BOSTON – At the American Diabetes Association’s recent 2021 Scientific Sessions, Massachusetts General Hospital (MGH) researchers presented positive updates from their studies of the Bacillus Calmette-Guérin (BCG) vaccine to safely and significantly lower blood sugar.
In type 1 diabetes, an autoimmune disease for which there is currently no cure, T cells attack the pancreas and destroy its ability to produce insulin, a hormone that is essential for glucose to enter the cells. to produce energy. In previous work, Denise Faustman, MD, PhD, director of the MGH Immunobiology Laboratory, and colleagues found that BCG enhances a substance called TNF, which eliminates harmful T cells and stimulates the development of beneficial T cells called regulatory Tregs, supported.
Key insights include new insights into how the response to BCG vaccination differs depending on a patient’s age of onset, and additional support for changing the role of BCG vaccination, glucose transport and Tregs. To date, 143 type 1 diabetics have received at least two doses of BCG, including 25 patients enrolled in a recently launched pediatric-onset adult study. Until the approval by the FDA, MGH plans to start a multicenter pediatric study this year.
“More data from randomized double-blind clinical trials will be announced as we get closer to further evaluation of the Phase II trial,” said Faustman, lead investigator for BCG clinical trials at MGH. “We continued to demonstrate BCG’s ability to reset and restore the immune system.”
In 2018, MGH published follow-up results from the Phase I study in long-term diabetics treated with BCG, which showed a sustained, clinically and statistically significant decrease in HbA1c levels that persisted after eight years of follow-up. The new data presented at ADA includes:
Type 1 diabetics with an onset age below 21 years have a faster response time and greater change in HbA1c than adult type 1 diabetics.
Over a period of three years, BCG reduced gene expression in Tregs in type 1 diabetics to a pattern consistent with non-type 1 controls.
The two-year HbA1c response in patients with juvenile onset of disease is consistent with the three-year response seen in the Phase 1 study.
“BCG is an old vaccine, but it appears to have new capabilities,” says Nigel Curtis, MD, PhD, of the Murdoch Children’s Research Institute in Melbourne, Australia. He leads worldwide clinical studies on the beneficial and undesirable effects of the BCG vaccine, but was not involved in the current study. “This new data from MGH complements our growing knowledge of how BCG alters the body’s response to autoimmune and infectious diseases.”
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The results of the MGH team form the basis for the reading of the ongoing five-year phase 2 study, which is currently underway and is expected to be completed in two years. For more information on clinical trials, visit http://www.faustmanlab.org or email DiabetesTrial@partners.org.
Via the Massachusetts General Hospital
Founded in 1811, Massachusetts General Hospital is the original and largest teaching hospital for Harvard Medical School. The Mass General Research Institute runs the largest hospital-based research program in the country, with more than $ 1 billion in annual research and more than 9,500 researchers working in more than 30 institutes, centers, and departments. In August 2020, Mass General was named # 6 on America’s Best Hospitals list by US News & World Report.
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