In the United States alone, 1.25 million people suffer from type 1 diabetes.
A vaccine used over 100 years ago for tuberculosis (bacillus Calmette-Guerin) has shown promise in reversing this disease. This vaccine is now commonly used for treating bladder cancer and is considered to be safe.
An announcement made yesterday at the 75th Scientific Sessions of the American Diabetes Association said that the FDA will test the vaccine on 150 people who are in an advanced stage of type one diabetes.
The body of a person with type 1 diabetes does not produce insulin due to the immune system destroying the cells that create insulin. T cells are produced, and these cells create problems in the pancreatic islets, where insulin is produced. The vaccine works by eliminating these T cells.
Patients with diabetes injected with the vaccine saw an increase in the levels of a substance called tumor necrosis factor. The increased level of TNF in the system destroys the T cells that are hindering the production of insulin.
In a previous trial, patients were injected with the tuberculosis vaccine twice within a four-week time frame. The results showed that the dangerous T cells were gone, and some people even began to secrete insulin on their own.
Dr. Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory in Boston, is very excited about the results the BCG vaccine has been showing.
“In the phase I (preliminary) trial we demonstrated a statistically significant response to BCG, but our goal in (this trial) 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.”
This new five-year trial will start this summer. Those who are enrolled will range in ages from 18 to 60-years-old. The trial will use the same format as was used before by injecting patients twice within a four-week period. Patients will then have one injection a year for the next four years.
Not all diabetes experts are confident that this treatment will work. Robert Sobel, an assistant professor of endocrinology at Northwestern University’s Feinberg School of Medicine, explains why he is skeptical.
“I think it’s a stretch to say this would have a huge impact on the millions plus type I diabetes patients in this country. We would love to do something to preserve or repopulate their beta cell mass. Historically, we have watched it dwindle and have not been able to do something (in time).”
Time will tell if this vaccine will become a viable treatment option for type 1 diabetes or not.