NCT05947890 Evaluating the Safety and Immunogenicity of MTBVAC
| NCT ID | NCT05947890 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | HIV Vaccine Trials Network |
| Condition | HIV I Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2027-04-05 |
Trial Parameters
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Brief 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
Eligibility Criteria
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 stud
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