TB Vaccine Could Reverse Type 1 Diabetes

A generic vaccine that has been used to prevent tuberculosis for 90 years may also hold the key to reverse type 1 diabetes in adults.

A phase II clinical trial of bacillus Calmette-Guérin (BCG) and its ability to improve diabetes symptoms has been approved by the U.S. Food and Drug Administration (FDA), which will involve five years of investigation.

The study will be led by Dr. Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory. Faustman and her research team were the first to discover that advanced type 1 diabetes could be reversed in mice with the BCG vaccine.

"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," Faustman said in a statement.

A 'lasting therapeutic response' is the goal

BCG, which is also used to treat bladder cancer, elevates levels of a specific protein that helps to regulate abnormal white blood cell count - the mechanism that leads to autoimmune type 1 diabetes.

In the first phase of clinical trials, BCG appeared to improve insulin secretion and eliminate harmful T-cells that cause diabetes.

The phase II trial will include 150 adults with type 1 diabetes who will receive either BCG injections or a placebo over the course of a five-year period.

"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," Faustman said.

Source: Massachusetts General Hospital

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