drugset / Trial / NCT02337868
Phase 1 Trial of Inactivated West Nile Virus Vaccine
RandomizedParallel-groupDouble-blindPrevention
Summary
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults \> /=18 and \< 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 4 mcg.
Timeline
- Start
- 2015-03-31
- Primary completion
- 2016-12-16
- Completion
- 2016-12-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HydroVax-001 | Vaccine | 1 ug | Intramuscular |
| Subject | HydroVax-001 | Vaccine | 4 ug | Intramuscular |