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

Sponsor
Khon Kaen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01954810
Collaborator
(none)
88
Enrollment
1
Location
1
Arm
7
Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Japanese encephalitis chimeric vaccine (JECV)
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Oct 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Japanese encephaltis chimerix vaccine

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)
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
Other Names:
  • IMOJEV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neutralizing antibody titers after JECV vaccination [28 days]

      Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    72 Months to 80 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Pediatrics, Faculty of Medicine, Khon Kaen University Muang Khon Kaen Thailand 40002

    Sponsors and Collaborators

    • Khon Kaen University

    Investigators

    • Principal Investigator: Pope Kosalaraksa, M.D., Khon Kaen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pope Kosalaraksa, Associate Professor, Khon Kaen University
    ClinicalTrials.gov Identifier:
    NCT01954810
    Other Study ID Numbers:
    • JEC24
    First Posted:
    Oct 7, 2013
    Last Update Posted:
    Oct 8, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Pope Kosalaraksa, Associate Professor, Khon Kaen University
    JECV
    IMOJEV
    Booster response
    Children
    antibody response
    Duration
    Additional relevant MeSH terms:
    Encephalitis, Japanese
    Encephalitis

    Study Results

    No Results Posted as of Oct 8, 2013