NCT01488890

Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine

Evaluation of the Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Administered With or Without Yellow Fever Vaccine in US Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dengue
• Dengue Fever
• Dengue Hemorrhagic Fever
• Yellow Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus	0.5 mL, Subcutaneous
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus	0.5 mL, Subcutaneous
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus	0.5 mL, Subcutaneous
BIOLOGICAL	Yellow Fever	0.5 mL, Subcutaneous

Timeline

• Start date: 2011-12-06
• Primary completion: 2013-09-27
• Completion: 2013-09-27
• First posted: 2011-12-08
• Last updated: 2022-03-24
• Results posted: 2019-06-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study