Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children

Study Overview
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Brief Summary
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This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.

Detailed Description
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This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.

Official Title
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Assessment of Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: Japanese encephalitis chimeric vaccine (JECV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up. Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative. Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures In good general health, based on medical history and physical examination Exclusion Criteria: Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05 Planned participation in another clinical trial during the Day0-Day28 period Receipt of live vaccine within 4 weeks preceding the trial vaccination Planned receipt of any vaccine in the 4 weeks following the trial vaccination Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Ages Eligible for Study
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Minimum Age: 72 Months
Maximum Age: 80 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Japanese encephaltis chimerix vaccine<br>This is a single-arm study. Japanese encephalitis chimeric vaccine (JECV) will be administered to all subjects and check for antibody response 4 weeks after vaccination. | Biological: Japanese encephalitis chimeric vaccine (JECV)<br>* Japanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination<br>* Other names: IMOJEV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibody titers after JECV vaccination | Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28) | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JECV, IMOJEV, Booster response, Children, antibody response, Duration