GSK3858279 (GSK)

GSK3858279 is an unadjuvanted recombinant subunit vaccine candidate developed by GSK for the prevention of respiratory syncytial virus (RSV) infections in infants through maternal immunization. The vaccine contains the RSV prefusion F protein (RSVPreF3), a highly conserved surface protein that is the primary target for potent neutralizing antibodies. By vaccinating pregnant women, the candidate aims to induce high titers of maternal antibodies that are transferred across the placenta to provide passive immunity to the newborn during the first months of life. In February 2022, GSK voluntarily halted the Phase 3 clinical development program, including the GRACE (NCT04224181) and RSV MAT 009 (NCT04605159) trials, following a recommendation from an Independent Data Monitoring Committee (IDMC) which identified a safety signal concerning an increased risk of preterm births and neonatal deaths in the vaccine group compared to the placebo group.

Other names

RSV MATunadjuvanted RSVPreF3 vaccineRSV maternal vaccineRSVPreF3RSVPreF-3RSVPreF 3