Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Dengue Dengue Fever Dengue Hemorrhagic Fever Dengue Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Received monovalent Vero dengue vaccine in Study DIV12

Group Type EXPERIMENTAL

Chimeric dengue serotype (1, 2, 3, 4)

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous, 1 dose

2

Received Yellow fever vaccine in Study DIV12

Group Type EXPERIMENTAL

Chimeric dengue serotype (1, 2, 3, 4)

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous, 1 dose

3

Flavivirus-naive subjects

Group Type EXPERIMENTAL

Chimeric dengue serotype (1, 2, 3, 4)

Intervention Type BIOLOGICAL

0.5mL, Subcutaneous, 1 dose

Interventions

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Chimeric dengue serotype (1, 2, 3, 4)

0.5 mL, Subcutaneous, 1 dose

Intervention Type BIOLOGICAL

Chimeric dengue serotype (1, 2, 3, 4)

0.5 mL, Subcutaneous, 1 dose

Intervention Type BIOLOGICAL

Chimeric dengue serotype (1, 2, 3, 4)

0.5mL, Subcutaneous, 1 dose

Intervention Type BIOLOGICAL

Other Intervention Names

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ChimeriVax™ Dengue Tetravalent Vaccine ChimeriVax™ Dengue Tetravalent Vaccine ChimeriVax™ Dengue Tetravalent Vaccine

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes