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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: | NCT00537147 |
West Nile (WN) virus infection is an emerging disease. Infection with WN virus may lead to paralysis, coma, and death. The purpose of this study is to determine the safety of and immune response to a two-dose regimen of 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 |
Biological: WN/DEN4delta30 vaccine 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 a 2-Dose Regimen of West Nile/Dengue 4-3'delta30 Chimeric Virus Vaccine (WN/DEN4delta30), a Live Attenuated Vaccine for West Nile Encephalitis |
Estimated Enrollment: | 50 |
Study Start Date: | September 2009 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1 vaccination of a 10^4 plaque-forming units (PFU) dose of WN/DEN4delta30 vaccine administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.
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Biological: WN/DEN4delta30 vaccine
Live attenuated WN/DEN4delta30 vaccine (one of two doses)
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2: Experimental
1 vaccination of a 10^5 PFU dose of WN/DEN4delta30 vaccine administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.
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Biological: WN/DEN4delta30 vaccine
Live attenuated WN/DEN4delta30 vaccine (one of two doses)
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3: Placebo Comparator
1 vaccination of a placebo administered as 0.5 ml subcutaneously in deltoid at study entry and Day 180.
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Biological: Placebo
Placebo for WN/DEN4delta30 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/DEN4delta30, which is derived from the DEN4 dengue virus and wild-type WN serotypes.
This study will last at least 32 weeks. Participants in Cohort 1 will be randomly assigned to receive 1X10^4 plaque-forming units (PFU) WN/DEN4delta30 or placebo at study entry and Day 180. Cohort 2 will be randomly assigned to receive a higher dose of WN/DEN4delta30, 10^5 PFU, or placebo at study entry and Day 180. Immediately after receiving their injections, participants will be observed for 30 minutes for immediate adverse reactions.
After each vaccination, participants will be asked to monitor their temperatures three times every day for 16 days. Study visits will occur every other day after each vaccination until Day 16, followed by three additional visits at selected days through Day 180 post-vaccination. Blood collection, medical history, vital signs measurement, and a targeted physical exam will occur at all visits. Participants will also be required to keep temperature diaries until Day 16 after vaccination. Female participants will have a urine pregnancy test performed within 60 days of study entry, and on Days 28, 42, 150, 180, 208, and 222. Pregnancy prevention counseling will occur 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, District of Columbia | |
Center for Immunization Research, Johns Hopkins School of Public Health (DC Location) | |
Washington, District of Columbia, United States, 20037 | |
United States, Maryland | |
Center for Immunization Research, Johns Hopkins School of Public Health (MD Location) | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Anna Durbin, M.D. | Center for Immunization Research (CIR), 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 242, WIRB Protocol Number 20071891 |
Study First Received: | September 27, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00537147 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chimeric West Nile Virus West Nile Virus Dengue Virus |
Dengue Fever West Nile Fever Central Nervous System Diseases West Nile Encephalitis Healthy Encephalitis Dengue Hemorrhagic Fever |
Fever Virus Diseases Central Nervous System Infections Dengue West Nile Virus Arbovirus Infections |
RNA Virus Infections Flavivirus Infections Flaviviridae Infections West Nile Fever Nervous System Diseases Central Nervous System Diseases Central Nervous System Viral Diseases |
Encephalitis Virus Diseases Encephalitis, Viral Central Nervous System Infections Arbovirus Infections Encephalitis, Arbovirus |