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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Occurrence of any AE related to the study vaccine through day 57 after the second vaccination
Timeframe: Day 1 post first vaccination to Day 57 post second vaccination
Occurrence of Grade 3 laboratory toxicities related to the study vaccine from first vaccination through day 15 after the second vaccination
Timeframe: Day 1 post first vaccination to Day 15 post second vaccination
Occurrence of Grade 3 unsolicited adverse events related to the study vaccine from first vaccination through day 57 after the second vaccination
Timeframe: Day 1 post first vaccination to Day 57 post second vaccination
Occurrence of SAEs related to the study vaccine at any time during the study
Timeframe: Day 1 post first vaccination to Day 365 post second vaccination
Occurrence of solicited local AE and reactogenicity signs and symptoms in the 14 days after each vaccination
Timeframe: Day 1 post first vaccination to Day 14 post first and second vaccination
Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 14 days after each vaccination
Timeframe: Day 1 post first vaccination to Day 14 post first and second vaccination