Clinical trial NCT00707642: Safety Study of HBV-002 West Nile Vaccine in Healthy Adults
Official title: Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: West Nile Virus Disease
Keywords: West Nile Virus
West Nile Vaccine
West Nile virus disease
Hawaii Biotech
Lead sponsor: Hawaii Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.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 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

Primary outcomes:
measure: Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects
timeFrame: 38 weeks
Secondary outcomes:
measure: To assess the immunogenicity of HBV-002
timeFrame: 38 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Covance Clinical Research Unit
state: Hawaii
Study officials:
affiliation: Hawaii Biotech
name: Jay Winship, M.D.
role: STUDY_DIRECTOR
References: