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
in 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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Respiratory Tract Infections
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Respiratory Syncytial Virus, Human
/
Respiratory Syncytial Virus Infections
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Respiratory Syncytial Virus Vaccines
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Influenza, Human
Type of study:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
Aspects:
Patient_preference
Limits:
Aged
/
Humans
/
Middle aged
Language:
En
Journal:
Influenza Other Respir Viruses
/
Influenza and other respiratory viruses
/
Influenza other respir. viruses
Journal subject:
VIROLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Country of publication: