Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Phase 1/2
Completed
NCT05639894
| Condition | Respiratory Syncytial Virus Immunization |
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| Phase | Phase 1/2 |
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| Sponsor | Sanofi Pasteur, a Sanofi Company |
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| Status | Completed |
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| Enrollment | 865 participants |
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| Interventions | RSV vaccine candidate |
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| Start date | Nov 17, 2022 |
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| Completion date | May 2, 2025 |
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| Results posted | Aug 5, 2026 |
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Summary
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage were to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage evaluated the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population. Brief Summary of Stage 2: The study also incorporated a Stage 2 (Phase IIa, dose-ranging design) that included adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants were randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses were performed, minimally at D07 and D28.
Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Up to 30 minutes post-primary vaccination on Day 1 · Participants
| Stage 1: Sentinel Cohort: RSV Vaccine Dose A1 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose A2 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose B1 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose B2 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose C1 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose C2 | 0 Participants |
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Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
From Day 1 (first dose of primary vaccination) up to Day 8 (7 days post-primary vaccination on Day 1) · Participants
| Stage 1: Sentinel Cohort: RSV Vaccine Dose A1 | 4 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose A2 | 2 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose B1 | 5 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose B2 | 5 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose C1 | 7 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose C2 | 7 Participants |
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Stage 1 (Sentinel and Main Cohort) and Stage 2: Number of Participants With Unsolicited Adverse Events
From Day 1 (first dose of primary vaccination) up to Day 29 (28 days post-primary vaccination on Day 1) · Participants
| Stage 1: Sentinel Cohort: RSV Vaccine Dose A1 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose A2 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose B1 | 1 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose B2 | 0 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose C1 | 4 Participants |
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| Stage 1: Sentinel Cohort: RSV Vaccine Dose C2 | 1 Participants |
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