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Celiac Vaccine Phase I Trial Finished

New vaccine for celiac disease finished Phase I trial. The results summary are as follows: 34 test subjects were double blinded to test the safety of the new Nexvax2 vaccine for patients diagnosed with celiac disease. All patients were HLA-DQ 2 or 8 positive. In all, 19 subjects received the vaccine. Three different doses were administered. Side effects were common with higher doses and included:
  • Nausea
  • vomiting
  • 1 subject withdrew from the trial due to “severe gastrointestinal symptoms”
In several patients, the injection created symptoms similar to that of typical gluten exposure. I am all for the advancement of science and knowledge, but I have a hard time understanding why we need a vaccine for a disease that is completely controlled through diet modification. The concern of Anderson et al (the group developing the vaccine), is that patients following strict gluten free diets still don’t heal. The motivation to develop a vaccine is based on this concern. The bigger question is – Why aren’t these patients healing? Research studies have confirmed that the majority of patients on a classic gluten free diet don’t heal (even after 5 years). The TRUE Gluten Free Diet is the answer – For the past 10 years, I have seen patient after patient diagnosed with celiac disease and/or gluten sensitivity not respond or properly heal while following the traditionally defined gluten free diet (wheat, barley, rye, and sometimes oat free). Gluten is not properly defined. Patients that go on a traditional gluten free diet don’t heal because they are still eating gluten (just in different forms). A TRUE Gluten Free Diet provides a platform for these people to heal without the need for drugs, vaccinations, etc. If you are gluten free and still having trouble, you would benefit greatly from this video… All the best, Dr. Osborne – AKA The Gluten Free Warrior

41 Responses

  1. REALLY, Dr.??? You are saying you don’t see why we need a vaccine when this can be controlled by diet? That’s like saying we shouldn’t have a vaccine for chicken pox or polio when these can be managed by staying in a bubble! Are you gluten intolerant? gluten intolerance is a difficult thing to manage and be constantly aware of, taking days to recover from gluten exposure for some. Why wouldn’t we want to do something that allows us not to be checking all the labels and asking questions in restaurants and having to educate people all the time to our problem, drawing attention to ourselves, having to be set apart, researching constantly and having to compare everyone’s study findings on certain foods, not knowing who to believe when there are so many conflicting views on the subject??? I am all for someone trying to find a vaccination or something that will allow my body to work as it should, simply; without the symptoms, discussed in the findings, but sometime, someway.

    1. Comparing a food based disease to chicken pox is apples to oranges. Diet is easy to change. Being exposed to a virus, not so.
      Don’t get me started on vaccines. Chicken pox vaccine is worthless.

      Back on topic:
      A vaccine is not necessary when we know and can control the cause of the disease. I am gluten sensitive. React terribly to the stuff. The fact of the matter is, if you want to avoid gluten in all forms, eating out should be stopped. Reading food labels should not be necessary. Real food comes without labels. Your body will work as it should if you treat it right (real food, exercise, sunshine, etc).

      1. First – People do still DIE from the chicken pox and from other common problems. Second – And even with real food just something being cross contaminated is a big problem for some of us. I would love to just enjoy a night out and not worry about what is in or has touched my food.

      2. You must have plenty of money to afford a fully gluten free in contaminated life. Some of us cant always afford healthy gluten free foods so i still dont get all my nutrients properly and some of us live with loves ones who eat gluten and i am so miserable from cross contamination in my life that it depresses me and i do not have a good quality of life. I will never go back to gluten even with a vaccine but it would be nice to not have to worry about being in pain every time i get a little gluten in my system im actually quite disappointed that you as a gf society page that you dont understand where people like me are coming from.

      3. Diet is easy to change?

        Do you understand the notion of cross-contamination? I have no problem eating gluten, but watching my daughter go through an exposure is heartbreaking. Her last exposure was from a fountain soft drink in a shopping mall. Whoever loaded the straw dispenser must have had flour or dough on their hands.

        Diet is easy to change?… Try going sugar free for a week. Try going truly 100% gluten free for a week. Try going salt-free for a week. Unless you have the time and/or money to have every meal home-cooked from scratch every single day, you cannot do it in this country. Sure, there are “gluten free” options in the supermarket. Do the research and find out how many of those are not really gluten free. They treat it like just another fad diet thing, like organic or low-fat. Also, most of them just aren’t that good.

        My daughter would like to go to an ordinary restaurant with her friends and not feel like the odd one out because she can’t eat the food. (as for “gluten free” menu items. Right. I’ve worked in restaurants. Cross-contamination of ingredients is the norm. How many times have you gotten a stray french fry in your onion rings? Ask any competent, experienced cook.

        My daughter would like to order popcorn at the theater (they also sell pretzels and hot dogs, and the employees don’t wash their hands between customers.) I personally would like to have bread at dinner again, and the other kids would like to have donuts once in a while. But when one member of the family is as intensely reactive as my daughter is, it’s a whole family lifestyle.

        Fortunately, I can cook. And I personally do have the time to cook every meal from scratch every day. And I enjoy it and am happy to do it for the sake of my 13 year old daughter. But it’s still quite a burden. If there were a good and safe vaccine, I would encourage her to get it. (Of course, it will still be her decision.)

        Even without a chicken pox vaccine, your life would probably be mostly normal. Celiac without diet modification robs people of life every single day.

        1. I am familiar with cross contamination. One of the many reasons I don’t recommend eating out, and like you, prepare foods at home.
          I don’t eat sugar, nor do I recommend it to patients, so I am also very familiar with the challenges.
          A couple of things you mentioned that I would turn your attention to:
          1. Soda fountain drinks contain corn sugar
          2. Popcorn is obviously corn, but it is also typically cooked in GMO corn oil.

          Have you considered that corn gluten might be part of the problem as well?
          Here is an article <<== with several medical references on corn gluten.
          Best of luck to you and your daughter,
          Dr. Osborne

      4. I agree with you 100%. Why not having the option of making our bodies response to gluten the way it should and live a normal life with out being set apart from the rest, reading labels all the time which doesn’t even ensure it is save to eat it anyway cause every thing even the gluten free stuff is subject to cross contamination and on top of that dealing with the people who doesn’t know anything about it having to explain our business to everyone all the time and they still don’t care if we get contaminated or not especially in restaurants. Suffering from Celiac is not only about being gluten free (which is not really easy to begin with) and not to mention it is not cheap either, is about changing our whole life style. Is not only about being deprived of gluten and the things we like and that we were use to ate our whole lives before being diagnosed is also about being deprived of our social life and even our culture in some ways depending your ethnicity. People don’t make you part of their parties, gatherings or outings cause they are not willing or able to modify their menus for just one person. Like many of us here I feel left out and depressed all the time and even if you still try to be careful about what you eat when you go out is not easy to see people in your table eating the same things you are deprived of while also exposing you to get contaminated. I feel so bad and compassionate for those who live with family members who are not gluten free like those who have kids at home and having to clean their cookies, crackers and cereal messes all the time, it is a constant battle. I am lucky that only one of my two daughters still live with me who is an adult and understand and support me with my condition but even her life had to change due to my celiac not being allowed to eat at home the things we always ate before just for my safety. I can’t imagine how my life would had been if I was diagnosed when I was still married and having my other daughter living in the same house, not everyone is willing to change their life style because of someone else and its not fare either. I can’t wait till this vaccine is out in the market and make our lives a little easier and more enjoyable.

  2. There is absolutely NO WAY I would get a vaccination! We are so over-vaccinated in this country, all for the big Pharma’s like Merck to make more money and all these vaccines come with harsh side effects and some we don’t even know about for years! Real food, while it’s hard because you can’t conform to the society around you who eat store bought cakes, canned goods full of junk – why would you want to conform to a lifestyle like that? Yes, I feel awkward at social gatherings, only because they don’t understand and most don’t want to, because it threatens their way of life/eating. I’ll deal with the awkward and continue to make the right and healthy choices for me and my family. It’s a total change if lifestye, but it is the way we were created and made to eat in the first place. You never heard of break, cakes, pastries in the Garden of Eden did you?

  3. I agree TOTALLY that a vaccine is worthless, and we shouldn’t have to read labels since real food comes without labels. Because of 40 years of damage, I do not eat out AT ALL. It’s just not worth taking the chance on cross contamination – but mainly – the food is basically “dead,” and doesn’t really give them that much nutrition. People who don’t pay attention to what their bodies are telling them will pay a dear price later on down the road. They must take charge of their own bodies – no one else will – especially when most of the options are offering adding more toxic poison into it. If we get trash into our car’s gas line, it doesn’t run right. We change the oil and filters, and we never consider what the liver is having to do to filter out all the garbage we put into it, including vaccines.

  4. I can see both sides of this: yes, in an ideal world all we have to do is change our diet and feel great. BUT unfortunately our world isn’t an easy place to live, and NO I do not eat out either. It is still difficult to check the source of everything and I’m not just talking about labels: how the food is grown, what the animals are fed etc. Even just having to be “around” other people eating gluten. For example our kids went to a church party, we sent our own food for them, talked to them about it ahead of time; they are very educated on what NOT to eat (basically nothing that we didn’t make) and comfortable with this. The woman in charge knows our situation and I am usually there to keep an eye out, but I couldn’t be there that specific day. They came home with a craft project made from macaroni noodles! Just the chance of contamination scares me, but it’s out of my hands and in cases like this having a vaccine to protect against a reaction would be assuring.

  5. I don’t know if i would take the vaccine or not. i was diagnosed with Coeliac Disease when i was nearly 41. i am 47 this year and i have to say that even though i follow strict gluten free and lactose free diet i dont feel much better then i did when i was diagnosed. so i really dont know. i would have to see what further testing showed.

  6. not eating out is a rediculouse way to deal with it! im not saying the vaccine is but you are just segragating yourself from society and normal life. some of us want a normal life. if its available and safe eventually if people want to use it its their choice. its not wrong to want to have cake at your wedding or a beer with your friends on a hot sunny day or to be able to just grab a sandwich from the shop when your busy. what you call “real food” is healthy and i love eating food iv made from scratch but its a pain to do every day. a bit of convenience is good and iv been diagnosed for 9 years and eat out all the time its called using common sense and asking about ingredients and picking carefully. you cant live your life in a bubble as you said!

  7. A vaccine would be great. This is the first step. Of course we are cautious because it is new. Have you read the articles saying a gluten free diet is not reducing the mortality rates foe those with celiac disease? I think I would take the vaccine and still eat Gluten free but hope to not worry about cross contamination.
    It would be amazing. I’m saving for Australia already!

  8. I as 28 and was diagnosed with Coeliac (Yes, I am from Australian, Yes I am a Hospital Pharmacist, No I don’t work with any of the abovementioned gastroenterologists/specialists) Disease just six weeks ago. While I find breakfast, lunch and evening meal quite easy to manage gluten free as I rarely have take-out and enjoy home cooked, fresh meals. I am all for NexVax2 and will be asking my gastroenterologist about signing up as a volunteer at my next follow up. Why? Because I hate having to ask questions, draw attention to myself and trouble my friends and family to eat at only certain places when we go out. I live in Melbourne and it is a joy to experience our wonderful and world-class restaurants and cafes without stress and hassle.

  9. “…but I have a hard time understanding why we need a vaccine for a disease that is completely controlled through diet modification.”

    A truly puerile, dismissive and naive point of view offering an absence of understanding on the celiac disease. Being written by a supposedly reputable domain, the condescending tone discredits the writer and undermines the importance of scientific/medical innovation in developing cures.

    This luddite viewpoint, in conjunction with pseudo-journalisam, is facetious at best. The reality for many celiac sufferers is; hardship in not only parting with additional funds to procure “gluten free” items, but the constant battle to locate truly gluten-free outlets when dining out. Trotting down the path of being ostracised from most “favourable” food outlets available to you prior to diagnosis, as most do not have gluten-free alternatives, is another matte.

    If at any point in time, an iota of gluten is ingested, sufferers are faced with horrendous gastro-intestinal abnormalities for periods lasting up to 24 hours in some cases. The mere thought of a vaccine is incredible. The testing is for this reason exactly: Observer the functionality and isolate problem areas, hence the “Phase I”.

    Jurno-hack needs to grab daddies hand and move along.

    1. Interesting criticisms coming from Anonymous. If things were left to you, the world would be enabled and coddled into disease. Using eloquent wording and a false sense of superiority are tools of children who have an entitlement mentality. The reality for celiac sufferers is; the right diet means health.

      Comment-hack needs to grab mommies apron and pray for wisdom to strike.

      1. All your advice is nice, but you still haven’t addressed the COST issue. I am not gluten sensitive, I am celiac sprue positive. I am as gluten free as I can be. I eat at home and take my own drinks out when I go shopping. It is the most expensive diet modification lifestyle to maintain. I live in classic small town America, and so the options are quite limited. It like grazing all the time on lettuce or cabbage because that is what is available. The expense is what limits choices in the grocery store as well. No preservatives equals short shelf life which is extra expense for them. Please do not make it sound easy as a crustless pie, because it is not.

      2. Are you really a Dr??? Thank God your not my teenage son with Celiacs Dr! Telling him, oh just never go out to eat with your friends. Stay home and eat stale gf bread that tastes like cardboard. Even following a gf diet like you say will not heal the gut after 5 years, so why would you NOT be open minded to science or a vaccine that can make that happen AND enjoy eating real food again?? You clearly live in the stone ages.

  10. I would take a vaccine. I miss my food, and I’m now limited in other areas… such as active duty
    No need for a vaccine???

  11. Why give drugs that will have side effects, when all you have to do is avoid certain foods? Treating the symptoms and not the cause again….Go with nature, not fight it… that’s what I think anyway.

    Changing a lifestyle is harder to do than opting to take medication. With support, we can keep searching for answers to eat completely gluten free….. We should be spending all our concentration on conquering this. If we opt for the easy route by having a vaccine, I fear we will become lazy.

    Good old westernised medical model again! Quick fixes, treating symptoms and not the causes.

  12. I think this is great. I`m from Sweden and got Coeliac Disease when I was one year old (1987), and now I`m 25 years old. When I heard there was a vaccin “on the way” I was happy. Now, we maybe can eat ordinery cookies, hamburgers, and pizza. I think our cookies and other things are very dry, so I look forward too it.

  13. i wuld take vacine pils anything-anythingg and people that dont wona take vacine they have mild reaction to gluten i have worst off all i swalow 6 incches and suocide is my only option in thise moments so please stop saying that you wont take vacine -i wont one now

  14. Yes give me the vaccine. I want to eat out, I want to eat a doughnut and I don’t want to have to continue paying way over the top for gluten free alternative food.

  15. I too will take the vaccine as soon as it is available. I travel a lot. It’s very hard to eat pure and natural foods when you are living out of a suitcase and hotel/accomodations. Some places have cooking facilities. A lot don’t. When I need to be in the cbd, I am restricted to convenience shops which don’t carry a lot of real food.
    I’ve never had Chicken Pox. When my son was little I kept him far away from any suspected cases of Chicken Pox for my sake as well as his. He had the vaccine as soon as it came out. I don’t hassle other people about their food/medical decisions. I expect them to not hassle me about mine.

  16. I will be eating a huge cheesesteak and drinking a Miller lite while they are injecting me. Can’t wait!!!!

  17. I would have a vaccine the moment one became available. Being coeliac and following a gluten free diet is hard work and I feel I miss out on a lot. Eating when socializing is tricky and I’m tired of having no food whilst others tuck into savouries and sandwiches. Travel is difficult and I hate having to quiz waiters and hoping they have understood so that I won’t end up being sick. To me, gluten free substitutes are poor at best and I’d do anything to be able to eat normal food again.

  18. It is not about just eating the right food….it is about feeling normal again. From the office morning teas to occasional eating out. This article is really a pseudo journalism/medicine at its best. Yes being gluten in tolerant won’t kill you like other serious diseases but it’s a constant cycle of isolation and you will be reminded about it day in and day out, on a myriad of occasions.

    I would take the vaccine, just because I can eat like normal ppl once in a while….Even if there was a medicine that worked only for one meal……so that I don’t need to stand isolated in a corner in the office after meeting nibbles.

    P.S. I could not have said it better than comment from Anonymous June 17, 2011 at 1:35 am.

  19. Don’t eat out. Please!

    I will be the first in line with my sleeve rolled up and ready to go with a cold frothy beer waiting in the car for me when I have the vaccine. Living with coeliac disease is not living.

    I’m with Anonymous June 17, 2011 at 1:35 am.

    1. I live in Australia, I am 46, and was fortunate enough to have been diagnosed as a Coeliac when I was just 18 months old, by a very clever and attentive pediatrician. I participated in the trial for this drug more than 10 years ago and had really forgotten all about it till recently.

      Whilst I don’t know life outside of a Gluten Free diet, I would have this vaccine in a heart beat. For the pure convenience of life, as well as the obvious cost bias (GF food is extremely expensive) this would be a no brainer, given the chance.

      I bake my own bread, but the loaves still end up costing over $6 for the cost of ingredients, a ready made loaf of decent GF bread can be in excess of $10 AUD. The cost for an average family (i.e. 2 adults and 2 children) with more than one Coeliac in the family is significant.

  20. I would welcome a vaccine simply because celiac sprue affects EVERY aspect of our lives. I would like to be able to get my iron out of my food and not through an IV. I would love to be able to build up B-12 and not have to have a shot every other day and so on with calcium and folate, and etc. If it enabled me to eat “normal” food again, that would just be a bonus. But if I could just be healthy again…yeah, you bet.

  21. WOW! I am glad I found your website. Hopefully I can save some of your readers from the extensive and incredible misinformation you disseminate. You clearly do not have celiac disease yourself, and seem to have absolutely no knowledge of the condition. It is quite clear you only trying to profit through sales from your webpage. Unfortunately you are spreading false information, and clearly preying on those unfortunate enough to believe your tripe. There are so many falsehoods in these pages, I can’t even count. For example, suggesting that corn gluten might be a hidden danger for celiac patients is absurd. Corn “gluten” is in no way related to wheat gluten, despite what you might believe. It was just unfortunately given that name, much like I could call a fish a peanut, but that won’t make it a danger to someone with a nut allergy. I question your credentials and wonder what kind of a “Doctor” you really are. Chiropractor perhaps? You are certainly not a medical doctor nor a PhD, otherwise you would likely have some understanding of the science behind the conditions you discuss. If you had ever even met anyone with celiac disease, you would understand immediately difficulties involved in eating a truly gluten-free diet, and the desirability for a vaccination that would provide immune tolerability. Please stop hurting people by trying to sell your lies as factual information.

    1. Hi Dr. Steve,
      You sure have a lot of opinions. You won’t be “saving” anyone here. I am proud to be a chiropractor among other things. Your attack on the profession just shows your ignorance. You must be a medical doctor. Your pomposity and assumptions, and know it all attitude certainly fit the bill. Actually, that was rude of me. I know a lot of really great medical doctors, and I would hate to put them in the same categorization as you. Have you even read the research on corn gluten? Obviously not. You espouse the celiac diagnosis as if it were owned by gluten. Truth is, a lot of things can cause villous atrophy, not just alpha-gliadin. I can go on and on, but the truth is, you sir, have already made of your mind.

      Comments are always welcome on Gluten Free Society, but you need to have something worth saying beyond opinion, rhetoric, and the classic chiro bashing.
      All the best,
      Dr. O

  22. You people that don’t want a vaccine are completely crazy. I’d take it in a heartbeat. For some the diet may be easy to feel better but for others, like myself, the diet is restricted so much due to cross-reactivity issues… Imagine not being able to eat wheat, corn, dairy, eggs, soy, buckwheat, brown and white rice…basically every grain causes me celiac symptoms. I get sick literally every other day. Those that go gluten free and feel fine are lucky. Again, vaccine in a freaking heartbeat please!!!!

    1. Tell me about it. I’ve had severe IBS, lactose & gluten intolerances since I was 5 yrs old and would do just about anything to be able to even just gluten again. A gluten free, lactose free, low FODMAP diet is extremely hard to maintain without cross-contamination. It’d just make life so much easier and more “normal”.

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