NCT00707642

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

Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hawaii Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• West Nile Virus Disease

Interventions

Type	Name	Description
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
BIOLOGICAL	WN-80E	Three injections of the study vaccine \[Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)\] given one month apart
BIOLOGICAL	WN-80E	Three injections of the study vaccine \[High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)\] given one month apart
BIOLOGICAL	WN-80E	Three injections of the study vaccine \[High Dose WN-80E API (50 µg)\] given one month apart

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-07-01
• Last updated: 2009-06-16

Locations

1 site across 1 country: United States