Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

Status Recruiting

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

Clinical Trial Details

NCT number	NCT05180591
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Denise L Faustman, MD, PhD
Phone	617-726-4084
Email	diabetestrial@partners.org
Status	Recruiting
Phase	Phase 2
Start date	March 22, 2022
Completion date	March 2027

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