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

NCT00707642 | Completed Phase 1 DMC

• 1 other identifier: HBV-002-C-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

West Nile Virus Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  38 weeks

Secondary Outcomes (1)

• To assess the immunogenicity of HBV-002

  38 weeks

Study Arms (4)

1

EXPERIMENTAL

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

Biological: WN-80E

2

EXPERIMENTAL

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

Biological: WN-80E

3

EXPERIMENTAL

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

Biological: WN-80E

4

EXPERIMENTAL

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

Biological: WN-80E

Interventions

WN-80E BIOLOGICAL

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

Also known as: HBV-002 vaccine

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawaii Biotech, Inc.: lead

Study Sites (1)

Covance Clinical Research Unit

Honolulu, Hawaii, 96813, United States

Location

Study Officials

• Jay Winship, M.D.

  Hawaii Biotech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2008
• First Posted: July 1, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

US (1)