Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 2, 2011
November 14, 2014
May 2010
October 2012   (final data collection date for primary outcome measure)
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.
seroconversion rate after primary vaccination [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
To determine the seroconversion rate of JEVac Tm after primary vaccination
Complete list of historical versions of study NCT01408537 on ClinicalTrials.gov Archive Site
  • 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.
  • Geometric mean titer of NT after primary and booster [ Time Frame: March 2012 ] [ Designated as safety issue: No ]
    To determine the geometric mean titers (GMT) of neutralizing antibody of JEVACTM 1 month after primary and then after booster vaccinations.
  • adverse events of vaccine [ Time Frame: september 2011 ] [ Designated as safety issue: Yes ]
    To determine the adverse events of JEvac TM along the study
  • neutralization antibody persistence one year after the primary vaccination [ Time Frame: march 2012 ] [ Designated as safety issue: No ]
    To determine the neutralization antibody persistence one year after the primary JEVACTM vaccination.
Not Provided
Not Provided
 
Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Encephalitis, Japanese B
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).
Experimental: JEVAC
JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year
Intervention: Biological: JEVAC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
December 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
1 Year to 3 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01408537
JE0153
No
Pornthep Chanthavanich, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Pornthep Chanthavanich, MD Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
Mahidol University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP