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CYD Dengue Vaccine
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Ensayo de Sanofi en Dengue Fever · Dengue Hemorrhagic Fever · Human Immunodeficiency Virus (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 133
- Centros
- 4
- Fin del objetivo primario
- ene 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en nov 2019.
Qué mide
Percentage of Participants With Unsolicited Systemic Adverse Event (AE) (Within 30 minutes after each injection) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe 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.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02741128), actualizada en ene 2024.