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Can a tuberculosis vaccine help fight HIV? new study explores

NCT ID NCT05004038

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether the BCG vaccine, normally used to prevent tuberculosis, could reduce the hidden HIV reservoir in people living with HIV who are on antiretroviral therapy. Sixty participants received either a single BCG shot or a placebo. Researchers measured changes in HIV DNA levels in blood cells over six months to see if the vaccine could help control the virus.

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 (Bacillus Calmette-Guérin)
What this could lead to
If successful, this could show that BCG vaccination helps shrink the hidden HIV reservoir, potentially pointing toward a way to better control or even eliminate HIV.
What could go wrong
This is a small, early-phase study with only 60 participants. The effect on the HIV reservoir may be minimal or temporary, and BCG is not a cure for HIV.

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

60 people

The number who actually took part.

Started

Jan 2022

Finished

Sep 2023

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 years and older

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: * Informed consent as documented by signature (see Informed Consent Form), * Age ≥18 years, * HIV-1 infection under continuous antiretroviral therapy for ≥1.5 years as requested in the Systems X Cohort, * Current participation in the Swiss HIV Cohort Study and past participation in the Systems X Cohort. Exclusion Criteria: * History of virological failure or treatment interruption at any time, defined as HIV-1 viral load \>200c/ml at two consecutive measurements at least 4 weeks apart, * CD4 T-cell count \<200/μl at any time or \<350/μl during the past 1 year * Presence of other relevant immunosuppression according to the investigator in addition to HIV (a daily steroid intake of ≥20mg is considered clinically relevant), * History of or current clinical evidence of active tuberculosis, * Previous positive tuberculin skin test or tuberculosis INF-gamma release assay (Quantiferon-Test) within the past 10 years, * Previous BCG-vaccination within the past 10 years, * Known allergy to BCG vaccine or any of its components, * Documented current febrile illness at screening or in the past 7 days. * Women who are pregnant or breast-feeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University Hospital Zurich

    Zurich, 8091, Switzerland

More trials for these conditions

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