Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever; Yellow Fever
MeSH terms: Dengue; Yellow Fever; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus; Yellow Fever
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 390.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue fever; Dengue Hemorrhagic Fever; CYD dengue vaccine; Yellow Fever; Flavivirus

Summary:

      The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1,
      2, 3 and 4) following a compressed schedule in 3 different populations.

      Primary Objectives:

        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes
           at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month [M] 13) and
           Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been
           previously administered.

        -  To describe the persistence of the humoral immune response to each of the 4 parental
           dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and
           Group 2 (M12), irrespective of whether or not YF vaccine has been previously
           administered.

      Secondary Objective:

        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes
           at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2,
           irrespective of whether or not YF vaccine has been previously administered.

        -  To describe the humoral immune response to each of the 4 parental dengue virus serotypes
           at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group
           1 (N=60) and Group 2 (N=60), and in Group 3 (N=120).

        -  To describe by FV status at baseline the humoral immune response to each of the 4
           parental dengue virus serotypes at baseline and 28 days after each injection of CYD
           dengue vaccine in Groups 1, 2, and 3.

        -  To describe the safety profile after each injection of CYD dengue vaccine and/or YF
           vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged >= 18 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

          -  For participants classified as YF positive (+) to be included in Groups 1 and 2,
             previous vaccination (3 months to 10 years) with YF vaccine confirmed by acceptable
             documentation.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female must be post-menopausal for at least 1 year,
             surgically sterile, or using 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 of any vaccine in the 4 weeks preceding the first trial vaccination or planned
             receipt of any vaccine in the 4 weeks following each trial vaccination

          -  For all participants classified as YF negative (-), any previous vaccination against
             Flavivirus (FV) diseases (including Japanese Encephalitis [JE], tick-borne
             encephalitis, and YF)

          -  For participants classified as YF+, previous vaccination against FV diseases except YF
             (including JE and tick-borne encephalitis)

          -  For all participants, any FV vaccination planned during the trial period outside the
             study protocol

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C

          -  Self-reported history of FV infection (e.g., JE, Dengue, YF, West Nile), confirmed
             either clinically or serologically

          -  Known systemic hypersensitivity to any of the vaccine components, 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

          -  Current alcohol abuse or drug addiction

          -  Chronic illness that, in the opinion of the investigator, is 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

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature >= 38.0°C [>=100.4°F]). A
             prospective participant should not be included in the study until the condition has
             resolved or the febrile event has subsided

          -  Previous residence (> 12 months) in, or travel in the last 30 days to FV endemic
             regions

          -  History of thymic pathology (thymoma), thymectomy, or myasthenia.