Boston-based Massachusetts General Hospital (MGH), in partnership with NYU Langone Health, announced on March 1, 2022, a multi-center phase 2 clinical trial has launched to investigate a new BCG vaccine treatment for pediatric type 1 diabetes, even in subjects with established disease.
The BCG vaccine is an avirulent tuberculosis strain Mycobacterium bovis historically given to protect against tuberculosis.
It has been the most widely administered vaccine in the history of medicine.
There are currently no approved therapies to reverse or slow the progression of type 1 diabetes.
Insulin, the last major therapeutic innovation in the treatment of type 1 diabetes, was introduced more than 100 years ago.
Also known as juvenile-onset diabetes, type 1 diabetes is a life-altering autoimmune disease predominantly diagnosed in children in which the body is no longer able to regulate blood sugars.
"The physical, financial, and psychological impact a type 1 diabetes diagnosis has on children and their families cannot be underestimated," says Siham Accacha, MD, in an MGH press statement.
"The concept that a practical, safe, and very affordable vaccine with known clinical benefits can potentially reverse type 1 diabetes by possibly lowering HbA1c, a measure of glucose, and possibly decrease insulin, has to be explored. NYU Langone Health is excited to participate."
Dr. Accacha is a pediatric endocrinologist at NYU Langone Health and co-investigator of the Repeat BCG Vaccinations for the Treatment of Pediatric Type 1 Diabetes study.
Considered extremely safe, BCG is on the World Health Organization's List of Essential Medicines and is given to roughly 100 million children per year.
BCG is also one of the most affordable medicines, costing less than a dollar a dose in many parts of the world.
According to a media report, the global BCG vaccine industry estimates a CAGR of 4.8% from 2021 to 2030.
Source: Precision Vaccinations