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Evaluating the Safety and Immunogenicity of MTBVAC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Evaluating the Safety and Immunogenicity of MTBVAC

A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of MTBVAC

NCT05947890•HIV Vaccine Trials Network

Summary

The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa

Detailed Description

This study will evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa. The study will be conducted in two parts (Part A and B). Part A will include two Cohorts (Cohort 1 and 2) and each Cohort will have four groups. Part B will have one Cohort which will also have four groups. Participants will be recruited into three cohorts (Cohorts 1-3) based on their HIV status and, for People Living With HIV, their CD4+ T cell count and WHO clinical stage prior to ART initiation/re-initiation. Within each cohort, they will be stratified into subgroups based on their IGRA status. For Cohorts 1 and 2 which will enroll simultaneously, participants will be randomized to receive MTBVAC or BCG according to the ratio of the planned sample sizes within the cohort; there is no placebo group in this trial. Enrollment of Cohort 3 will proceed if safety criteria are met for Cohorts 1 and 2, with randomization to MTBVAC and BCG. Participants in all groups will receive a single ID study product injection of 0.1 mL in volume and will be followed for 48 weeks.

Eligibility

Age

12 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age of 12 through 55 years, on the day of enrollment.
•Access to a participating HVTN or ACTG CRS and willingness to be followed for the planned duration of the study.
•For volunteers 18 years of age or older: ability and willingness to provide informed consent.
•For volunteers less than 18 years of age: parent or legal guardian is willing and able to provide informed consent for potential participant's study participation; in addition, when applicable per ethics committee policies and procedures, potential participant is willing and able to provide written assent for study participation.
•Assessment of Understanding (AoU): volunteer demonstrates understanding of this study and completes a questionnaire prior to vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
•Prior receipt of BCG vaccine in infancy as determined by the site investigator.
•Agrees not to enroll in another study of an investigational study product until after the last scheduled clinic visit. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 605/A5421 PSRT are required prior to enrollment into HVTN 605/A5421.
•Good general health as shown by medical history, physical exam, and screening laboratory tests and assessed by the site investigator.
•Willingness to receive HIV-related test results.
•For volunteers living without HIV:
+18 more criteria

Exclusion Criteria

•Weight less than 40 kg
•Known significant exposure to TB or receipt of tuberculin skin test in the six months prior enrollment, as determined by the site investigator based on potential participant/parent/guardian report and available medical records. \[Note: Significant exposure is defined as close contact with a person who has active TB and has not completed TB treatment. Close contact is defined as sleeping in the same contiguous house/dwelling, and/or working or socializing in close proximity in an enclosed space frequently (eg, several times a week).\]
•History of prior active TB disease, as determined by the site investigator based on participant/parent/guardian report and available medical, laboratory or radiographic records.
•Evidence of active TB disease as determined by the site investigator based on participant/parent/guardian report and available medical records, results from physical examination, two-view chest X-ray, and M.tb nucleic acid testing from an expectorated sputum, including a review of any available radiography; and, for volunteers living with HIV and a CD4 count \<200 cells/mm3, a positive urine LAM test.
•Receipt of TB preventive therapy within 28 days prior to enrollment or expected to initiate TB preventive therapy during the study as determined by the site investigator based on participant/parent/guardian report and available medical records Note: Clinical indication for receipt of TB preventive therapy will be determined by the site investigator consistent with local standard guidelines. Potential participants on TB preventive therapy during screening may be enrolled once the exclusionary timeframes indicated above have elapsed. If the screening period is exceeded while this requirement is being met, a new screening attempt should be initiated.
•For volunteers living with HIV: current active AIDS-defining condition as determined by the site investigator based on participant/parent/guardian report and available medical records
•Blood products received within 120 days before vaccination.
•Investigational study products (non-vaccine) received within 28 days before vaccination.
•Pregnant or breastfeeding.
•Investigational TB vaccine(s) received in a prior TB vaccine trial or BCG vaccination outside infancy. For volunteers who have received control/placebo in a TB vaccine trial, the HVTN 605/A5421 PSRT will determine eligibility on a case-by-case basis.
+29 more criteria

Locations (16)

Soweto - Gauteng

Johannesburg, Gauteng, South Africa

Johannesburg - CHRU

Westdene, Gauteng, South Africa

Durban - Botha's Hill CRS

Durban, KwaZulu-Natal, South Africa

Durban - Wentworth

Durban, KwaZulu-Natal, South Africa

Cape Town - UCTLI

Cape Town, Western Cape, South Africa

Cape Town - Emavundleni

Cape Town, Western Cape, South Africa

Cape Town - Groote Schuur

Cape Town, Western Cape, South Africa

Worcester - SATVI

Worcester, Western Cape, South Africa

Cape Town - Khayelitsha

Cape Town, South Africa

Durban - Chatsworth

Chatsworth, South Africa

Key Dates

Start Date

January 30, 2024

Primary Completion Date

April 5, 2027

Completion Date

April 5, 2027

Last Updated

March 12, 2026

Enrollment

276

ESTIMATED participants

Conditions

HIV I InfectionTuberculosis

Interventions

MTBVAC

BIOLOGICAL

BCG

BIOLOGICAL

Contacts

Kylie McCloskey

CONTACT

206-667-7629 kmcclosk@fredhutch.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating the Safety and Immunogenicity of MTBVAC

Inclusion Criteria

Exclusion Criteria

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