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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05432583 | A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions | PHASE1 | ACTIVE NOT_RECRUITING | 318 | — | — | Dec 8, 2022 | Oct 1, 2026 | Oct 20, 2025 | 6 | United States |
For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
| Arm | Type | Description |
|---|---|---|
| Part A - BNT163 | EXPERIMENTAL | Escalating dose levels |
| Part A - Placebo | PLACEBO_COMPARATOR | Isotonic NaCl solution (0.9%) |
| Part B - BNT163 Dose 1 | EXPERIMENTAL | - |
| Part B - BNT163 Dose 2 | EXPERIMENTAL | - |
| Part C - BNT163 | EXPERIMENTAL | One fix dose level of BNT163 |
| Part C - Placebo | PLACEBO_COMPARATOR | Isotonic NaCl solution (0.9%) |
| Name | Type | Description |
|---|---|---|
| BNT163 | BIOLOGICAL | Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection |
| Placebo | OTHER | Placebo |
Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Have given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures. * Are aged 18 to 55 years, have a body mass index over 18.5 kg/m\^2 a...