drugset / Trial / NCT00118924
Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults
Phase 1
Completed
28 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2005-07
- Primary completion
- 2007-07
- Completion
- 2007-07
Publications
- Background Beran J. Immunisation against tick-borne encephalitis by widely used vaccines: short-term history and current recommendations. Clin Microbiol Infect. 2005 May;11(5):424-6. doi: 10.1111/j.1469-0691.2005.01115.x. No abstract available.
- Background Chang GJ, Kuno G, Purdy DE, Davis BS. Recent advancement in flavivirus vaccine development. Expert Rev Vaccines. 2004 Apr;3(2):199-220. doi: 10.1586/14760584.3.2.199.
- Background Lai CJ, Monath TP. Chimeric flaviviruses: novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Virus Res. 2003;61:469-509. doi: 10.1016/s0065-3527(03)61013-4.
- Background Pletnev AG, Bray M, Hanley KA, Speicher J, Elkins R. Tick-borne Langat/mosquito-borne dengue flavivirus chimera, a candidate live attenuated vaccine for protection against disease caused by members of the tick-borne encephalitis virus complex: evaluation in rhesus monkeys and in mosquitoes. J Virol. 2001 Sep;75(17):8259-67. doi: 10.1128/jvi.75.17.8259-8267.2001.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LGT(TP21)/DEN4 | Vaccine | 1000 unknown | Subcutaneous |
| Subject | LGT(TP21)/DEN4 | Vaccine | 100000 unknown | Subcutaneous |