A randomized, placebo controlled, double-blind (within dosing group), sequential dose escalation study. This phase 1 trial addresses the urgent need for a vaccine to prevent disease resulting from infection with West Nile virus (WNV), a virus that is primarily spread to people by the bite of an infected mosquito. The purpose of this Phase 1 trial is to evaluate the safety and immunogenicity of the HydroVax-001B WNV vaccine in healthy adult volunteers. The study Population will consist of healthy male and non-pregnant, non-breastfeeding female adults, 18 to 49 years of age, inclusive. Potential participants with a history of prior flavivirus infection or receipt of any flavivirus vaccine or monoclonal antibody, and those who likely had a prior flavivirus infection based on exposure history will be ineligible for the study. Participants will be randomized to receive HydroVax-001B WNV vaccine or placebo in a 12:3 ratio within a dosage group. Participants will be sequentially enrolled into two dosage groups. The primary objective is to assess the safety and reactogenicity of 4 mcg versus 10 mcg dose of the HydroVax-001B WNV vaccine administered intramuscularly (IM) on Days 1, 29 and 181.
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Frequency of any unsolicited adverse events (AEs)
Timeframe: Day 1 through Day 29
Frequency of related Grade 3 laboratory toxicities
Timeframe: Day 1 through Day 15
Frequency of related serious adverse events (SAE) overall and in each dose group through the end of the study
Timeframe: Day 1 through study completion, approximately 13 months
Frequency of solicited local adverse events (AEs)
Timeframe: Day 1 through Day 8
Frequency of solicited systemic adverse events (AEs)
Timeframe: Day 1 through Day 8
Incidence of any unsolicited adverse events (AEs)
Timeframe: Day 1 through Day 29
Incidence of related Grade 3 laboratory toxicities
Timeframe: Day 1 through Day 15
Incidence of related serious adverse events (SAE) overall and in each dose group through the end of the study
Timeframe: Day 1 through study completion, approximately 13 months
Incidence of solicited local adverse events (AEs)
Timeframe: Day 1 through Day 8
Incidence of solicited systemic adverse events (AEs)
Timeframe: Day 1 through Day 8
Severity of any unsolicited adverse events (AEs)
Timeframe: Day 1 through Day 29
Severity of solicited local adverse events (AEs)
Timeframe: Day 1 through Day 8
Severity of solicited systemic adverse events (AEs)
Timeframe: Day 1 through Day 8