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

October 6, 2013 updated by: Pope Kosalaraksa, Khon Kaen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Department of Pediatrics, Faculty of Medicine, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • IMOJEV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutralizing antibody titers after JECV vaccination
Time Frame: 28 days
Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Pope Kosalaraksa, M.D., Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 6, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEC24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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