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. / 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 Galan; Schaefer, Axel; Roy, Nathalie; Stephan, Brigitte; Molnar, Daniel; Kostanyan, Lusine; Powers, John H; Hulstrøm, Veronica.
in: INFLUENZA OTHER RESP, Jahrgang 2024, Nr. 18, e13236, 02.2024, S. 1-8.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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
AU - Curran, Desmond
AU - Matthews, Sean
AU - Cabrera, Eliazar Sabater
AU - Pérez, Silvia Narejos
AU - Breva, Lina Pérez
AU - Rämet, Mika
AU - Helman, Laura
AU - Park, Dae Won
AU - Schwarz, Tino F
AU - Melendez, Isabel Maria Galan
AU - Schaefer, Axel
AU - Roy, Nathalie
AU - Stephan, Brigitte
AU - Molnar, Daniel
AU - Kostanyan, Lusine
AU - Powers, John H
AU - Hulstrøm, Veronica
N1 - © 2024 GSK. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.
PY - 2024/2
Y1 - 2024/2
N2 - 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.
AB - 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.
KW - Humans
KW - Aged
KW - Middle Aged
KW - Respiratory Syncytial Virus Vaccines/therapeutic use
KW - Breakthrough Infections
KW - Viral Fusion Proteins
KW - Respiratory Syncytial Virus Infections/epidemiology
KW - Respiratory Syncytial Virus, Human
KW - Respiratory Tract Infections
KW - Influenza, Human/prevention & control
KW - Antibodies, Viral
KW - Antibodies, Neutralizing
U2 - 10.1111/irv.13236
DO - 10.1111/irv.13236
M3 - SCORING: Journal article
C2 - 38314063
VL - 2024
SP - 1
EP - 8
JO - INFLUENZA OTHER RESP
JF - INFLUENZA OTHER RESP
SN - 1750-2640
IS - 18
M1 - e13236
ER -
