drugset / Trial / NCT02741128

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

NCT02741128

Phase 2 Completed 133 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2019-11-06
Primary completion
2023-01-19
Completion
2023-01-19

Drugs

EvaluationDrugModalityDoseRoute
Subject CYD Dengue Vaccine Vaccine 0.5 ml Subcutaneous