Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Tetravalent CYD Dengue Vaccine , 5555 formulation; Tetravalent CYD Dengue Vaccine , 5553 formulation; Tetravalent CYD Dengue Vaccine, 4444 formulation
Intervention description: A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.; A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively; A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue fever; Dengue hemorrhagic fever; Dengue virus

Summary:

      This study used 3 different formulations of tetravalent CYD dengue vaccine.

      The primary objective of the study was to evaluate the neutralizing antibody response after 2
      doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and
      Month 6.

      The secondary objectives were:

        -  To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.

        -  To describe the neutralizing antibody responses to each of the 3 vaccine formulations.

        -  To describe vaccine viremia after the first and second dose of each of the 3 vaccine
           formulations in a subset of participants.
    

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.

          -  Provision of informed consent signed by the participant or another legally acceptable
             representative.

          -  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 until at least 4
             weeks after the last study vaccination.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

          -  Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

          -  For a woman of child-bearing potential, known or suspected pregnancy or positive
             serum/urine pregnancy test.

          -  Breast-feeding woman.

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the first trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Known or suspected 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 corticosteroids
             therapy (at a dose of at least 10 mg). Topical steroids were allowed.

          -  Known systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the trial vaccine or to a vaccine containing any of the
             same substances.

          -  Chronic illness at a stage that could interfere with trial conduct or completion, in
             the opinion of the investigator.

          -  Current or past alcohol abuse or drug addiction that may interfere with the
             participant's ability to comply with trial procedures.

          -  Receipt of blood or blood-derived products in the past 3 months, that might interfere
             with the assessment of immune response.

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

          -  Planned receipt of any vaccine in the 4 weeks following each of the trial
             vaccinations.

          -  Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus
             seropositivity in blood sample taken at Screening.

          -  Participant deprived of freedom by an administrative or court order, or in an
             emergency setting, or hospitalized without his/her consent.

          -  Clinically significant laboratory test abnormalities (as determined by the
             investigator) in blood sample taken at Screening.

          -  Previous residence in, travel or planned travel of more than 2 weeks during the study
             period to areas with high dengue infection endemicity.

          -  Reported history of flavivirus infection as reported by the participant.

          -  Previous vaccination against flavivirus diseases (including Japanese encephalitis,
             tick-borne encephalitis, and yellow fever).

          -  Flavivirus vaccination planned during the trial period.