The U.S. Food and Drug Administration has approved a mid-stage trial to test the efficacy of a century-old tuberculosis vaccine on reversing type 1 diabetes, according to a Reuters report.
The vaccine, called bacillus Calmette-Guerin or BCG, was first used in humans in 1921 to prevent TB and has been used more recently in the treatment of bladder cancer.
In a small preliminary trial, a team led by Denise Faustman, MD, PhD, director of the Massachusetts General Hospital Immunobiology Laboratory in Boston, found that two BCG injections given four weeks apart temporarily raised the levels of a substance called tumor necrosis factor, which eliminated the damaging T cells in the blood of individuals with type 1 diabetes. Patients also showed evidence of small, temporary return of insulin secretion.
In the FDA-approved trial, roughly 150 adults ages 18 to 60 with advanced cases of the disease will receive two injections, four weeks apart, of either BCG or placebo, and then annual injections for the next four years.
"In the phase I (preliminary) trial we demonstrated a statistically significant response to BCG, but our goal in (this trial) is to create a lasting therapeutic response," Dr. Faustman said in a statement. "We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease."
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