Active — Not RecruitingPhase 4

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

China250 participantsStarted 2024-11-14

Plain-language 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Permanent residents aged 6 years (inclusive) and older; * Healthy individuals as determined clinically after inquiring about medical history and conducting relevant physical examinations; * Individuals who meet the vaccination criteria for the inactivated Japanese encephalitis vaccine (Vero cells); * Participants must provide informed consent to receive vaccination and blood c collection; minors must obtain informed consent from their guardians; * Participants planned to be included in Group A must have previously completed the full vaccination schedule for the Japanese encephalitis vaccine (including live attenuated vaccine or inactivated vaccine). Exclusion Criteria: * Participants are unwilling to sign the informed consent form; * History of allergy to the vaccine or its components, severe adverse reactions to the vaccine such as allergies, urticaria, breathing difficulties, angioedema, or abdominal pain; * Individuals with encephalopathy, uncontrolled epilepsy, and other progressive neurological diseases; * History of seizures or convulsions, or family history of psychiatric disorders; * Presence of congenital malformations or developmental disorders, genetic defects, and severe malnutrition; * Individuals with autoimmune diseases, congenital or acquired immunodeficiencies, or family history of autoimmune diseases or immunodeficiencies; * Any acute diseases or acute exacerbations of chronic diseases in the past 7 days; * Treatment with immunosuppr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of JE neutralizing antibody levels in low-prevalence areas to evaluate the risk of JE transmission.

Timeframe: Prior to administration of the first vaccine dose.

Seroconversion rate and average neutralizing antibody levels against JE on the 28th day after vaccination.

Timeframe: On the 28th day after vaccination.

Trial details

NCT IDNCT06678373

SponsorLiaoning Chengda Biotechnology CO., LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Japanese Encephalitis trials