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Trial record 1 of 1 for:    H-040-008
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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: ChimeriVax™-JE vaccine Biological: JE-VAX® vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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®).
Study Start Date : May 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ixiaro JE-Vax

Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: ChimeriVax™-JE vaccine
0.5 mL, subcutaneously
Other Name: ChimeriVax™-JE
Active Comparator: JE-VAX®
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
 Biological: JE-VAX® vaccine
1.0 mL, subcutaneously
Other Name: JE-VAX®


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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']

  4. 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).

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319592


Locations
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United States, Kansas
Clinical Pharamacology Center
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Sanofi
PRA Health Sciences
Investigators
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Principal Investigator: Nancy L Abdou, MD PRA Health Sciences
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00319592    
Other Study ID Numbers: H-040-008
First Posted: April 27, 2006    Key Record Dates
Results First Posted: August 16, 2012
Last Update Posted: August 20, 2012
Last Verified: August 2012
Keywords provided by Sanofi:
Japanese encephalitis
ChimeriVax™-JE
JE-VAX®
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
Infections
 Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs