Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Study Overview
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Brief Summary
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Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent neuropsychiatric sequelae. The disease occurs mostly among children aged <10 years. There is no specific antiviral treatment for JE. Vaccination is the single most important control measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd, China JEVAC in Thai children. 152 healthy Thai children aged between 1-3 years will be vaccinated with JEVAC in a dose of 0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3 strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse events will be observed throughout the study period.

Official Title
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Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Conditions
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Encephalitis, Japanese B

Intervention / Treatment
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* Biological: JEVAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Thai children aged 1- 3 years No previous history of JE vaccination Available for all visited schedule in the study period. Written inform consent signed by a parent or guardian Exclusion Criteria: Known serious underlying diseases such as nervous system, heart, kidney and liver diseases. Known hypersensitivity to JE vaccine composition such as human albumin, dextran 40, etc. Previous history of JE disease. Receive the blood component within the past 3 months, Known history of immunocompromised conditions such as HIV/AIDS, malignancy. Under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug. Febrile illness (temperature ≥37.5°C) or acute illness/infection on the day of vaccination Plan to leave the study area before the end of study period. Participating in other clinical trials.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JEVAC<br>JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year | Biological: JEVAC<br>* Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion Rate After Primary Vaccination | To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation. | 28 days after second dose of JEVAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer of NT After Primary and Booster Vaccination | To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations. | 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC | 
| Adverse Events of Vaccine | To determine the adverse events of JEVAC | 7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively | 
| Neutralizing Antibody Persistence One Year After the Primary Vaccination | To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination. | 1 year after primary vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inactivated Japanese encephalitis vaccine, vero cell, children, immunogenicity, safety