Calendario›SNY›HSV 2 Formulation 1 · HSV15
HSV 2 Formulation 1 · HSV15
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
Ensayo de Sanofi en Genital Herpes (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 24
- Centros
- 4
- Fin del objetivo primario
- may 2021
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2020.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A».
Qué mide
Number of participants with immediate adverse events (Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objectives of the study are: * To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). * To evaluate the efficacy of the investigational vaccine regimens with respect to: * the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule * the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule The secondary objectives of the study are: * To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group
Más ensayos de SNY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04222985), actualizada en oct 2022.