Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
Primary Purpose
Japanese Encephalitis
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Japanese encephalitis chimeric vaccine (JECV)
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis focused on measuring JECV, IMOJEV, Booster response, Children, antibody response, Duration
Eligibility Criteria
Inclusion Criteria:
- 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.
- Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
- Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
- In good general health, based on medical history and physical examination
Exclusion Criteria:
- 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
- Planned participation in another clinical trial during the Day0-Day28 period
- Receipt of live vaccine within 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- 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
- 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
Sites / Locations
- Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Japanese encephaltis chimerix vaccine
Arm Description
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.
Outcomes
Primary Outcome Measures
Neutralizing antibody titers after JECV vaccination
Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)
Secondary Outcome Measures
Full Information
NCT ID
NCT01954810
First Posted
September 26, 2013
Last Updated
October 6, 2013
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT01954810
Brief Title
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
Keywords
JECV, IMOJEV, Booster response, Children, antibody response, Duration
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Japanese encephaltis chimerix vaccine
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Japanese encephalitis chimeric vaccine (JECV)
Other Intervention Name(s)
IMOJEV
Intervention Description
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
Primary Outcome Measure Information:
Title
Neutralizing antibody titers after JECV vaccination
Description
Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
72 Months
Maximum Age & Unit of Time
80 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
In good general health, based on medical history and physical examination
Exclusion Criteria:
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
Planned participation in another clinical trial during the Day0-Day28 period
Receipt of live vaccine within 4 weeks preceding the trial vaccination
Planned receipt of any vaccine in the 4 weeks following the trial vaccination
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pope Kosalaraksa, M.D.
Phone
+66-89-7112236
Email
pkosalaraksa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pope Kosalaraksa, M.D.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surapon Wiangnon, M.D.
Phone
+66-43-348382
Email
suraponwiangnon@gmail.com
First Name & Middle Initial & Last Name & Degree
Pope Kosalaraksa, M.D.
12. IPD Sharing Statement
Learn more about this trial
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
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