Actively Recruiting
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
Led by Massachusetts General Hospital · Updated on 2025-12-10
100
Participants Needed
1
Research Sites
260 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 in new onset pediatric Type 1 diabetes.
CONDITIONS
Official Title
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 1 diabetes more than 3 months but less than 12 months before randomization
- Male or female aged 8 to under 18 years at screening and under 18 at randomization
- HIV antibody negative at screening
- Negative pregnancy test if female at screening
- Negative for tuberculosis with a QuantiFERON-TB test before randomization
- Provided informed consent and child assent as appropriate
- Diagnosed with Type 1 diabetes by WHO/ADA glucose criteria prior to enrollment
- Presence of at least one diabetes-related autoantibody before randomization
- Treated with insulin before screening
- Able and willing to follow the study protocol including self-measuring plasma glucose
You will not qualify if you...
- Clinically significant abnormal blood counts or chemistries at screening
- Elevated creatinine above Grade 1 at screening
- History of chronic infectious diseases like HIV or untreated hepatitis
- History or positive test for tuberculosis or high mycobacterial exposure
- Current use of systemic glucocorticoids or likely need for high dose steroids
- Participation in another clinical trial within 28 days before screening
- Previous participation in biologic or drug intervention trials for Type 1 Diabetes
- 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
- History of recurrent ketoacidosis with hospitalizations
- History of keloid formation
- Chronic kidney disease or significant diabetes complications
- Body mass index below 5th or above 95th percentile
- Blood pressure above 90th percentile for age and sex
- Fever above 99.8 F or abnormal heart rate at screening
- History of proliferative diabetic retinopathy
- History of type 2 diabetes or severe obesity
- Diabetes onset before age 1
- Monogenic diabetes or diabetes secondary to cystic fibrosis
- Lacking diabetes-specific autoantibodies
- History of severe diabetes complications or non-compliance
- Conditions affecting red blood cell turnover
- Pregnancy, breastfeeding, or inadequate contraception if female
- Living with someone immunosuppressed or at high risk for infections
- Participation in other BCG or immunotherapy diabetes trials
- Use or planned use of type 2 diabetes drugs or oral blood sugar medications
- History of prior BCG vaccination or positive tuberculosis tests
- Not born in the United States
- Known hypersensitivity to trial products
- Planned medication changes affecting glucose metabolism
- Any condition risking safety or compliance
- Recent diagnosis of cancer
- Severe hypoglycemic episodes or unawareness
- Multiple recent diabetic ketoacidosis hospitalizations
- Recent treatment with diabetes medications other than insulin
- 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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