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Phase 1 Trial of Inactivated West Nile Virus Vaccine

NCT02337868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-01-28

No results posted yet for this study

Summary

This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults \> /=18 and \< 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 4 mcg.

Conditions

  • West Nile Viral Infection

Interventions

BIOLOGICAL

HydroVax-001

HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29

OTHER

Placebo

0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-16
Completion
2016-12-16
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 NCT02337868 on ClinicalTrials.gov