RecruitingPhase 2NCT05866536

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


Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Start Date

May 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether repeat BCG vaccinations (typically used for tuberculosis prevention) can help protect the insulin-producing cells in children recently diagnosed with type 1 diabetes, potentially reducing how much insulin they need. **Your child may be eligible if...** - They are between 8 and 17 years old at the time of screening - They were diagnosed with type 1 diabetes between 3 and 12 months ago - They test negative for HIV and tuberculosis - They have at least one diabetes-related autoantibody present in their blood - They are currently on insulin therapy **Your child may NOT be eligible if...** - They were diagnosed with type 1 diabetes less than 3 months ago or more than 12 months ago - They test positive for HIV or tuberculosis - They have other significant health conditions that might interfere with the study - They are female and have a positive pregnancy test Talk to your child's doctor to see if this trial is right for them.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Immunobiology Labs CNY 149

Charlestown, Massachusetts, United States

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NCT05866536


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