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NCT06745921 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy Adults
A Phase 1 study of West Nile Viral Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06745921: Active Phase 1 study of West Nile Viral Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06745921 is a Phase 1 study of West Nile Viral Infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06745921, a Phase 1 study of West Nile Viral Infection, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Sodium Chloride, 0.9%
- BIOLOGICAL HydroVax-001B WNV
Study Locations (1)
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 1 |
What the registry record for NCT06745921 still lists
NCT06745921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with West Nile Viral Infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06745921 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06745921 about?
NCT06745921 is a clinical study titled "Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy Adults". 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 infe...
What is the current status of trial NCT06745921?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-02-24. Estimated completion is 2027-11-01.
What conditions does trial NCT06745921 study?
This clinical trial studies the following conditions: West Nile Viral Infection.
What interventions are being tested in trial NCT06745921?
The interventions under investigation include: Placebo (OTHER), Sodium Chloride, 0.9% (OTHER), HydroVax-001B WNV (BIOLOGICAL).
Who is sponsoring clinical trial NCT06745921?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06745921 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06745921's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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