NCT05866536 Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
| NCT ID | NCT05866536 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-04 |
| Primary Completion | 2028-05 |
Trial Parameters
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Brief 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 Criteria
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-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Legally Acceptable Representative (LAR) of the Subject must sign and date the Informed Consent Form (according to local requirements). The child must sign and date the Child Assent Form or provide oral assent, if required according
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