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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Participants were randomized to 4 different groups to receive either CYD dengue vaccine
      and/or YF vaccine. Participants who already received YF vaccine prior to enrolment were
      randomized to one of the 2 groups receiving CYD dengue vaccine alone. Participants were
      evaluated for immunogenicity, antibody persistence, reactogenicity and safety.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Other intervention name(s): CYD Dengue Vaccine; CYD Dengue Vaccine; CYD Dengue Vaccine; YF VAX®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue fever; Dengue Hemorrhagic Fever; CYD dengue vaccine; Yellow Fever; Flavivirus