Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

Study Overview
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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

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.

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

Conditions
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Dengue, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus

Intervention / Treatment
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* Biological: Chimeric dengue serotype (1, 2, 3, 4)
* Biological: Chimeric dengue serotype (1, 2, 3, 4)
* Biological: Chimeric dengue serotype (1, 2, 3, 4)


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue, Dengue fever, Dengue hemorrhagic fever, Dengue virus