At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
LGT(TP21)/DEN4 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 12, 2005·Updated Jan 21, 2008
In Brief
A Phase 1 clinical trial evaluating LGT(TP21)/DEN4 and Placebo for Tick-Borne Encephalitis. Completed, enrolled 28 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTick-Borne Encephalitis
CountriesUnited States
CollaboratorsJohns Hopkins Bloomberg School of Public Health
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedJul 2005
Primary CompletionJul 2007
TodayJul 2026
First PostedJul 12, 2005
Enrollment StartJul 1, 2005
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 21.0 years ago
Interventions
LGT(TP21)/DEN4biological
Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
Placebobiological
Placebo for LGT(TP21)/DEN4 vaccine