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

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ClinicalTrials.gov Identifier: NCT00319592
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : August 16, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 28, 2006
First Posted Date  ICMJE April 27, 2006
Results First Submitted Date  ICMJE July 11, 2012
Results First Posted Date  ICMJE August 16, 2012
Last Update Posted Date August 20, 2012
Study Start Date  ICMJE May 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Official Title  ICMJE 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®).
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Japanese Encephalitis
Intervention  ICMJE
  • Biological: ChimeriVax™-JE vaccine
    0.5 mL, subcutaneously
    Other Name: ChimeriVax™-JE
  • Biological: JE-VAX® vaccine
    1.0 mL, subcutaneously
    Other Name: JE-VAX®
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
60
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319592
Other Study ID Numbers  ICMJE H-040-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE PRA Health Sciences
Investigators  ICMJE
Principal Investigator: Nancy L Abdou, MD PRA Health Sciences
PRS Account Sanofi
Verification Date August 2012

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