Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
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 in new onset 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 new onset Phase II Pediatric study, the investigators will attempt to test if even more significant eff…
Eligibility
- Age range
- 8–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Type 1 diabetic subjects diagnosed more than 3 months ago and less than 12 months ago at the time of randomization. * 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. * Human chorionic gonadotropin (hCG) negative at the time of the screening visit, if female. * M. tuberculosis (TB) negative using a QuantiFERON-TB test prior to randomization, as judged by the Investigator. * Informed consent and child assent, as age-appropriate, obtained before any trial…
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