Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CYD Dengue Vaccine | Vaccine | 0.5 ml | Subcutaneous |