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

June 13, 2009 updated by: Hawaii Biotech, Inc.

Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been identified by the CDC as a significant public health risk. Since the introduction of West Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the U.S. and parts of Canada. In addition, more recent findings show evidence of West Nile virus human and equine infection in several countries of tropical America. The virus has now been found in bird populations in all 48 states of the continental U.S, and human cases of West Nile disease have been documented in 45 states and the District of Columbia. To date, there is no approved commercial vaccine available for prevention of West Nile virus disease in humans.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ECG, clinical laboratory evaluation [hematology, biochemistry, urinalysis])
  • Body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 Metropolitan Life table

Exclusion Criteria:

  • Current active infection process including URI or influenza
  • Positive serum test for HIV, Hepatitis B surface antigens and/or Hepatitis C antibodies
  • History of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: West Nile, 4 dengue serotypes, yellow fever (YF), and Japanese encephalitis (JE)
  • Subject has resided in flavivirus (West Nile, 4 dengue serotypes, YF, and JE) endemic areas or has a history of receipt of Yellow Fever or Japanese encephalitis virus vaccines
  • History of alcohol or other substance abuse within 1 year of screening
  • Use of corticosteroids or immunosuppressive drugs within 30 days of screening (Use of topical or nasal corticosteroids are not excluded.)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Administration of immunoglobulins within three months of the first vaccination or planned during the study period
  • Receipt of any vaccines or investigational or non-registered product other than HBV-002 within 30 days prior to screening or planned receipt throughout the study.
  • Receipt of another study vaccines within 30 days prior to screening
  • Receipt of blood products within 6 months of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Low Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg)
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
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
Other Names:
  • HBV-002 vaccine
Experimental: 2
Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)
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
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
Other Names:
  • HBV-002 vaccine
Experimental: 3
High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)
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
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
Other Names:
  • HBV-002 vaccine
Experimental: 4
High Dose WN-80E API (50 µg), no adjuvant
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
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
Other Names:
  • HBV-002 vaccine
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
Other Names:
  • HBV-002 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects
Time Frame: 38 weeks
38 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the immunogenicity of HBV-002
Time Frame: 38 weeks
38 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawaii Biotech, Inc.

Investigators

  • Study Director: Jay Winship, M.D., Hawaii Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 29, 2008

First Submitted That Met QC Criteria

June 29, 2008

First Posted (Estimate)

July 1, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2009

Last Update Submitted That Met QC Criteria

June 13, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV-002-C-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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