Clinical trial NCT00730288: Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
Official title: Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Virus
Keywords: Dengue
Dengue fever
Dengue hemorrhagic fever
Dengue virus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

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).

Primary outcomes:
measure: Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
timeFrame: 28, 60 and 180 days post vaccination
measure: Safety: To provide information concerning the safety of ChimeriVax™
timeFrame: 28 days post-vaccination and entire study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Qiao M, Shaw D, Forrat R, Wartel-Tram A, Lang J. Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans. Am J Trop Med Hyg. 2011 Oct;85(4):724-31. doi: 10.4269/ajtmh.2011.10-0436.