Japanese Encephalitis
Conditions
Keywords
JECV, IMOJEV, Booster response, Children, antibody response, Duration
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.
Interventions
BIOLOGICALJapanese 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
Sponsors
Khon Kaen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
72 Months to 80 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody titers after JECV vaccination | 28 days | Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28) |
Countries
Thailand
Contacts
Primary ContactPope Kosalaraksa, M.D.
Outcome results
None listed