A Respiratory Syncytial Virus (RSV) Prefusion F Protein Candidate Vaccine (RSVPreF3-OA) is Efficacious in Adults ≥ 60 Years of Age (YOA)

Background RSV-associated acute respiratory infections (ARI), particularly lower respiratory tract diseases (LRTD), present a significant disease burden in older adults. Results from an ongoing study show the vaccine efficacy (VE) of the AS01E-adjuvanted RSVPreF3-OA in adults ≥60 YOA.

Methods This phase 3, observer-blind, placebo-controlled, (NCT04886596) enrolled adults ≥60 YOA in several countries. Participants were randomized (1:1) to receive a single dose of RSVPreF3-OA or placebo before the RSV season. The primary objective was to demonstrate VE of a single dose of RSVPreF3-OA in preventing RSV-confirmed (qRT-PCR) LRTD during one RSV season. VE is reported also against severe RSV-confirmed LRTD, RSV-confirmed ARI, RSV-confirmed LRTD and RSV-confirmed ARI.

Results A total of 26,664 participants were enrolled, of whom 24,960 (RSVPreF3-OA: 12,466; placebo: 12,494) were included in the efficacy analysis. The mean age was 69.5 (±6.5) years. Over a median follow-up of 6.7 months, 47 RSV-confirmed LRTD episodes were reported (RSVPreF3-OA: 7; placebo: 40), resulting in a VE of 82.6% (96.95% CI: 57.9–94.1), thus the primary objective was met. Consistently high VE across the clinical spectrum of RSV disease, from RSV-confirmed ARI (71.7% [95% CI: 56.2–82.3]) to severe RSV-confirmed LRTD (94.1% [95% CI: 62.4–99.9]) was observed. High VE was seen in different age groups and regardless of RSV subtype, baseline comorbidity or pre-frail status.

Conclusion A single RSVPreF3-OA dose is highly efficacious against RSV-confirmed LRTD and RSV-confirmed ARI in adults ≥60 YOA, regardless of RSV disease severity, RSV subtype, baseline comorbidity and pre-frail status.

Interessenkonflikt

Michael G. Ison: GlaxoSmithKline: Advisor/Consultant (), Grant/Research Support (). Alberto Papi: CHIESI, ASTRAZENECA, GSK, BI, MENARINI, NOVARTIS, ZAMBON,MUNDIPHARMA, SANOFI, AVILLION: Honoraria (); CHIESI, ASTRAZENECA, GSK,NOVARTIS, SANOFI, IQVIA, AVILLION, ELPEN PHARMACEUTICALS: Advisor/Consultant (),Board Member (); CHIESI, ASTRAZENECA, GSK, SANOFI: Grant/Research Support (). Joanne M. Langley: GSK, Merck, Medicago, Sanofi, VBI, VIDO, Entos, Pfizer: Grant/Research Support (). Dong-Dun Lee: No financial relationships to disclose. Isabel Leroux-Roels: Curevac: payment to my institution for the conduct of clinical trials (); GSK: payment to my institution for the conduct of clinical trials (); ICON Genetics: payment to my institution for the conduct of clinical trials (); Janssen Vaccines (J&J): Board Member (), payment to my institution for the conduct of clinical trials (); Osivax: payment to my institution for the conduct of clinical trials (). Federico Martinon-Torres: GlaxoSmithKline, Pfizer, Sanofi, Merck, Moderna, Astra Zeneca, Biofabri, Janssen, Novavax: Advisor/Consultant (), Clinical trials fees paid to my institution (), Grant/Research Support (), Honoraria (). Tino F. Schwarz: GlaxoSmithKline: Advisor/Consultant (). Richard N. van Zyl-Smit: MSD, Pfizer, GSK, Astra Zeneca, Roche, Novartis, Boehringer Ingelheim, Cipla, J&J, Glenmark: Advisor/Consultant (), Honoraria (). Nancy Dezutter: GlaxoSmithKline: GSK employee (), Stocks/Bonds (). Nathalie De Schrevel: GlaxoSmithKline: GSK employee (). Laurence Fissette: GlaxoSmithKline: GSK employee (), Stocks/Bonds (). Marie-Pierre David: GlaxoSmithKline: GSK employee (), Stocks/Bonds (). Marie Van Der Wielen: GlaxoSmithKline: GSK employee (), Stocks/Bonds (). Lusine Kostanyan: GlaxoSmithKline: GSK employee (), Stocks/Bonds (). Veronica Hulstrøm: GlaxoSmithKline: GSK employee ()

Publication History

Article published online:
02 May 2023