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Old TB vaccine shows promise for type 1 diabetes control

NCT ID NCT02081326

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether repeated doses of the BCG vaccine (originally for tuberculosis) can help adults with long-standing type 1 diabetes lower their blood sugar levels. About 150 participants receive either BCG or a placebo over 5 years, with follow-up for 10 years. The goal is to see if BCG can improve sugar control even when the pancreas has little function left, and also protect against infections like COVID-19.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jun 2015

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Type 1 diabetes treated continuously with insulin from time of diagnosis * Age 18-65 * HIV antibody negative * Normal CBC * HCG negative (females) * Anti-GAD Positive (except for subjects with c-peptide \<10pmol/L) * Fasting or stimulated c-peptide between 5-200 pmol/L * Participation in protocol #2001P001379, "Autoimmunity: In Vitro Pathogenesis and Early Detection" Exclusion Criteria: * History of chronic infectious disease such as HIV or hepatitis * History of tuberculosis, TB risk factors, positive interferon-gamma release assay (IGRA, also known as the T-SPOT.TB test), or BCG vaccination * Current treatment with glucocorticoids (other than intermittent nasal or eye steroids), or disease or condition likely to require steroid therapy * Other conditions or treatments associated with increased risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason * Current treatment with aspirin \> 160 mg/day or chronic, daily NSAIDs * Current treatment with antibiotics * History of keloid formation * Average HbA1c over the past 5 years (or since diagnosis if duration is less than 5 years) \<6.5 or \> 8.5% * History or evidence of chronic kidney disease (serum creatinine \> 1.5mg/dL) * History of proliferative diabetic retinopathy that has not been treated with laser therapy * History of neuropathy, foot ulcers, amputations, or kidney disease * Pregnant or not using acceptable birth control * Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason)

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Conditions

The condition(s) this trial relates to.

COVID-19 diabetes mellitus latent autoimmune diabetes in adults type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diabetes COVID19 Diabetes mellitus, type I Diabetes mellitus, type one

Contacts and locations

Locations

  • Immunobiology Labs CNY 149

    Charlestown, Massachusetts, 02129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.