We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954810
Recruitment Status : Unknown
Verified October 2013 by Pope Kosalaraksa, Khon Kaen University.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Pope Kosalaraksa, Khon Kaen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Japanese Encephalitis 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: IMOJEV


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   72 Months to 80 Months   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954810


Contacts
Layout table for location contacts
Contact: Pope Kosalaraksa, M.D. +66-89-7112236 pkosalaraksa@yahoo.com

Locations
Layout table for location information
Thailand
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
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
Layout table for investigator information
Principal Investigator: Pope Kosalaraksa, M.D. Khon Kaen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pope Kosalaraksa, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01954810    
Other Study ID Numbers: JEC24
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013
Keywords provided by Pope Kosalaraksa, Khon Kaen University:
JECV
IMOJEV
Booster response
 Children
antibody response
Duration
Additional relevant MeSH terms:
Layout table for MeSH terms
Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections