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Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

Primary Purpose

Dengue, Dengue Fever, Dengue Hemorrhagic Fever

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Chimeric dengue serotype (1, 2, 3, 4)
Chimeric dengue serotype (1, 2, 3, 4)
Chimeric dengue serotype (1, 2, 3, 4)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue focused on measuring Dengue, Dengue fever, Dengue hemorrhagic fever, Dengue virus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Received monovalent Vero dengue vaccine in Study DIV12

Received Yellow fever vaccine in Study DIV12

Flavivirus-naive subjects

Outcomes

Primary Outcome Measures

Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
Safety: To provide information concerning the safety of ChimeriVax™

Secondary Outcome Measures

Full Information

First Posted
August 6, 2008
Last Updated
February 23, 2018
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00730288
Brief Title
Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
Official Title
Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
Keywords
Dengue, Dengue fever, Dengue hemorrhagic fever, Dengue virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Received monovalent Vero dengue vaccine in Study DIV12
Arm Title
2
Arm Type
Experimental
Arm Description
Received Yellow fever vaccine in Study DIV12
Arm Title
3
Arm Type
Experimental
Arm Description
Flavivirus-naive subjects
Intervention Type
Biological
Intervention Name(s)
Chimeric dengue serotype (1, 2, 3, 4)
Other Intervention Name(s)
ChimeriVax™ Dengue Tetravalent Vaccine
Intervention Description
0.5 mL, Subcutaneous, 1 dose
Intervention Type
Biological
Intervention Name(s)
Chimeric dengue serotype (1, 2, 3, 4)
Other Intervention Name(s)
ChimeriVax™ Dengue Tetravalent Vaccine
Intervention Description
0.5 mL, Subcutaneous, 1 dose
Intervention Type
Biological
Intervention Name(s)
Chimeric dengue serotype (1, 2, 3, 4)
Other Intervention Name(s)
ChimeriVax™ Dengue Tetravalent Vaccine
Intervention Description
0.5mL, Subcutaneous, 1 dose
Primary Outcome Measure Information:
Title
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
Time Frame
28, 60 and 180 days post vaccination
Title
Safety: To provide information concerning the safety of ChimeriVax™
Time Frame
28 days post-vaccination and entire study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
Adelaide
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21976579
Citation
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.
Results Reference
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Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

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