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

NCT05866536 Phase 2 RECRUITING

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.

Details

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2023-05-04
Completion	2028-05

Conditions

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

Interventions

• Bacillus Calmette-Guérin
• Saline Injection

Primary outcomes

• Change in HbA1c values — 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, and 5 years after initial BCG/placebo injection
  A change in hemoglobin A1c (HbA1c) values for new onset pediatric type 1 diabetics compared to self.

Countries

United States