Progress is being made on an insulin vaccine for preventing type 1 diabetes in high-risk children, researchers have revealed.
Type 1 diabetes is an auto-immune disease that can be identified among children without symptoms by testing for islet autoantibodies.
Researchers believe a vaccine could prevent the immune system reactions that lead to the destruction of insulin-producing islets in the pancreas.
Other autoimmune diseases are also triggered by specific antibodies – and researchers have been developing antigen-specific therapies – in which a substance is used to cause an immune response to prevent, stabilise, or reverse immune-related diseases.
This research involved antigen-specific therapy using insulin. Children at high risk for type 1 diabetes were given a daily high dose of oral insulin. This led to an immune response to insulin without triggering hypoglycaemia.
The team, led by Dr Ezio Bonifacio, of the Technische Universitat Dresden, Germany, say this immune response prior to the development of autoantibodies may prevent autoimmunity and subsequent type 1 diabetes.
They gave 25 genetically at-risk children, aged two to seven years, either oral insulin at varying doses or placebo once a day for three to 18 months. Just 20% of the children given placebo developed an immune response to insulin, compared with 83% treated with the highest dose (67.5mg) of insulin.
Side-effects were similar in the two groups, and none of the insulin doses caused hypoglycaemia. This supports the need for a phase 3 trial, the authors reported in the Journal of the American Medical Association.
They write: "The Pre-POINT pilot study demonstrated that daily oral administration of 67.5mg of insulin to genetically at-risk healthy children without signs of islet autoimmunity resulted in an immune response without hypoglycaemia. The immune response observed in insulin-treated children did not display the features typically associated with type 1diabetes."
Bonifacio, E. et al. Effects of High-Dose Oral Insulin on Immune Responses in Children at High Risk for Type 1 Diabetes. JAMA 21 April 2015 doi:10.1001/jama.2015.2928
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