Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05547464 | Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers | PHASE1 | ACTIVE NOT_RECRUITING | 497 | — | — | Jul 31, 2023 | Jan 1, 2027 | Mar 18, 2026 | 8 | Mozambique, South Africa |
| NCT05537038 | Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers | PHASE1 | COMPLETED | 120 | — | — | Apr 18, 2023 | Dec 8, 2025 | Dec 22, 2025 | 3 | Germany |
Part A and Part B
Part A and Part B
Part A and Part B
Part A and Part B
Part A and Part B. In Part A, from Dose 1 up to 168 days post-Dose 3. In Part B, from Dose 1 up to 28 days post- Dose 3.
Part A and Part B
| Arm | Type | Description |
|---|---|---|
| Part A: BNT164a1 | EXPERIMENTAL | Escalating dose levels |
| Part A: BNT164b1 | EXPERIMENTAL | Escalating dose levels |
| Part B: BNT164a1 Dose level (DL) 1 | EXPERIMENTAL | - |
| Part B: BNT164a1 DL 2 | EXPERIMENTAL | - |
| Part B: BNT164b1 DL 1 | EXPERIMENTAL | - |
| Part B: BNT164b1 DL 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Isotonic sodium chloride (NaCl) solution (0.9%) |
| BNT164a1 | EXPERIMENTAL | Escalating dose levels |
| BNT164b1 | EXPERIMENTAL | Escalating dose levels |
| Name | Type | Description |
|---|---|---|
| BNT164a1 | BIOLOGICAL | Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection |
| BNT164b1 | BIOLOGICAL | Multi-antigen RNA vaccine for active immunization against tuberculosis administered as intramuscular injection |
| Placebo | OTHER | Placebo |
Inclusion Criteria (applicable to Part A and Part B unless otherwise specified): * Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures. * Are 18 to 55 years of age inclusive (in Part A) or 18 years of age or older (in Part B)...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |