FDA approves MGH developed BCG vaccine to reverse Type 1 Diabetes clinical trial

Individuals suffering from or at high risk of getting type-1 diabetes have good news waiting for them. The FDA has given the permission of carrying out phase 2 clinical trial of a type-1 diabetes vaccine. The vaccine in question was found to be effective when tested on a group of mice; now, it will undergo human trials.

Experts might often explain diabetes mellitus as a disease that causes an increase in blood glucose levels; however, physical abnormalities caused by the condition are not that simple. Medical practitioners have classified it into three categories based on the factor causing the condition; they are: type-1 diabetes, type-2 diabetes, and gestational diabetes.

The vaccine we are discussing is meant for preventing type-1 diabetes mellitus. Researchers have focused primarily on formulating a vaccine for type-1 diabetes as it’s an autoimmune disease and the least preventable form of the disease.

For those who don’t know: an individual develops type-1 diabetes when his or her pancreas secretes little or no insulin, as a result of which, sugar instead of entering the cells gets deposited in the patient’s bloodstream.

Researchers have recently found that a vaccine that has been used for preventing tuberculosis for years might be effective to prevent type-1 diabetes. The name of the vaccine is Bacillus Calmette-Guerin. FDA has granted a human trial of Bacillus Calmette-Guerin; the vaccine will be tested on 150 adults.

This research has been led by Dr. Denise Faustman of Massachusetts General Hospital’s Immunobiology Laboratory. Recently, Dr Faustman announced that according to studies conducted by him and his colleagues to date, Bacillus Calmette-Guerin or BCG is capable of increasing levels of tumor necrosis factor (TNF) and thereby triggers excretion of the harmful T cells found in individuals suffering from type-1 diabetes mellitus.


The team under Dr. Faustman is currently planning to carry out a bigger trial to present more accurate results. This upcoming trial will go on for a period of five years; during this period, scientists will be examining BCG’s ability of reversing type-1 diabetes.

According to Dr. Rober Sobel, a representative of Feinberg School of Northwestern University, at this moment, it would be an exaggeration if someone says that BCG will have an immense impact on millions of type-1 diabetes mellitus patients in the US. However, Dr. Sobel has said that scientists will keep on trying to find ways of preserving or repopulating the beta cell mass of these patients.