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Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
This study is currently recruiting participants.
Verified by Sanofi-Aventis, August 2008
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00740155
  Purpose

This is part of an ongoing effort to develop a satisfactory dengue vaccine:

Primary objective:

To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates.

To describe the immune response after each vaccination of dengue vaccine.


Condition Intervention Phase
Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases
Biological: Bivalent CYD-1,3 Dengue (Vero)
Biological: Bivalent CYD-2,4 Dengue (Vero)
Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)
Biological: Japanese encephalitis virus vaccine inactivated
Phase II

MedlinePlus related topics: Dengue Fever Hemorrhagic Fevers
Drug Information available for: Japanese Encephalitis Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine [ Time Frame: 12 months post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: August 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Bivalent CYD-1,3 Dengue (Vero)
0.5 mL, SC
2: Experimental Biological: Bivalent CYD-2,4 Dengue (Vero)
0.5 mL, SC
3: Experimental Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
0.5 mL, SC
4: Experimental Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)
0.5 mL, SC
5: Active Comparator Biological: Japanese encephalitis virus vaccine inactivated
0.5 mL, SC

Detailed Description:

Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.

  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.
  • Informed consent form signed.
  • 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 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.

Exclusion Criteria :

  • History of thymic diseases or thymectomy.
  • For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test
  • Breast-feeding
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Human Immunodeficiency Virus (HIV), Hepatitis B (HBs Ag) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
  • Laboratory abnormalities considered clinically significant upon the Investigator's judgment or above the intensity thresholds (defined in the protocol) in blood sample taken at screening.
  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Previous residence in or travel of more than 2 weeks to areas with high dengue infection endemicity.
  • Known 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 (i.e. egg, egg products, proteins of rodent or neural origin, gelatin, and thimerosal.
  • History of urticaria after hymenoptera envenomation.
  • History of flavivirus infection as reported by the subject.
  • Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
  • Planned travel during the present trial period to areas with high dengue infection endemicity.
  • 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 corticosteroid therapy (at a dose of a t least 10 mg).
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past 3 months.
  • Any vaccination in the 4 weeks preceding the first trial vaccination.
  • Vaccination planned in the 4 weeks following any trial vaccination.
  • Flavivirus vaccination planned during the present trial period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740155

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
Mexico
Recruiting
Tlalpan, Mexico, 14050
Recruiting
Valle de Chalco, Mexico, 56613
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: CYD11
Study First Received: May 7, 2008
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00740155  
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Sanofi-Aventis:
Dengue virus
Dengue fever
Dengue hemorrhagic fever
Dengue diseases

Study placed in the following topic categories:
Virus Diseases
Fever
Signs and Symptoms
Hemorrhagic Fevers, Viral
Dengue
Hemorrhagic fever
Viral hemorrhagic fever
Dengue fever
Healthy
Arbovirus Infections
Dengue Hemorrhagic Fever

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Body Temperature Changes

ClinicalTrials.gov processed this record on January 16, 2009