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

West Nile Virus Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707642
• Other study ID #: HBV-002-C-101
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2008
• Last updated: June 13, 2009
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Hawaii Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Virus Diseases
• West Nile Virus Disease

Intervention

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
• WN-80E
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
• WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
• WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Hawaii Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects		38 weeks	Yes
Secondary	To assess the immunogenicity of HBV-002		38 weeks	Yes