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Sponsored by: |
Hawaii Biotech, Inc. |
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Information provided by: | Hawaii Biotech, Inc. |
ClinicalTrials.gov Identifier: | NCT00707642 |
The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.
Condition | Intervention | Phase |
---|---|---|
West Nile Virus Disease |
Biological: WN-80E |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults |
Estimated Enrollment: | 24 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Low Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg)
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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
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2: Experimental
Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)
|
Biological: WN-80E
Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart
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3: Experimental
High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)
|
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart
|
4: Experimental
High Dose WN-80E API (50 µg), no adjuvant
|
Biological: WN-80E
Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
|
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hawaii Biotech ( Beth-Ann Coller, Ph.D. ) |
Study ID Numbers: | HBV-002-C-101 |
Study First Received: | June 29, 2008 |
Last Updated: | November 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00707642 |
Health Authority: | United States: Food and Drug Administration |
West Nile Virus West Nile Vaccine West Nile virus disease Hawaii Biotech |
Virus Diseases West nile virus Healthy Aluminum Hydroxide |