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World first: Celiac disease VACCINE trialed in Australia – April 09. Will it cure all celiacs & will you still need or want to eat Gluten Free Food?

If you are a celiac, your miracle cure is under way – being trialed in Melbourne Australia from April 2009! It could conceivably desensitize people with celiac disease to the point that the villi in their small intestine are not damaged by the gluten protein. However with the need for extensive testing in this three phase trial, the vaccine may not be ready for release for several years.

Before we go into the details of such a cure it should be noted that this vaccine might not be a ‘magic bullet’ that makes people permanently immune to the gluten protein, it might ‘only’ desensitize them. Also be aware that if you choose to undertake the ‘therapy’ there are no guarantees of how you will react, and the only way to regularly check to see if you have been ‘cured’ would be regular intestine biopsies. As it is known that some people take over two years to heal their intestines from gluten damage, how risky will this strategy be? It is expected that testing will be extensive so these questions may all sit under the ‘devil’s advocate’ category, and all may be well.

An even more philosophical question is what effect covering up the cause of your disease will have on your body. Books have been written that suggest that it is the increased gluten potency in wheat and other gluten grains as well as increased use in manufactured foods that has led to an overdose of gluten. Our bodies then pass a ‘tipping point’ where our genetic predisposition to CD turns into an active disease. If this is true, how wise would it be to continue ingesting unnaturally high levels of gluten, once ‘cured’ just because we can? Sure it would make life simpler not following a gluten free diet, however maybe we should wait for gluten to be decreased at the source, the growing fields, before we return to a gluten filled diet.

Different types of celiac disease identified

With all these issues under consideration, I am sure that every celiac would still be interested in a ‘cure’. A July 2007 article based on research conducted in Victoria, Australia, showed that “Celiac disease – is strongly associated with human leukocyte antigen (HLA) DQ2 and to a lesser extent with HLA DQ8.”

“HLA genes are part of the major histocompatibility complex (MHC), which plays a pivotal role in the immune system. HLA-DQ2 mediated celiac disease is common in people of European ancestry, with about 90 per cent of sufferers positive for DQ2. Another five per cent possess HLA DQ8. In China and East Asia, DQ2 genes are rare while DQ8 genes are as common as in Europe.”

So it appears that this preliminary research has been able to isolate two main versions of celiac disease. However the molecular workings of the immune response in the two antigens appear to be very different. The researchers discovered that T-cells in people with DQ8-associated celiac disease reacted quite differently to the small proteins in gluten than the T-cells in people with the DQ2 form of the disease.

“At the moment a gluten-free diet is the only treatment for celiac disease but nearly half the people on the diet still have damage to their small intestine. Consequently other therapies, including a vaccine and three different drugs, are in various stages of development. The research team believes celiac disease might be the first example of an immune disease where treatments are customized according to the genetic make-up of the patient.”

The celiac vaccine discovery

The discovery that lead to the creation of the vaccine was that the one critical part of wheat gluten protein that was toxic was the common genetic version (HLA DQ2) of celiac disease. “As much as the identity of the toxic component of gluten was important, it was the way in which it was found that has proven to be even more important. By eating gluten in wheat, rye, or barley for three days (even a single meal will suffice in some people), immune cells (T cells) that damage the small intestine are mobilized into blood for a few short days. The T cells in blood can be monitored and analyzed to define what part of gluten they recognize. The parts of gluten recognized by the vast majority of T cells involved in celiac disease can be condensed to a few “short” fragments of gluten that remain after its digestion in the gut. These gluten fragments can be synthesized using fairly standard chemistry and are the basis for the celiac vaccine.”

The Celiac Vaccine Trials

The original research began at Oxford England in 1997. The work continued in Australia in 2002 and by April 2009 Bob Anderson from the Walter and Eliza Hall Institute of Medical research (Melbourne, Australia) will commence the first world trials of a celiac vaccine that could reduce or eradicate the need for being gluten free. In fact Bob Anderson calls the vaccine a “next-generation desensitization therapy” that has been successful in mice and is soon to be tested on celiacs.

“The vaccine will be tested on 40 volunteers with celiac disease over 11 months to establish that it does not harm them. In a subsequent phase 2 trial, which is designed to find out if the treatment is effective, volunteers will receive the treatment and then be challenged with foods containing gluten. Their immune response and intestines will then be examined to see if a tolerance to gluten has developed. The therapy involves repeatedly injecting solutions of gluten at increasing concentrations. The aim is to desensitize the subjects slowly, in a similar way to hay fever and dust allergy desensitization treatments.”

Testing process

“For a new drug to be accepted for use in people in Australia, Europe, or North America it must have progressed successfully from Phase 1 (safety) studies usually involving up to about 30 volunteers, to Phase 2 (efficacy) studies to show that “it works” in people with the medical condition of interest (typically about 200 volunteers in several locations around the world), and to Phase 3 (similar to Phase 2 but involving several thousand volunteers in many sites around the world).”

The celiac vaccine future

Due to difficulties in funding, Bob Anderson (Walter and Eliza Hall Institute) co-founded a commercial company called Nexpep to develop the vaccine. Nucleus Network, Centre for Clinical Studies (CCS) in the Alfred Hospital in Melbourne, will be conducting the Phase 1 clinical trial.

The difficulty he has faced, besides the technical issues, is the low diagnosis level of celiac disease and the mass of associated symptoms has made a vaccine cure unattractive to traditional pharmaceutical companies. These companies always prefer well defined markets to accurately forecast payback periods for their R&D and marketing expenses.

The facts are that for this vaccine to prove financially viable, The US will need to approve the drug and doctors and celiacs will need to accept the treatment. One report estimates that only 600,000 people are diagnosed with celiac disease (out of the 5 million with celiac disease in North America and Europe).  

Compounded to the funding challenges is that previously, globally, there have only been three “randomized, controlled” studies of the gluten free diet – one in children and two in adults – the largest with 57 participants.”

The assessment of the vaccine treatment will require repeated endoscopy and collection of small intestine biopsies which are expensive and un-enjoyable for volunteers. However a recent trial in Italy has shown that biopsies are still the only ‘almost’ guaranteed method of assessing gluten damage. The study findings showed that “two years after adopting a gluten free diet, about half those people diagnosed with celiac disease continued to have villous atrophy as severe as when they were first diagnosed. Only about one in five of those with severe intestinal damage (villous atrophy) on a gluten free diet had raised (abnormal) blood levels of transglutaminase antibody, meaning that standard blood tests to monitor disease activity were relatively ineffective.”

So while the development of this vaccine is an important step in potentially eradicating celiac disease, philosophical questions still remain as issues for the long term efficacy of the vaccines. As an Australian first, this research is applauded by the gluten free community. We wish the researchers and medical staff all of the best in demystifying this illusive disease.

Article references are available on the gluten free pages website. 

About the Author

In the Last few years I have had a strong interest in e-marketing and website optimisation. My strongest desire is to be working in the sustainability industry which causes large reductions in greenhouse gases. Save the planet, save the people… www.glutenfreepages.com.au

Ashley Knoote-Parke – Live at NSA 2009

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Video Demystified: A Handbook for the Digital Engineer $79.95 What doesn’t have a video component nowadays? i-Pod, cell phone, computer, they all have video, and, of course, television which is a major source of our entertainment and information. Any engineer involved in designing, manufacturing, or testing video electronics needs this book!Each edition of Video Demystified has sold thousands of copies and answered many questions for engineers across the globe. This fifth edition will keep you up-to-date on the use of next-generation video and audio codecs—H.264, VC-1, Dolby Digital Plus, DTS-HD, etc.—along with the all the latest information on how to convey and process related data, such as closed captioning, aspect ratio information, and the new xvYCC color space being widely adopted. All broadcast, cable, and satellite specifications are being updated to take advantage of these new codecs and standards.Key Features*Latest information on how the new audio and video codecs are being used*All broadcast, cable, and satellite standards completely updated*Essential information for the upcoming transition of television signals from analog to digitalAbout the Author Keith Jack is Director of Product Marketing at Sigma Designs. Sigma Designs develops and markets high-performance, highly-integrated System-on-a-Chip (SoC) semiconductors for IPTV Set-top Boxes, Blu-ray and HD DVD Players/Recorders, HDTVs, Digital Media Adapters, and Portable Media Players. Prior to joining Sigma Designs, Mr. Jack held various marketing and chip design positions at Harris Semiconductor, Brooktree, and Rockwell International. He has been involved in over 40 multimedia chips for the consumer market.

Wireless Data Demystified $6.46 UNDERSTAND WIRELESS DATA COMPLETELY, EASILY WITH WIRELESS DATA DEMYSTIFIED Wireless subscribers are up, but revenue per subscriber isn’t – and it isn’t going to be unless wireless service providers can provide more than plain-vanilla voice services. The road to successful deployment of data services has been difficult, but it is essential if the industry is going to survive. This book takes you inside the data services that will – one way or another – transform the wireless industry. John R. Vacca wrote the book on wireless data, literally: His Wireless Broadband Networks Handbook is the field’s standard professional reference. Now, in Wireless Data Demystified, he offers a book anyone can understand—without being a certified technical expert. And if you are a technical expert, you will find here the essentials you need, without wading through hundreds of pages of technical detail. You must read this book if— * understanding wireless data technologies and their future is your career * you want a sightline on interlinked wireless data technologies – and a realistic timeline on what’s really happening now * wireless e-mail, e-commerce, audio, video, stock quotes, information retrieval, and other subscriber services are part of your plan for the future * networks, technologies, and the protocols that deliver wireless data services are your responsibility * making the move from straight wireless voice services to data is your company’s survival strategy – or should be * basic network design and deployment concepts, clearly explained, could put you ahead of the pack * implementing fixed wireless or WLL (wireless local loop) is a service possibility * you’re a network manager, administrator, or technician, or work in wireless sales or marketing * you can see past the troubled present to future investment potential of wireless data Transmitting wireless data will

World Class Manufacturing By Richard J. Schonberger $13.99 In his best-selling book <I>Japanese Manufacturing Techniques,</I> Richard J. Schonberger revolutionized American manufacturing theory and, more important, practice. In that breakthrough book, he revealed that Japanese manufacturing excellence was not culturally bound. Offering the first demystified explanation of the simple techniques that fueled Japan’s industrial success, he demonstrated how the same methods could be put to work as effectively in U.S. plants.<P>Now, in <I>World Class Manufacturing,</I> Schonberger returns to tell the success stories of nearly 100 American corporations — including Hewlett-Packard, Harley-Davidson, General Motors, Honeywell, and Uniroyal — that have adopted the famed just-in-time production and “total quality control” strategies. Based on his firsthand experience as a major consultant to American industry, he examines how they did it — and illustrates how the same concrete, specific steps used by these top companies can be implemented in any factory today. What’s more, Schonberger shows that his bold concepts and reforms apply equally to all industries, whether the product is computers, pasta, or trucks, and to all divisions — from manufacturing and engineering to accounting and marketing.<P>According to Schonberger, world-class manufacturing depends on blended management — rather than domination by a separate group of managers — which marshalls resources for <I>continual rapid improvement.</I> To achieve world-class status, companies must change procedures and concepts, which in turn leads to recasting relations among suppliers, purchasers, producers, and customers. Acknowledging the difficulty inherent in such changes, Schonberger stresses that employee involvement and interaction, both on the shop floor and in the decision-making/problem-solving process, is key. Wary of those who view improvement in terms of modernizing equipment, he points out that making maximum use of people and current machinery is a company’s first pr

World Class Manufacturing By Richard J. Schonberger $18.95 In his best-selling book <I>Japanese Manufacturing Techniques,</I> Richard J. Schonberger revolutionized American manufacturing theory and, more important, practice. In that breakthrough book, he revealed that Japanese manufacturing excellence was not culturally bound. Offering the first demystified explanation of the simple techniques that fueled Japan’s industrial success, he demonstrated how the same methods could be put to work as effectively in U.S. plants.<P>Now, in <I>World Class Manufacturing,</I> Schonberger returns to tell the success stories of nearly 100 American corporations — including Hewlett-Packard, Harley-Davidson, General Motors, Honeywell, and Uniroyal — that have adopted the famed just-in-time production and “total quality control” strategies. Based on his firsthand experience as a major consultant to American industry, he examines how they did it — and illustrates how the same concrete, specific steps used by these top companies can be implemented in any factory today. What’s more, Schonberger shows that his bold concepts and reforms apply equally to all industries, whether the product is computers, pasta, or trucks, and to all divisions — from manufacturing and engineering to accounting and marketing.<P>According to Schonberger, world-class manufacturing depends on blended management — rather than domination by a separate group of managers — which marshalls resources for <I>continual rapid improvement.</I> To achieve world-class status, companies must change procedures and concepts, which in turn leads to recasting relations among suppliers, purchasers, producers, and customers. Acknowledging the difficulty inherent in such changes, Schonberger stresses that employee involvement and interaction, both on the shop floor and in the decision-making/problem-solving process, is key. Wary of those who view improvement in terms of modernizing equipment, he points out that making maximum use of people and current machinery is a company’s first pr