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Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

CompletedPhase 2

Sponsor: Sanofi

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

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

Countries: Australia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 40 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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).

Locations (1)

Adelaide, Australia