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

Primary Purpose

West Nile Virus Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

WN-80E

About this trial

This is an interventional prevention trial for West Nile Virus Disease focused on measuring West Nile Virus, West Nile Vaccine, West Nile virus disease, Hawaii Biotech

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Covance Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Low Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg)

Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)

High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)

High Dose WN-80E API (50 µg), no adjuvant

Outcomes

Primary Outcome Measures

Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects

Secondary Outcome Measures

To assess the immunogenicity of HBV-002

Full Information

NCT ID

NCT00707642

First Posted

June 29, 2008

Last Updated

June 13, 2009

Sponsor

Hawaii Biotech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00707642

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hawaii Biotech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

West Nile Virus Disease

Keywords

West Nile Virus, West Nile Vaccine, West Nile virus disease, Hawaii Biotech

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Low Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg)

Arm Title

Arm Type

Experimental

Arm Description

Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)

Arm Title

Arm Type

Experimental

Arm Description

High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)

Arm Title

Arm Type

Experimental

Arm Description

High Dose WN-80E API (50 µg), no adjuvant

Intervention Type

Biological

Intervention Name(s)

WN-80E

Other Intervention Name(s)

HBV-002 vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

WN-80E

Other Intervention Name(s)

HBV-002 vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

WN-80E

Other Intervention Name(s)

HBV-002 vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

WN-80E

Other Intervention Name(s)

HBV-002 vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects

Time Frame

38 weeks

Secondary Outcome Measure Information:

Title

To assess the immunogenicity of HBV-002

Time Frame

38 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jay Winship, M.D.

Organizational Affiliation

Hawaii Biotech

Official's Role

Study Director

Facility Information:

Facility Name

Covance Clinical Research Unit

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

12. IPD Sharing Statement

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

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