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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03483961 | Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults | PHASE2 | COMPLETED | 445 | — | — | Apr 18, 2018 | Sep 21, 2020 | Jul 3, 2023 | 3 | United States |
To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.
| Arm | Type | Description |
|---|---|---|
| Group 1: 20 mcg/unadjuvanted (Day 1 & 29) | EXPERIMENTAL | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) |
| Group 2: 6 mcg/adjuvanted (Day 1 & 29) | EXPERIMENTAL | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 3: 10 mcg/adjuvanted (Day 1 & 29) | EXPERIMENTAL | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547) | EXPERIMENTAL | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) |
| Group 5: 6 mcg/adjuvanted (Day 15 & 29) | EXPERIMENTAL | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 6: 10 mcg/adjuvanted (Day 15 & 29) | EXPERIMENTAL | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 7: 20 mcg/adjuvanted (Day 15 & 29) | EXPERIMENTAL | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 8: 40 mcg/adjuvanted (Day 29) | EXPERIMENTAL | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 9: 20 mcg/adjuvanted (Day 1 & 29) | EXPERIMENTAL | 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 |
| Group 10: 40 mcg/adjuvanted (Day 1) | EXPERIMENTAL | 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. |
| Name | Type | Description |
|---|---|---|
| CHIKV VLP/unadjuvanted | BIOLOGICAL | Vaccine consists of virus-like particles of chikungunya virus antigens |
| CHIKV VLP/adjuvanted | BIOLOGICAL | Adjuvanted formulation includes Alhydrogel |
| Placebo | BIOLOGICAL | Placebo is vaccine diluent alone |
Inclusion Criteria: 1. Male or female 2. Age 18 to 45 years old (inclusive) 3. Using an acceptable method of contraception (if female of childbearing potential). 4. Able and willing to provide informed consent for study participation. Exclusion Criteria: 1. Current acute febrile illness. 2. Clini...