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Celiac Vaccine Clears First Big Clinical Trial

Will a vaccine work against celiac disease?

Photo: Andres Rueda

Celiac.com 04/03/2017 - Massachusetts biotech firm ImmusanT has announced the successful completion of its first phase 1b trial of Nexvax2, an immunotherapy drug designed to protect celiac sufferers from the adverse effects of gluten exposure, including gastrointestinal symptoms, such as diarrhea, abdominal pain and bloating.

Nexvax2 is a drug that relies on three peptides designed to promote T cells involved in the inflammatory reaction in celiac disease to become tolerant to gluten. The company hopes that an initial course will promote gluten-tolerance, which can then be maintained by periodic boosters of the vaccine.

The phase 1b trial in 38 patients showed no issues with safety or tolerability, and indicated that the immunotherapy seemed to work as designed.  The study also helped ImmusanT to determine dosages for phase 2 trials to determine if Nexvax2 can protect patients on a gluten-free diet from inadvertent gluten exposure, which ImmusanT sees as the quickest route to approval.

If Nexvax2 proves to be effective in preventing accidental gluten exposure in celiac patients, the company plans a follow-up program to see if immunotherapy with Nexvax2 can eliminate the need for a gluten-free diet in celiac patients; a step that represents a daunting challenge, and is somewhat of a Holy Grail for celiac researchers.

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ImmusanT is also developing diagnostic protocols for the vaccine, which are designed to guide its use and help improve diagnosis rates.

Nexvax2 is just the latest in a large crop of auxiliary treatments aimed at celiac disease. Switzerland's Anokion teamed up with Japanese pharma Astellas in 2015 to form Kanyos, a company working on an immunotherapy for celiac disease along with type 1 diabetes. A company called Sanofi is also working with Selecta on a similar approach.

Meanwhile, in 2013 AbbVie licensed rights to Alvine Pharmaceuticals AVL003, an oral therapy designed to break down gluten in the GI tract before it can cause damage.

So, stay tuned celiac sufferers, the next few years could produce some very interesting new treatments for celiac disease, something considered impossible just ten years ago.

Source: Fierce Biotech

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17 Responses:

Sara P
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said this on
03 Apr 2017 9:40:05 AM PDT
Krispy Kreme for a week if this becomes a reality!

Christina Sirr
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said this on
04 Apr 2017 1:06:24 PM PDT
Sure get a vaccine that supposedly cures an autoimmune disease that was most likely caused by vaccines...makes sense if you don't mind following the big pharma religion to the grave.

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said this on
12 Apr 2017 5:54:06 AM PDT
Please site the evidence that vaccines cause celiac disease.

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said this on
04 Apr 2017 8:06:14 PM PDT
Take Sanofi out and shoot them. Now they have developed a BS vaccine to cure an auto immune disease that was caused by vaccines, in the first place. My hope is that no one is fooled by this enormous lie. Those of us who are gluten intolerant or celiac don't need this garbage. With proper diet we are improving our health and we don't need you or your filth!

( Author)
said this on
05 Apr 2017 3:28:04 PM PDT
Vaccines do not cause autoimmune diseases, this is a fully debunked myth.

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said this on
11 Apr 2017 1:54:56 AM PDT
Catryna White - rnCeliac disease was first identified in ancient Greece - they didn't have vaccines!rnCeliac health improved during World Wars due to lack of flour. If you look at the history of celiac disease and it's genetic trait you wouldn't believe such rubbish.

Jefferson Adams
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said this on
13 Apr 2017 6:35:32 PM PDT
Thanks for commenting!

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said this on
05 Apr 2017 9:44:53 PM PDT
Great news. Let's hope the next phase works too as being coeliac is a living hell and want to be free of worry about food and live again.

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said this on
10 Apr 2017 10:55:58 AM PDT
I've lived with celiac and Crohn's all my life and for the nay-sayers on this list, get with the program. There are so many other dangerous side-effects due to inflammation and not related to stomach-aches and frequent bathroom stops that are scary. I've managed my entire life of 62 years and believed the same thing in my younger years. One example is blood clots in my legs due to inflammation affecting my aorta causing it to throw out clots. I've never smoked or had even a single drink of alcohol my entire life and my cholesterol is great and blood pressure is almost always perfect so doctors were confused why I had arterial clotting in my leg and believe it's all related to inflammation from both Crohn's and celiac. We all need to encourage researchers to keep up the good work! I do agree that drug companies have received well deserved criticism and wish the government would see healthcare as important as gun rights!

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said this on
10 Apr 2017 2:32:26 PM PDT
This is AMAZING news! Having had Celiac for about 16 years now, I have been hoping and praying for something like this for SO long. I rarely look forward to events where food is being served because of the obvious. While eating gluten-free has certainly improved over the last several years, if this vaccine works, AND is safe (for those who somehow see this vaccine as a negative thing!) it will change so many lives making the almost inevitable/accidental cross contamination a thing of the past so that we can be healthier! Plus, it will make going to parties, and everything involved around food, a true joy again! Thanks for the great news and, hopefully, keep it coming!!

Chattanooga Charlie
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said this on
10 Apr 2017 4:33:49 PM PDT
I have never see any meaningful info that vaccines cause Coeliac disease. Many vaccines do have some possible bad or no helpful outcomes for a certain set of recipients. I had to go to ER after a Flu vaccine. I have the gene that says that I am high risk for Coeliac disease. My father died from Coeliac disease. In any case, I would be very leery of anything involving autoimmunity. There are many of the new autoimmune biologics that can have very serious consequences. A very well regarded Endocrinologist along with others see Coeliac disease patients with other autoimmune disorders. I would want to know the possible bad effects before even considering such a vaccine.

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said this on
11 Apr 2017 5:09:48 AM PDT
Yes, thank you! Vaccines do NOT cause autoimmune disease. I am a health care professional and I wish that more of us would speak out against this myth!

Debbie Stevens
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said this on
11 Apr 2017 6:09:15 AM PDT
Gluten is destructive for many people. Why develop a vaccine against it? Get rid of the glyphosate soaked wheat! Get to the root cause of the problem. We need food that is healthy and nutritious, not harmful to us.

Jefferson Adams
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said this on
13 Apr 2017 6:45:13 PM PDT
That story about glyphosate-soaked wheat is also a myth. There is zero actual evidence to support those claims. There is zero evidence that glyphosate causes celiac disease. Much greater chance that things like reovirus are a cause. Also, using your logic, you might just as well say: Smallpox is destructive for many people. Why develop a vaccine against it? The logic just doesn't work.

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said this on
11 Apr 2017 12:20:29 PM PDT
Question: Is there a treatment that now stops the immediate reaction to gluten and also stops damage occurring to the villi? The treatments that are being tested in the article seem to be singular instead of all inclusive. And how much will these treatments cost? If the high cost of the testing device is any indication, we are looking breaking the bank just to eat "bread". I will continue to be gluten free via diet which is free. - sorry didn't mean to do any rhyming here.

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said this on
11 Apr 2017 2:11:26 PM PDT
No thanks. We don't really need bread to survive. Celiac disease has contributed to my RA, MS, Sjogren's, and OP. How would I know one vaccine would not trigger response that is not foreseen? Sometimes we guinea pigs for the drug companies. They are trying to treat the symptom, not the cause. Further down the road, we will see what this has done to people.

Jefferson Adams
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said this on
13 Apr 2017 6:49:11 PM PDT
You do realize that one reason humans are actually alive in such large numbers is because of bread? You do realize that the vast majority of people have zero problem with wheat and bread, that they are actually part of a healthy diet for most people? Lastly, I didn't feel like a guinea pig when I got my polio vaccine. Not sure where you're coming from on this.

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Cycling Lady, LMAO at IBeStumped! So true. Yes, he is trying the band aid approach it seems. That's probably the most frustrating thing of all. So yesterday I get a call back from his office and they say to stop taking the Viberzi and switch back to Imodium! I reminded them that Imodium didn't work, I had already used it 8 days with no changes. His assistant informed me that that is all he can recommend at this time until he sees me at my next appointment which is 5/24! I live near Chicago and I am about to make an appointment to go to the University of Chicago hospital which is the top celiac research hospital in the country. Hopefully they can give me better answers.

7Hi jen and welcome No-one can diagnose remotely via nterwe posts but if there was such a game as celiac / gluten sensitive bingo, I would be calling 'House!' having read your account above... Lots of things fit the pattern as I'm sure your lurking has revealed. It's a tricky condition to diagnose however so you may have a little wait before you join the coolest club in town and get your funky celiac membership card For now it's really important that you stay on gluten. Keep eating it as accurate testing requires it. Ask your doctor to check the boxes for celiac testing alongside your liver blood tests. There should be enough in your history to get this without hassle but if they're reluctant INSIST and don't be afraid to assert your reasonable suspicion and wish to clarify and exclude. A good liver specialis will be aware of the possible links so you should be ok. If not gt second opinion. Ask for a full celiac panel as there are variety of tests. Find further info here There's a lot to take in, but be positive, I think you are on the right track and if so, you could soon be feeling better than you ever thought possible!

Hello, I am in a job that I travel every 3rd week...It gets challenging becuase many times I am doing audits of warehouses and they dont even have a cafeteria. I usually bring gluten-free protein bars as a back up if I have to miss a meal and then eat when I get back to the hotel. Just a suggestion because they certainly fill me up....Have a safe trip...Kelly

Hello all, I'm a new member here but have lurked for a while. I'm looking for some advice regarding my medical history, possible symptoms of celiac and next steps. General info: female, low level smoker, drink alcohol, aged 32. I started having bad gastro issues when I was around 17. Since then I've consistently suffered from chronic diarrhoea, frequent discomfort in the tummy area, feelings of dehydration despite drinking at least eight glasses a day and frequent fatigue for no real reason. In 2008/9 I visited the doctor as my diarrhoea was having an effect on my studies at the time. The doctor tested me for allergies; eggs, fish, gluten and lactose and did a "standard" blood test. Everything came back fine except my liver results, which were elevated to double (I did not the see the results for myself so can't say which enzymes etc). I was told to drink less and take Imodium. The doctor implied that perhaps I was stressed and / or anxious and, still being young plus a student who regularly went out drinking, I accepted this advice and carried on with my life. I would here add that I am not an unusually stressed person - in fact, learning to deal with my unpredictable bowels has forced me to be quite a laid-back person! Fast forward to 2016. I had been living with my partner for two years by this point who had noticed my bowel habits and informed me that this was definitely not normal. He encouraged me to try out a gluten free diet since I was apprehensive about visiting a doctor only to be fobbed off with Imodium again. I did the diet as strictly as a newbie can for around two months before we set off travelling. During the diet I noticed that after a couple of weeks of extreme tiredness I felt quite a lot better - I kept a food journal at the time which showed that I almost immediately had diarrhoea once after eating an ice-cream, i felt bloated and unwell after an attempt to make oat muffins (maybe i didn't cook them very well though!) and I felt bloated and had diarrhoea after eating some fish fried in flour (We made a mistake in ordering them but I didn't want to complain). My partner also reported that my mood swings (which I admit can be a little unpredictable) were much better. Once we started travelling I gave up and ate what I was given as we were staying with friends etc much of the time. Toward the end of our trip I started to feel extremely tired, to the point of having to stay in for "rest" days, and my guts were very unhappy. I chalked it up to irregular eating patterns, too many beers and late nights in general. During the trip I also had an extreme hangover after drinking wheat beer. And, while of course I accept that any overindulgence can make you ill, I really felt that that level of hangover was quite out of the ordinary. Finally, I developed a strange lump under my armpit during this period. Now back at home, I decided to go to the doc and check out the odd lump under my armpit. The doctor was pretty confident that it was nothing to worry about cancer-wise but she ordered a battery of blood tests just to be sure. The lump is fine (good news) but the results showed elevated GGT, high-ish ALT and normal AST liver enzymes plus signs of dehydration in red bloods / higher (but not concerning) levels of white bloods. I'm scheduled to go back for another blood test to double-check liver function and discuss results - if it is again high she will send me for a ultrasound. Does this history chime with anyone here? I know that the correct course in basic health terms is to stop drinking for some time (easily done) and stop smoking forever (easy to say...) but I cannot help but think that something else is going on here. I will discuss this with my doctor and make clear that my bowel issues have not been resolved and that the initial IBS diagnosis wasn't based on any thorough testing so to speak. In the meantime - does anyone have any advice for me in times of avenues to research or experience of similar symptoms? Gluten remains in my diet but in all other respects it could be regarded as very healthy, I think anyway... (pescatarian, plenty of fruit and veg, little to no sugar on a daily basis, not much dairy to speak of...) Thanks in advance and sorry for bending everyone's' ear about this... I guess it's just taken a long time for me to admit I might be sick and I need some help. Jen

Wish I could give you a hug. Unfortunately I know how that feels with Neurologists, Internists, Endocrinologists, Rheumatologists, GIs..... I got so tired of crying my drive home after refusing yet another script for Prozac. I do hope your GI can give you some answers even if it is just to rule out other possible issues. Keep on the gluten and we are here for you.