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Type 1 diabetes: On the way to an insulin vaccine

Little girl and Doctor checking blood sugar levels

Pseudoscience claims about vaccines are seemingly hitting a fever pitch. Despite that, a new vaccine may be on the horizon for children at risk for diabetes, and that is a good thing. Researchers have found that children at risk for type 1 diabetes, who were given daily doses of oral insulin, developed a protective immune response to the disease that could lay the groundwork for a vaccine against the chronic illness.

The international pilot study, was carried out in the U.S., Germany, Austria and the United Kingdom.

“This is the first time we have seen a healthful immune response from any therapy used in children who are at a high risk of type 1 diabetes,” said Georgeanna Klingensmith, MD, who led the U.S. side of the research.

“The results showed that it was safe and none of the children developed diabetes, insulin antibodies or hypoglycemia.”

Children receiving the highest dose of oral insulin showed the greatest immune response.

Type I diabetes is a chronic, life-threatening disease causing up to 200 deaths each year nationwide. Children who have the disease must inject insulin several times a day for the rest of their lives because their own immune system has killed the cells in their pancreas that create insulin.

In this study, children who had a strong family history of type 1 diabetes were given oral insulin or a placebo once a day for three to 18 months to determine if the insulin could provoke an immune response without side-effects. The children were between two and seven years old.

Only two out of 10 children treated with a placebo showed any immune response.

But among those receiving oral insulin, the immunity increased with the dosage.

  • 16.7 percent of children who received 2.5 mg of insulin a day saw an immune response.
  • 33 percent of children who received 7.5 mg of insulin showed an immune response.
  • 83.3 percent of children taking 67.5 mg of insulin a day demonstrated an immune response.

“The results show that the oral insulin was safe,” Klingensmith said.

“They also tell us that we need to do a larger trial with more children to see if these findings hold up.”

While Klingensmith is reluctant to read too much into the findings, under a best case scenario, they could lead to the development of a vaccine for type 1 diabetes.

“That is the ultimate goal,” she said.

Ezio Bonifacio, PhD, Anette G. Ziegler, MD, Georgeanna Klingensmith, MD, Edith Schober, MD, Polly J. Bingley, MD, Marietta Rottenkolber, Anke Theil, PhD, Anne Eugster, PhD, Ramona Puff, PhD, Claudia Peplow, Dipl Eoc Troph, Florian Buettner, Ph, Karin Lange, PhD, Jörg Hasford, MD, & Peter Achenbach, MD (2015). Effects of High-Dose Oral Insulin on Immune Responses in Children at High Risk for Type 1 Diabetes
The Pre-POINT Randomized Clinical Trial Journal of American Medical Association : 10.1001/jama.2015.2928

Jay S. Skyler, MD (2015). Toward Primary Prevention of Type 1 Diabetes Journal of American Medical Association : 10.1001/jama.2015.2054.

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