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
Document Type
Journal Article
Publication Date
2-1-2024
Journal
Influenza and other respiratory viruses
Volume
18
Issue
2
DOI
10.1111/irv.13236
Keywords
acute respiratory infections; older adults; patient‐reported outcome; quality of life; respiratory syncytial virus
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 (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 ( = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group ( = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); = 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; = 0.4125) and 0.0786 (95% CI: -0.0340, 0.1913; = 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.
APA Citation
Curran, Desmond; Matthews, Sean; Cabrera, Eliazar Sabater; Pérez, Silvia Narejos; Breva, Lina Pérez; Rämet, Mika; Helman, Laura; Park, Dae Won; Schwarz, Tino F.; Melendez, Isabel Maria; Schaefer, Axel; Roy, Nathalie; Stephan, Brigitte; Molnar, Daniel; Kostanyan, Lusine; Powers, John H.; and Hulstrøm, Veronica, "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). GW Authored Works. Paper 4392.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/4392
Department
Medicine