Safety Study of HBV-002 West Nile Vaccine in Healthy Adults
Completed · Phase 1
Conditions studied: West Nile Virus Disease
In brief
The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.
Key facts
- Study ID
- NCT00707642
- Run by
- Hawaii Biotech, Inc.
- People needed
- 25
- Starts
- 2008-05-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2009-06-16
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Covance Clinical Research Unit — Honolulu, Hawaii, United States
Full record on ClinicalTrials.gov
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