Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00617344

First received: February 6, 2008

Last updated: April 13, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 6, 2008
Last Updated Date	April 13, 2012
Start Date ^ICMJE	April 2008
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 6, 2008)	Neutralizing antibody titers to each of four dengue virus serotypes in 2 groups of subjects after the second vaccination [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00617344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 6, 2008)	Safety: Adverse events in the first 28 days after each injection and SAEs during the entire trial. Immunogenicity: Neutralizing antibody titers to each of the dengue virus serotypes for each vaccine at baseline and 30 days after vaccinations [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Official Title ^ICMJE	Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US
Brief Summary	This is a follow up study using three different formulations for each serotype with the aim of testing immunogenicity and reactogenicity Primary Objective: Immunogenicity: To evaluate immunogenicity by neutralizing antibody response post dose 2. Secondary Objectives: Safety: To evaluate safety following three formulations of ChimeriVax™ Tetravalent Dengue Vaccine. Immunogenicity: To describe the neutralizing antibody responses after each dose.
Detailed Description	This is a phase II, double-blind, randomized, descriptive, multicenter study in US adult subjects. Subjects will be randomized to receive a total of three doses of ChimeriVax™ Tetravalent Dengue Vaccine from one particular formulation.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Dengue Fever Dengue Hemorrhagic Fever Dengue Virus
Intervention ^ICMJE	Biological: ChimeriVax™ Tetravalent Dengue Vaccine A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively. Biological: ChimeriVax™ Tetravalent Dengue Vaccine A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Study Arm (s)	Experimental: Group 1 Participants received the CYD 5555 formulation. Intervention: Biological: ChimeriVax™ Tetravalent Dengue Vaccine Experimental: Group 2 Participants received the CYD 5553 formulation. Intervention: Biological: ChimeriVax™ Tetravalent Dengue Vaccine Experimental: Group 3 Participants received the CYD 4444 formulation. Intervention: Biological: ChimeriVax™ Tetravalent Dengue Vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	260
Completion Date	February 2010
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy, as determined by medical history, clinical examination, and biological safety parameters. Aged 18 to 45 years on the day of inclusion. Provision of informed consent signed by the subject or another legally acceptable representative. For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination. Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test. Breast-feeding woman. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. Planned participation in another clinical trial during the present trial period. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids are allowed. Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator. Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures. Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations. Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C seropositivity in blood sample taken at Screening. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening. Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity. (Please refer to Appendix 5 of the protocol.) Reported history of flavivirus infection as reported by the subject. Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever) Flavivirus vaccination planned during the trial period.
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00617344
Other Study ID Numbers ^ICMJE	CYD12
Has Data Monitoring Committee	Yes
Responsible Party	Sanofi
Study Sponsor ^ICMJE	Sanofi
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sanofi
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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