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

Encephalitis, Japanese B Clinical Trial

— JE0153  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408537
• Other study ID #: JE0153
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2011
• Last updated: November 14, 2014
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

1. Healthy Thai children aged 1- 3 years

2. No previous history of JE vaccination

3. Available for all visited schedule in the study period.

4. Written inform consent signed by a parent or guardian

Exclusion Criteria:

1. Known serious underlying diseases such as nervous system, heart, kidney and liver diseases.

2. Known hypersensitivity to JE vaccine composition such as human albumin, dextran 40, etc.

3. Previous history of JE disease.

4. Receive the blood component within the past 3 months,

5. Known history of immunocompromised conditions such as HIV/AIDS, malignancy.

6. Under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug.

7. Febrile illness (temperature =37.5°C) or acute illness/infection on the day of vaccination

8. Plan to leave the study area before the end of study period.

9. Participating in other clinical trials.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Encephalitis, Japanese B

Intervention

Biological:
• JEVAC
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).

Locations

Country	Name	City	State
Thailand	Department Tropical Pediatrics	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No