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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
28
Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
Placebo for LGT(TP21)/DEN4 vaccine
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance
Time frame: Throughout study
Immunogenicity of vaccine against anti-Langat neutralizing antibody
Time frame: At Days 0, 28, 42, and 180
Recovery of virus from the blood of a vaccinee or seroconversion
Time frame: Throughout study
Immunogenicity of the LGT(TP21)/DEN4 vaccine against other TBE viruses
Time frame: Throughout study
Durability of antibody responses to Langat and other TBE viruses
Time frame: At Day 180
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