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

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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27 Responses:

 
Barb
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said this on
10 Sep 2012 6:06:20 PM PST
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.

 
Rowly
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said this on
11 Sep 2012 7:06:20 PM PST
You're an idiot.

 
Jamie
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said this on
17 Sep 2012 8:40:06 AM PST
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.

 
Jeff
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said this on
18 Sep 2012 6:12:36 AM PST
There's far more involved here than wheat, barley, and rye, Jamie. Try studying up on our grains being genetically modified by Monsanto and others over the past couple of decades. That's the point. You guys go after someone who is simply putting information out there that you're not aware of and you slam her for it. Do you think it's pure coincidence that there are millions more being diagnosed each year with celiac disease compared to just a decade ago? It's our food supply being altered that's creating the problem.

 
Anne
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said this on
19 Sep 2012 9:49:23 AM PST
The reason that more people are being diagnosed is that the methods of diagnosis are far better now (and more doctors are aware of the symptoms). No one really knows the cause of celiac disease - scientists are still trying to figure it out. It is highly unlikely that it is caused by GMO wheat. And yes, I am a scientist in the field, not the uneducated public.

 
Madeleine LB
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said this on
05 Mar 2013 1:46:45 PM PST
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.

 
Robert
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said this on
11 Sep 2012 5:52:51 PM PST
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.

 
SonataNo8
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said this on
12 Sep 2012 9:14:15 AM PST
I'm going to be all over this. Barb, I think you've lost it!

 
Dawn
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said this on
12 Sep 2012 9:22:14 AM PST
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.

 
Debbie
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said this on
17 Sep 2012 6:51:09 AM PST
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!

 
Dennis
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said this on
17 Sep 2012 10:34:50 AM PST
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.

 
B Summers
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said this on
17 Sep 2012 11:39:15 AM PST
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?

 
Jeff
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said this on
18 Sep 2012 6:09:12 AM PST
B Summers and Barb point out something a lot of you probably don't follow or pay any attention to because frankly most Americans are more in-tune with who won last years American Idol than their own health. It's fine that some of you want a vaccine that works and I'd certainly consider it. But the truth is Big Pharma and the FDA have some massive corruption problems. Read Dr. Mercola's site or Suzanne Somers' book "Knockout" (among many others) before you assume that Barb is tossing out "misinformation." Our wheat today is genetically modified as are 90% of our grains. More than likely the broad onset of celiac disease is the result of genetically modified grains in our diet. Geez people. Cut others some slack. You need to make your decisions and let others make theirs without being so ornery.

 
Thomas Hessley
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said this on
17 Sep 2012 1:54:02 PM PST
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.

 
debb
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said this on
17 Sep 2012 2:43:09 PM PST
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).

 
Donna
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said this on
17 Sep 2012 6:00:02 PM PST
Haven't any of you read "Wheat Belly"?

 
David Schanz
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said this on
17 Sep 2012 7:06:37 PM PST
Hmmm... I wonder if this vaccine would help non celiac gluten intolerant people. I guess that would depend on whether or not celiac disease and plain gluten intolerance are actually as closely related as some believe they are. I sometimes envy people with celiac disease since it is better understood than non celiac gluten intolerance. It's easier to cure something that is understood and it looks like they are getting close.

 
Amber
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said this on
17 Sep 2012 11:07:41 PM PST
I'm with Barb! A vaccine for everything?! Really? What about your responsiblity to just eat balanced!? Because that's what this is really about. Our food in US is bursting with wheat and wood pulp and any other nutritionally/ cheap filler these huge corporations can cram into "food". Vaccines are lazy and the side effects should matter to anyone willing to have them injected into their body.

 
Mel
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said this on
18 Sep 2012 4:07:28 AM PST
Barb and Debb, I am right with you. Eating gluten-free after how I used to feel has changed my life. No way will I go back to eating that so called "healthy" garbage. Maybe if the grains weren't GMO this issue wouldn't have cropped up in the first place. While I do think this may be beneficial to those with a severe gluten allergy, there is no way I would take just to eat it again. I pay less for groceries now that I stopped paying for processed food altogether anyway. Not sure why someone up there insisted it was so outrageously expensive.

 
Belford
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said this on
18 Sep 2012 9:08:01 AM PST
What have we all learned from being Celiacs? Know what you put in your body! Do we know how the vaccine will affect us 5 years from now? No.

 
Daya
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said this on
19 Sep 2012 10:48:03 AM PST
Hear, hear, Belford.

 
Becca
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said this on
19 Sep 2012 9:11:14 AM PST
I agree with most people on this feed. I mean I just got diagnosed and I would love to be "normal". This is very difficult for me to get used to. I am sick of living in fear of food, something that is supposed to be good for me. It's truly the hardest thing that I have ever had to do. Yeah there are a lot more choices these days, but even then you have to be careful for cross contamination and gluten-poisoning is not a fun thing to deal with. I would be all over this vaccine in a heart beat. I dont want to live off of starch and vitamins for the rest of my life. Nor do I want to continue to break the bank.

 
Sharon
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said this on
24 Sep 2012 1:08:33 PM PST
What I do know from personal experience is that those in my family with either celiac disease or gluten sensitivity have had issues with "turning" or building titers - immunity to a variety of diseases with their vaccinations. As a healthcare major, prior to entering college, I had to be revaccinated for all communicable diseases including small pox - not boosters but complete revaccination. Several months later I contracted rubella - German measles - the doctors were astonished that I had absolutely no titer despite being revaccinated several months earlier. Some 30+ years later in my first year of my diagnosis – all my odd health issues throughout my life now make sense.

My kids (non-biological) have low IgAs (very low) - thus tested negative for celiac disease - though they clearly have issues with gluten, and we and the doctor did not want to put them through the biopsy. Because they were from foreign countries, the pediatric adoption specialist who questioned their level of vaccinations/quality drew titers to find that one kid had to have his polio series redone, the other his Hep B...for which after three attempts at the Hep B series he has never developed a titer. (Recall the recent studies that note that something like 70% kids with celiac disease have problems building immunity with that vaccine.) They both demonstrated exposure to TB and had to be treated for that. My husband also has a gluten issue with related problems and has found improved health in our gluten-free house. Despite vaccines and boosters several years ago we all contracted pertussis - whooping cough. Both kids had issues with chronic ear infections into their teens, one reacts to just about every antibiotic (leaky gut issue?), both have environmental allergies, as well as many other issues that have clearly improved on a gluten-free diet.

So my question is: Will this vaccine even work for celiac disease and gluten sensitive folks who have impaired immune systems? Based on my “local” study – I think not – though perhaps if they recover first and build up their immunity. I know, I know celiac disease is the autoimmune disease, not gluten sensitivity, but it seems my gluten sensitive crew presents with celiac disease-like symptoms – as noted in a recent study on wheat sensitivity.

 
JustMe
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said this on
23 Oct 2012 6:41:55 PM PST
I think I'd be pretty keen for a vaccine that made it possible for me not to get sick if I was accidentally exposed to gluten - no longer being worried about eating out would be a fantastic thing with my job. I'm not sure that I'd ever choose to eat it knowingly, but not always being worried about the accidental would be fabulous.

As for Gardasil also being used for boys - Gardasil vaccinates against Human Papilloma Virus which can be carried by men and women - however men don't have a cervix so it doesn't cause cervical cancer in them - passing the virus to their female partner can however have very bad effects. Add to that studies showing reduced rates of other cancers in vaccinated people (male and female) and you have an idea of why they wish to vaccinate everyone. I'm not saying it's perfect but surely its something? And I agree that big pharma probably do make an absolute fortune but for what benefits to the community? Smallpox vaccines all but eliminated smallpox... what else could be the same?

 
June Tate
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said this on
17 Dec 2012 7:59:46 AM PST
At my last celiac support group meeting, we were given information on this trial. It's my understanding that it involves a double-blind "cookie test" in which participants do not know if they're being given gluten-free cookies or cookies that contain gluten.

For a celiac to ingest gluten can be dangerous. I lost 50 pounds and had pancreatitis, gastritis, cholecystitis, and malnutrition before I was diagnosed 3 months ago.

As much as I would like to see a "cure" for the destruction that gluten can cause in our bodies, I do not want to risk having my immune system damage my enteral villi in the process, increasing my own risk for GI cancers and lymphoma.

Those who choose to participate: you are brave! I do not have that much courage and selflessness.

 
Lian Renaud
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said this on
03 Nov 2013 4:36:18 AM PST
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.

 
Christy
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said this on
15 Jan 2015 9:13:55 PM PST
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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