| If you are a celiac, your miracle cure is under | | | | that remain after its digestion in the gut. These |
| way - being trialled in Melbourne Australia beginning | | | | gluten fragments can be synthesized using fairly |
| April 2009! It could conceivably desensitize people | | | | standard chemistry and are the basis for the |
| with CD to the point that the villi in their small | | | | celiac vaccine." |
| intestine are not damaged by the gluten protein. | | | | The Celiac Vaccine Trials |
| However with the need for extensive testing in | | | | The original research began at Oxford England in |
| this three phase trial, the vaccine may not be | | | | 1997. The work continued in Australia in 2002 and |
| ready for release for several years. | | | | by April 2009 Bob Anderson from the Walter and |
| Before we go into the details of such a cure it | | | | Eliza Hall Institute of Medical research (Melbourne, |
| should be noted that this vaccine might not be a | | | | Australia) will commence the first world trials of a |
| 'magic bullet' that makes people permanently | | | | celiac vaccine that could reduce or eradicate the |
| immune to the gluten protein, it might 'only' | | | | need for being gluten free. In fact Bob Anderson |
| desensitize them. Also be aware that if you | | | | calls the vaccine a "next-generation desensitization |
| choose to undertake the 'therapy' there are no | | | | therapy" that has been successful in mice and is |
| guarantees of how you will react, and the only | | | | soon to be tested on celiacs. |
| way to regularly check to see if you have been | | | | "The vaccine will be tested on 40 volunteers with |
| 'cured' would be regular intestine biopsies. As it is | | | | CD over 11 months to establish that it does not |
| known that some people take over two years to | | | | harm them. In a subsequent phase 2 trial, which is |
| heal their intestines from gluten damage, how | | | | designed to find out if the treatment is effective, |
| risky will this strategy be? It is expected that | | | | volunteers will receive the treatment and then be |
| testing will be extensive so these questions may | | | | challenged with foods containing gluten. Their |
| all sit under the 'devil's advocate' category, and all | | | | immune response and intestines will then be |
| may be well. | | | | examined to see if a tolerance to gluten has |
| An even more philosophical question is what | | | | developed. The therapy involves repeatedly |
| effect covering up the cause of your disease will | | | | injecting solutions of gluten at increasing |
| have on your body. Books have been written | | | | concentrations. The aim is to desensitize the |
| that suggest that it is the increased gluten | | | | subjects slowly, in a similar way to hay fever and |
| potency in wheat and other gluten grains as well | | | | dust allergy desensitization treatments." |
| as increased use in manufactured foods that has | | | | Testing process |
| led to an overdose of gluten. Our bodies then | | | | "For a new drug to be accepted for use in people |
| pass a 'tipping point' where our genetic | | | | in Australia, Europe, or North America it must |
| predisposition to CD turns into an active disease. | | | | have progressed successfully from Phase 1 |
| If this is true, how wise would it be to continue | | | | (safety) studies usually involving up to about 30 |
| ingesting unnaturally high levels of gluten, once | | | | volunteers, to Phase 2 (efficacy) studies to show |
| 'cured' just because we can? Sure it would make | | | | that "it works" in people with the medical condition |
| life simpler not following a gluten free diet, | | | | of interest (typically about 200 volunteers in |
| however maybe we should wait for gluten to be | | | | several locations around the world), and to Phase |
| decreased at the source, the growing fields, | | | | 3 (similar to Phase 2 but involving several |
| before we return to a gluten filled diet. | | | | thousand volunteers in many sites around the |
| Different types of CD identified | | | | world)." |
| With all these issues under consideration, I am | | | | The celiac vaccine future |
| sure that every celiac would still be interested in a | | | | Due to difficulties in funding, Bob Anderson |
| 'cure'. A July 2007 article based on research | | | | (Walter and Eliza Hall Institute) co-founded a |
| conducted in Victoria, Australia, showed that | | | | commercial company called Nexpep to develop |
| "Celiac disease - is strongly associated with human | | | | the vaccine. Nucleus Network, Centre for Clinical |
| leukocyte antigen (HLA) DQ2 and to a lesser | | | | Studies (CCS) in the Alfred Hospital in Melbourne, |
| extent with HLA DQ8." | | | | will be conducting the Phase 1 clinical trial. |
| "HLA genes are part of the major | | | | The difficulty he has faced, besides the technical |
| histocompatibility complex (MHC), which plays a | | | | issues, is the low diagnosis level of CD and the |
| pivotal role in the immune system. HLA-DQ2 | | | | mass of associated symptoms has made a |
| mediated CD is common in people of European | | | | vaccine cure unattractive to traditional |
| ancestry, with about 90 per cent of sufferers | | | | pharmaceutical companies. These companies |
| positive for DQ2. Another five per cent possess | | | | always prefer well defined markets to accurately |
| HLA DQ8. In China and East Asia, DQ2 genes are | | | | forecast payback periods for their R&D and |
| rare while DQ8 genes are as common as in | | | | marketing expenses. |
| Europe." | | | | The facts are that for this vaccine to prove |
| So it appears that this preliminary research has | | | | financially viable, The US will need to approve the |
| been able to isolate two main versions of CD. | | | | drug and doctors and celiacs will need to accept |
| However the molecular workings of the immune | | | | the treatment. One report estimates that only |
| response in the two antigens appear to be very | | | | 600,000 people are diagnosed with CD (out of the |
| different. The researchers discovered that T-cells | | | | 5 million with CD in North America and Europe). |
| in people with DQ8-associated CD reacted quite | | | | Compounded to the funding challenges is that |
| differently to the small proteins in gluten than the | | | | previously, globally, there have only been three |
| T-cells in people with the DQ2 form of the | | | | "randomized, controlled" studies of the gluten free |
| disease. | | | | diet - one in children and two in adults - the |
| "At the moment a gluten-free diet is the only | | | | largest with 57 participants." |
| treatment for celiac disease but nearly half the | | | | The assessment of the vaccine treatment will |
| people on the diet still have damage to their small | | | | require repeated endoscopy and collection of small |
| intestine. Consequently other therapies, including a | | | | intestine biopsies which are expensive and |
| vaccine and three different drugs, are in various | | | | un-enjoyable for volunteers. However a recent |
| stages of development. The research team | | | | trial in Italy has shown that biopsies are still the |
| believes CD might be the first example of an | | | | only 'almost' guaranteed method of assessing |
| immune disease where treatments are | | | | gluten damage. The study findings showed that |
| customized according to the genetic make-up of | | | | "two years after adopting a gluten free diet, |
| the patient." | | | | about half those people diagnosed with celiac |
| The celiac vaccine discovery | | | | disease continued to have villous atrophy as |
| The discovery that lead to the creation of the | | | | severe as when they were first diagnosed. Only |
| vaccine was that the one critical part of wheat | | | | about one in five of those with severe intestinal |
| gluten protein that was toxic was the common | | | | damage (villous atrophy) on a gluten free diet had |
| genetic version (HLA DQ2) of CD. "As much as | | | | raised (abnormal) blood levels of transglutaminase |
| the identity of the toxic component of gluten was | | | | antibody, meaning that standard blood tests to |
| important, it was the way in which it was found | | | | monitor disease activity were relatively |
| that has proven to be even more important. By | | | | ineffective." |
| eating gluten in wheat, rye, or barley for three | | | | So while the development of this vaccine is an |
| days (even a single meal will suffice in some | | | | important step in potentially eradicating celiac |
| people), immune cells (T cells) that damage the | | | | disease, philosophical questions still remain as |
| small intestine are mobilized into blood for a few | | | | issues for the long term efficacy of the vaccines. |
| short days. The T cells in blood can be monitored | | | | As an Australian first, this research is applauded |
| and analyzed to define what part of gluten they | | | | by the gluten free community. We wish the |
| recognize. The parts of gluten recognized by the | | | | researchers and medical staff all of the best in |
| vast majority of T cells involved in CD can be | | | | demystifying this illusive disease. |
| condensed to a few "short" fragments of gluten | | | | |