Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05866536
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Bacillus Calmette-Guérin — BIOLOGICAL
    2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
  • Saline Injection — BIOLOGICAL
    2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial

Study Details

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.

Key Dates

Start date
May 4, 2023
Status verified
Dec 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bacillus Calmette-Guérin
    2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
  • Placebo Comparator: Saline Injection
    2 placebo injections spaced 4 weeks apart at the beginning of the trial

Primary Outcome Measure

Change in HbA1c values [ Time Frame: 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, and 5 years after initial BCG/placebo injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Immunobiology Labs CNY 149CharlestownMassachusetts02129
Denise L Faustman, MD, PhD
[email protected]
617-726-4084
Denise L. Faustman, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlestown, MA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Immunobiology Labs CNY 149· Charlestown, MA

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