Health-e-Solutions comment: Is there a cure for type 1 diabetes? Although this is not considered a cure, and despite the significant hurdles that remain, an insulin vaccine is one of the most promising strategies to prevent type 1 diabetes, with major advantages including convenience and safety. It remains to be seen if a type 1 diabetes vaccine can provide long-lasting protection.
A vaccination against type 1 diabetes may soon be available to young children: the Pre-POINTearly vaccination study will involve children between the ages of six months and two years from across Germany who have a first-degree relative with type 1 diabetes. In the preceding Pre-POINT study a positive immune response was triggered in children aged between two and seven years with the aid of powdered insulin. The follow-up Pre-POINTearly study will now test whether this effect can be confirmed by giving very young children oral insulin, and whether type 1 diabetes can be prevented in the long term.
The new Pre-POINTearly vaccination study will treat children between the ages of six months and two years who carry a genetic risk of developing type 1 diabetes or have a family history of the disease, but who have not yet developed an autoimmune response. As in the preceding Pre-POINT study, the participants will take the insulin in powder form with their food every day for twelve months. The daily dose will be gradually increased from 7.5 mg to 67.5 mg. Medical examinations will be conducted at three-month intervals in order to monitor the general health of the participants. In the preceding study, oral insulin was shown to be well tolerated and safe. Hypoglycemia or other adverse effects such as allergies did not occur.
Why oral insulin as a vaccine?
When insulin is given orally, it is absorbed through the mucous membranes of the mouth and the intestines, and is split into smaller components during the digestive process. That is why oral insulin — in contrast to insulin that is injected — has no influence whatsoever on blood sugar levels. Instead it acts like a vaccine that trains the immune system. “The autoimmune response that causes type 1 diabetes in childhood is often initially directed at the insulin,” explains Prof. Anette-Gabriele Ziegler, Director of the Institute of Diabetes Research. The aim of the Pre-POINTearly study is therefore to build up immune tolerance to insulin and thus block the autoimmune process.” It is hoped that insulin in powder form will stimulate the growth of protective immune cells and thus prevent the destruction of beta cells.
“The unique factor about this double-blind study is that the insulin was administered as a prophylactic vaccine to the children before they had developed an autoimmune response – that is before they produced autoantibodies.
“This is a revolutionary way to prevent type 1 diabetes, but it is quite logical that if the body’s immune system doesn’t learn how to make the protective responses by itself, we need to give it a little help.”
The working group headed by Professor Joerg Hasford of the Institute for Medical Information Processing, Biometrics and Epidemiology at LMU Munich is responsible for the methodology, data coordination and statistical evaluation of the Pre-POINT and Pre-POINTearly studies.
Health-e-Solutions comment: Type 1 diabetes is becoming increasingly prevalent in children. Each year about six percent more children under the age of five are diagnosed than in the previous year. Often the autoimmune process, which precedes clinical symptoms of the disease, begins in the first two years of life. Early preventive steps must therefore be taken at this stage in a child’s development.
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Story Source: The above post is reprinted from materials provided by Helmholtz Zentrum Muenchen – German Research Centre for Environmental Health. Note: Materials may be edited for content and length.