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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03425149 | Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults | PHASE1 | COMPLETED | 67 | — | — | Feb 24, 2018 | Nov 16, 2018 | Jul 5, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment Group I | EXPERIMENTAL | 0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.5 ml Placebo on Day 7 |
| Treatment Group II | EXPERIMENTAL | 0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.5 ml Placebo on Day 28 |
| Treatment Group III | EXPERIMENTAL | 0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.25 ml Placebo on Day 7 |
| Treatment Group IV | EXPERIMENTAL | 0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.25 ml Placebo on Day 28 |
| Treatment Group V | PLACEBO_COMPARATOR | 0.5 ml Placebo on Day 0, 7 and 28 |
| Name | Type | Description |
|---|---|---|
| VLA1601 | BIOLOGICAL | purified inactivated ZIKV vaccine candidate adsorbed on alum |
| Placebo | BIOLOGICAL | Phosphate buffered saline (PBS) |
Inclusion Criteria: 1. Subject is 18 to 49 years of age on the day of screening (Visit 0); 2. Subject has a Body Mass Index (BMI) of ≥18.5 and \<30 kg/m2 on the day of screening (Visit 0); 3. Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written i...