Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Massachusetts General Hospital
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.
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 b…
Eligibility
- Age range
- 8–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Type 1 diabetic subjects treated with insulin and \> 24 months since diagnosis at the time of the screening visit (existing diabetes). * Male or female, age 8 - \<18 years at the time of the screening visit and \<18 at the time of randomization. * HIV antibody negative at the time of the screening visit. * M. tuberculosis (TB) negative using a QuantiFERON-TB test prior to randomization, as judged by the iInvestigator. * Human chorionic gonadotropin (hCG) negative at the time of the screening visit, if female. * On a continuous glucose monitoring (CGM) at the time of the…
Interventions
- BiologicalBacillus Calmette-Guérin
2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
- BiologicalSaline Injection
2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
Location
- Immunobiology Labs CNY 149Charlestown, Massachusetts