6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Other Specified Vaccination Encephalitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single arm

1 blood draw

Group Type OTHER

Blood draw

Intervention Type OTHER

One-time blood draw

Interventions

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Blood draw

One-time blood draw

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes