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Could a TB vaccine stop diabetes? new trial hopes so

NCT ID NCT05591339

Prevention Sponsor: Bandim Health Project Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the BCG vaccine, normally used for tuberculosis, can prevent type 2 diabetes in people with pre-diabetes. Researchers in Guinea-Bissau will give two doses of BCG or a placebo to 200 adults and track their blood sugar levels. The goal is to see if the vaccine reduces inflammation and insulin resistance, potentially stopping pre-diabetes from becoming full-blown diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BCG vaccine
What this could lead to
If it works, this could point toward a low-cost way to prevent type 2 diabetes in at-risk populations.
What could go wrong
This is a small, early-phase trial in one country, so results may not apply elsewhere. The BCG vaccine can cause local reactions and is not proven for diabetes prevention.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

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

Started

Dec 2023

Expected to finish

Aug 2029

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 64 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 for BCG trial: * Ages 18-64 * Planning to continue living in the study area * F-glucose from 5.6-6.9 mmol/L and HbA1c between 39-47mmol/mol. Exclusion Criteria for BCG trial: * HIV infection (an HIV test to be done before enrolment) * Pregnancy (a pregnancy test to be done before enrolment in women in the childbearing age) * Chemotherapy

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Conditions

The condition(s) this trial relates to.

diabetes mellitus prediabetes syndrome type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

BCG vaccination reaction Diabetes mellitus

Contacts and locations

Locations

  • Bandim Health Project

    Bissau, 1004, Guinea-Bissau

More trials for these conditions

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