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

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.

Study Overview

• Status: Completed
• Conditions: Encephalitis, Japanese B
• Intervention / Treatment: Biological: JEVAC

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Department Tropical Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JEVAC; JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Pornthep Chanthavanich, MD, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (ESTIMATE): August 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: safety; children; immunogenicity; inactivated Japanese encephalitis vaccine; vero cell
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: JE0153