NCT05866536

Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus
• Type 1 Diabetes
• Diabetes type1
• Autoimmune Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Bacillus Calmette-Guérin	2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
BIOLOGICAL	Saline Injection	2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial

Timeline

• Start date: 2023-05-04
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2023-05-19
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study