6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Phase 4

Completed

• Conditions: Post Other Specified Vaccination Encephalitis
• Interventions: Other: Blood draw

• Registration Number: NCT02039440
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Study Start: 2014-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

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Exclusion Criteria

• Subjects who received a further dose of any Japanese Encephalitis Vaccine 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
• simultaneous participation in another clinical study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Blood draw	1 blood draw

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT	1.5 years

Secondary Outcome Measures

Name	Time	Method
Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT	1.5 years

Trial Locations

Locations (1)

Institute for Specific Prophylaxis and Tropical Medicine; 🇦🇹 Vienna, Kinderspitalgasse 15, Austria