Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

Sanofi

Status and phase: Completed; Phase 2

Conditions: Dengue Hemorrhagic Fever; Dengue Fever; Dengue; Dengue Virus

Treatments: Biological: Chimeric dengue serotype (1, 2, 3, 4)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730288

CYD10

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

1

Experimental group

Description:

Received monovalent Vero dengue vaccine in Study DIV12

Treatment:

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

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

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

2

Experimental group

Description:

Received Yellow fever vaccine in Study DIV12

Treatment:

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

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

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

3

Experimental group

Description:

Flavivirus-naive subjects

Treatment:

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

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

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