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  1. Celiac.com 11/05/2018 - ImmusanT, Inc. is a clinical stage company looking to deliver innovative peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, initiated enrollment in Australia and New Zealand for its celiac disease vaccine. Along with Nexvax2, ImmusanT is working to develop vaccines for other HLA-associated autoimmune diseases, including type 1 diabetes. The Phase 2 trials will assess the safety, tolerability and efficacy of its celiac vaccine, Nexvax2, on celiac patients who carry the immune recognition genes for HLA-DQ2.5. Carriers of HLA-DQ2.5 account for approximately 90% of people with disease, and Nexvax2 is designed to protect these patients from the effects of gluten exposure. Nexvax2 is currently the only disease-modifying therapeutic candidate in clinical development for patients with celiac disease. Injections of Nexvax2 are designed to reprogram T cells that trigger an inflammatory response to gluten, thereby suppressing inflammation in patients with celiac disease. Phase 1 studies showed Nexvax2 to be safe and well-tolerated at even its highest dose levels. In Phase 2 clinical trials, ImmusanT hopes to confirm clinical efficacy of Nexvax2 administered by injection into the skin for treatment of celiac disease. The study plan consists of an initial screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up. The trials will be conducted at sites in Melbourne, Perth, Adelaide and Brisbane, in addition to sites in New Zealand. For the U.S. study researchers will enroll approximately 150 patients across the U.S., Australia and New Zealand. Phase 2 is a randomized, double-blind, placebo-controlled clinical study of Nexvax2 in adults with confirmed celiac disease who have followed a gluten-free diet for at least a year prior to screening. “This trial is important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet,” and will “test if Nexvax2 can specifically target the immune response to gluten in people with celiac disease and modify associated symptoms,” said Jason Tye-Din, MBBS, Ph.D., principal investigator at the Royal Melbourne Hospital and head of celiac research at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia. For more information about RESET CeD, including inclusion and exclusion criteria, please visit www.clinicaltrials.gov (Identifier: NCT03644069).
  2. 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.
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