6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Phase 4CompletedNCT02039440

Medical University of Vienna67 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Post Other Specified Vaccination Encephalitis

Interventions

Blood drawOTHER

One-time blood draw

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute for Specific Prophylaxis and Tropical Medicine

Vienna, Kinderspitalgasse 15, Austria

Outcomes

Primary Outcomes

Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT

Time frame: 1.5 years

Secondary Outcomes

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

Time frame: 1.5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.