NCT02741128

Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults

Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue. Primary Objective: * To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. Secondary Objectives: * To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. * To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue. * To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue. Observational Objective: * To describe the FV (YF, Dengue, Zika) serological status in the study population at baseline.

Detailed description

Eligible subjects were randomized in a 2:1 ratio into 1 of 2 groups to receive 3 injections of either CYD dengue vaccine or placebo at 0, 6, and 12 months. The enrollment of subjects was carried out in two steps, including an early safety data review before the second step. The duration of each subject's participation in the study was approximately 18 months.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue Vaccine	0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
BIOLOGICAL	Placebo (NaCl 0.9%) vaccine group	0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

Timeline

• Start date: 2019-11-06
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2016-04-18
• Last updated: 2024-07-19
• Results posted: 2024-07-19

Locations

4 sites across 1 country: Brazil