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Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

NCT05180591•Massachusetts General Hospital

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.

Detailed Description

Published Phase I data on repeat BCG vaccinations in long term adult type 1 diabetics showed specific death of some of the disease-causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. The BCG vaccine also had beneficial metabolic effects that resets the utilization of sugars and significantly improves blood sugars by stably lowering HbA1c values for up to 8 years in subjects in the treatment group and not in the placebo group. In this Phase II Pediatric study, the investigators will attempt to test if even more significant effects can be seen in a pediatric population. Eligible volunteers will either be vaccinated with BCG twice, one month apart or receive a placebo treatment. Both groups will be followed for five years.

Eligibility

Age

8 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
+3 more criteria

Exclusion Criteria

•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.
+29 more criteria

Locations (1)

Immunobiology Labs CNY 149

Charlestown, Massachusetts, United States

Key Dates

Start Date

March 22, 2022

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

December 10, 2025

Enrollment

150

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 1Diabetes type1Autoimmune Diabetes

Interventions

Bacillus Calmette-Guérin

BIOLOGICAL

Saline Injection

BIOLOGICAL

Contacts

Denise L Faustman, MD, PhD

CONTACT

617-726-4084 diabetestrial@partners.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

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