Alberto Papi, David M G Halpin, Robert G Feldman, Michael G Ison, Tino F Schwarz, Dong-Gun Lee, Raffaele Antonelli Incalzi, Laurence Fissette, Stebin Xavier, Marie-Pierre David, Jean-Philippe Michaud, Shady Kotb, Céline Maréchal, Aurélie Olivier, Veronica Hulstrøm, Marie Van der Wielen
Post hoc analyses of the AReSVi-006 trial suggest that adjuvanted RSVPreF3 may help prevent RSV-ARI, RSV-LRTD and RSV-related complications in medically stable older adults with underlying medical conditions like COPD and asthma.
BACKGROUND: We explored the efficacy of AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine (adjuvanted RSVPreF3) in subpopulations of participants with underlying medical conditions in the multi-country, phase 3 AReSVi-006 trial (conducted between May 2021 and May 2024).
METHODS: Medically stable ≥60-year-olds were 1:1-randomised to receive one adjuvanted RSVPreF3 or placebo dose pre-RSV season 1. In exploratory post hoc analyses in subgroups of participants with underlying conditions (including COPD, asthma, diabetes and obesity (body mass index ≥30 kg·m-2)), we evaluated efficacy of one vaccine dose against RSV-related lower respiratory tract disease (RSV-LRTD), RSV-related acute respiratory illness (RSV-ARI) and RSV-ARI-related complications (e.g., pneumonia, COPD/asthma exacerbation and cardiovascular events). We also evaluated (post hoc) RSV-ARI-related systemic corticosteroid and antibiotics use in participants with COPD or asthma.
RESULTS: The efficacy analyses comprised 12 468 vaccine and 12 498 placebo recipients. Efficacy against RSV-LRTD over three RSV seasons was similar among participants with COPD (75.1%, 95% CI: 40.2-91.4), asthma (65.8%, 31.0-84.7), diabetes (69.8%, 37.5-87.1) and obesity (74.1%, 56.4-85.5) as in the overall study population (62.9%, 97.5% CI: 46.7-74.8). Efficacy was also observed against RSV-ARI in these subgroups. Efficacy against RSV-ARI-related complications was 74.4% (95% CI: 11.2-95.2) in participants with COPD and 60.8% (-9.9-88.7) in those with asthma. Among participants with COPD, 15.4% (1.9-45.4) of RSV-ARI episodes in vaccine versus 22.4% (12.5-35.3) in placebo recipients were treated with systemic corticosteroids, and 46.2% (19.2-74.9) versus 56.9% (43.2-69.8) with antibiotics.
CONCLUSIONS: Post hoc analyses of the AReSVi-006 trial suggest that adjuvanted RSVPreF3 may help prevent RSV-ARI, RSV-LRTD and RSV-related complications in medically stable older adults with underlying medical conditions like COPD and asthma.