Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could this new vaccine end tuberculosis?

NCT ID NCT06272812

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This study tests a new vaccine called MTBVAC to see if it can prevent tuberculosis (TB) disease in teens and adults aged 14 to 45 who live in areas where TB is common. About 5,500 volunteers will receive either the vaccine or a placebo, and researchers will track who develops TB over three years. The goal is to find a safe and effective way to protect people from this serious lung infection.

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 5,500 people

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

Started

Feb 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

14 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Is male or female aged 14 through 45 years on Study Day 1. 2. Has completed the written (or thumb printed and witnessed) informed consent process (participants older than 18 years) or has completed the written parental consent and participant assent process (participants younger than 18 years) before any study-related procedures were performed. 3. Participants who, in the opinion of the investigatory, can and will comply with the requirements of the protocol (e.g., to stay in contact with the Clinical Research Centre (CRC), return for follow-up visits) 4. Has general good health as confirmed by medical history and physical examination. 5. All participants born female who are engaging in sexual activity that could lead to pregnancy must commit to use an acceptable method of contraception from 21 days prior to Study Day 1 and for the 2 months after vaccination. Acceptable contraception includes: 1. Condoms (male or female) with or without spermicide 2. Diaphragm or cervical cap with spermicide 3. Intrauterine device 4. Hormonal contraception (combined estrogen and progestogen, or progestogen-only), including contraceptive implant or injectable 5. Successful vasectomy in the male partner, considered successful if a woman reports that a male partner has: documentation of azoospermia by microscopy (1 year ago) or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy 6. Not of reproductive potential, such as having undergone hysterectomy, bilateral oophorectomy or tubal ligation, postmenopausal (any age and amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \> 40 IU/L), surgically sterile. 7. Sexual abstinence. All participants born female who are not heterosexually active at screening must agree to utilize an acceptable method of contraception if they become heterosexually active as outlined above. 6. All male participants should agree to use barrier contraception with their female partners for at least 2 weeks after vaccination. 7. Has not shared the same enclosed living space with someone diagnosed with TB for one or more nights or for frequent or extended daytime periods during the 6 months prior to Study Day 1. 8. HIV negative at screening. 9. Negative clinical screening questionnaire and Xpert MTB/RIF negative sputum sample for pulmonary TB disease at screening. Exclusion Criteria: 1. Acute illness and/or axillary temperature ≥37.5°C on Study Day 1. 2. Current suspicion or evidence (including but not limited to sputum Xpert MTB/RIF positive) of active TB disease at any CRC. An attempt must be made to obtain sputum from each participant; persons who are sputum unproductive will be assumed to be Xpert MTB/RIF negative. 3. History of previous TB disease and/or treatment for TB disease. 4. History of TB preventative therapy, not including BCG vaccination. 5. Received any investigational drug or investigational vaccine within 42 days before Study Day 1, or planned use during the study period. 6. Planned administration/administration of a licensed vaccine not foreseen by the study protocol in the period starting 28 days before Study Day 1 and ending 28 days after vaccine administration. 7. Prior receipt of any investigational TB vaccine candidate before Study Day 1. Note: receipt of placebo in a previous TB vaccine trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval. 8. Chronic administration of immunosuppressive medication within 42 days before Study Day 1 (inhaled and topical corticosteroids are permitted). 9. Any confirmed or suspected immunosuppressive, immunodeficient, or autoimmune condition based on medical history and physical examination (no laboratory testing required). 10. Concurrent, or planned participation in any other investigational study during the study period. (Concurrent participation in an observational trial not requiring blood or tissue sample collection is not an exclusion.) 11. Received immunoglobulin or blood products within 42 days before Study Day 1, or planned administration during the study period. 12. History or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. 13. Pregnant or lactating/nursing female, or positive urine pregnancy test during screening or pre-vaccination on Study Day 1. 14. Indeterminate IGRA test result at screening. 15. Any current, or history of, medication use or medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, might compromise the safety of the participant or make it unlikely that the participant will comply with the protocol.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Tuberculosis (TB) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Be Part Research Pty Ltd.

    Paarl, South Africa

  • Desmond Tutu Health Foundation, Masiphumelele Research Office

    Sunnydale, South Africa

  • Ifakara Health Institute

    Dar es Salaam, Tanzania

  • JOSHA Research

    Bloemfontein, South Africa

  • Kenya Medical Research Institute

    Nairobi, Kenya

  • Perinatal HIV Research Unit

    Johannesburg, South Africa

  • South African Tuberculosis Vaccine Initiative

    Cape Town, South Africa

  • Synergy Biomedical Research Institute

    East London, South Africa

  • TASK Applied Science Pty Ltd. TASK Delft

    Cape Town, South Africa

  • TASK Eden Pty Ltd.

    George, South Africa

  • The Aurum Institute Rustenburg Clinical Research Centre

    Rustenburg, South Africa

  • The Aurum Institute Tembisa Clinical Research Centre

    Tembisa, South Africa

  • UCTLI CLII - Centre for Lung Infection and Immunity

    Cape Town, South Africa

  • University of Cape Town Lung Institute PtyLtd. Centre for Tuberculosis Research Innovation

    Cape Town, South Africa

  • Victoria Biomedical Research Institute

    Kisumu, Kenya

  • Wellcome Centre for Infectious Diseases Research in Africa

    Cape Town, South Africa

More trials for these conditions

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