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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Khon Kaen University
Sponsor:
Information provided by (Responsible Party):
Pope Kosalaraksa, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01954810
First received: September 26, 2013
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   72 Months to 80 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954810

Contacts
Contact: Pope Kosalaraksa, M.D. +66-89-7112236 pkosalaraksa@yahoo.com

Locations
Thailand
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    suraponwiangnon@gmail.com   
Principal Investigator: Pope Kosalaraksa, M.D.         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Pope Kosalaraksa, M.D. Khon Kaen University
  More Information

No publications provided

Responsible Party: Pope Kosalaraksa, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01954810     History of Changes
Other Study ID Numbers: JEC24
Study First Received: September 26, 2013
Last Updated: October 6, 2013
Health Authority: Thailand: Food and Drug Administration
Thailand: Ethical Committee

Keywords provided by Khon Kaen University:
JECV
IMOJEV
Booster response
Children
antibody response
Duration

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014