Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults

March 2, 2015 updated by: Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Tlalpan, Mexico, 14050
      • Valle de Chalco, Mexico, 56613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105)
Experimental: Group 1
Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105)
Experimental: Group 3
Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
Experimental: Group 4
Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
Active Comparator: Group 5
Biological: JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
Other Names:
  • JE-VAX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
Time Frame: 12 months post-vaccination
12 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYD11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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