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Phase 2Active, not recruitingNCT05180591

Repeat BCG vaccination in pediatric T1D

What this study tests

A placebo-controlled Phase 2 study of repeat BCG vaccination in children with established T1D. The registry lists active, not recruiting, with an estimated enrollment of 150; it has not confirmed that 150 were enrolled. Primary completion is estimated for March 2031.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-06-26.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Children aged 8 to under 18 with insulin-treated T1D for more than two years, CGM use, detectable residual C-peptide and at least one diabetes autoantibody. The protocol includes HbA1c, infection, medication and other eligibility restrictions. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results are posted. The June 26 registry update lists active, not recruiting, an estimated enrollment of 150 and estimated primary completion in March 2031. These are plans, not an efficacy result.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Change in HbA1c values

The full picture

What is being tested

Massachusetts General Hospital is comparing repeated BCG vaccination with saline placebo in children with established T1D. The main outcome is change in HbA1c. BCG remains investigational for treating T1D; this trial has not reported efficacy results.

September registry check

ClinicalTrials.gov lists the study as active, not recruiting. Its enrollment field remains estimated: 150, which must not be reported as 150 confirmed participants. Estimated primary completion is March 2031. The separate adult BCG study is not a result from this pediatric cohort.

Study record and full eligibility.

Sources

  1. [1]
    NCT05180591: Repeat BCG vaccination in pediatric T1D · Trial registry — Registry updated 26 June 2026, checked 16 September: active, not recruiting; estimated enrollment 150.
  2. [2]