NCT00730288

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

August 6, 2008

Last Update Submit

February 23, 2018

Conditions

DengueDengue FeverDengue Hemorrhagic FeverDengue Virus

Keywords

DengueDengue feverDengue hemorrhagic feverDengue virus

Outcome Measures

Primary Outcomes (2)

  • Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™

    28, 60 and 180 days post vaccination

  • Safety: To provide information concerning the safety of ChimeriVax™

    28 days post-vaccination and entire study duration

Study Arms (3)

1

EXPERIMENTAL

Received monovalent Vero dengue vaccine in Study DIV12

Biological: Chimeric dengue serotype (1, 2, 3, 4)

2

EXPERIMENTAL

Received Yellow fever vaccine in Study DIV12

Biological: Chimeric dengue serotype (1, 2, 3, 4)

3

EXPERIMENTAL

Flavivirus-naive subjects

Biological: Chimeric dengue serotype (1, 2, 3, 4)

Interventions

Chimeric dengue serotype (1, 2, 3, 4)BIOLOGICAL

0.5 mL, Subcutaneous, 1 dose

Also known as: ChimeriVax™ Dengue Tetravalent Vaccine
1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Adelaide, Australia

Location

Related Publications (1)

  • Qiao M, Shaw D, Forrat R, Wartel-Tram A, Lang J. Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans. Am J Trop Med Hyg. 2011 Oct;85(4):724-31. doi: 10.4269/ajtmh.2011.10-0436.

    PMID: 21976579RESULT

MeSH Terms

Conditions

DengueSevere Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Medical Monitor

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 8, 2008

Study Start

August 1, 2006

Primary Completion

August 1, 2007

Study Completion

January 1, 2008

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

AU(1)