The Food and Drug Administration (FDA) has granted approval to the initiation of a Phase 2 clinical trial evaluating the use of generic vaccine bacillus Calmette-Guerin (BCG) to reverse advanced type 1 diabetes, as announced by Denise Faustman, MD, PhD, director of the Massachusetts General Hospital (MGH) Immunobiology Laboratory at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston, MA.

In the five-year double-blinded Phase 2 trial, researchers will investigate whether repeat BCG vaccination can clinically improve type 1 diabetes in adults 18–60 years of age who have small but still detectable levels of insulin secretion from the pancreas. Adults (n=150) with long-term type 1 diabetes will be randomized to receive two injections four weeks apart of either BCG or placebo and then a single injection annually for the next four years. Patients will be closely monitored over the five-year trial period. The primary outcome measure will be improved results on the HbA1c blood test.

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Previously in the Phase 1 clinical trial, two injections of BCG spaced four weeks apart led to temporary elimination of diabetes-causing T cells and provided evidence of a small, transient return of insulin secretion. The Phase 2 clinical study will include more frequent dosing over a longer time period to determine the potential of repeat BCG vaccination to ameliorate the autoimmune state and improve clinical parameters such as HbA1c.

BCG is currently approved for vaccination against tuberculosis and for the treatment of bladder cancer. The vaccine is known to elevate levels of the immune modulator tumor necrosis factor (TNF). Increased TNF levels also stimulated production of protective regulatory T cells.

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