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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
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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
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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
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Journal Article
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
2024
Overview
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 (1:1) 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.
Publisher
John Wiley & Sons, Inc
Subject
/ Adults
/ Aged
/ Antigens
/ Chest
/ Humans
/ Influenza, Human - drug therapy
/ Influenza, Human - prevention & control
/ Placebos
/ Proteins
/ Respiratory Syncytial Virus Infections - epidemiology
/ Respiratory Syncytial Virus Infections - prevention & control
/ Respiratory Syncytial Virus Vaccines - therapeutic use
/ Respiratory Syncytial Virus, Human
/ Respiratory Tract Infections
/ Vaccines
/ Viruses
