Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus
Started May 2023
Longer than P75 for phase_2 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2023
CompletedFirst Submitted
Initial submission to the registry
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
December 10, 2025
December 1, 2025
5 years
May 10, 2023
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c values
A change in hemoglobin A1c (HbA1c) values for new onset pediatric type 1 diabetics compared to self.
1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, and 5 years after initial BCG/placebo injection
Secondary Outcomes (2)
Change in C-peptide
1, 2, 3, 4, and 5 years after initial BCG/placebo injection
Change in insulin usage
1, 2, 3, 4, and 5 years after initial BCG/placebo injection
Other Outcomes (1)
Exploratory: Change in hypoglycemia
1, 2, 3, 4, and 5 years after initial BCG/placebo injection
Study Arms (2)
Bacillus Calmette-Guérin
EXPERIMENTAL2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
Saline Injection
PLACEBO COMPARATOR2 placebo injections spaced 4 weeks apart at the beginning of the trial
Interventions
2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
Eligibility Criteria
You may qualify if:
- 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 to local requirements.
- Previously diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) prior to study enrollment by WHO/ADA diagnostic criteria for glucose levels (FPG = 7.0 mmol/L \[126 mg/dL\]) or plasma glucose levels 2-hours after 75-gm oral glucose load of = 11.1 mmol/L (200 mg/dL) or a casual plasma glucose \>200 mg/dL with symptoms.
- Presence of one or more of the following prior to randomization: antibodies to glutamic acid decarboxylase (GAD), islet cell autoantibody (ICA), protein tyrosine phosphatase-like protein antibodies (IA-2), Insulin autoantibodies (IAA), zinc transporter 8 antibodies (ZnT8).
- Treatment with insulin prior to the screening visit, as judged by the Investigator.
- Ability and willingness to adhere to the protocol, including performing self-measured plasma glucose profiles (Subject and LAR(s) should be evaluated as a unit), as judged by the Investigator.
You may not qualify if:
- Clinically significant abnormal screening CBC and chemistries (excluding glucose), as judged by the Investigator.
- Clinically significant screening creatinine elevations above Grade 1, as judged by the Investigator.
- History of chronic infectious disease, such as HIV or untreated or active hepatitis at the time of the screening visit, as judged by the Investigator.
- History of tuberculosis, positive interferon-gamma release assay (IGRA, also known as the QuantiFERON-TB test), including history of a positive test with a high reactivity to mycobacteria of non-tuberculosis variety, prior to randomization (subjects should not be excluded based on history of false positive tests), as judged by the investigator.
- Current treatment with glucocorticoids (other than intermittent nasal or eye steroids, asthma inhaler, or topical steroids), or disease or condition likely to require high dose steroid or immunosuppressive therapy at the time of the screening visit, as judged by the Investigator. This does not include replacement therapies for conditions such as growth hormone deficiencies, Addison's disease, or hypothyroidism.
- Simultaneous participation in any other clinical trial while enrolled in this clinical trial or participation in another clinical trial within 28 days before the screening visit. Note: Clinical trials do not include non-interventional studies.
- Previous participation in the treatment group in biologic or drug intervention trials for Type 1 Diabetes such as anti-CD3.
- Other active chronic conditions, diseases, and/or treatments associated with increased risk of serious side effects and/or morbidities at the time of the screening visit, as judged by the Investigator. This includes conditions that increase the risk of infections, current immunosuppressive therapies for other autoimmune diseases, or patients with a previous history of severe burns.
- Chronic treatment with aspirin \> 160 mg/day or chronic, daily NSAIDs at the time of the screening visit, as judged by the Investigator.
- Current treatment with chronic antibiotics that interfere with BCG viability at the time of the screening visit, as judged by the Investigator.
- History of recurrent ketoacidosis with hospitalizations due to non-compliance at the time of the screening visit, as judged by the Investigator.
- History of keloid formation at the time of the screening visit, as judged by the Investigator.
- History or evidence of chronic kidney disease (serum creatinine \> 1.5mg/dL), significant protein in the urine, or other significant and/or active diabetes related complication at the time of the screening visit, as judged by the Investigator.
- Screening BMI of \<5th percentile or \>95th percentile.
- Screening blood pressure \>90th percentile for their age and sex.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Immunobiology Labs CNY 149
Charlestown, Massachusetts, 02129, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise L Faustman, MD, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Immunobiology Laboratory
Study Record Dates
First Submitted
May 10, 2023
First Posted
May 19, 2023
Study Start
May 4, 2023
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
December 10, 2025
Record last verified: 2025-12