The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults ≥60 years of age.
Influenza Other Respir Viruses
; 18(2): e13236, 2024 Feb.
Article
em En
| MEDLINE
| ID: mdl-38314063
ABSTRACT
Background:
Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022).Methods:
In this phase 3 trial, adults aged ≥60 years were randomized (11) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models.Results:
In the RSVPreF3 OA group (N = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI] -9.86, 23.85; p = 0.4125) and 0.0786 (95% CI -0.0340, 0.1913; p = 0.1695).Conclusions:
The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
Problema de saúde:
1_doencas_nao_transmissiveis
/
1_doencas_transmissiveis
/
2_enfermedades_transmissibles
/
2_muertes_prematuras_enfermedades_notrasmisibles
Assunto principal:
Infecções Respiratórias
/
Vírus Sincicial Respiratório Humano
/
Infecções por Vírus Respiratório Sincicial
/
Vacinas contra Vírus Sincicial Respiratório
/
Influenza Humana
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Limite:
Aged
/
Humans
/
Middle aged
Idioma:
En
Revista:
Influenza Other Respir Viruses
Assunto da revista:
VIROLOGIA
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Bélgica