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Found 21 results

  1. Celiac.com 06/20/2018 - Currently, the only way to manage celiac disease is to eliminate gluten from the diet. That could be set to change as clinical trials begin in Australia for a new vaccine that aims to switch off the immune response to gluten. The trials are set to begin at Australia’s University of the Sunshine Coast Clinical Trials Centre. The vaccine is designed to allow people with celiac disease to consume gluten with no adverse effects. A successful vaccine could be the beginning of the end for the gluten-free diet as the only currently viable treatment for celiac disease. That could be a massive breakthrough for people with celiac disease. USC’s Clinical Trials Centre Director Lucas Litewka said trial participants would receive an injection of the vaccine twice a week for seven weeks. The trials will be conducted alongside gastroenterologist Dr. James Daveson, who called the vaccine “a very exciting potential new therapy that has been undergoing clinical trials for several years now.” Dr. Daveson said the investigational vaccine might potentially restore gluten tolerance to people with celiac disease.The trial is open to adults between the ages of 18 and 70 who have clinically diagnosed celiac disease, and have followed a strict gluten-free diet for at least 12 months. Anyone interested in participating can go to www.joinourtrials.com. Read more at the website for Australia’s University of the Sunshine Coast Clinical Trials Centre. Source: FoodProcessing.com.au
  2. Celiac.com 05/29/2017 - Currently, a gluten-free diet is the only way to manage celiac disease. Can a celiac vaccine change that? One company thinks so. ImmusanT corporation has developed a therapeutic vaccine, Nexvax2, that is specifically designed to treat celiac disease. The vaccine is an adjuvant-free mix of three peptides that include immunodominant epitopes for gluten-specific CD4-positive T cells. The vaccine is designed to neutralize gluten-specific CD4-positive T cells to further antigenic stimulation. As part of their efforts to evaluate the vaccine, a team of researchers recently set out to investigate the efficacy of epitope-specific immunotherapy targeting CD4-positive T cells in celiac disease. Specifically, they assessed the safety and pharmacodynamics of the Nexvax2 vaccine in patients with celiac disease on a gluten-free diet. An article detailing the findings of their most recent effort, titled Epitope-specific immunotherapy targeting CD4-positive T cells in celiac disease: two randomized, double-blind, placebo-controlled phase 1 studies, appeared in the Lancet. The research team included Gautam Goel, PhD, Tim King, MBBChir, A James Daveson, MBBS, Jane M Andrews, MBBS, Janakan Krishnarajah, MBBS, Richard Krause, MD, Gregor J E Brown, MBBS, Ronald Fogel, MDCM, Charles F Barish, MD, Roger Epstein, MD, Timothy P Kinney, MD, Philip B Miner Jr, MD, Jason A Tye-Din, MBBS, Adam Girardin, BS, Juha Taavela, MD, Alina Popp, MD, John Sidney, BS, Prof Markku Mäki, MD, Kaela E Goldstein, BS, Patrick H Griffin, MD, Suyue Wang, PhD, John L Dzuris, PhD, Leslie J Williams, MBA, Prof Alessandro Sette, DrBiolSc, Prof Ramnik J Xavier, MD, Prof Ludvig M Sollid, MD, Prof Bana Jabri, MD, and Dr Robert P Anderson, MBChB. To assess the safety and pharmacodynamics of the vaccine in patients with celiac disease on a gluten-free diet, ImmusanT recently conducted two randomized, double-blind, placebo-controlled, phase 1 studies at 12 community sites in Australia, New Zealand, and the USA, in HLA-DQ2·5-positive patients aged 18–70 years who had celiac disease and were following a gluten-free diet. The goal of the study was to document the number and percentage of adverse events in the treatment period in an intention-to-treat analysis. The study enrolled a total of 108 participants from Nov 28, 2012, to Aug 14, 2014, in the three-dose study, and from Aug 3, 2012, to Sept 10, 2013, in the 16-dose study. Overall, 62 (57%) of 108 participants were randomly assigned after oral gluten challenge and 20 (71%) of 28 participants were randomly assigned after endoscopy. None of the study participants, investigators, or staff knew which patients received a given treatment; these details were known only by the study’s lead pharmacist. In the three-dose study, participants received either Nexvax2 60 μg, 90 μg, or 150 μg weekly, or placebo over 15 days; in a fourth biopsy cohort, patients received either Nexvax2 at the maximum tolerated dose (MTD) or a placebo. In the 16-dose study, participants received Nexvax2 150 μg or 300 μg or placebo twice weekly over 53 days; in a third biopsy cohort, patients also received either Nexvax2 at the MTD or a placebo. In both studies, about 5% of the participants reported were vomiting, nausea, and headache. Among participants given the MTD, four of eight subjects in the third cohort experienced adverse gastrointestinal treatment-emergent events; zero of three participants had adverse events in the biopsy cohort in the three-dose study, while five events occurred in five (63%) of eight participants in the first cohort, and three events in two (29%) of seven participants in the biopsy cohort of the 16-dose study. Those who received the vaccine at the MTD on either schedule showed no significant difference between average villous height to crypt depth ratio in distal duodenal biopsies, as compared with those who received placebo. In the 4-week post-treatment period, ascending dose cohorts underwent a further double-blind crossover, placebo-controlled oral gluten challenge, which had a fixed sequence. Meanwhile, biopsy cohorts received a gastroscopy with duodenal biopsies and quantitative histology within 2 weeks without oral gluten challenge. Of the participants who completed the post-treatment oral gluten challenge per protocol, interferon γ release assay to Nexvax2 peptides was negative in two (22%) of nine placebo-treated participants in the three-dose study. Compared with two (33%) of six who received Nexvax2 60 μg, five (63%) of eight who received Nexvax2 90 μg, and six (100%) of six who received Nexvax2 150 μg (p=0·007); in the 16-dose study, none (0%) of five placebo-treated participants had a negative assay versus six (75%) of eight who received Nexvax2 150 μg (p=0·021). The MTD of Nexvax2 was 150 μg for twice weekly intradermal administration over 8 weeks, which modified immune responsiveness to Nexvax2 peptides with no adverse impact on duodenal histology. Patients who received the intradermal administration of the vaccine reported gastrointestinal symptoms were not subtantially different to those seen with oral gluten challenge. While the commercial release of a viable vaccine is likely still some time away, early-phase trials have shown promise. Based on these results, ImmusanT will continue clinical development of this potentially therapeutic vaccine for celiac disease. Both trials were completed and closed before data analysis. Trials were registered with the Australian New Zealand Clinical Trials Registry, numbers ACTRN12612000355875 and ACTRN12613001331729. Source: The Lancet Affiliations: The researchers are variously affiliated with the Division of Gastroenterology and Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, MA, USA, the Broad Institute of Harvard and Massachusetts Institute of Technology, Cambridge, MA, USA; the Department of Gastroenterology, Auckland City Hospital, Auckland, New Zealand; the School of Medicine, University of Queensland, Brisbane, QLD, Australia; the Department of Gastroenterology & Hepatology, Royal Adelaide Hospital, Adelaide, SA, Australia; the Linear Clinical Research, Nedlands, WA, Australia; the Department of Gastroenterology, Alfred Hospital, Prahran, VIC, Australia; the Clinical Research Institute of Michigan, Chesterfield, MI, USA; the University of North Carolina School of Medicine, Chapel Hill, NC, USA; Wake Gastroenterology and Wake Research Associates, Raleigh, NC, USA; Atlantic Digestive Specialists, Portsmouth, NH, USA; Ridgeview Medical Center, Waconia, MN, USA; Oklahoma Foundation for Digestive Research, Oklahoma City, OK, USA; ClinSearch, Chattanooga, TN, USA; the Immunology Division, Walter and Eliza Hall Institute of Medical Research, Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia; the Murdoch Children's Research Institute and Department of Gastroenterology, Royal Melbourne Hospital, Parkville, VIC, Australia; the Immunology Division, Walter and Eliza Hall Institute of Medical Research, Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Alfred Rusescu Institute for Mother and Child Care and Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, La Jolla, CA, USA; the Tampere Center for Child Health Research and Department of Pediatrics, University of Tampere Faculty of Medicine and Life Sciences and Tampere University Hospital, Tampere, Finland; the Centre for Immune Regulation, KG Jebsen celiac Disease Research Centre, and Department of Immunology, University of Oslo, Oslo, Norway; the Oslo University Hospital-Rikshospitalet, Oslo, Norway; Department of Pediatrics, Department of Medicine, University of Chicago, Chicago, IL, USA; and ImmusanT in Cambridge, MA, USA.
  3. Celiac.com 12/22/2017 - Venture capital firms Arch Venture, and Vatera are betting big on biotech startup ImmusanT, the makers of potential celiac disease vaccine Nexvax2. Arch and Vatera have funded a $40 million B round that will support ImmusanT's development of their celiac treatment through Phase II testing. Full data are expected in mid-2019. As part of it's efforts, Arch Venture partner and former head of research at Celgene, Tom Daniel, will join the board at ImmusanT. Additionally, renowned immunologist and Arch managing director Steven Gillis will also join the board at ImmusanT. Nexvax2 is the first prong in ImmusanT's efforts to develop a treatment that creates immune system tolerance to thwart autoimmune diseases. If they are successful in tackling celiac disease, the company is looking to expand the technology to include treatments for type 1 diabetes and other ailments. Celiac disease is a great place to start, says ImmusanT CEO Leslie Williams, because scientists already know the antigen that triggers the disease. Williams says that her company has scoured 17,000 peptides to "create a hierarchy of the key components that trigger the T cell response" in celiac disease. Nexvax2 is designed to work by slowly coaxing the immune system to ignore the trigger. Patients exposed to Nexvax2 react as if they have eaten gluten, says Williams. The goal is to harness that immune reactions and to modulate it. Williams is looking to double the size of the company's tiny 7-person staff as the ImmusanT journeys through a mid-stage trial. She will then look to an expanded set of programs as well as the data to determine the best direction for the company. Williams says that all options are currently open, including another funding round, an IPO or even a strategic deal. Read more at: endpts.com
  4. Celiac.com 07/19/2016 - The world's first vaccine aimed at curing celiac disease is slated to begin full trials later this year, and residents of the Australian state of Victoria will be among the first humans to give it a try against celiac disease. The vaccine, called Nexvax2, was developed by Australian scientist Dr Bob Anderson, and is aimed at giving celiac patients a chance to overcome their immune reaction to the gluten found in products containing wheat, rye and barley. Nexvax2 aims to de-sensitise patients to three peptides contained in gluten that trigger a damaging reaction in their immune system. Previous trials on 150 patients from Melbourne, Perth, Adelaide, Brisbane and Auckland were aimed at finding a safe dosage rather than assessing its ability to beat celiac disease. Results from those favorable earlier trials were released in May, and Dr Anderson says that the larger phase II study, also being undertaken in the US and Europe, will assess how well the vaccine works against celiac disease. Dr Anderson first identified the peptides triggering coeliac disease and began developing the vaccine while working at Melbourne's Walter and Eliza Hall Institute, before travelling to Boston for six weeks as part of a sister city arrangement through the City of Melbourne, where he made contact with ImmusanT to further the discovery. This is certainly exciting news for people with celiac disease, many of whom may benefit from such treatment. Stay tuned for news on the progress of these trials. Source: dailysecrets.press
  5. Celiac.com 10/02/2017 - For anyone following the efforts by ImmusanT to develop a vaccine for celiac disease, the company's recent presentations at the 2017 International Celiac Disease Symposium (ICDS) in New Delhi, India, were welcome news. Nexvax2® is a therapeutic vaccine intended to protect against the effects of gluten exposure while maintaining a gluten-free diet in HLA-DQ2.5+ patients with celiac disease. The company announced at ICDS 2017 that it has presented data showing the immunologic basis for the early clinical effects of gluten in celiac disease. Presented in two poster presentations and an oral presentation, the company says its data show that "early cytokine changes in blood following gluten ingestion could provide the basis for a new diagnostic for celiac disease in patients on a gluten free diet with an uncertain diagnosis," said Robert Anderson, MBChB, Ph.D., Chief Scientific Officer of ImmusanT. The company says its results are "significant" because celiac disease sufferers often adopt a gluten-free diet prior to being diagnosed by a doctor. This can cause problems and lead to unreliable or misleading results with current diagnostic tests. ImmusanT says that their data demonstrate that early changes in circulating cytokines after a single gluten exposure may offer a clinical way to assess celiac disease activity. The company says that the data, along with the potential to differentiate between celiac disease and non-celiac gluten sensitivity (NCGS) by assessing IL-2 levels, support the science behind targeted immunotherapies such as Nexvax2®. Read more at BusinessWire.com
  6. Celiac.com 09/12/2017 - Are we at the beginning of the end for celiac disease? The last few years have seen numerous advances in celiac diagnosis and treatment. People diagnosed recently and in the future face a very different world than that faced by celiacs just five or ten years ago. In the old days, the process of properly diagnosing involved blood tests, endoscopies, and biopsies. In the near future, a simple blood test may do the trick. In the old days, the only treatment was a life-long gluten-free diet. That is still true, but the writing of change is on the wall. Here are five advances that will change the way celiac disease is diagnosed and treated in the future. These advances may well signal the beginning of the end of celiac disease as we know it. Blood Test Diagnosis (Without Biopsy) Researchers are getting better at identifying likely celiac cases using blood tests alone, without biopsy. As these techniques are refined and integrated into medicine, chances are pretty good that in the near future, large numbers of people will be diagnosed for celiac disease without the need for biopsy confirmation. Can Antibodies Spot Celiac Disease in Kids Without a Biopsy? Kids Can Get Accurate Celiac Diagnosis Without Biopsy Celiac Diagnosis Without Biopsy Can Be Useful in Some Cases Portable Gluten Detectors Imagine a future where you can take a bit of food you're not sure about, and pop it in a portable tester that will tell you if the food is gluten-free. A few years ago, that might have been the future of science fiction. With several companies looking to introduce just such kits, that future looks a lot more certain. Innovative Device Eliminates Gluten-Free Guesswork This Device Can Help Tell You If Your Food Is Actually Gluten-Free nimasensor.com Enzymes Enzymes that break down gluten might help people with celiac disease to enjoy a more normal life by protecting them from minor gluten contamination, and allowing them a bit more confidence when eating away from home. A number of manufacturers are currently working on enzyme treatments that are specifically designed to break down gluten for people with celiac disease. AN-PEP Shows Promise in Breaking Down Gluten in Stomach Enzyme Shows Promise In Dissolving Gliadin Peptides in Celiac Patients Could Carnivorous Plant Enzymes Act Like Beano for Gluten? Could Enzymes from Oral Bacteria Treat Celiac Disease Bio-Therapeutics—Hookworms They sound gross. The thought of having their guts infected with a parasitic worm makes people's skin crawl. However, researchers have documented the gut healing abilities of parasites like hookworm. When hookworms are introduced into the gut of people with celiac disease in the right amount, and kept at therapeutic levels, patients see their celiac symptoms disappear and their guts return to a healthy, normal condition. While still very much in the experimental phase, researchers are keen to investigate various strains and to determine the best therapeutic levels for these treatments. If all goes well, treatments based on parasitic worms will likely become more viable and more common in the future. Celiac Patients Tolerate Wheat Spaghetti After Hookworm Treatment Have Celiac Disease? Try a Little Hookworm with that Pasta! Can Bloodsucking Parasites Help Treat Asthma and Celiac Disease? Controversial Pig Parasite May Soon Be Sold In Germany To Treat Disease Bio-Therapeutics—Fecal Transplant Could fecal transplants be used to cure or to treat celiac disease? Much like hookworms, once you get past the 'yuck' factor, fecal transplants are proving to be cheap, easy, reliable way to treat gut conditions like C-Diff and, possibly celiac disease. The idea is to get some healthy poop in your gut to inoculate it with beneficial microbes. The effects are nothing short of astonishing. As they are studied, developed and refined, look for bio-therapeutic approaches like fecal transplant to play a role in treating gut contains like celiac disease. A Case of Refractory Celiac Disease Cured By Fecal Microbiota Transfer Vaccine A vaccine against celiac disease would be a holy grail of sorts. Receive a dose, or maybe multiple doses over time and become immune to the adverse effects of gluten. Several companies are working on a vaccine that would basically eliminate celiac disease. Many of these have moved through the early trial phases and several have shown enough promise to move to trials in humans. This is a very exciting area of research that may pay huge dividends in the near future. Celiac Disease Vaccine Set to Begin Full Human Trials Would You Try a Vaccine for Celiac Disease? Celiac Vaccine Clears First Big Clinical Trial This Vaccine Could Be a Game-Changer for People with Celiac Disease The main takeaway from these developments is that we are now living in an age where the diagnosis and treatment of celiac disease is the focus of tremendous research and development on numerous fronts. Many of these will likely result in products, tests, or treatments for celiac disease that were unimaginable just 5 or 10 years ago.
  7. 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. 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
  8. Celiac.com 08/26/2016 - News that ImmusanT company is beginning full human trials for their celiac disease vaccine, NexVax 2, brought a number of comments from our readers. We first reported on their effort way back in 2002, with our story, Australian Researchers Begin Work on a Vaccine for Celiac Disease. We followed up over the years, with stories in 2009, First Ever Celiac Disease Vaccine Trials Underway in Australia and again in 2011, with articles reporting on the company's efforts to raise investment funds, titled ImmusanT Raises $20 Million in Series A Financing to Advance Immunotherapeutic and Diagnostic for Celiac Disease and on how ImmusanT's Celiac Vaccine Passed Phase I Clinical Trials and in 2012, with Is a Vaccine for Celiac Disease Just Around the Corner? Comments generally ran toward the affirmative side, with many people expressing excitement or interest in such a vaccine. From Jared M: I hope this research goes well. The bread, crackers and pizza I can live without. But I would really like to be able to drink a good IPA again. The sorghum beers are horrible. I am quickly growing tired of ciders. I would definitely pay for this treatment if it works. From Toni: I have celiac. That [a vaccine] would be wonderful. From Traci: I would like to be involved in a study for this immunization. From Linda Haas: Can't wait to hear more about the progress made on this vaccine...it sounds very promising! From Donda: I'm thrilled with the possibility of this coming to market. From Muriel Weadick: This is what all celiacs have been waiting for, and I am sure I am not alone in wishing the company success. From Suzanne: A vaccine like this would make it easier to eat out and go on vacation. Jeanne Burge wrote: I would gladly volunteer for the trials in the US. Hope this works! Still, a few comments ran toward the less than glowing side, with some people expressing trepidation, or outright distrust toward such a vaccine. From Cathi: My Question is, "What will be the side effects of this turning off the body's ability to fight Gluten?" Will there still be destruction some place else and maybe worse? So, many times a pill is created to help one thing only to find out that it created another problem some place else in the body. Frankly, I am worried. From Donna: Absolutely agree with you, Cathi. There is always a problem and side effects with ANY drug! My question is this - WHAT ELSE will be shut off? Will we be even MORE susceptible to other illnesses? I am worried as well! From Balm: Thanks but no thanks. I'll remain a celiac and continue to eat healthy. While trying to fix one problem, some will end up with far worse problems. From Jonnys: Stupid idea! Just another way to make more money off of people. Certainly, those who may have a weakened or compromised immune system should consult with a physician before receiving most vaccines. But, in adults with a healthy immune system, such a vaccine would likely present little or no danger to the recipient. Most people with celiac disease have healthy immune systems, so the likelihood of any adverse reaction will be slight. Of course, this is all theoretical, even at this point, as vaccine trials have so far not proven how well the vaccine actually works in preventing or curing celiac disease. So, the question is, if such a vaccine is proven safe and effective, would you be open to trying it, or not?
  9. Celiac.com 03/30/2012 - A company called Microtest Laboratories is manufacturing doses of what they claim may be the first effective vaccine treatment for celiac disease. At this point, the only treatment for celiac disease is to avoid gluten in the diet. Other companies are working on vaccines for celiac disease, and several working trials are underway. However, this new drug's creator, ImmusanT, based in Cambridge says that, unlike other vaccines, which prevent an infection, their drug, Nexvax2 works by changing the immune system so it no longer attacks gluten. Production on Nexvax2, began last week, Steven G. Richter, Microtest’s president and science director, told a local reporter. So far, ImmusanT has raised $20 million in investor capital to bring the vaccine to market. Regarding the path from concept to manufacturing for Nexvax2, Richter says that the process has been anything but straightforward. "It's arty process," he told a local reporter, "you have to develop protocols for all the manufacturing and plans to do all of the work aseptically. You have to get all those protocols and plans approved through the regulatory process. Then you have to do the work.” Microtest is initially manufacturing 9,000 vials for ImmusanT: two 3,000-dose batches of vaccine and a 3,000-dose batch of inert placebo to be used in the clinical trial. Richter says that the control group contains everything except the active vaccine. ImmusanT is looking to start the first clinical trials in the second quarter of this year by testing the doses on people with celiac disease. The full article, in Massliveonline.com quotes Leslie J. Williams, president and CEO of ImmusanT, as saying that “The test will be if it [the vaccine] induces a tolerance for gluten in the diet." The report says that Williams and the company hope to get the vaccine commercially available by 2017. Will the company succeed? Will they have a successful vaccine available in just five short years? Let us know what you think.
  10. Celiac.com 07/01/2015 - Children with celiac disease show an impaired immune response to the hepatitis B vaccine, and neither a gluten-free diet, nor additional vaccine boosters seem to change that, according to research presented at the 33rd Annual Meeting of the European Society for Paediatric Infectious Diseases. Although a number of studies have documented this reduced response, most have been limited by low numbers of patients with celiac disease, and/or lower numbers of control patients, said Maria José Pérez, MD, from Henares Hospital in Coslada, Spain. Two of those prior studies that implicated gluten in the impaired vaccine response, showed that celiac patients who follow a gluten-free diet have a hepatitis B vaccine response that is similar to that in the general population after celiac patients switch to a gluten-free diet. In their study, Dr. Pérez and her colleagues looked at the immune response to the vaccine in children with celiac disease. The team evaluated 214 children with celiac disease and 346 control patients who had completed the hepatitis B vaccine regimen in the first year of life. All patients were vaccinated before gluten was introduced into their diets. They measured gluten antibody levels for each child to determine vaccine response. Kids who showed levels of hepatitis B surface antibody under 10 mUI/mL were defined as non-responsive to the vaccine. Overall, non-response was 8% higher in children with celiac disease than in control subjects (68.7% vs 60.7%). For children younger than 5 years, this difference was a whopping 20%, with a rate of 50.0% for celiac children, compared with 30.1% for the control group (P = .015). In children with celiac disease, the researchers found no relation between level of antibody and time since the last intake of gluten. So, one important takeaway is that gluten consumption or avoidance does not change the immune response to hepatitis B vaccine in patients with celiac disease. Over time, levels of antibody decreased in both groups, so doctors assessing immune response to hepatitis B vaccine should factor in the amount of time elapsed since vaccination, says Dr. Pérez. The prospective study involved 72 children with celiac disease who were vaccinated in the first year of life and whose antibody levels were below 10 mUI/mL. The researchers found no change in levels after the children received a single vaccine booster. In light of these results, the research team advises that children with celiac disease and undetectable levels of antibody be revaccinated with a full series of the vaccine. Source: 33rd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID): Abstracts 463 and 464 and poster MPW06. Presented May 15, 2015.
  11. 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. New 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: http://www.sacbee.com/2012/09/04/4784050/immusant-initiates-clinical-trials.html
  12. Celiac.com 04/24/2014 - Though some celiacs will tell you they’re content to remain gluten-free for life, being able to freely consume gluten is the dream of many a person with celiac disease. ImmusanT is one of the few companies working on an actual vaccine for celiac disease. Over the next few months, ImmusanT is likely to begin reporting data from two separate early-stage clinical trials for NexVax2, a celiac disease vaccine. That data will offer the first glimpse into the potential for ImmusanT to treat celiac disease, and into the viability of the company’s peptide immunotherapy platform. The current two studies are Phase 1b trials, designed to confirm the safety of NexVax2, and to find a range of potential doses for the company’s next trials. Success at this stage still means a very long process for ImmusanT, as numerous clinical hurdles remain. Meanwhile, several other companies trying to find non-vaccine treatments for celiac disease. Both San Carlos, CA-based Alvine Pharmaceuticals and Baltimore, MD-based Alba Therapeutics, for instance, are developing drugs to supplement an existing gluten-free diet. Rather than being full-blown vaccines, these drugs are intended to reduce or eliminate adverse gluten-reactions due to simple gluten-contamination. Another company, Sitari Pharmaceuticals, fueled by $10 million in capital, and a joint venture with GlaxoSmithKline and Avalon Ventures, is also looking to pursue treatments for the digestive disorder. For its part, ImmusanT remains committed to its goal of developing a vaccine that will allow celiac patients to eat all the gluten they want. The company says its drug is currently the only treatment in development “focusing on disease modification so patients can resume an unrestricted diet.” Source: Xconomyc.com
  13. A team of researchers recently took a look at how well the hepatitis B vaccine protected people with celiac disease over time. Specifically, they evaluated what is called long-term antibody persistence and immune memory to hepatitis B virus in adult celiac patients vaccinated as adolescents. The research team included F. Zingone, F. Morisco, A. Zanetti, L. Romanò, G. Portella, P. Capone, P. Andreozzi, R. Tortora, and C.Ciacci. They are affiliated with the Department of Clinical and Experimental Medicine of Federico II University of Naples in Italy. They set out to investigate the anti-HBs antibody persistence and immune memory to hepatitis B virus in adult celiacs vaccinated as adolescents, along with the effects of a booster administration in non-protected individuals. They found that, eleven years after receiving the initial vaccine dose, the percentage of vaccinees with blood levels ≥ 10 mIU/ml and antibody geometric mean concentrations (GMCs) were lower among celiac patients than among control subjects (68.6% vs 91.7%, p Patients with anti-HBs below 10 mIU/ml received a booster dose and were retested after two weeks to measure response levels. Post-booster anti-HBs levels were still The study shows that, compared with healthy control subjects, people with celiac disease have lower seroprotective levels of anti-HBs eleven years after main vaccination, in addition to having a substantially lower response rate to a booster dose of the hepatitis B vaccine. Do you have celiac disease? Have you had a hepatitis B vaccine? Have you had trouble getting proper immunity levels with the hepatitis B vaccine? Is this news to you? Share your comments below. Source: Vaccine. 2011 Jan 29;29(5):1005-8. doi: 10.1016/j.vaccine.2010.11.060.
  14. Hello I have not been on for a long time so I am hoping you all can help me. I have a chance to do a study for a vaccine so I can eat normal again. I was diagnosed with blood and endoscopy. I really didn't have any symptoms. I found out by accident in 09 and have been gluten-free since. Any way....this study is for a vaccine and I would have to eat gluten cookies every other day for 4 days, then get a vaccine. Thats pretty much the gist of it. ......I think. And I get $800.00 for doing it. Can any one please tell me if this is a bad thing to do or safe or unsafe. Thank you so much for reading. Valerie
  15. 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.
  16. Celiac.com 05/23/2011 - ImmusanT, Inc., a biotechnology start up based in Cambridge, Massachusetts, is testing a vaccine to desensitize celiac patients to gluten. It is called Nexvax2, and it has already passed Phase I clinical trials, which means that it is safe and tolerable to humans. Nexvax2 is slated to begin Phase II trials, which address efficacy, within the next year. Nexvax2 was developed by Nexpep Pty, Ltd., a company in Melbourne, Australia. It is based on their findings that only three peptides are responsible for eliciting the majority of the T cell response that goes on to destroy the intestines of celiac patients. HLA molecules function to present these toxic peptides to T cells; this presentation is what activates the T cells, instigating the inflammatory response. Thus, this vaccine relies on the HLA type. It is specific for celiacs with the HLA-DQ2 haplotype, accounting for about 90% of celiac patients. Nexvax2 encompasses these three proprietary peptides, presenting them to T cells in the absence of a second, T-cell stimulatory signal. T cell recognition of the HLA-DQ2 bound toxic peptides thus occurs in a non-inflammatory environment, establishing tolerance to dietary gluten. This peptide based approach has been successful in generating tolerance in people with cat-sensitive asthma, and has not been used more broadly because it has been difficult to identify the correct toxic epitopes. Similar efforts are underway to discover and develop peptide-based therapeutic vaccines for other autoimmune diseases, including multiple sclerosis, Type-1 diabetes, and rheumatoid arthritis, but celiac disease is an ideal target for the technology because the HLA types that activate the inflammatory T cells in celiac disease are so well defined. The vaccine consists of a weekly or monthly injection, and would allow those with celiac disease to resume eating "normal" levels of gluten without suffering adverse effects. Other therapies that have proposed to treat celiac disease, such as those promoted by the companies Alva, Alba, and Chemocentryx, did not aim to replace the gluten free diet; they allowed only small, intermittent exposure to gluten. During the Phase I trial of Nexvax2, some people who got the injections containing the highest doses of the toxic peptides suffered gastrointestinal distress; they thus inadvertently acted as a positive control, indicating that the peptides administered are in fact the correct ones. ImmusanT is also partnering with INOVA Diagnostics to use reactivity to these peptides as a diagnostic test both for celiac disease and for those celiac patients who might be good candidates for the Nexvax2 vaccine - i.e. those 90% who are HLA-DQ2 rather than those who are HLA-DQ8. Source: http://www.sciencedaily.com/releases/2011/05/110509091559.htm
  17. Celiac.com 12/18/2008 - Celiac disease is a life-long autoimmune disease. When people with celiac disease consume the gluten proteins found in wheat, rye and barley they damage the lining of the gut, which prevents normal digestion and absorption of food. There is currently no cure for the celiac disease. The only treatment is life-long adherence to a strict gluten-free diet. If a gluten-free diet is not followed, the disease can ultimately lead to ill health and life-threatening conditions including malnutrition, osteoporosis, bowel cancer, and may cause infertility problems. The charity group Coeliac UK, recently hosted a conference at the Royal Society of Arts in central London where, among the latest findings in celiac disease research, they announced progress on the development of a possible vaccine for the condition. Dr. Bob Anderson of the Autoimmunity and Transplantation Division of Australia’s Walter and Eliza Hall Institute has led a research team that has isolated the toxic elements of gluten, paving the way for a possible vaccine that will suppress or prevent gluten toxicity. The research indicates that the toxic, autoimmune response in celiac patients exposed to wheat is triggered by just few dominant peptides in the gluten protein. This small number of offending peptides makes it exponentially easier for researchers to develop a vaccine. Dr. Anderson is a joint founder and CEO of Nexpep, an Australian company that is actively working to develop a vaccine to treat celiac disease. Dr. Anderson’s team has created a peptide-based therapeutic vaccine to treat the main problem T-cell epitopes of gluten. The vaccine has the potential to treat at about 80% of people with celiac disease and having the appropriate genetic background. Similar to traditional desensitization therapy for allergies, the peptide-based vaccines are given in multiple small doses over a course of injections in an effort to create immune tolerance not only to the selected gluten fragments, but also lower the toxicity of related toxic gluten molecules. Nexpep is currently raising capital for a clinical trial program for a peptide-based therapeutic vaccine and intends to commence a Phase 1 clinical trial in the first half of 2009. Reference: http://www.medicalnewstoday.com/articles/131745.php
  18. Celiac.com 09/21/2009 - Failure of the hepatitis B vaccine in people with celiac disease is common. In fact, vaccine failure occurs in about 50% of all attempts to vaccinate people with celiac disease against hepatitis B. Research shows that age at celiac diagnosis and other factors can influence response rates. The August 12 issue of the medical journal Vaccine features a timely article on failure of the hepatitis B vaccine in people with celiac disease, which asks the very sensible question of whether it is time to reevaluate our current vaccine procedures. One of the most important signs of non-responsiveness to the hepatitis B vaccine is a genetic marker called human leukocyte antigen (HLA) phenotype DQ2. It's interesting that people with celiac disease often carry these same genetic markers, and that fact is at the center of one hypothesis about why celiac patients are less able to respond to the hepatitis B vaccine. A team of researchers recently set out to assess responsiveness rates to the hepatitis B vaccine among patients with celiac disease. The team was made up of S. Leonardi, M. Spina, L. Spicuzza, N. Rotolo, and M. La Rosa of the Broncho-Pneumology & Cystic Fibrosis Unit of the Department of Pediatrics at the University of Catania, in Catania, Italy. The team describes the results of a retrospective study on celiac patients vaccinated with three intramuscular injections of recombinant hepatitis B vaccine (Engerix in doses of 10mug at 3, 5 and 11 months of age. Their results showed that half of the celiac disease patients (50%) failed to respond to the vaccine course, and that those who did best were less than 18 months of age at the time of diagnosis for celiac disease; that group showed a significantly higher response rate to the vaccine. The study confirms that celiac patients have a far higher failure rate for hepatitis B vaccination than healthy control subjects. These results strengthen the call to re-evaluate current hepatitis B vaccine strategies for patients with celiac disease and to assess whether to recommend a course of re-vaccination. Source: Vaccine - August 12, 2009.
  19. Celiac.com 06/30/2008 - The results of a Hungarian study published recently in the June issue of Pediatrics suggest that people with untreated celiac disease show abnormal resistance to the hepatitis B (HBV) vaccine, while celiac patients on a gluten-free diet show a near normal response to the vaccine. A team of doctors led by Dr. Eva Nemes, at the University of Debrecen, administered 2 to 3 doses of recombinant HBV vaccine to 128 patients with celiac disease and an age matched control group of 113 non-celiac patients within a 6-month period. Twenty-two of the celiac patients were following a gluten-free diet when they received the vaccine. One month after the last HBV vaccination, the team took blood samples to look for anti-HBV antibodies. The group of 22 patients who received the vaccination while on a gluten-free diet had a sero-conversion rate of 95.5%, which means that more than 9 out of 10 patients developed the desired resistance to hepatitis B. The other 106 patients with celiac disease, as well as the control group, were vaccinated at approximately 14 years of age, and their immune response was evaluated by measuring anti-HBV titers about two years later. Of the 106 subjects with celiac disease, seventy had been diagnosed and were maintaining a strict gluten-free diet when they were vaccinated, twenty-seven were undiagnosed and untreated, and nine were diagnosed, but not following a gluten-free diet. The seventy subjects with celiac disease that was diagnosed and treated showed a sero-conversion rate of 61.4%. Given the size of the study samples, that’s not significantly different from the 75.2% sero-conversion rate for the control group. The big difference arose in those subjects with undiagnosed celiac disease, who showed a response rate of just below 26%, which was substantially lower than the control group and the treated celiac patients. The nine patients with active celiac disease who were not faithfully following a gluten-free diet showed a response rate of 44.4%. The thirty-seven subjects with celiac disease who had failed to respond to the vaccine were placed on a gluten-free diet and given a follow-up vaccine. One month later 36 of them (over 97%) showed a positive response to the vaccine. The team concluded that the positive response to the vaccine by celiac patients who were following a gluten-free diet, and the high resistance shown by subjects with undiagnosed celiac disease, and those not following a gluten-free diet, indicates that active celiac disease may play a major role in a failure to respond to the vaccine. The team recommends that newly diagnosed patients be checked for resistance to the HBV vaccine, and that those showing resistance be placed on a gluten-free diet before receiving a follow-up dose. They did not go so far as to suggest that those showing resistance to the HBV vaccine be screened for celiac disease, but that would not seem unreasonable, given their results. Pediatrics 2008; 121:e1570-e1576.
  20. Am J Gastroenterol. 2003 Oct;98(10):2289-92 Celiac.com 11/26/2003 - The results of a study conducted by Dr. Joseph Murray and colleagues at the Mayo Clinic in Rochester, Minnesota indicate that an unusually high number of those with celiac disease do not develop immunity from the hepatitis B vaccine. The team looked at 23 clinically diagnosed celiacs who had been given a full series of hepatitis B vaccines. Out of this group they identified 19 who had been tested for hepatitis B Vaccine response, and of the 19 tested, 13 subjects did not develop long-term immunity to the vaccine, which was determined by utilizing the negative qualitative or quantitative anti-HBs antibody titer. The researchers note a strong association in celiac disease with a particular HLA genotype of DQ2, which is also seen in nonresponders to the hepatitis B vaccine. Each of the subjects in the study was either homozygous or heterozygous for DQ2. The researchers postulate that a majority of celiacs may be non-responsive to the vaccine because they have "a failure of induction of humoral immune response needed for development of long term immunity." The researchers are still uncertain of the specific cause of the failed immune system response in those with celiac disease.
  21. Celiac.com 10/29/2002 - Dr Robert Anderson, Research Fellow at the Nuffield Department of Medicine at the University of Oxford (now based at the Royal Melbourne Hospital in Australia), and colleagues recently announced their intent to begin work on a vaccine that could cure celiac disease. The Australian teams work will be based on Dr. Andersons earlier groundbreaking Oxford research that identified the specific set of protein sequences in gluten that cause damage to the guts of those with celiac disease (see: Nature Medicine 6, 337 - 342 - 01 Mar 2000). In addition to finding a possible cure for celiac disease the teams research could open the door for a specific diagnostic test for the disease, new treatment and prevention strategies, and even the possibility of producing grains that do not contain the harmful sequences. Dr. Andersons future research will focused on proving that a specific "toxic peptide" can be used to desensitize or induce tolerance in people with celiac disease, and any vaccine would likely be the "toxic peptide" itself or a modified form of it. The Australian team also announced their agreement for the commercialization of new celiac disease technology developed by the University of Oxford. BTG and Isis will develop diagnostic tests and treatments for gluten intolerance. BTG is a London-based technology transfer company which has bought the rights to the teams discovery, and Isis Innovation Ltd, is Oxford Universitys wholly-owned technology transfer company that was established in 1988 and is a world leader in university technology transfer. Under the terms of the Isis agreement, BTG will have exclusive access to the Universitys technology for use in the diagnosis, prevention and treatment of celiac disease. The technology is based on identification of the particular epitopes that cause priming of the immune system in celiac disease. BTG will underwrite all costs associated with the development and commercialization of the technology, and will share any revenue from commercialization of the technology with Isis and the University.