NCT02514746

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

Assessment of Long Term Immunogenicity of Japanese Encephalitis Live Attenuated SA-14-14-2 Vaccine in Previously Vaccinated Bangladeshi Children and Antibody Response and Safety to a Booster Dose

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 43 Months – 51 Months
• Healthy volunteers: Accepted

Summary

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).

Detailed 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.

Conditions

• Encephalitis, Japanese

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine	0.5 mL subcutaneous injection

Timeline

• Start date: 2015-07-30
• Primary completion: 2016-12-15
• Completion: 2017-01-12
• First posted: 2015-08-04
• Last updated: 2020-10-19
• Results posted: 2020-10-19