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

Phase 4

• Conditions: Japanese Encephalitis
• Interventions: Biological: Japanese encephalitis chimeric vaccine (JECV)

• Registration Number: NCT01954810
• Lead Sponsor: Khon Kaen University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2013-09-26
• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-04
• Last Update Submitted: 2013-10-06
• Study First Posted: 2013-10-07
• Last Update Posted: 2013-10-08
• Primary Completion: 2013-12
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. 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.
2. Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
3. Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
4. In good general health, based on medical history and physical examination

Exclusion Criteria

1. 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
2. Planned participation in another clinical trial during the Day0-Day28 period
3. Receipt of live vaccine within 4 weeks preceding the trial vaccination
4. Planned receipt of any vaccine in the 4 weeks following the trial vaccination
5. Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
6. 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
7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Japanese encephaltis chimerix vaccine	Japanese encephalitis chimeric vaccine (JECV)	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.

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody titers after JECV vaccination	28 days	Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)

Trial Locations

Locations (1)

Department of Pediatrics, Faculty of Medicine, Khon Kaen University; 🇹🇭 Muang, Khon Kaen, Thailand