A phase II clinical trial to test the effectiveness of the vaccine bacillus Calmette-Guérin or BCG to reveres advanced type 1 diabetes has been approved by the U.S. Food and Drug Administration or FDA.

The trail will soon begin to enroll patients. The trial is five year long which will determine whether or not repeated BCG vaccine will improve the condition of adults between the age of 18 and 60 with type 1 diabetes who still have detectable levels of insulin secretion.

The vaccine has already proven to reverse advanced type 1 diabetes in mice.

Denise Faustman, director of the Massachusetts General Hospital or MGH Immunobiology Laboratory and also the principle investigator of the study said, “We have learned a lot since the early studies in mice – not just about how BCG works but also about its potential therapeutic benefits, similar to what are being seen in trials against other autoimmune diseases, We are so grateful to all of the donors, large and small, who have made this trial possible – especially the Iacocca Foundation, which has believed in us and has been a supporter since our early days. Our goal is to complete enrollment and also to raise the remaining funds needed for the trial by the end of this year.”

FDA has approved the BCG vaccine for tuberculosis and for the treatment of bladder cancer; it works by elevating levels of the immune modulator tumor necrosis factor or TNF. Research has shown that it can temporarily eliminate abnormal white blood cells linked to autoimmune type 1 diabetes, and also stimulate regulatory T-cells.

In the phase I clinical trial, two injections of BCG administered over the course of two weeks proved to temporarily get rid of diabetes causing T cells, triggering a small return of insulin secretions. This new trail will provide more frequent dosing over a longer period of time to determine its effectiveness.

Faustman said, “In the phase I clinical trial we demonstrated a statistically significant response to BCG, but our goal in phase II is to create a lasting therapeutic response. 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. In addition to our phase I trial, we took guidance from the BCG clinical trials that are underway globally for other autoimmune diseases such as multiple sclerosis.”