Clinical trial NCT00740155: Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
Official title: Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases
Keywords: Dengue virus
Dengue fever
Dengue hemorrhagic fever
Dengue diseases
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
measure: Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
timeFrame: 12 months post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tlalpan
country: Mexico
city: Valle de Chalco
country: Mexico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Dayan GH, Galan-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naive adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131.