NCT06678373

Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Liaoning Chengda Biotechnology CO., LTD · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the neutralizing antibody levels and prevalence risk of Japanese encephalitis among residents in low-endemic areas, as well as to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in healthy populations. The study uses an open-label, single-arm trial design with a sample size of 250 participants. Primary endpoints include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, and incidence of adverse events.

Detailed description

This study aims to gain an in-depth understanding of neutralizing antibody levels against Japanese encephalitis among residents in low-endemic areas to assess potential outbreak risks and to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in a healthy population. This open-label, single-arm trial is structured in two phases: Phase I will involve stratified sampling of residents aged 6 years and older for serological testing, followed by administration of the inactivated JE vaccine to assess safety, with serological testing conducted 28 days post-vaccination. Phase II will conduct serological testing 365 days post-primary immunization to evaluate immune persistence. The target population includes residents aged 6 and older, divided into Group A (ages 6-17), Group B (ages 18-39), and Group C (ages 18+), with different vaccine dosages for each group. Inclusion criteria encompass age, health status, and informed consent, while exclusion criteria cover allergies, serious illness, and recent vaccination. Primary endpoints will include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, average antibody levels, and post-vaccination adverse event incidence. The project is scheduled to begin in October 2024 and conclude in December 2026, with the primary research unit being the Liaoning Provincial Center for Disease Control and Prevention, aiming to provide a scientific basis for JE control and prevention in this region.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Liaoning Chengda Inactivated Japanese Encephalitis Vaccine	The patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine.
BIOLOGICAL	Liaoning Chengda Inactivated Japanese Encephalitis Vaccine	The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days.
BIOLOGICAL	Liaoning Chengda Inactivated Japanese Encephalitis Vaccine	The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days.

Timeline

• Start date: 2024-11-14
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2024-11-07
• Last updated: 2024-12-13

Locations

1 site across 1 country: China