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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Summary

The aim of the study is 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.

Clinical Trial Description

Eligible subjects will be 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 will be 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 will be approximately 18 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02741128
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date October 28, 2019
Completion date January 19, 2023
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