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Clinical Trial Summary

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes.

Clinical Trial Description

Published Phase I data on repeat BCG vaccinations in long term adult type 1 diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. The BCG vaccine also had beneficial metabolic effects that resets the utilization of sugars and significantly improves blood sugars by stably lowering HbA1c values for up to 8 years in subjects in the treatment group and not in the placebo group. In this Phase II Pediatric study, the investigators will attempt to test if even more significant effects can be seen in a pediatric population. Eligible volunteers will either be vaccinated with BCG twice, one month apart or receive a placebo treatment. Both groups will be followed for five years. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05180591
Study type Interventional
Source Massachusetts General Hospital
Contact Denise L Faustman, MD, PhD
Phone 617-726-7084
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date February 2022
Completion date February 2027

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