Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever
Intervention: CYD Dengue Vaccine; CYD Dengue Vaccine; Japanese Encephalitis Vaccine; Japanese Encephalitis Vaccine
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Dengue fever; CYD dengue vaccine; IXIARO JE vaccine; Flavivirus

Summary:

      The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects
      of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese
      encephalitis (JE) vaccine.

      Primary Objectives:

        -  To describe and compare the humoral immune response to each of the 4 parental dengue
           virus serotypes at baseline and 28 days after each CYD dengue vaccine dose.

        -  To describe the persistence of the humoral immune response to each of the 4 parental
           dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not
           JE vaccine had been previously administered.

      Secondary Objectives:

        -  To describe the safety profile after each injection of CYD dengue vaccine.

        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes
           at baseline and 28 days after each CYD dengue vaccine dose when administered with or
           after JE virus vaccine in Groups 3 and 4.

        -  To describe the persistence of the humoral immune response to each of the 4 parental
           dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months
           post-dose 3 in Groups 1 and 3 with the compressed schedule.

        -  To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD
           vaccine dose administered in Groups 1-4.

        -  To describe the JE humoral immune response at baseline and 28 days after each injection
           of CYD dengue vaccine in Groups 3 and 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged greater than or equal to (>=)18 to less than or equal to (<=) 45 years on the day
             of inclusion.

          -  Informed consent form had been signed and dated.

          -  Able to attend all scheduled visits and complied with all trial procedures.

          -  Participant was in good health, based on medical history and physical examination.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (were considered
             of non-childbearing potential, a female had to be post- menopausal for at least 1
             year, surgically sterile, or used an effective method of contraception or abstinence
             from at least 4 weeks prior to the first vaccination and until at least 4 weeks after
             the last vaccination).

          -  Participation in the 4 weeks preceding the first trial vaccination, or planned
             participation during the present trial period, in another clinical trial investigating
             a vaccine, drug, medical device, or medical procedure.

          -  Receipt or planned receipt of any vaccine, outside the study protocol in the 4 weeks
             preceded or followed trial vaccinations. (If influenza activity warranted vaccination
             of healthy young adults, influenza vaccination was encouraged and did not lead to
             study exclusion).

          -  Any history of FV vaccination, or planned FV vaccination during the trial period.

          -  Previous residence (greater than [>]12 months) in, or travel in the last 30 days to
             dengue endemic regions.

          -  Receipt of immune globulins, blood or blood-derived products in the 3 months prior to
             first vaccination or planned use during the study period.

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceded 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Known systemic hypersensitivity to any of the vaccine components (including protamine
             sulfate), or history of a life-threatening reaction to the vaccine(s) used in the
             trial or to a vaccine containing any of the same substances, including dry natural
             latex.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Excessive alcohol consumption or drug addiction.

          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it
             might interfere with trial conduct or completion.

          -  Identified as an employee of the Investigator or study center, with direct involvement
             in the proposed study or other studies under the direction of that Investigator or
             study center, as well as family members (i.e., immediate, husband, wife and their
             children, adopted or natural) of the employee or the Investigator.

          -  Temporary Exclusion Criteria: Moderate or severe acute illness/infection (according to
             Investigator judgment) on the day of vaccination or febrile illness (temperature >=
             38.0 degree Celsius [>= 100.4 degree fahrenheit]). A prospective participant was not
             included in the study until the condition had resolved or the febrile event had
             subsided. If the delay for the febrile illness exceeded the window between screening
             and vaccination, or if deemed necessary by the Investigator, a prospective participant
             might be re-screened once the fever had resolved.