Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

February 23, 2018 updated by: Sanofi

Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Received monovalent Vero dengue vaccine in Study DIV12
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Names:
  • ChimeriVax™ Dengue Tetravalent Vaccine
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5mL, Subcutaneous, 1 dose
Other Names:
  • ChimeriVax™ Dengue Tetravalent Vaccine
Experimental: 2
Received Yellow fever vaccine in Study DIV12
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Names:
  • ChimeriVax™ Dengue Tetravalent Vaccine
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5mL, Subcutaneous, 1 dose
Other Names:
  • ChimeriVax™ Dengue Tetravalent Vaccine
Experimental: 3
Flavivirus-naive subjects
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Names:
  • ChimeriVax™ Dengue Tetravalent Vaccine
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5mL, Subcutaneous, 1 dose
Other Names:
  • ChimeriVax™ Dengue Tetravalent Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
Time Frame: 28, 60 and 180 days post vaccination
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
28 days post-vaccination and entire study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 23, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYD10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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