FDA Approves Type-1 Diabetes Vaccine Trial

The U.S. Food and Drug Administration (FDA) has approved the second phase of the BCG vaccine’s Type 1 Diabetes Clinical Trial.

This was announced by Dr. Denise Faustman, one of the principal investigators, and director of the Massachusetts General Hospital during the 75th Scientific Sessions of the American Diabetes Association, last Sunday.

The Bacille Calmette-Guerin (BCG) vaccine has been widely used for the prevention of tuberculosis for 80 years, especially among babies and young children who are most susceptible to the disease.
But, this time, the medical world is taking a giant step in using the BCG vaccine in helping patients with type 1 diabetes. People with type 1 diabetes suffer from their body’s failure to produce insulin that converts sugar, starches, and other foods into energy.

“We have learned a lot since the early studies in mice,” said Dr. Faustman, in a public release, “not just about how BCG works, but also, about its potential therapeutic benefits, similar to what is being seen in trials against other autoimmune diseases.”

In the first phase of the clinical trial, Dr. Faustman’s research team had been successful in documenting the ability of the BCG vaccine in temporarily removing abnormal white blood cells that cause autoimmune type 1 diabetes among mice and humans. This was through the BCG vaccines’ capability in raising the level of immune modulation tumor necrosis factor, which eliminates the abnormal white blood cells and even acts as a catalyst in the production of protective regulatory T cells.

With the FDA approval of the clinical testings’ second phase, Dr. Faustmanís team is aiming for the reversal of advanced type 1 diabetes through increased dosing and longer administration of the BCG vaccine. About 150 adult-patients with long term type 1 diabetes are expected to participate in the said five-year clinical trial that can bring brighter hope for more people afflicted with the disease.

Dr.Faustman thanked all their donors and the Iacocca Foundation for their support. Out of the target funding of $25M, more than $19 million has already been raised for the remarkable clinical trial to get underway.