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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Center for Immunization Research |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00094718 |
West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis, coma, and death. The purpose of this study is to test the safety of and immune response to a WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed against dengue virus.
Condition | Intervention | Phase |
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West Nile Fever Encephalitis |
Biological: WN/DEN4-3'delta30 Biological: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase 1 Study of the Safety and Immunogenicity of West Nile/Dengue-4 3'delta30 Chimeric Virus Vaccine (WN/DEN4-3'delta30), a Live Attenuated Vaccine for West Nile Encephalitis |
Enrollment: | 56 |
Study Start Date: | February 2005 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
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Biological: WN/DEN4-3'delta30
Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses)
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2: Experimental
One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^4 PFU dose) into the deltoid region of either arm. This arm may enroll after the results from Arm 1 are analyzed.
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Biological: WN/DEN4-3'delta30
Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses)
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3: Experimental
One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^5 PFU dose) into the deltoid region of either arm. This arm may enroll after the results from Arm 2 are analyzed.
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Biological: WN/DEN4-3'delta30
Live attenuated WN/DEN4-3'delta30 vaccine (one of three doses)
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4: Placebo Comparator
One subcutaneous vaccination with placebo vaccine into the deltoid region of either arm.
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Biological: Placebo
Placebo for WN/DEN4-3'delta30 vaccine
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WN is widely distributed in Africa and Europe, where it is usually associated with mild illness. In the United States, WN is considered a public health threat because severe illness caused by WN infection has caused paralysis, coma, and death, especially in the elderly. This study will evaluate the safety and immunogenicity of a live attenuated chimeric virus, WN/DEN4-3'delta30, which is derived from the DEN4 dengue virus and wild-type WN serotypes.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive the lowest dose of WN/DEN4-3'delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of WN/DEN4-3'delta30 or placebo. Cohort 3 will begin only after safety review of all participants in Cohort 2. Participants in Cohort 3 will receive the highest dose of WN/DEN4-3'delta30 or placebo. Immediately after receiving their injections, participants will be observed for 30 minutes for immediate adverse reactions.
After vaccination, participants will be asked to monitor their temperatures every day for 16 days and on Day 19. Study visits will occur every other day after vaccination until Day 16, followed by 5 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins School of Public Health | |
Baltimore, Maryland, United States, 21205 | |
United States, Tennessee | |
Vanderbilt University School of Medicine | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Anna Durbin, MD | Center for Immunization Research, Johns Hopkins School of Public Health |
Responsible Party: | Center for Immunization Research, Johns Hopkins School of Public Health ( Anna Durbin, MD ) |
Study ID Numbers: | CIR 206, H.22.04.10.06.A1 |
Study First Received: | October 21, 2004 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00094718 |
Health Authority: | United States: Food and Drug Administration |
Chimeric Virus Vaccine West Nile Virus Dengue Virus |
West Nile Fever Central Nervous System Diseases Dengue fever Healthy Brain Diseases Encephalitis Dengue Hemorrhagic Fever |
Fever Virus Diseases Central Nervous System Infections Dengue West nile virus West nile encephalitis Arbovirus Infections |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |