drugset / Trial / NCT02933281
MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa
Phase 1/2
Completed
144 enrolled
International AIDS Vaccine Initiative
Biofabri, S.L · collabSouth African Tuberculosis Vaccine Initiative · collabUniversidad de Zaragoza · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
MTBVAC at four dose levels: 5 x 10\^3 CFU, 5 x 10\^4 CFU, 5 x 10\^5 CFU, and 5 x 10\^6 CFU. The active control is BCG (5 x 10\^5 CFU). Participants will receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0.
Timeline
- Start
- 2018-05-14
- Primary completion
- 2021-09-05
- Completion
- 2021-09-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BCG | Vaccine | 500000 unknown | Other |
| Subject | MTBVAC | Vaccine | 5000 unknown | Other |
| Subject | MTBVAC | Vaccine | 50000 unknown | Other |
| Subject | MTBVAC | Vaccine | 500000 unknown | Other |
| Subject | MTBVAC | Vaccine | 5e+06 unknown | Other |