Status:
COMPLETED
Safety Study of HBV-002 West Nile Vaccine in Healthy Adults
Lead Sponsor:
Hawaii Biotech, Inc.
Conditions:
West Nile Virus Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00707642
Start Date
May 1 2008
End Date
June 1 2009
Last Update
June 16 2009
Active Locations (1)
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1
Covance Clinical Research Unit
Honolulu, Hawaii, United States, 96813