A vaccine being tested on humans could reverse Type 1 diabetes.

From diabetic foot ulcers to an increased risk of cardiovascular events, the complications of diabetes can be devastating. The widespread metabolic disorder continues to grow to epidemic proportions: According to the American Diabetes Association, an estimated 29.1 million people in the U.S. had diabetes as of 2012, and it takes seventh place in the leading causes of death in America.

There’s no cure for diabetes at this time, but researchers have been hard at work finding new ways to treat and prevent the disease. Their efforts have helped improve the quality of life for people with diabetes and prevented amputations, and a new breakthrough may actually reverse Type 1 diabetes: a simple vaccine.

The U.S. Food and Drug Administration has approved a trial to test the vaccine bacillus Calmette-Guerin (BCG) on humans. Many people may already be familiar with BCG – it is a widely used vaccine to defend the body against tuberculosis, and it’s also used to treat certain forms of bladder cancer.

How will the study work?

The double-blinded trial will take place at Massachusetts General Hospital and will involve 150 adults diagnosed with advanced Type 1 diabetes. Some will receive two injections of the vaccine four weeks apart, while the others will receive a placebo, followed by a single injection once per year for four years. The results will be measured through continuous HbA1c blood testing. If successful, blood testing will show heightened levels of tumor necrosis factor (TNF), a substance that eliminates T-cells in the body that cause Type 1 diabetes.

This is the second phase of testing, which comes after successful results on another group of humans. In that test, the vaccine proved to increase TNF levels and reduce T-cells. However, the effects of the vaccine wore off with time. The aim of the upcoming five-year study will be to test the long-term application of the vaccine, as Dr. Denise Faustman, lead researcher and director of the immunology laboratory at Massachusetts General, explained in a press release.

“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. “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.”

Implications for the future

The hope is that more frequent injections over long periods of time will help the researchers determine the efficacy of the BCG in reversing Type 1 diabetes permanently. If successful, Type 1 diabetes patients may someday soon treat their condition with something as simple as a yearly shot. The vaccine could help prevent a wide array of complications associated with the metabolic disorder, including heart disease, neuropathy, diabetic foot ulcers, kidney damage, eye damage and amputation.

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