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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 in new onset 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 new onset Phase II Pediatric study, the investigators will attempt to test if even more significant effects can be seen in a new onset 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 NCT05866536
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 May 4, 2023
Completion date May 2028

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