Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

Dengue Clinical Trial

Official title:

Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730288
• Other study ID #: CYD10
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2008
• Last updated: February 23, 2018
• Start date: August 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria :

• Aged 18 to 40 years on the day of inclusion.

• 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.

Exclusion Criteria :

• 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.

• Any vaccination in the four weeks preceding the trial vaccination.

• Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.

• Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.

• Positive flavivirus serological test in blood sample taken at screening (for Controls only).

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Virus
• Fever
• Severe Dengue

Intervention

Biological:
• Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
• Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
• Chimeric dengue serotype (1, 2, 3, 4)
0.5mL, Subcutaneous, 1 dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Australia, 

References & 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™		28, 60 and 180 days post vaccination
Primary	Safety: To provide information concerning the safety of ChimeriVax™		28 days post-vaccination and entire study duration