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.; MedDRA version: 16.1Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 16.1Level: LLTClassification code 10069544Term: Japanese encephalitis immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 16.1Level: LLTClassification code 10023120Term: Japanese B viral encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 16.1Level: PTClassification code 10069535Term: Japanese encephalitis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1Level: LLTClassification code 10023119Term: Japanese B encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 16.1Level: LLTClassification code 10023122Term: Japanese B virus encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 16.1Level: PTClassification code 10014596Term: Encephalitis Japanese BSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2013-004366-34-DE
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-22
• Last Update Posted: 27 October 2014

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.
Severe 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
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.;Timepoint(s) of evaluation of this end point: 2014