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

PATH

Status and phase: Completed; Phase 4

Conditions: Encephalitis, Japanese

Treatments: Biological: Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02514746

PR-15036 (Other Identifier)

JEV07

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 561 patients

Sex: All

Ages: 43 to 51 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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561 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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