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Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine in Healthy Adults

NCT06745921 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this 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

  • West Nile Viral Infection

Interventions

BIOLOGICAL

HydroVax-001B WNV

A vaccine to West Nile Virus (WNV) that is prepared by propagating naturally attenuated Kunjin strain of WNV on well characterized low-passage Vero cells. The vaccine contains 10 mcg of inactivated purified whole virion WNV formulated in a volume of 0.5 mL/dose with 0.10% aluminum hydroxide, 10% D-sorbitol, 0.001% Polysorbate 80 (Tween80) in 10 mM phosphate-buffer with 350 mM NaCl.

OTHER

Placebo

Placebo

OTHER

Sodium Chloride, 0.9%

0.9% Sodium Chloride Injection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-10-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745921 on ClinicalTrials.gov