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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03992872 | Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317) | PHASE2 | COMPLETED | 60 | — | — | Nov 20, 2019 | Jan 19, 2021 | Oct 16, 2024 | 2 | United States |
Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317. PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.
| Arm | Type | Description |
|---|---|---|
| Prior Alpha | EXPERIMENTAL | All study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines. |
| Control: Naïve Alpha | ACTIVE_COMPARATOR | All study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve participants will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity. |
| Name | Type | Description |
|---|---|---|
| Chikungunya | BIOLOGICAL | Virus Like Particle |
Inclusion Criteria: * Age 18 to 65 years old (inclusive) * For women of childbearing potential, a negative pregnancy test at screening and on vaccination day, practicing highly effective contraception for at least 30 days prior to vaccination, and willing to use a highly effective method of contrac...