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: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Virus
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 260
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Participants received the CYD 5555 formulation.
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
Experimental: Group 2
Participants received the CYD 5553 formulation.
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Experimental: Group 3
Participants received the CYD 4444 formulation.
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617344

Locations
United States, Alabama
Birmingham, Alabama, United States, 35235
United States, California
San Diego, California, United States, 92103
Vallejo, California, United States, 94589
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Springfield, Missouri, United States, 65802
United States, Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Sanofi
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00617344     History of Changes
Other Study ID Numbers: CYD12
Study First Received: February 6, 2008
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Dengue fever
Dengue hemorrhagic fever
Dengue virus

Additional relevant MeSH terms:
Fever
Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on October 19, 2014