Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00730288

Purpose

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

Condition	Intervention	Phase
Dengue Dengue Fever Dengue Hemorrhagic Fever Dengue Virus	Biological: Chimeric dengue serotype (1, 2, 3, 4)	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Dengue Fever Hemorrhagic Fevers

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™ [ Time Frame: 28, 60 and 180 days post vaccination ] [ Designated as safety issue: No ]
Safety: To provide information concerning the safety of ChimeriVax™ [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	35
Study Start Date:	August 2006
Study Completion Date:	January 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Received monovalent Vero dengue vaccine in Study DIV12	Biological: Chimeric dengue serotype (1, 2, 3, 4) 0.5 mL, Subcutaneous, 1 dose
2: Experimental Received Yellow fever vaccine in Study DIV12	Biological: Chimeric dengue serotype (1, 2, 3, 4) 0.5 mL, Subcutaneous, 1 dose
3: Experimental Flavivirus-naive subjects	Biological: Chimeric dengue serotype (1, 2, 3, 4) 0.5mL, Subcutaneous, 1 dose

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730288

Locations

Australia

Adelaide, Australia

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc ( Medical Monitor )
Study ID Numbers:	CYD10
Study First Received:	August 6, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730288 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: National Health and Medical Research Council

Keywords provided by Sanofi-Aventis:

Dengue
Dengue fever
Dengue hemorrhagic fever
Dengue virus

Additional relevant MeSH terms:

Virus Diseases
Fever
Signs and Symptoms
RNA Virus Infections
Hemorrhagic Fevers, Viral
Flaviviridae Infections

Flavivirus Infections
Dengue
Body Temperature Changes
Arbovirus Infections
Dengue Hemorrhagic Fever

ClinicalTrials.gov processed this record on November 30, 2009