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Trial record 5 of 56 for:    "Encephalitis, Japanese"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pornthep Chanthavanich, Mahidol University
ClinicalTrials.gov Identifier:
NCT01408537
First received: August 2, 2011
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Encephalitis, Japanese B
Biological: JEVAC
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Seroconversion Rate After Primary Vaccination [ Time Frame: 28 days after second dose of JEVAC ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: Yes ]
    To determine the adverse events of JEVAC

  • Neutralizing Antibody Persistence One Year After the Primary Vaccination [ Time Frame: 1 year after primary vaccination ] [ Designated as safety issue: No ]
    To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.


Enrollment: 152
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408537

Locations
Thailand
Department Tropical Pediatrics
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Pornthep Chanthavanich, MD Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
  More Information

No publications provided

Responsible Party: Pornthep Chanthavanich, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
ClinicalTrials.gov Identifier: NCT01408537     History of Changes
Other Study ID Numbers: JE0153
Study First Received: August 2, 2011
Results First Received: April 23, 2013
Last Updated: November 14, 2014
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Mahidol University:
inactivated Japanese encephalitis vaccine
vero cell
children
immunogenicity
safety

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014