Autor:innen:
M. Ison (Chicago, Illinois, US)
A. Papi (Ferrara, IT)
J. Langley (Halifax, CA)
D. Lee (Seoul, KP)
I. Leroux-Roels (Ghent, BE)
F. Martinon-Torres (Santiago de Compostela, ES)
T. Schwarz (Würzburg, DE)
R. van Zyl-Smit (Cape Town, ZA)
N. Dezutter (Wavre, BE)
N. de Schrevel (Rixensart, BE)
L. Fissette (Wavre, BE)
M. David (Wavre, BE)
M. Van Der Wielen (Wavre, BE)
L. Kostanyan (Wavre, BE)
V. Hulstrom (Wavre, BE)
Background: RSV-associated acute respiratory infections (ARI), particularly lower respiratory tract diseases (LRTD), present a significant disease burden in older adults. Currently, there are no approved vaccines against RSV. We present results from an ongoing study designed to demonstrate the vaccine efficacy (VE) of the AS01E-adjuvanted RSVPreF3 OA in adults ≥60 YOA.
Methods: This ongoing, phase 3, observer-blind, placebo-controlled, multi-country study (NCT04886596) enrolled adults ≥60 YOA from the northern and southern hemispheres. 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 LRTD during one RSV season (criterion: lower limit of VE confidence interval [CI] >20%). VE is reported also against severe RSV-confirmed LRTD, RSV-confirmed ARI, RSV-confirmed LRTD and RSV-confirmed ARI by RSV subtype (RSV-A and RSV-B), and RSV-confirmed LRTD by age, baseline comorbidity and frailty status. RSV-A/B was confirmed by quantitative RT-PCR.
Results: A total of 26,664 participants were enrolled, of whom 24,966 (RSVPreF3 OA: 12,467; placebo: 12,499) were included in the exposed set and 24,960 (RSVPreF3 OA: 12,466; placebo: 12,494) in the efficacy analysis. The mean age was 69.5 (±6.5) years and 51.7% were women. Over a median follow-up of 6.7 months (maximum 10.1 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. RSV-A- and RSV-B-specific VE was shown against RSV-confirmed LRTD (84.6% and 80.9%) and RSV-confirmed ARI (71.9% and 70.6%). VE against RSV-confirmed LRTD was >80% in 60–69- and 70–79-year-olds, but very few cases (n=5) were reported to conclude on VE in ≥80-year-olds. High VE was also observed in participants with pre-existing comorbidities (94.6%) and in pre-frail participants (92.9%). Throughout the follow-up period, there was no evidence of waning VE against RSV-confirmed LRTD and RSV-confirmed ARI.
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.
Funding: GlaxoSmithKline Biologicals SA
Acknowledgement: Medical writing (Ioana Sima) and coordination support were provided by Modis c/o GSK