Immunogenicity of inactivated vero cell culture-derived Japanese encephalitis vaccine in children and adolescents after hematopoietic stem cell transplantatio

Phase 4

Completed

• Conditions: Japanese encephalitis; Japanese encephalitis vaccine; Hematopoietic stem cell transplantation

• Registration Number: TCTR20191104001
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-15
• Study Start: 2019-11-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Patients who had finished their hematopoietic stem cell transplantation for more than 1 year

Exclusion Criteria

No immunosuppressive therapy at least 6 months before enrollment
No evidence of acute or chronic graft versus host disease at the time of enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroconversion rate at 1 month after primary series of revaccination and 1 month after booster dose Antibody level against JE virus using plaque reduction neutralization test

Secondary Outcome Measures

Name	Time	Method
Adverse event after each dose of vaccine Observation and telephone call,Increment of JE specific T lymphocyte at 1 month after primary series of revaccination and 1 month after booster dose Number of JE specific T lymphocyte usinf interferon gamma releasing assay