FDA approves mid-stage trial of vaccine to reverse type 1 diabetes
Diabetes researchers are hoping that an almost century-old vaccine for preventing tuberculosis may also reverse type 1 diabetes.
The FDA has approved a mid-stage trial to test the vaccine, called bacillus Calmette-Guerin (BCG), in 150 adults with advanced cases of the disease.
The approval was announced Sunday at the 75th Scientific Sessions of the American Diabetes Association by Dr. Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory in Boston and principal investigator of the study.
According to the American Diabetes Association, 5 percent of people with diabetes - or roughly three million individuals - have type 1, in which the immune system attacks and destroys insulin-producing beta cells in the pancreas.
Faustman told Reuters Health that the BCG vaccine temporarily raises levels of a substance called tumor necrosis factor, or TNF – and the higher TNF levels can eliminate the damaging T cells in the blood of individuals with type 1 diabetes.
In a small preliminary trial, Faustman’s team found that two BCG injections given four weeks apart temporarily eliminated diabetes-causing T cells. Patients also showed evidence of small, temporary return of insulin secretion.
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.
If this trial is successful, the next step w Continue reading