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

Purpose

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

Condition	Intervention	Phase
West Nile Virus Disease	Biological: WN-80E	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults

Resource links provided by NLM:

Drug Information available for: Algeldrate

U.S. FDA Resources

Further study details as provided by Hawaii Biotech, Inc.:

Primary Outcome Measures:

Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects [ Time Frame: 38 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the immunogenicity of HBV-002 [ Time Frame: 38 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	May 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart Other Name: 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 [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart Other Name: HBV-002 vaccine
Experimental: 4 High Dose WN-80E API (50 µg), no adjuvant	Biological: WN-80E Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart Other Name: HBV-002 vaccine

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707642

Locations

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

Sponsors and Collaborators

Hawaii Biotech, Inc.

Investigators

Study Director:

Jay Winship, M.D.

Hawaii Biotech

More Information

No publications provided

Responsible Party:	Beth-Ann Coller, Ph.D., Hawaii Biotech
ClinicalTrials.gov Identifier:	NCT00707642 History of Changes
Other Study ID Numbers:	HBV-002-C-101
Study First Received:	June 29, 2008
Last Updated:	June 13, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hawaii Biotech, Inc.:

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

Additional relevant MeSH terms:

Virus Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013