Actively Recruiting
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Led by Massachusetts General Hospital · Updated on 2025-12-10
150
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female children aged 8 to under 18 years at screening and randomization
- Diagnosed with Type 1 diabetes treated with insulin for more than 24 months before screening
- Negative HIV antibody test at screening
- Negative M. tuberculosis test using QuantiFERON-TB prior to randomization
- Negative pregnancy test if female at screening
- Using continuous glucose monitoring (CGM) and willing to continue throughout the study
- Detectable screening C-peptide level between 1.5 pmol/L and 300 pmol/L (4.5 to 900 pg/mL)
- Informed consent and child assent obtained as appropriate
- Diagnosis of Type 1 diabetes confirmed by WHO/ADA criteria before enrollment
- Presence of at least one diabetes-related autoantibody before randomization
- On basal-bolus insulin regimen or insulin pump therapy at screening
- Willingness and ability to follow the study protocol and self-monitor glucose as judged by investigator
You will not qualify if you...
- Abnormal screening blood counts or chemistries judged clinically significant
- Elevated creatinine above Grade 1 at screening
- History of chronic infectious diseases like HIV or untreated hepatitis
- History or positive test for tuberculosis or significant mycobacteria exposure
- Current treatment with systemic glucocorticoids or immunosuppressive therapy (some exceptions)
- Participation in another clinical trial within 28 days prior to screening
- Previous participation in biologic or drug trials for Type 1 diabetes such as anti-CD3
- Other active chronic conditions increasing risk of serious side effects
- Chronic use of high-dose aspirin or daily NSAIDs
- Use of chronic antibiotics interfering with BCG viability
- History of recurrent diabetic ketoacidosis with hospitalizations due to non-compliance
- History of keloid formation
- Average HbA1c less than 7.0% or greater than 9.0% over past 3 months
- Evidence of chronic kidney disease or significant diabetes complications
- BMI below 5th percentile or above 95th percentile
- Blood pressure above 90th percentile for age and sex
- Fever over 99.8 F at screening
- Heart rate outside 50-120 bpm
- History of active proliferative diabetic retinopathy
- History of type 2 diabetes or severe obesity
- Diabetes onset before age 1
- Monogenic or cystic fibrosis-related diabetes
- Lack of diabetes-specific autoantibodies
- History of severe neuropathy, myocardial infarcts, psychiatric disease affecting participation
- Conditions affecting red blood cell turnover
- Pregnancy, breastfeeding, or inadequate contraception in females
- Living with immunosuppressed individuals
- Current participation in other BCG or immunotherapy diabetes trials
- Use or planned use of Type 2 diabetes medications
- Planned significant changes in diabetes care
- Prior BCG vaccination or positive T-spot tuberculosis test
- Not born in the United States
- Known hypersensitivity to trial products
- Planned use of medications affecting glucose metabolism within 14 days
- Any condition jeopardizing safety or protocol compliance
- History of malignant neoplasms within past 5 years
- Current severe hypoglycemia unawareness or multiple recent diabetic ketoacidosis episodes
- Recent use of non-insulin diabetes medications
- History of lupus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Immunobiology Labs CNY 149
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
Research Team
D
Denise L Faustman, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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