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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: | NCT00118924 |
Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere, especially Europe and Asia. TBE infection may lead to central nervous system problems and death. The purpose of this study is to test the safety of and immune response to a TBE vaccine in healthy adults. The vaccine is related to a live attenuated virus developed against dengue virus infection.
Condition | Intervention | Phase |
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Tick-Borne Encephalitis |
Biological: LGT(TP21)/DEN4 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 Tick-Borne Langat/Dengue 4 Chimera (LGT(TP21)/DEN4), a Live Attenuated Vaccine for Tick-Borne Encephalitis |
Enrollment: | 28 |
Study Start Date: | July 2005 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One subcutaneous vaccination with a 10^3 PFU dose of LGT(TP21)/DEN4 vaccine given in the deltoid region of either arm. A second booster vaccination will be given 6 months after the first vaccination.
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Biological: LGT(TP21)/DEN4
Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
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2: Experimental
One subcutaneous vaccination with a 10^5 PFU dose of LGT(TP21)/DEN4 vaccine given in the deltoid region of either arm. A second booster vaccination will be given 6 months after the first vaccination. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.
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Biological: LGT(TP21)/DEN4
Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
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3: Placebo Comparator
One subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm. A second placebo vaccination will be given 6 months after the first vaccination.
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Biological: Placebo
Placebo for LGT(TP21)/DEN4 vaccine
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TBE is a common illness in Europe and Asia, where it is usually associated with mild illness but sometimes leads to long-term symptoms and even death. This study will evaluate the safety and immunogenicity of a live attenuated chimeric virus, LGT(TP21)/DEN4, which is derived from the Langat flavivirus and DEN4 dengue virus serotypes.
Each volunteer will be involved in the study for 180 days. Participants in Cohort 1 will be randomly assigned to receive LGT(TP21)/DEN4 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 LGT(TP21)/DEN4 or placebo.
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, Tennessee | |
Vanderbilt University School of Medicine | |
Nashville, Tennessee, United States, 37232-2581 |
Principal Investigator: | Anna Durbin, MD | Center for Immunization Research, Johns Hopkins School of Public Health |
Principal Investigator: | Peter Wright, MD | Vanderbilt University School of Medicine |
Responsible Party: | Center for Immunization Research, Johns Hopkins School of Public Health ( Anna Durbin, MD ) |
Study ID Numbers: | CIR 182, H.22.03.09.26.B2 |
Study First Received: | July 8, 2005 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00118924 |
Health Authority: | United States: Food and Drug Administration |
Dengue Vaccine Tick-Borne Illnesses Flavivirus |
Central Nervous System Diseases Dengue fever Healthy Brain Diseases Encephalitis Tick-Borne Diseases Dengue Hemorrhagic Fever |
Encephalitis, Tick-Borne Virus Diseases Tick-borne encephalitis Central Nervous System Infections Dengue Arbovirus Infections |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |