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Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

NCT05180591 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-10

No results posted yet for this study

Summary

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Denise L Faustman, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180591 on ClinicalTrials.gov