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

NCT01408537 | Completed Phase 3 Results

• 1 other identifier: JE0153
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Encephalitis, Japanese B

Keywords

inactivated Japanese encephalitis vaccine; vero cell; children; immunogenicity; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Geometric Mean Titer of NT After Primary and Booster Vaccination

  28 days after second vaccination, before and 28 days after booster vaccination with JEVAC

• Adverse Events of Vaccine

  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

  1 year after primary vaccination

Study Arms (1)

JEVAC

EXPERIMENTAL

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

Biological: JEVAC

Interventions

JEVAC BIOLOGICAL

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).

JEVAC

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department Tropical Pediatrics

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Dr. Pornthep Chanthavanich
• Organization: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Thailand

tmpct@mahidol.ac.th

6623549161

Study Officials

• Pornthep Chanthavanich, MD

  Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Tropical Pediatrics, Faculty of Tropical Medicine

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 18, 2014
• Results First Posted: November 18, 2014

Record last verified: 2014-11

Locations

TH (1)