A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00319592
First received: April 28, 2006
Last updated: August 16, 2012
Last verified: August 2012

April 28, 2006
August 16, 2012
May 2005
September 2006   (final data collection date for primary outcome measure)
  • Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine [ Time Frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination ] [ Designated as safety issue: No ]
    Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.
  • Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE [ Time Frame: Day 0 up to Day 56 post-vaccination ] [ Designated as safety issue: No ]
    Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
  • Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine. [ Time Frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose ] [ Designated as safety issue: No ]
    Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']
  • Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® [ Time Frame: Day 0 (pre-vaccination) up to month 12 post-vaccination ] [ Designated as safety issue: No ]
    Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
  • Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® [ Time Frame: Day 0 up to Day 6 post-vaccination ] [ Designated as safety issue: No ]
    Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Not Provided
Complete list of historical versions of study NCT00319592 on ClinicalTrials.gov Archive Site
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A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Japanese Encephalitis
  • Biological: ChimeriVax™-JE vaccine
    0.5 mL, subcutaneously
    Other Name: ChimeriVax™-JE
  • Biological: JE-VAX® vaccine
    1.0 mL, subcutaneously
    Other Name: JE-VAX®
  • Experimental: ChimeriVax™-JE
    Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
    Intervention: Biological: ChimeriVax™-JE vaccine
  • Active Comparator: JE-VAX®
    Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
    Intervention: Biological: JE-VAX® vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent obtained.
  • Aged ≥18 to <49 years.
  • In good general health.
  • Available for the study duration, including all planned follow-up visits.
  • Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

  • Clinically significant abnormalities on laboratory and vital sign assessments.
  • Anaphylaxis or other serious adverse reactions
  • Administration of another vaccine within 30 days of study treatment period.
  • Physical examination indicating any significant medical condition.
  • Intention to travel out of the area prior to the study visit on Day 56.
  • Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
  • Pregnancy.
  • Excessive alcohol consumption, drug abuse.
  • Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Both
18 Years to 48 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00319592
H-040-008
No
Sanofi
Sanofi
PRA International
Principal Investigator: Nancy L Abdou, MD PRA International
Sanofi
August 2012

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