GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) was recently approved for expanded use by the U.S. Food and Drug Administration (FDA), following the completion of last year’s Phase 3 trial (NCT06389487) which demonstrated the immune response and evaluated the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults between the ages of 18 and 49 years old who are at increased risk for respiratory syncytial virus (RSV) disease compared to adults 60 and older. The expansion is significant largely due to the volume of adults affected by RSV annually, particularly those who are at increased risk of severe RSV illness due chronic cardiovascular disease, chronic lung or respiratory disease, and other conditions. GSK's RSV vaccine contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant before administration.

The expanded age indication for Arexvy includes adults ages 18 through 49 years old who are at increased risk of lower respiratory tract disease caused by RSV. Initially, in 2023, Arexvy was approved by the FDA for the prevention of lower respiratory tract disease caused by RSV in adults 60 and older, and saw its first expanded age indication approval in 2024 for the prevention of RSV lower respiratory tract disease in adults 50 through 59 years old who are at increased risk.

Today, we are spotlighting the trial, A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above, which led to Arexvy’s latest approved expanded age indication.

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above
  • Sponsor: GlaxoSmithKline
  • Description: The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk for RSV disease, compared to older adults  60 YOA and above.
  • Intervention: RSVPreF3 OA investigational vaccine
  • Primary Outcome Measures:
    • Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers; Time frame: At day 31.
    • Part A: Percentage of Participants with Seroresponse Rate in RSV-A Neutralizing Titers; Time frame: Day 31 compared with baseline (day 1).
    • Part A: RSV-B Neutralizing Titers Expressed as Group Geometric Mean Titers; Time frame: At day 31.
    • Part A: Percentage of Participants with Seroresponse Rate in RSV-B Neutralizing Titers; Time frame: Day 31 compared with baseline (day 1).
  • Study Details
  • Source

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