share this comment


    Link to comment
    Share on other sites

    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.

    Share this comment


    Link to comment
    Share on other sites
    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.

    Share this comment


    Link to comment
    Share on other sites
    Guest SonataNo8

    Posted

    I'm going to be all over this. Barb, I think you've lost it!

    Share this comment


    Link to comment
    Share on other sites

    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.

    Share this comment


    Link to comment
    Share on other sites

    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!

    Share this comment


    Link to comment
    Share on other sites
    You're an idiot.

    I agree she is an idiot. Goodies we are not supposed to eat? I am sorry wheat, barley and rye are not bad things to eat.

    Share this comment


    Link to comment
    Share on other sites

    It would be nice not to have to read every label at the grocery store and then pay a fortune just to buy groceries. I hope the not too distant future is not too distant.

    Share this comment


    Link to comment
    Share on other sites
    Guest B Summers

    Posted

    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?

    Share this comment


    Link to comment
    Share on other sites
    Guest Thomas Hessley

    Posted

    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.

    Share this comment


    Link to comment
    Share on other sites



    Your content will need to be approved by a moderator

    Guest
    You are commenting as a guest. If you have an account, please sign in.
    Add a comment...

    ×   Pasted as rich text.   Paste as plain text instead

      Only 75 emoji are allowed.

    ×   Your link has been automatically embedded.   Display as a link instead

    ×   Your previous content has been restored.   Clear editor

    ×   You cannot paste images directly. Upload or insert images from URL.


  • 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.

  • Related Articles

    Jefferson Adams
    Celiac.com 04/06/2009 - Celiac sufferers around the globe are anxiously awaiting word from Australia, as the world's first vaccine trials for the treatment of celiac disease get underway in Melbourne. In April, Bob Anderson, of the Walter and Eliza Hall Institute of Medical research, will begin the initial phase of the first-ever trials for a celiac vaccine that, if successful, might just mean the end of gluten-free diets for those with celiac disease.
    The treatment has been successful in mice and is now ready to be tested on humans. In this initial phase, 40 volunteers with celiac disease will receive doses of the vaccine over an 11-month period to determine that it will cause no harm. Once researchers make sure the vaccine is safe, they will begin phase II trial, wherein they give vaccine doses to trial subjects and evaluate their responses to gluten challenges to determine the efficacy of the vaccine. Evaluation will include an examination of immune response and intestinal condition to determine the level of gluten tolerance.
    The vaccine therapy involves repeatedly injecting solutions of gluten at increasing concentrations. The goal is to reduce and ultimately eliminate gluten sensitivity slowly, in a manner similar to common allergy desensitization treatments. The road to the development of this treatment has not been easy. Dr. Anderson is that rare combination of medical doctor (gastroenterologist) and PhD scientist who is able to develop practical treatments from bedside observations. After struggling to gain funding throughout his research career, he eventually patented his vaccine and co-founded Nexpep in an effort to develop the vaccine on his own. Because, like common dust and hay fever allergy therapies, this treatment approach may allow people with celiac disease to actually consume the gluten that produces the toxic reaction and reduce or even eliminate that reaction via vaccination. This approach will also serve as a model for a vaccine approach for other immune conditions such as type 1 diabetes, rheumatoid arthritis and multiple sclerosis.
    Until recently, doctors thought celiac disease was rare. But according to statistics, it is twice as common as type1 diabetes or breast cancer. Celiac disease is now known to strike one per cent of Americans, but although modern blood testing has made early detection accurate and efficient, most people with celiac disease still do not know that they have it. Just 3% of sufferers have been diagnosed, leaving nearly 3 million people undiagnosed, and therefore unable to benefit form simple treatment in the form of a gluten-free diet. Long-term risks for untreated celiac disease include malnutrition, infertility, osteoporotic fractures, liver failure and various cancers. Symptoms can vary between individuals, with some experiencing no symptoms at all, even though damage to the bowel and general health still occurs whether or not symptoms are present.
    Presently, long-term monitoring of dietary compliance for celiac patients is haphazard at best, and standards for gluten-free products have yet to take effect in the USA and other countries. Geoff Withers, director of pediatric gastroenterology at Brisbane's Royal Children's Hospital, points out that a gluten-free diet is "notoriously difficult. It is expensive and lifelong, and comes at a cost to the individual." Even treatment with a gluten-free disease is no panacea. People on gluten-free diets routinely suffer from a deficiency of certain vitamins, especially B vitamins. Roughly half of those following gluten-free diets have impaired intestinal healing due to compliance issues, and that means they are in danger of associated risks which include cancer.
    A successful vaccine could have massive consequences for treatment of celiac disease, and might radically improve the lives of those with the condition.


  • Popular Contributors

×