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Safety Study of HBV-002 West Nile Vaccine in Healthy Adults

NCT00707642 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2009-06-16

No results posted yet for this study

Summary

The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.

Conditions

  • West Nile Virus Disease

Interventions

BIOLOGICAL

WN-80E

Three injections of the study vaccine \[Low Dose of WN-80E API (5 µg) + Alhydrogel (3.5 mg)\] given one month apart

BIOLOGICAL

WN-80E

Three injections of the study vaccine \[Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)\] given one month apart

BIOLOGICAL

WN-80E

Three injections of the study vaccine \[High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)\] given one month apart

BIOLOGICAL

WN-80E

Three injections of the study vaccine \[High Dose WN-80E API (50 µg)\] given one month apart

Sponsors & Collaborators

  • Hawaii Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Jay Winship, M.D. · Hawaii Biotech

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT00707642 on ClinicalTrials.gov