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ACTIVE NOT RECRUITING
NCT06745921
PHASE1

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine, HydroVax-001B WNV in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-02-24

Completion Date

2027-11-01

Last Updated

2026-04-03

Healthy Volunteers

Yes

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

Locations (1)

Saint Louis University Center for Vaccine Development

St Louis, Missouri, United States