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Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00730288
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE August 6, 2008
First Posted Date  ICMJE August 8, 2008
Last Update Posted Date February 27, 2018
Study Start Date  ICMJE August 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2008)
  • Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™ [ Time Frame: 28, 60 and 180 days post vaccination ]
  • Safety: To provide information concerning the safety of ChimeriVax™ [ Time Frame: 28 days post-vaccination and entire study duration ]
Original Primary Outcome Measures  ICMJE Same as current
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 Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
Official Title  ICMJE Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine
Brief Summary

To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine

Primary Objectives:

  • To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
  • To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
Detailed Description This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Virus
Intervention  ICMJE
  • Biological: Chimeric dengue serotype (1, 2, 3, 4)
    0.5 mL, Subcutaneous, 1 dose
    Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
  • Biological: Chimeric dengue serotype (1, 2, 3, 4)
    0.5mL, Subcutaneous, 1 dose
    Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
Study Arms  ICMJE
  • Experimental: 1
    Received monovalent Vero dengue vaccine in Study DIV12
    Intervention: Biological: Chimeric dengue serotype (1, 2, 3, 4)
  • Experimental: 2
    Received Yellow fever vaccine in Study DIV12
    Intervention: Biological: Chimeric dengue serotype (1, 2, 3, 4)
  • Experimental: 3
    Flavivirus-naive subjects
    Intervention: Biological: Chimeric dengue serotype (1, 2, 3, 4)
Publications * Qiao M, Shaw D, Forrat R, Wartel-Tram A, Lang J. Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans. Am J Trop Med Hyg. 2011 Oct;85(4):724-31. doi: 10.4269/ajtmh.2011.10-0436.

*   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: August 6, 2008)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Aged 18 to 40 years on the day of inclusion.
  • Informed consent form signed.
  • For a woman, inability to bear a child or negative serum pregnancy test.
  • Completed the one-year follow-up of Study DIV12.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination.

Exclusion Criteria :

  • History of thymic pathology (thymoma), thymectomy, or myasthenia gravis.
  • Breast-feeding.
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Previous flavivirus vaccination, e.g. Japanese encephalitis or yellow fever.
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Planned participation in another clinical trial during the present trial period.
  • History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy.
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past three months.
  • Vaccination planned in the four weeks following the trial vaccination.
  • Flavivirus vaccination planned during the present trial period.
  • Planned travel during the present trial period to areas with high dengue endemicity.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent.
  • Participation in another clinical trial in the four weeks preceding the trial vaccination.
  • Any vaccination in the four weeks preceding the trial vaccination.
  • Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
  • Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.
  • Positive flavivirus serological test in blood sample taken at screening (for Controls only).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00730288
Other Study ID Numbers  ICMJE CYD10
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 Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date February 2018

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