An insulin vaccination trial will test whether giving very young children oral insulin can prevent type 1 diabetes in the long-term.
German children between the ages of six months and two years who have a first-degree relative with type 1 diabetes will be recruited for the Pre-POINTearly vaccination study.
This trial follows up on the Pre-POINT study, an international collaboration coordinated by Professor Dr. Ezio Bonifacio at the Centre for Regenerative Therapies Dresden (CRTD), Germany.
The first study observed a positive immune response in children at risk of type 1 diabetes who were administered oral doses of insulin. The insulin was well tolerated by the children and shown to be safe.
The Pre-POINTearly vaccination study will treat children with powdered insulin who have not developed an autoimmune response. Their daily dose will increase gradually from 7.5mg to 6.75mg and medical examinations will be conducted at three-month intervals.
The researchers hope the oral insulin – which does not affect blood glucose levels as it is absorbed in the mouth and intestines before splitting into smaller components during digestion – could prevent the autoimmune destruction of insulin-producing beta cells and stimulate the growth of protective immune cells.
Prof. Anette-Gabriele Ziegler, Director of the Institute of Diabetes Research said: “The autoimmune response that causes type 1 diabetes in childhood is often initially directed at the insulin. The aim of the Pre-POINTearly study is therefore to build up immune tolerance to insulin and thus block the autoimmune process.”

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