Skip to main content
OpenTrials
Completed

NCT Number: NCT01408537

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department Tropical Pediatrics

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Seroconversion Rate After Primary Vaccination

    Time frame: 28 days after second dose of JEVAC

    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 outcomes

  1. Geometric Mean Titer of NT After Primary and Booster Vaccination

    Time frame: 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC

    To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.

  2. Adverse Events of Vaccine

    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

    To determine the adverse events of JEVAC

  3. Neutralizing Antibody Persistence One Year After the Primary Vaccination

    Time frame: 1 year after primary vaccination

    To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Acronym: JE0153

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2011
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.