West Nile Viral Infection Clinical Trial
Official title:
A Double Blind, Randomized, Placebo-Controlled, Phase I Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine, HydroVax-001, in Healthy Adults
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.
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 at a single site. The study will consist of two dosing groups of HydroVax-001 vaccine to be enrolled sequentially. Each dose group will consist of 20 individuals who receive HydroVax-001 and 5 who receive placebo. Controls will receive sterile 0.9 percent NaCl placebo intramuscularly at days 1 and 29. The study duration is approximately 25 months (12 month enrollment, 13 month follow up) and subject participation duration of approximately 14 months. 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. The secondary objective is to assess WNV-specific plaque reduction neutralization test (PRNT50) responses after a first dose and after a second dose of HydroVax-001 WNV vaccine given at doses of 1 mcg and 4 mcg. This study aims to recruit up to 50 men and women between the ages of 18 and 50. The study duration is approximately 25 months at a single site and subject participation duration is approximately 14 months. ;