Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

NCT05180591 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2019P002835
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 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 on pediatric Type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1; Diabetes type1; Autoimmune Diabetes

Keywords

Diabetes Mellitus, Type One; Diabetes Mellitus, Type I; Autoimmune Diabetes; Insulin Dependent Diabetes Mellitus 1; IDDM

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c values

  A change in hemoglobin A1c (HbA1c) values for 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 (4)

• Change in hypoglycemia

  1, 2, 3, 4, and 5 years after initial BCG/placebo injection

• 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

• Change in adjusted HbA1c

  1, 2, 3, 4, and 5 years after initial BCG/placebo injection

Other Outcomes (2)

• Exploratory: Change in autoantibodies

  1, 2, 3, 4, and 5 years after initial BCG/placebo injection

• Exploratory: Change in overall inflammation

  1, 2, 3, 4, and 5 years after initial BCG/placebo injection

Study Arms (2)

Bacillus Calmette-Guérin

EXPERIMENTAL

2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial

Biological: Bacillus Calmette-Guérin

Saline Injection

PLACEBO COMPARATOR

2 placebo injections spaced 4 weeks apart at the beginning of the trial

Biological: Saline Injection

Interventions

Bacillus Calmette-Guérin BIOLOGICAL

2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial

Also known as: BCG

Bacillus Calmette-Guérin

Saline Injection BIOLOGICAL

2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial

Saline Injection

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Type 1 diabetic subjects treated with insulin and \> 24 months since diagnosis at the time of the screening visit (existing diabetes).
• 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.
• M. tuberculosis (TB) negative using a QuantiFERON-TB test prior to randomization, as judged by the iInvestigator.
• Human chorionic gonadotropin (hCG) negative at the time of the screening visit, if female.
• On a continuous glucose monitoring (CGM) at the time of the screening visit, and willing to be on a CGM for the entire study, as judged by the Investigator.
• Has detectable screening C-peptide (1.5 pmol/L - 300 pmol/L or 4.5 pg/mL - 900 pg/mL).
• 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).
• Ongoing daily treatment with a basal-bolus insulin regimen using a basal insulin analogue or Insulin pump therapy at the time of 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.
• Average venous HbA1c over the past 3 months \<7.0% or \>9.0% at the time of the screening visit (the average includes the HbA1c ran at screening).
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Immunobiology Labs CNY 149

Charlestown, Massachusetts, 02129, United States

RECRUITING

Related Links

• Faustman Lab Research Website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Denise L Faustman, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise L Faustman, MD, PhD

CONTACT

617-726-4084; diabetestrial@partners.org

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: December 6, 2021
• First Posted: January 6, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)