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Second Tuberculosis Vaccine Treatment for Type 1 Diabetes Underway

A clinical trial to investigate whether repeated injections of the tuberculosis vaccine bacille Calmette-Guérin holds promise…

The researchers announced the start of their phase 2 trial at the American Diabetes Association (ADA) 75th Scientific Sessions in Boston. Study author Denise Faustman, MD, director of the immunobiology laboratory at Massachusetts General Hospital in Boston, added that, “BCG is showing so much promise in worldwide trials [for conditions such as multiple sclerosis].”

The BCG vaccine works by increasing levels of tumor necrosis factor (TNF) in the body, Faustman said. In type 1 diabetes, higher TNF levels appear to reduce abnormal white blood cells responsible for the related autoimmunity, and stimulate production of protective regulatory T cells.

The phase 1 trial of the vaccine lasted 20 weeks. The average time the study volunteers had diabetes was 15 years.

They were randomly assigned to receive two injections of the vaccine or a placebo. The treatment was associated with temporary elimination of diabetes-causing T cells as well as a small, transient return of insulin secretion.

The new randomized, double-blind trial will include 150 adults aged 18 to 60 years. Volunteers will receive two injections, of either the vaccine or a placebo, 2 weeks apart. Then they’ll be given a single injection annually for the next 4 years. This summer, she and her colleagues will begin enrolling patients ages 18 to 60 in a larger five-year trial. Participants will have low but detectable levels of insulin secretion from the pancreas. They’ll receive two injections, four weeks apart, of either BCG or placebo, and then annual injections for the next four years.

Faustman said initially they’ll need to do blood tests every 2 weeks or so. Eventually, blood tests will only need to be done every 6 months to once a year.

Practice Pearls:

  • The BCG vaccine works by increasing levels of tumor necrosis factor (TNF) in the body.
  • The phase 1 trial of the vaccine lasted 20 weeks.
  • In the initial study, treatment was associated with temporary elimination of diabetes-causing T cells as well as a small, transient return of insulin secretion.

Announced the start of their phase 2 trial at the American Diabetes Association (ADA) 75th Scientific Sessions in Boston, June 2015