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Massive TB vaccine trial could save millions

NCT ID NCT06062238

Vaccine Sponsor: Gates Medical Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This large study tests an experimental vaccine called M72/AS01E-4 to see if it can prevent tuberculosis (TB) in teens and adults. About 20,000 people will receive either the vaccine or a placebo. The goal is to find a safe and effective way to stop TB, a 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

20,080 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Apr 2028

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

15 to 44 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: * Capable of giving informed consent or informed assent (as appropriate). For participants below the age of consent, the participant's parent, or legally authorized representative (LAR) will be required to sign a statement of informed consent, in addition to the minor's signed statement of assent. * In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of diary cards as applicable, and return for follow-up visits). * Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety. * Agree to provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial. * Healthy, or with preexisting stable disease, as established by medical history and physical examination and as determined by the investigator. * Negative sputum Xpert Ultra or similar assay result at screening. * Both males and females are included. Females are included with restrictions. Females must either be of non-childbearing potential, defined as pre-menarche, have a history of either current tubal ligation, hysterectomy, or ovariectomy, or post-menopause, or, if she is of childbearing potential, she has practiced abstinence from penile-vaginal intercourse or adequate contraception for 28 days prior to vaccination, has a negative pregnancy test on the day of screening and the day of first vaccination, and agrees to continue abstinence or adequate contraception until 2 months after the second dose of trial intervention. * HIV-negative test result at screening (IGRA-Positive Cohort and IGRA-Negative Cohort only). * HIV Cohort only: Participants with documented HIV infection who fulfill all of the following criteria: 1. Have reactive anti-HIV antibody at screening. 2. Have been on antiretroviral therapy (ART) for at least 3 consecutive months at screening and agree to remain on ART throughout the trial. 3. Have documented HIV Ribonucleic acid (RNA) \<200 copies per milliliter (/mL) at screening. 4. Have Cluster of differentiation (CD)4+ cell count ≥200 cells/microliter (μL) at screening. 5. Have had Tuberculosis preventive therapy (TPT) in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators. 6. Have an IGRA-positive or negative result at screening. Exclusion criteria: * Current TB, or history of TB or treatment for TB disease. * Clinical suspicion of pulmonary TB at screening, defined as a participant presenting with one or more of the following signs or symptoms: unexplained cough, unexplained fever, night sweats, unintentional weight loss, hemoptysis, pleuritic chest pain. * Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol, or that will interfere with the assessments or the safety of the participant. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., invasive, or malignant cancers), other than HIV infection in the HIV Cohort. * Known bleeding disorder that is considered a contraindication to intramuscular injection or phlebotomy. * Any cytotoxic drugs or administration of medications known to have a major impact on the immune system, as determined by the investigator, within 90 days prior to Day 1. These include immune globulin, blood, or blood products, potent immunosuppressants and immunomodulators, and systemic corticosteroids (exceeding 20 mg/day prednisone equivalent). Inhaled, topical, and intra-articular corticosteroids are allowed. * Planned receipt of blood, or blood products during the trial period. * Receipt or planned receipt of any vaccine in the period starting 28 days before, and ending 28 days after, each dose of the trial vaccine. * History of previous administration of an experimental Mtb vaccine including M72/AS01E in a previous trial. * History of allergy or hypersensitivity to the trial intervention, excipients, or related Substances. * An indeterminate IGRA test result at screening * Female participants with any one of the following conditions: currently pregnant or lactating; having positive serum pregnancy test during the screening window, positive urine pregnancy test on Day 1, planning a pregnancy within 2 months after completion of the vaccination series. * Only in the HIV Cohort: Safety laboratory values at screening that are of concern, based on investigator's judgment. Note that preexisting stable chronic disease will not necessarily lead to exclusion, especially if laboratory values are graded as mild. * Participation in an interventional clinical trial in which the participant has been or will be exposed to an investigational product (pharmaceutical product or device), within 28 days prior to signing consent or assent, or during the trial period. * Individuals who are acting as personnel for this trial, or who have immediate family members (brother, sister, child, parent, or the spouse/partner) who are acting as personnel for this trial. * Child in Care, defined as a child who is under the care (control or protection) of an agency, organization, institution or entity by the courts, the government body, acting in accordance with powers conferred in them by law or regulations. The definition of a child in care can include a child who is cared for by foster parents or living in a care home or institution, provided that the arrangements fall within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed LAR. * Participants who had a Tuberculin Skin Test (TST) within 6 months prior to Day 1.

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Conditions

The condition(s) this trial relates to.

tuberculosis prevention target

As listed by the trial registrant

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

Tuberculosis

Contacts and locations

Locations

  • 1001-Gates MRI Investigational Site

    Paarl, 7626, South Africa

  • 1002-Gates MRI Investigational Site

    Mtubatuba, 3935, South Africa

  • 1003-Gates MRI Investigational Site

    Cape Town, 7700, South Africa

  • 1004-Gates MRI Investigational Site

    Middelburg, 1050, South Africa

  • 1005-Gates MRI Investigational Site

    Pretoria, 0152, South Africa

  • 1006-Gates MRI Investigational Site

    Cape Town, 7530, South Africa

  • 1007-Gates MRI Investigational Site

    Johannesburg, 2193, South Africa

  • 1008-Gates MRI Investigational Site

    Cape Town, 7925, South Africa

  • 1009-Gates MRI Investigational Site

    Durban, 3610, South Africa

  • 1010-Gates MRI Investigational Site

    East London, 5201, South Africa

  • 1011-Gates MRI Investigational Site

    Soweto, 1818, South Africa

  • 1012-Gates MRI Investigational Site

    Ladysmith, 3370, South Africa

  • 1013-Gates MRI Investigational Site

    Port Elizabeth, 6001, South Africa

  • 1014-Gates MRI Investigational Site

    Jouberton, 2574, South Africa

  • 1015-Gates MRI Investigational Site

    Soweto, 2013, South Africa

  • 1016-Gates MRI Investigational Site

    Brits, 0250, South Africa

  • 1017-Gates MRI Investigational Site

    Klerksdorp, 2570, South Africa

  • 1018-Gates MRI Investigational Site

    Johannesburg, 1864, South Africa

  • 1019-Gates MRI Investigational Site

    Rustenburg, 0299, South Africa

  • 1020-Gates MRI Investigational Site

    Johannesburg, 2001, South Africa

  • 1021-Gates MRI Investigational Site

    Cape Town, 7405, South Africa

  • 1022-Gates MRI Investigational Site

    Cape Town, 7784, South Africa

  • 1023-Gates MRI Investigational Site

    Worcester, 6850, South Africa

  • 1024-Gates MRI Investigational Site

    Cape Town, 7505, South Africa

  • 1025-Gates MRI Investigational Site

    Tembisa, 1632, South Africa

  • 1026-Gates MRI Investigational Site

    Durban, 4068, South Africa

  • 1027-Gates MRI Investigational Site

    Kimberley, 8301, South Africa

  • 1028-Gates MRI Investigational Site

    Johannesburg, 1401, South Africa

  • 1029-Gates MRI Investigational Site

    Durban, 4091, South Africa

  • 1030-Gates MRI Investigational Site

    Vereeniging, 1935, South Africa

  • 1031-Gates MRI Investigational Site

    Johannesburg, 1811, South Africa

  • 1032-Gates MRI Investigational Site #1

    Tembisa, 1632, South Africa

  • 1033-Gates MRI Investigational Site

    Bloemfontein, 9301, South Africa

  • 1034-Gates MRI Investigational Site

    Cape Town, 7750, South Africa

  • 1201-Gates MRI Investigational Site

    Nairobi, 00202, Kenya

  • 1202-Gates MRI Investigational Site

    Kisumu, 40100, Kenya

  • 1203-Gates MRI Investigational Site

    Homa Bay, 40300, Kenya

  • 1204-Gates MRI Investigational Site

    Mombasa, 80103, Kenya

  • 1205-Gates MRI Investigational Site

    Eldoret, 30100, Kenya

  • 1206-Gates MRI Investigational Site

    Kericho, 20200, Kenya

  • 1207-Gates MRI Investigational Site

    Kilifi, 80108, Kenya

  • 1208-Gates MRI Investigational Site

    Machakos, 90100, Kenya

  • 1209-Gates MRI Investigational Site

    Nairobi, 00100, Kenya

  • 1301-Gates MRI Investigational Site

    Lusaka, 50697, Zambia

  • 1302-Gates MRI Investigational Site

    Lusaka, 10101, Zambia

  • 1303-Gates MRI Investigational Site

    Lusaka, 412, Zambia

  • 1304-Gates MRI Investigational Site

    Ndola, 240262, Zambia

  • 2201-Gates MRI Investigational Site

    Bandung, 40161, Indonesia

  • 2202-Gates MRI Investigational Site

    Jakarta, 10430, Indonesia

  • 2203-Gates MRI Investigational Site

    Jakarta, 13230, Indonesia

  • 2204-Gates MRI Investigational Site

    Depok, 16424, Indonesia

  • 2205-Gates MRI Investigational Site

    Jakarta, 10510, Indonesia

  • 2401-Gates MRI Investigational Site

    Lilongwe, 0149, Malawi

  • 2402-Gates MRI Investigational Site

    Chichiri, 30096, Malawi

More trials for these conditions

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