Evaluating the Safety and Immunogenicity of MTBVAC

ConditionsHIV I Infection Tuberculosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age12-55

SponsorHIV Vaccine Trials Network

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

MTBVAC
Biological/Vaccine
The MTBVAC vaccine is a freeze-dried lyophilized pellet containing live attenuated strain MTBVAC01 derived from Mycobacterium tuberculosis (M.tb). Excipients include sucrose and sodium glutamate.
BCG
Biological/Vaccine
The active substance in BCG vaccine is a freeze-dried powder containing live attenuated Mycobacterium bovis BCG, Danish strain 1331 and sodium glutamate as a stabilizer. The powder is white and crystalline and may be difficult to see due to the small amount contained in each vial.

Treatment groups

276 Participants

are divided into 12 treatment groups

Treatment groups

See each treatment group below.

Group A: 1.1a - Adolescents and adults without HIV and negative interferon-gamma release assayExperimental treatment 1 intervention

Group B: 1.1b - Adolescents and adults without HIV and negative interferon-gamma release assayExperimental treatment 1 intervention

Group C: 1.2a - Adolescents and adults without HIV and positive interferon-gamma release assayExperimental treatment 1 intervention

Group D: 1.2b - Adolescents and adults without HIV and positive interferon-gamma release assayExperimental treatment 1 intervention

Group E: 2.1 a- Adolescents and adults with well-controlled HIV and negative interferon-gamma release assayExperimental treatment 1 intervention

Group F: 2.1.b - Adolescents and adults with well-controlled HIV and negative interferon-gamma release assayExperimental treatment 1 intervention

Group G: 2.2 a- Adolescents and adults with well-controlled HIV and positive interferon-gamma release assayExperimental treatment 1 intervention

Group H: 2.2 b- Adolescents and adults with well-controlled HIV and positive interferon-gamma release assayExperimental treatment 1 intervention

Group I: 3.1 a- Adults with well-controlled HIV and negative interferon-gamma release assayExperimental treatment 1 intervention

Group J: 3.1 b- Adults with well-controlled HIV and negative interferon-gamma release assayExperimental treatment 1 intervention

Group K: 3.2 a- Adults with well-controlled HIV and positive interferon-gamma release assayExperimental treatment 1 intervention

Group L: 3.2 b- Adults with well-controlled HIV and positive interferon-gamma release assayExperimental treatment 1 intervention