Drug intelligence / Profile preview

RSVPreF3

Development stage
Approved
Lead developer
GSK
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

RSVPreF3 is a recombinant protein subunit vaccine developed by GSK that targets the prefusion conformation of the respiratory syncytial virus (RSV) fusion (F) protein. The vaccine is designed to induce high levels of RSV-neutralizing antibodies to prevent lower respiratory tract disease (LRTD). It has been developed in two primary formulations: an adjuvanted version containing the AS01E liposome-based adjuvant system and an unadjuvanted version (RSVPreF3-Mat). The adjuvanted formulation, marketed under the brand name Arexvy, is the first RSV vaccine approved for use in adults aged 60 years and older. The unadjuvanted maternal formulation was intended for administration during pregnancy to provide passive immunity to infants; however, its Phase 3 clinical development (RSV MAT-009) was terminated in 2022 following a safety signal indicating an increased risk of preterm births in the vaccine group.

Brand names
Arexvy
Other names
RSVPreF3-MatRSVPreF-3-MatRSVPreF 3-MatRSV maternal vaccineRespiratory syncytial virus vaccine recombinant adjuvantedGSK3844764AGSK-3844764AGSK 3844764AGSK3888550AGSK-3888550AGSK 3888550A
02

Targets

RSV F (Respiratory syncytial virus fusion protein)

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