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Investigational hMPV
Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older
Ensayo de Sanofi en Human Metapneumovirus Immunization · Respiratory Syncytial Virus Immunization (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- En marcha, sin reclutar
- Participantes
- 1.530
- Centros
- 24
- Fin del objetivo primario
- ene 2027
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en nov 2024.
Qué mide
Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts) (Within 30 minutes after primary and booster vaccinations) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older. The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate). Overall, the study is designed to address the following goals: * Assess the safety profile of the candidate formulations. * Describe the immunogenicity profile of the candidate formulations. * Select the vaccine formulations (dose) for future development. * Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine. The study duration is as follows: -Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort Treatment duration: * Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination * Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination * Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination * Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06686654), actualizada en dic 2025.