6-year Antibody Check After Third Vaccination Against Japanese Encephalitis
The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.
Post Other Specified Vaccination Encephalitis
Other: Blood draw
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection|
- Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- Projected mean duration of protection after a booster dose of JE-VC [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age.
The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039440
|Institute for Specific Prophylaxis and Tropical Medicine||Not yet recruiting|
|Vienna, Kinderspitalgasse 15, Austria, 1090|
|Contact: Ines Zwazl 004314016038276 firstname.lastname@example.org|
|Principal Investigator: Herwig Kollaritsch, Prof. Dr.|
|Principal Investigator:||Herwig Kollaritsch, Prof. Dr.||Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15|