drugset / Trial / NCT02337868

Phase 1 Trial of Inactivated West Nile Virus Vaccine

NCT02337868 ↗

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

EvaluationDrugModalityDoseRoute
Subject HydroVax-001 Vaccine 1 ug Intramuscular
Subject HydroVax-001 Vaccine 4 ug Intramuscular

Indications