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

Japanese Encephalitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01954810
• Other study ID #: JEC24
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 26, 2013
• Last updated: October 6, 2013
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2013
• Source: Khon Kaen University
• Contact: Pope Kosalaraksa, M.D.
• Phone: +66-89-7112236
• Email: pkosalaraksa[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug AdministrationThailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 72 Months to 80 Months

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Faculty of Medicine, Khon Kaen University	Muang	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralizing antibody titers after JECV vaccination	Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)	28 days	Yes