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

NCT ID: NCT00707642

Last Updated: 2009-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

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.

Conditions

West Nile Virus Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

WN-80E

Intervention Type: BIOLOGICAL

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

2

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

Group Type: EXPERIMENTAL

WN-80E

Intervention Type: BIOLOGICAL

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

3

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

Group Type: EXPERIMENTAL

WN-80E

Intervention Type: BIOLOGICAL

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

4

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

Group Type: EXPERIMENTAL

WN-80E

Intervention Type: BIOLOGICAL

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

Interventions

WN-80E

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

WN-80E

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

Intervention Type: BIOLOGICAL

WN-80E

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

Intervention Type: BIOLOGICAL

Other Intervention Names

HBV-002 vaccine; HBV-002 vaccine; HBV-002 vaccine; HBV-002 vaccine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hawaii Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Hawaii Biotech

Principal Investigators

Jay Winship, M.D.

Role: STUDY_DIRECTOR

Hawaii Biotech

Locations

Covance Clinical Research Unit

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

HBV-002-C-101

Identifier Type: -

Identifier Source: org_study_id