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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Khon Kaen University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Pope Kosalaraksa, Khon Kaen University Identifier:
First received: September 26, 2013
Last updated: October 6, 2013
Last verified: October 2013
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 Intervention Phase
Japanese Encephalitis
Biological: Japanese encephalitis chimeric vaccine (JECV)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Neutralizing antibody titers after JECV vaccination [ Time Frame: 28 days ]
    Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)

Estimated Enrollment: 88
Study Start Date: October 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: IMOJEV

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.

Ages Eligible for Study:   72 Months to 80 Months   (Child)
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
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Please refer to this study by its identifier: NCT01954810

Contact: Pope Kosalaraksa, M.D. +66-89-7112236

Department of Pediatrics, Faculty of Medicine, Khon Kaen University Not yet recruiting
Muang, Khon Kaen, Thailand, 40002
Contact: Surapon Wiangnon, M.D.    +66-43-348382   
Principal Investigator: Pope Kosalaraksa, M.D.         
Sponsors and Collaborators
Khon Kaen University
Principal Investigator: Pope Kosalaraksa, M.D. Khon Kaen University
  More Information

Responsible Party: Pope Kosalaraksa, Associate Professor, Khon Kaen University Identifier: NCT01954810     History of Changes
Other Study ID Numbers: JEC24
Study First Received: September 26, 2013
Last Updated: October 6, 2013

Keywords provided by Khon Kaen University:
Booster response
antibody response

Additional relevant MeSH terms:
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017