At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Aged 18 to 50 Years in Brazil
In Brief
A Phase 2 clinical trial evaluating CYD Dengue Vaccine and Placebo (NaCl 0.9%) vaccine group for Dengue Fever and 2 related conditions. Completed, enrolled 133 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively