6-year antibody check after third vaccination against Japanese Encephalitis
- Conditions
- Study population: adult volunteers who received a booster dose of JE-VC in prestudy IC51-311, no specific medical condition is investigated, only antibody check.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-004366-34-AT
- Lead Sponsor
- Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Subjects who received a booster dose of JE-VC in study IC51-311
Subjects who are willing to give written informed consent to participate in the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Subjects who received a further dose of any Japanese Encephalitis since study IC51-311
Subjects immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy.
Current participation in another trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective is to refine the mathematical modeling of antibody decline and the duration of protection following a booster of JE-VC.;Secondary Objective: Secondary objective is to determine the persistence of JEV neutralizing antibodies approximately 6 years after a booster dose of JE-VC.;Primary end point(s): Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT.;Timepoint(s) of evaluation of this end point: 2014
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 2014;Secondary end point(s): Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers = 1:10 in a PRNT50<br>SPR stratified by Tick-borne encephalitis vaccination history.<br>GMT stratified by Tick-borne encephalitis vaccination history.<br>Projected mean duration of protection after a booster dose of JE-VC.