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Second Trial for Type 1 Diabetes Vaccine

Oral insulin vaccine may protect beta-cells from autoimmune destruction.

A potential vaccine for type 1 diabetes is undergoing its second trial. In type 1 diabetes, beta cells are attacked and destroyed by the immune system. Insulin is usually the initial target of this autoimmune response in young children. A vaccine could potentially sensitize the immune system to insulin and prevent propagation of the autoimmune reaction.

The vaccine is powdered insulin administered orally. Unlike subcutaneously administered insulin, oral insulin does not have any effect on serum glucose levels. After absorption, it is degraded. However, it is still able to be recognized by the immune system. One benefit of powdered insulin is that patients do not have to inject themselves, which some patients find inconvenient and painful.

The study, stylized as Pre-POINT early vaccination, will have young children as subjects. Children in Germany between the ages of six months and two years who have a first-degree relative with type 1 diabetes are eligible for the study. The previous Pre-POINT study involved children aged between two and seven years of age. A positive immune response was observed in these children after giving them powdered insulin. Powdered insulin was found to be well-tolerated in this preceding study as well.

The goal of this second study is to confirm this positive immune response in even younger children and to further investigate whether this vaccine can indeed prevent type 1 diabetes in the long term. The initial dose of the powdered insulin will be 7.5 mg with food. It will be titrated up to a maximum dose of 67.5 mg. Subjects will be examined every three months.

Practice Pearls:

  • Type 1 diabetes may be prevented by sensitizing the immune system to insulin, which is often the first target of the destructive autoimmune response that results in the condition.
  • Orally administered insulin does not affect glucose levels, but can still elicit an immune response. Oral insulin is being explored as a potential type 1 diabetes vaccine.
  • The oral insulin vaccine has previously been tested in children aged from 2 to 7. This study will test it on younger children aged six months to two years.

Type 1 diabetes prevention: insulin vaccine undergoes second trial. HelmholtzZentrum munchen. October 5, 2015.