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  • Kelly Carter
    Kelly Carter

    A Journey Through the Nexvax2 "Celiac Disease Vaccine" Clinical Trial

    Reviewed and edited by a celiac disease expert.

      Journal of Gluten Sensitivity Spring 2019 Issue


    Caption: Image: CC--National Museum of the U.S. Navy

    Celiac.com 03/22/2019 - I'm going to talk about my journey through the Nexvax2 trial. It is a clinical trial to study the effectiveness of this drug to prevent mucosal damage due to cross contamination. There are 4 phases to this trial - Screening, Updosing, Maintenance, and Post-Study. Each phase has different requirements from the patient and different goals.

    Screening for the Nexvax2 Clinical Trial

    I found out about the Nexvax2 trial from my sister. Her job involves keeping up with medical stocks. She saw that ImmusanT had started their clinical trial - a double, blind, placebo controlled study for an injection to retrain the immune system to stop recognizing gluten as a foreign invader. It works similarly to allergy shots desensitizing the immune system to gluten. I looked up the trial at ClinicalTrials.gov and made a phone call to the nearest location. 

    There were 35 trial locations across the US and a couple of locations in Australia. I live in Atlanta and the closest locations were in Jacksonville, FL or Nashville, TN. I decided to call Nashville because it is only a 4 hour drive compared to the 6 hour drive to Jacksonville.

    I called and talked to Nurse Ratchet (not her real name, to protect the innocent). She explained that it was a long trial, about 7 months, and that I had to be in Nashville twice a week for six weeks. She said she would send me the patient disclosure and she would answer any questions I had when I was ready. She also said that I needed to be able to prove my Celiac diagnosis with both positive blood work and positive endoscopic biopsy. I would have to be on a gluten free diet for 12 months. I would also have to carry the DQ2.5 gene and do a gluten challenge. I will also have to decide if I'm going to participate in the optional endoscopy portion of the trial.

    The twice a week for six weeks thing threw me for a loop. That would be a big time commitment, hard on my family, and very expensive. I wasn't sure we could do this.

    As my husband and I review the disclosure document, there is a lot of information to take in. One of the requirements to get in the trial is having the DQ2.5 gene. I've had genetic testing done several times and knew I had one copy of DQ2.5. In reading the documents, if you have one copy of DQ2.5, you have a 1 in 2 chance of receiving the drug. If you have two copies of DQ2.5, you have a 2 in 3 chance of receiving the drug. Nexvax2 does not work for those with DQ8. According to research, over 90% of people with Celiac have DQ2.5.

    So, I have 50/50 chance of getting the medicine and I have to be in Nashville twice a week for six weeks. That is a big time commitment for a 50/50 chance at the medicine. We decide it isn't worth it. Until, I talk to Nurse Ratchet and she confirms that if I get placebo in the trial, I will get the medicine when the drug is approved. Now we are talking. I have a 100% chance of getting the medicine - either sooner or later. We decide to go for it!!

    I find my medical records that demonstrate I have Celiac disease, send them to Nurse Ratchet and we schedule my first appointment - November 1.

    The first appointment lasts for 8 hours. The initial testing involves blood work, urine tests, EKG, physical, and do a gluten challenge. This is going to be a very long day. The gluten challenge is the most worrying part. I will have to ingest a lot of gluten - the equivalent of two slices of bread. They will gauge my reaction after the drink and monitor me for the next few hours. I have 5 minutes to consume the unflavored gluten drink.

    At this point, you might be thinking why would I purposefully ingest gluten? I'm poisoning myself. I know I'm going to be sick. What sane person does this? A person that is tired of being sick. I'm tired of worrying about food all the time. If this is what I have to endure to ensure that I can get better, I'm in.

    After consuming the gluten poison, we wait. After about an hour, I start feeling fatigue - mind numbing fatigue. The kind of fatigue that you just want to lay in a dark, cool room under a blanket thinking of nothing. At hour two, the vomiting starts. I throw up twice in about a 30 minute span. My reaction is severe enough to qualify into the study. But now I have to start to deal with the consequences of glutening myself. Once the testing is over, I get on an airplane and fly home. That was a miserable flight. I won't bore you with the unpleasant details, but know the flight was not good.

    I'm miserable the whole week after the gluten challenge. Fatigue, brain fog, gastrointestinal distress, and just feeling bad is what I dealt with for a week. A full seven days of being completely incapable of living my life in any meaningful way. It was a week of watching TV, ordering food in, and just breathing. Eventually I get better. When the malaise lifts, it lifts like opening a curtain to reveal bright sunshine. I am finally better.

    We opted to do the optional endoscopy study. I had to go back to Nashville at the beginning of December for the endoscopy. The flight, fasting, and doing the test in the early afternoon did not make for a great day. Really, it was a very bad day. Normally, I don't struggle with endoscopies. Normally I simply do the endoscopy and go eat a big meal and am fine for the rest of the day. This time I slept from about 1 hour before my procedure, through the procedure (they gave me good stuff to help with that), and then on the 4 hour car ride home. I slept a lot that day.

    Then we wait. We have to wait for all of the blood tests and endoscopy results. About a week after the endoscopy, Nurse Ratchet confirms I have made the cut. I'm in the trial! 

    During the trial, I had to promise to not start taking any supplements or medicine without letting them know. I had to put a card in my wallet that said that I was in a clinical trial and it not give me medicine until the doctor called this number.

    There are also surveys you have to fill out on the little device they give you. You have to do them every night and they must be completed between 6 pm and midnight. Most days it is two surveys - one asking about symptoms and one about your bowel movements. The one about the symptoms asks you to rate how your symptoms are on a scale of 1 to 10. The other asks how many bowel movements you've had and tell what they were like on the Bristol Stool Chart.

    In the whole 6 month period you are only allowed to miss 4 surveys. I set two alarms to remind me - one at 6 pm and one for 8:30 and carried the device with me at all times so I could do the survey when ready.

    We have completed phase 1 - the screening phase. Now, it is time for phase 2 - updosing.

    Updosing: Reaching the Nexvax2 Dosage

    In reading the consent document, updosing is important because when they tried to give people the full dose of the medication in Phase 1 trials the side effects were too dramatic and people dropped out. The main side effects of this medicine are headache, fatigue, and diarrhea.

    Those side effects are the same for me when I get cross contaminated so I wasn't worried about the side effects.

    On the first injection day, I had to be in Nashville for for 4 hours so medical personnel can watch you and make sure you don't have an allergic reaction. They use a small insulin needle to inject the drug, so it doesn't hurt. The shot does have to go into your belly, so that's a little weird. I would have preferred it in my arm! The first dose is a very small dose of the medicine with a lot of saline. Over time the amount of medicine increases and saline decreases until about half way through. About half way through the up dosing, you get the medicine straight, no chaser (no saline).

    The updosing is not a challenge. I did have periods where I did experience side effects. Occasionally, I had problems with fatigue and headache, but it did not affect my life or how I functioned. There was one time, specifically, I had an issue with fatigue and headache. This was a bad headache. It did not let up with ibuprofen or acetaminophen alternating every 4 hours. It was about half way through the updosing and it lasted for about 3 days. Then it lifted. Everything was gone and I was back to feeling good.

    Also over the course of this study, I've had periods of flushing. Flushing where my face and neck would turn bright red and feel like they are on fire. When this happens, I would take a Benadryl and go to bed. My mom thinks it is menopause, but that's just for old ladies, not me. The hardest part about updosing was the travel and the grind of going twice a week. I also was doing this in December and January. December and January are hard because of the holiday season, but we also have 3 family birthdays during the span of this period. But we made the best of it and one time the whole family came with me and we spent a couple of days in Nashville.

    Maintenance Dosing

    Once updosing is complete, maintenance dosing starts. Maintenance dosing is 10 weeks of twice weekly injections of the full amount of medicine. They are self-injections. The injections need to stay refrigerated, so I have this super cool cooler in my fridge. TSA didn't even flinch when I came through security!

    I got 20 auto-injectors for the ten weeks of twice weekly injections, alcohol swabs, and a log book. I had to log the date, time, and location of my injection. You inject in a pattern in your abdomen- upper right, lower left, lower right, and finally upper left. I will say this phase was a bit of a relief for me. It meant less travel and just kind of coasting along. Until, the food challenges - duh duh duh daaaaa!

    The food challenges are to see if the medicine is working. There are three food challenges - one gluten, one placebo, and one either gluten or placebo. So, you will get gluten at least once but not more than twice. The challenges are spaced two weeks apart.

    The procedure for the food challenge is much the same as at the initial gluten challenge. They do the normal stuff - weight, blood pressure, and temperature. Then they pull out the big white box with my name on it. Inside the big white box is three smaller white boxes. They all are sealed. These are my food challenge boxes. She takes the first box out and opens it. It contains a shaker bottle, a box of water, and two packets of powder. One packet of powder is flavoring and the other is the test material. She mixes the drink per the instructions and I have 5 minutes to consume this beverage.

    The drink is pink and overly sweet. (At the gluten challenge, there was no flavoring. Just straight up gluten.) The test drink tastes terrible, but I consume the beverage. Then we wait.

    We wait to see if my body reacts the same or differently to the initial gluten challenge at the start of the trial process. It is just a waiting game.

    They said I could keep the shaker bottle we mix my food challenge drinks in. They are really nice shaker bottles. I cannot keep them. I truly never want to see those shaker bottles again. Those shaker bottles are my enemy and I want no part of them. Those shaker bottles make me sick and I don't want them.

    I've done two food challenges to this point. One I had no reaction and the other I reacted. I threw up, but I wasn't tired for a week. I was tired for 24 hours.

    So, that's where we are. We are working through the process.

    I have no idea if I'm getting the medicine or placebo. I don't know if I got gluten at any of the food challenges. That is what makes this so hard. The mental gymnastics of am I getting the medicine or am I not - is very, very challenging. It can consume all of your thoughts if you let it.

    Post Trial

    I haven't gotten to this part yet, I'm still in the food challenges phase of the study. The final part of the study means I will turn in all my used autoinjectors and boxes, log from where and when I did injections, and be turned loose into the world with my new found protections against cross contamination. It will be exciting.

    Conclusion

    I don't know if I got medicine or placebo. I may never know for sure. I have guesses and theories but that is all I have, which makes this really hard mentally. It is hard to have symptoms or not have symptoms and not know if you are getting the medicine. But I think those mental gymnastics are not helpful. I went into this hoping for a cure with the expectation that I would not receive the medicine and would be sick quite often. I haven't been any more sick than I would have been living my life normally, so that's a good thing.

    Some people argue that they never want a medicine for Celiac. They don't want a vaccine or any part of anything from Big Pharma. They say putting gluten in your body is inflammatory and bad for everyone. They say Roundup causes Celiac disease and if you eat organic all will be fine.

    Here's my answer - If you don't want the medicine, don't take the medicine. It isn't required and nobody will force you to take it. But this disease has impacted my life so dramatically, I'm willing to try a new medicine to alleviate the symptoms. This disease has affected my family, my health, my social life, and my ability to vacation among other things.

    Even if this or any other medicine is approved, I'm not sure I would return to a full gluten diet. I don't mind a gluten free diet. I mind the constant vigilance I have to have all the time while eating three meals a day. I mind that many labels are not accurate when they say an item is gluten free, but it has barley or rye in the product. I mind that I can't just take a road trip with my family without carefully planning each meal along the route so that I'm sure I can eat safely. I mind that I have to ask every waiter 15 million questions before ordering at a restaurant in order to get a meal that is safe and even then I'll probably be sick. I mind that I can't engage in normal social activities, like sharing a meal with someone, without doing research on where we can go or just having to bring my own food. I mind not being able to have a scoop of ice cream with my kids at the beach in the summer. I mind a lot of things that this disease has imposed on me.

    I believe most other Celiac sufferers endure the same hardships I do in finding safe foods. So, finding a cure or at least something that makes our lives better is a worthy cause that should be encouraged and cheered. Maybe others don't share my struggles and that is great. Maybe they are happy never going to dinner or out with friends. I'm not. I want a normal life or even some semblance of one where I can do the most basic and ancient ritual of society - sharing a
    meal without fear.

    So, take the medicine or not - it's up to you, but don't knock the people who want it.


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    Hi Kelly,

    Thank you so much for writing about your experience. I was diagnosed with Celiac Disease about 5 years ago, but have been sickly most of my life and no one knew what was wrong with me. By time I was 60 (or 61) I was below 80 lbs and completely malnourished. That's when my family said "Maybe you have Celiac Disease" and I was finally diagnosed 2 months later. My tolerance is now ZERO for any amount of gluten. I have had 3 major gluten attacks since 2015. All 3 times I ended up with severe stomach spasms, vomiting, diarrhea, total body aches and ended up in the Emergency Department. Smaller cross contamination episodes cause me to have cramping, stomach aches and painful diarrhea. Surprisingly, after going completely gluten free once I was diagnosed I gain 25 pounds in 2-12 months. I cannot even have a small amount of gluten so I can totally relate to you when you talk about not being comfortable going on vacations. I cannot go visit at a friend's house for dinner as I was glutened at a family holiday dinner three years ago. So I stay away from holiday dinner except at my sister's house as my - my brother-in-law is VERY accommodating and prepares gluten free meals for me and even bakes me awesomely delicious gluten free deserts. I'm very fortunate that way. I'm still skeptical at some restaurants, especially ones that state they have "gluten sensitive" options, then I usually just eat a salad with oil and salt or bring my own dressing (and gluten free bread). Bless you for going through this trial. You're a trooper!!! I do hope you are getting the drug and not a placebo, and most importantly I hope it works, no only for you but for all of us out there who really need it. I would love to live a "normal life again. HUGS and I hope all goes well with you and the rest of the trial.

    Marlene 

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    Thanks for your relatorio about the trial. I can't imagine 'voluntarily' ingesting gluten since I was diagnosed with celiac in 2003. At this point my reaction is rapid violent vomiting!

    Over the past several months I've been working with a functional medical group to discover the root cause of the 3 autoimmune issues I deal with: celiac, arthritis and Hashimoto's. A big part of this is diet: NO sugars or substitutes, NO starches of any kind, no gluten (not  a problem), and all organic (also not a problem). Plus, no refined foods since just about all of them contain sugar.

    It sounds gruesome but, after the first week or so, it's really not a challenge. I've had to include 4 oz. of animal protein daily (I was vegan).

    Bottom line: I've lost weight, my skin gooks fabulous, and I have a lot more energy!

    I intend to stick with this regimen. I've gotten used to it, and love the optional snacks: 1c berries + 1/4c raw nuts or sm. apple with 2tbsp nut butter. Yum!

    Yes, they give me tons of supplements, and I get regular blood tests that cover 60 issues, way more than what is usually checked.

    As I said, I intend to continue with this regimen for the simple reason that I feel great. Not bad for 72!

     

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    Thank you for your interesting article, and for taking one for the team!  I’m sure it’s not fun, the symptoms are awful after being glutened, but knowing you are helping a lot of us, hopefully, especially the kids has to be rewarding.  

     I’ve had DH for k30 years and I still try to not make a big deal when going out to dinner with new people who don’t understand, the hurtful part is when they roll their eyes like I’m being ridiculous asking the waitress so many questions, believe me we would all like to no have to deal with this, but it’s life and I love life and try to do the best I can to stay well. 

    Good luck, I hope we all benefit from your sacrifice and someday can make the decision to take the medicine and have that donut or pizza we’ve wanted for years. Ha ha    

    I do have to say the gluten free food is so much better than it used to be!!

    Thanks again xxoo

     

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    Hi Kelly from north of Atlanta!

    Thank you so much for this article and all the detail you give.  That's really nice of you and means a lot to me because, should this become available, I'm going to look at using this medication.  I have DH, fairly new diagnosis (not quite a year), and I'm having a rough time with getting completely gluten free.  In my area there is no such thing as a restaurant serving gluten free food.  I'm finding a lot of gluten free food to be expensive and a disappointment - I can't afford to keep 'trying' all these foods and like you, I want to vacation.  (I've got to say, gluten free food must have been pretty bad previously if the commentary about it getting so good is accurate.)  Sadly, I think my sensitivity might be really high and that's why I have so much trouble getting gluten free - 20 ppm or less might not be enough.  Items that are labeled 'gluten free' end up not being free at all for me.  I'm so very tired of cooking every single meal without a respite.  Something like this would be a freedom for me - a chance to go places and do things without being chained to my home or having to take a portable kitchen with me.  Knowing what I might have to expect and the process/challenges you faced is very helpful even though it might be different for everyone.  Thank you again and best to you!  Hope to hear how it all resolves.

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    I applaud your investing in this trial.  I also share your thoughts about wanting it to be easier to travel and share food with family and friends.  I am too old  to participate in these trials but if I wasn't I would be doing them as well.  Hopefully, I will someday be able to enjoy food without worry because of your efforts.  Thank you.

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     Hi Kelly,  I’m a woman in my 60s and was diagnosed in 2016 with celiac, lymphatic and collagenous colitis.  Although I’ve had symptoms since my 40’s, your story, especially how it relates to family, friends and life in general really struck a cord.   Your description of how this disease changes your life, brought tears to my eyes.  Like so many of us it is our story too. Thank you for sharing it along with all the harrowing details you went through to help heal yourself and this community.  You are as much a hero as a soldier fighting a war.  It might start out with selfish motives but ends up for the greater good of all.  I hope for all our sakes that you received the vaccine and that you continue to get better!  Thank you!

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    Thank you for sharing your story! I am a mom of an eight year old little girl diagnosed a year ago. She too has violent reactions, although the more frightening part is that one of them is neurological; her legs go numb and she cannot walk. We bought the NIMA device last May and it has been instrumental in allowing our family to travel and eat out again like we used to. Of course, I am still hyper vigilant at all times, it’s just one more layer of assurance for us. I pray that this vaccine will someday be able to free my little girl from living with the life-altering challenges of this disease. She is too young to take part in a trial so it is people like you forging the path for her. Thank you.

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    Guest NashvilleCeliac

    Posted

    Thank you for this excellent description of the NexVax2 trial. I too am in this study at the Nashville location and have had almost the exact same experience that you have had.  It is such a relief to hear your story (especially your second gluten challenge reaction) .... I’m going in for my third and final challenge next week (crossing my fingers for a non-gluten shake).  Best of luck to you in the upcoming weeks! 

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    "I mind" everything as well!

    The last two paragraphs sums up our disease to a tee. 

    Last weekend, my wife and I went to a wedding and while everyone was enjoying their meals, I was in the parking garage eating cold chicken and vegetables in my passenger seat, I was not about to bring a cooler into their reception.

    Thanks for sharing your story, looking forward to the updates.

    Good Luck.  

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    Thank you so much for going through this grueling journey to advance celiac science for all! And thanks for writing about it here. I have identical twins who were diagnosed at 5 y/o and are now 8. It is so hard to manage their health and safety when we do anything that diverges from our entirely gluten-free home. I worry about all the amazing times they will miss out on in the future as we tend to gather around food culturally. Even the most well-intended people cannot really, safely provide gluten-free food for them in a group setting. I am working on my PhD in psychology currently and my research examines the effects of this on parents managing their children's celiac disease. There are so many psychological effects at play for people who are managing their disease, and it is only just beginning to be looked at. I honestly pray that what you and the other participants have done here makes my research obsolete! I so hope this vaccine provides a solution for those who want it. Thank you, thank you!

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  • About Me

    I was diagnosed with Celiac in 2012 and have been gluten free ever since.  I live in Atlanta with my husband and two medium sized children.  I run a blog at FatCeliac.net that covers real life issues with celiac disease, upcoming drug trials, and try to be a reliable source of information for the celiac community.

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