A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

NCT06272812 | Recruiting Phase 2 DMC

• 1 other identifier: IAVI C113
• Study Type: interventional
• Target: 5,500
• Locations: 3 countries
• Sites: 16

Brief Summary

A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.

Conditions

Tuberculosis (TB)

Outcome Measures

Primary Outcomes (1)

• To evaluate the protective efficacy of MTBVAC against bacteriologically confirmed PTB, not associated with HIV infection, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment, in baseline IGRA-positives.

  Incident cases of definite pulmonary TB disease in baseline IGRA-positive participants with clinical suspicion of pulmonary TB disease, with Mtb identified by at least two positive diagnostic tests (two positive microbiological cultures or two positive Xpert MTB/RIF Ultra assays, or one positive of each) from sputum specimens taken before initiation of TB treatment and confirmed HIV-negative at the time of TB diagnosis, over a period starting 28 days following vaccination and lasting up to 36 months post vaccination.

  36 Months

Secondary Outcomes (13)

• To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment.

  36 Months

• To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo.

  36 months

• To evaluate the protective efficacy of one dose of MTBVAC against definite Xpert MTB/RIF Ultra positive pulmonary TB disease not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo.

  36 months

• To evaluate the protective efficacy of one dose of MTBVAC against clinical TB, as compared to placebo, in the entire study population.

  36 Months

• To assess the safety and reactogenicity of one dose of MTBVAC, overall and stratified by IGRA status at baseline.

  6 months

Study Arms (2)

MTBVAC

EXPERIMENTAL

MTBVAC

Biological: MTBVAC

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

MTBVAC BIOLOGICAL

Vaccine Dose: MTBVAC 5x10\^5 Formulation (approximately, per standard dose): 3 - 17x10\^5 CFU Sucrose Sodium glutamate Presentation: Lyophilized pellet in vials (10 doses) Volume: 0.1 mL/dose Intradermal

MTBVAC

Placebo BIOLOGICAL

0.9% saline Volume: 0.1 mL/dose Intradermal

Placebo

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Is male or female aged 14 through 45 years on Study Day 1.
• 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.
• 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)
• Has general good health as confirmed by medical history and physical examination.
• 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:
• Condoms (male or female) with or without spermicide
• Diaphragm or cervical cap with spermicide
• Intrauterine device
• Hormonal contraception (combined estrogen and progestogen, or progestogen-only), including contraceptive implant or injectable
• 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
• 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.
• 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.
• All male participants should agree to use barrier contraception with their female partners for at least 2 weeks after vaccination.
• 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.

You may not qualify if:

• Acute illness and/or axillary temperature ≥37.5°C on Study Day 1.
• 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.
• History of previous TB disease and/or treatment for TB disease.
• History of TB preventative therapy, not including BCG vaccination.
• Received any investigational drug or investigational vaccine within 42 days before Study Day 1, or planned use during the study period.
• 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.
• 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.
• Chronic administration of immunosuppressive medication within 42 days before Study Day 1 (inhaled and topical corticosteroids are permitted).
• Any confirmed or suspected immunosuppressive, immunodeficient, or autoimmune condition based on medical history and physical examination (no laboratory testing required).
• Received immunoglobulin or blood products within 42 days before Study Day 1, or planned administration during the study period.
• History or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Pregnant or lactating/nursing female, or positive urine pregnancy test during screening or pre-vaccination on Study Day 1.
• Indeterminate IGRA test result at screening.
• 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.

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Biofabri, SLU: collaborator
• Universidad de Zaragoza: collaborator

Study Sites (16)

Victoria Biomedical Research Institute

Kisumu, Kenya

RECRUITING

Kenya Medical Research Institute

Nairobi, Kenya

RECRUITING

JOSHA Research

Bloemfontein, South Africa

RECRUITING

South African Tuberculosis Vaccine Initiative

Cape Town, South Africa

RECRUITING

TASK Applied Science Pty Ltd. TASK Delft

Cape Town, South Africa

RECRUITING

UCTLI CLII - Centre for Lung Infection and Immunity

Cape Town, South Africa

RECRUITING

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

Cape Town, South Africa

RECRUITING

Wellcome Centre for Infectious Diseases Research in Africa

Cape Town, South Africa

RECRUITING

Synergy Biomedical Research Institute

East London, South Africa

RECRUITING

TASK Eden Pty Ltd.

George, South Africa

RECRUITING

Perinatal HIV Research Unit

Johannesburg, South Africa

RECRUITING

Be Part Research Pty Ltd.

Paarl, South Africa

RECRUITING

The Aurum Institute Rustenburg Clinical Research Centre

Rustenburg, South Africa

RECRUITING

Desmond Tutu Health Foundation, Masiphumelele Research Office

Sunnydale, South Africa

NOT YET RECRUITING

The Aurum Institute Tembisa Clinical Research Centre

Tembisa, South Africa

RECRUITING

Ifakara Health Institute

Dar es Salaam, Tanzania

NOT YET RECRUITING

MeSH Terms

Conditions

Tuberculosis

Interventions

MTBVAC vaccine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Elana Van Brakel, MD

CONTACT

27.21.344.1200; evanbrakel@iavi.org

Ansuya Naidoo, MBChB

CONTACT

+27724152138; ANaidoo@iavi.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 22, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

ZA (13); KE (2); TA (1)