Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons.
Clin Infect Dis
; 78(6): 1732-1744, 2024 Jun 14.
Article
en En
| MEDLINE
| ID: mdl-38253338
ABSTRACT
BACKGROUND:
The adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post-dose 1.METHODS:
In this phase 3, blinded trial, ≥60-year-olds were randomized (11) to receive RSVPreF3 OA or placebo pre-season 1. RSVPreF3 OA recipients were re-randomized (11) to receive a second RSVPreF3 OA dose (RSV_revaccination group) or placebo (RSV_1dose group) pre-season 2; participants who received placebo pre-season 1 received placebo pre-season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary objective, success criterion lower limits of 2-sided CIs around efficacy estimates >20%).RESULTS:
The efficacy analysis comprised 24 967 participants (RSV_1dose 6227; RSV_revaccination 6242; placebo 12 498). Median efficacy follow-up was 17.8 months. Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI 48.2-80.0%) against RSV-LRTD and 78.8% (95% CI 52.6-92.0%) against severe RSV-LRTD. Efficacy over 2 seasons of a first dose followed by revaccination was 67.1% (97.5% CI 48.1-80.0%) against RSV-LRTD and 78.8% (95% CI 52.5-92.0%) against severe RSV-LRTD. Reactogenicity/safety of the revaccination dose were similar to dose 1.CONCLUSIONS:
One RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post-dose 1 was well tolerated but did not seem to provide additional efficacy benefit in the overall study population. CLINICAL TRIALS REGISTRATION ClinicalTrials.gov NCT04886596.Palabras clave
Texto completo:
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Banco de datos:
MEDLINE
Asunto principal:
Proteínas Virales de Fusión
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Virus Sincitial Respiratorio Humano
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Infecciones por Virus Sincitial Respiratorio
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Vacunas contra Virus Sincitial Respiratorio
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2024
Tipo del documento:
Article