Celiac disease (also known as coeliac disease in British English speaking countries) is an autoimmune disorder that afflicts the small intestine of certain individuals who are genetically predisposed to it. The disease afflicts between 1 in 1,750 and 1 in 105 people in the United States (or about 200,000 to 3,000,000 people) and usually, but not always, results in chronic diarrhea, low pediatric weight gain, and fatigue. This disease is caused by a reaction to a gluten protein found in wheat, and similar proteins found common grains such as barley and rye.
Upon exposure to gluten, the immune system causes an inflammatory reaction of the lining the small intestine. This interferes with the absorption of nutrients. The only known effective treatment is a lifelong gluten-free diet. This disease should not be confused with wheat allergy, which is also caused by a reaction to wheat proteins.
There are multiple problems with a gluten-free diet:
- Strict adherence to a gluten-free diet may limit the amount of folate, fiber, iron and other micronutrients consumed.
- Compliance may be an issue since products may not be labeled correctly, or individuals choose to eat grain-containing foods just for variety. Inadvertent gluten exposure is common. Biopsy of the small intestine 2 years after adopting gluten-free diet shows tissue damage persisting in up to 50% of adults and 25% of children with celiac disease.
- According to one study, regular consumption of as little as 50 mg gluten, the amount found in 1/100th of a standard slice of wheat bread, damages the intestine in celiac disease. A typical Western diet contains 16 g of gluten, more than 300-times the minimal toxic dose for someone with celiac disease.
- This study concludes that persistent inflammation of the small intestine is associated with greater risk of cancer and osteoporosis.
- One of the most important considerations is that a gluten-free diet costs about $2,000 annually, more than many medications.
A Cambridge, MA company, ImmusanT, decided to attack the disease like we do to many allergies, by “training” the immune system to ignore the gluten, a process similar to allergen immunotherapy, in which the patient is vaccinated with increasingly larger doses of an allergen (in this case the gluten) with the aim of inducing immunologic tolerance. But first, the company’s researchers had to determine what part of the gluten protein caused the autoimmune reactivity. They found three short peptides that were the fundamental cause of the autoimmune reaction in the gut, which allowed the company’s researchers to develop a much simpler vaccine to be used in the allergen immunotherapy.
From this research, ImmusanT developed Nexvax2, a vaccine that has been designed for celiac disease that is associated with the HLA DQ2 genetic marker, which present in 90% of individuals with celiac disease. Unfortunately, individuals without this marker do not respond to the three gluten peptides in the vaccine
As of this time, Nexvax2 has completed the Phase 1 trials last year, which will provide results of the initial safety of the vaccine in volunteers (and no real clinical results, though early indicators may be published). If all goes well, we might see the product on the market in 3-4 years. If you’re interested in being part of the clinical trials, and I have no vested interest in or recommendations for the trials one way or another, just search for Nexvax2 in ClinicalTrials.gov, which will give details on the groups who will be running the trials. Since the Phase 3 trials are randomized and blinded, you have no choice as to whether you’re in the placebo or vaccine group, but I suppose that if you’re gluten sensitive, you’ll know rather quickly. Of course, that may mean the study will be run without a placebo group, like almost all vaccine trials.
For celiac disease sufferers, this is a great leap forward. This is also how science works. Look at a disease. Determine it’s cause at the biochemical and immunological level. Ascertain how to block it in a safe and effective way. Then develop a safe and effective way to prevent it. Going gluten-free is expensive and, eventually, unhealthy. Vaccinating can be a cure, and, for a child, give them a healthier, better quality of life.
Not only do vaccines save lives today, they will save lives in the future.