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

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ClinicalTrials.gov Identifier: NCT00314145
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Sponsor:
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 ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: ChimeriVax™-JE Biological: JE-VAX® Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
Study Start Date : November 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
Drug Information available for: Ixiaro JE-Vax

Arms and Interventions
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Arm Intervention/treatment
Experimental: ChimeriVax™-JE
Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.
 Biological: ChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
Active Comparator: JE-VAX®
Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.
 Biological: JE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Up to Day 60 post-first vaccination ]
    Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.

  2. Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® [ Time Frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination ]

    Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.

    Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.



Secondary Outcome Measures :
  1. Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Up to Day 60 post-first vaccination ]
    Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).

  2. Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Day 60 post-first vaccination ]
    Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects aged 18 or above
  • Subjects in good general health.
  • Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

  • History of vaccination/infection with JE or Yellow fever or other flaviviruses
  • History of residence/travel to flavivirus endemic regions
  • History of anaphylaxis/serious adverse reactions
  • Administration of vaccine within 30 days of study or during treatment period
  • Clinically significant physical exam/medical history/lab abnormalities
  • Pregnancy
  • Excessive alcohol/drug abuse
  • Hypersensitivity to constituents of JE-VAX®
  • Blood transfusion/treatment with blood product within 6months of study and during study treatment period
  • Known/suspected immunodeficiency
  • Compromised blood brain barrier
  • Employees of Clinical Research Organization (CRO)/study site staff
  • Any other condition which would exclude subject.
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): NCT00314145


Locations
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United States, Illinois
Chicago, Illinois, United States, 60610
United States, Kansas
Shawnee Mission, Kansas, United States, 66216
United States, Montana
Missoula, Montana, United States, 59802
United States, Texas
Dallas, Texas, United States, 75231
United States, Washington
Tacoma, Washington, United States, 98403
Australia
Adelaide, Australia
Melbourne, Australia
New South Wales, Australia
Queensland, Australia
Victoria, Australia
Sponsors and Collaborators
Sanofi
Investigators
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Principal Investigator: Luis Angles, M.D. Heart of America Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00314145    
Other Study ID Numbers: H-040-009
First Posted: April 13, 2006    Key Record Dates
Results First Posted: December 5, 2012
Last Update Posted: December 6, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
 Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections