Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-30

Study Completion Date

2017-01-12

Brief Summary

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This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study will enrol Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05; NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).

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Detailed Description

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Study participants previously immunized with CD-JEV (Clinical Trials identifier: NCT01567865, JEV05) will have serum collected three and four years after initial vaccination to assess long-term immunogenicity. Four years after receiving the initial dose of CD-JEV, eligible participants will be vaccinated with a second subcutaneous dose of CD-JEV to assess the antibody response.

Participants will be monitored for safety for 28 days following receipt of the booster dose.

Conditions

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Encephalitis, Japanese

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Live Attenuated JE SA-14-14-2 Vaccine (CD-JEV)

Participants previously vaccinated with CD-JEV will receive a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine four years after initial vaccination.

Group Type EXPERIMENTAL

Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine

Intervention Type BIOLOGICAL

0.5 mL subcutaneous injection

Interventions

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Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine

0.5 mL subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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CD-JEV CD.JEVAX® RS.JEV®

Eligibility Criteria

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Inclusion Criteria

* Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV.
* Resides in the Matlab or Mirpur study area.
* At least one parent or guardian willing to provide written informed consent.

Exclusion Criteria

* Received a second dose of Japanese encephalitis vaccine within the past three years.
* Received immunoglobulins and/or any blood products within 90 days prior to enrollment.
* Been diagnosed with a primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection within the past three years.

Minimum Eligible Age

43 Months

Maximum Eligible Age

51 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes