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Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children (JE0153)

Primary Purpose

Encephalitis, Japanese B

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
JEVAC
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis, Japanese B focused on measuring inactivated Japanese encephalitis vaccine, vero cell, children, immunogenicity, safety

Eligibility Criteria

1 Year - 3 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department Tropical Pediatrics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JEVAC

Arm Description

JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Adverse Events of Vaccine
To determine the adverse events of JEVAC
Neutralizing Antibody Persistence One Year After the Primary Vaccination
To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.

Full Information

First Posted
August 2, 2011
Last Updated
November 14, 2014
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01408537
Brief Title
Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Acronym
JE0153
Official Title
Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Japanese B
Keywords
inactivated Japanese encephalitis vaccine, vero cell, children, immunogenicity, safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JEVAC
Arm Type
Experimental
Arm Description
JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year
Intervention Type
Biological
Intervention Name(s)
JEVAC
Intervention Description
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).
Primary Outcome Measure Information:
Title
Seroconversion Rate After Primary Vaccination
Description
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.
Time Frame
28 days after second dose of JEVAC
Secondary Outcome Measure Information:
Title
Geometric Mean Titer of NT After Primary and Booster Vaccination
Description
To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.
Time Frame
28 days after second vaccination, before and 28 days after booster vaccination with JEVAC
Title
Adverse Events of Vaccine
Description
To determine the adverse events of JEVAC
Time Frame
7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively
Title
Neutralizing Antibody Persistence One Year After the Primary Vaccination
Description
To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.
Time Frame
1 year after primary vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornthep Chanthavanich, MD
Organizational Affiliation
Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department Tropical Pediatrics
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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