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.
Age range
18 Years – 49 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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