Details

Autor(en) / Beteiligte

• Ison, Michael G
• Papi, Alberto
• Athan, Eugene
• Feldman, Robert G
• Langley, Joanne M
• Lee, Dong-Gun
• Leroux-Roels, Isabel
• Martinon-Torres, Federico
• Schwarz, Tino F
• van Zyl-Smit, Richard N
• Verheust, Céline
• Dezutter, Nancy
• Gruselle, Olivier
• Fissette, Laurence
• David, Marie-Pierre
• Kostanyan, Lusine
• Hulstrøm, Veronica
• Olivier, Aurélie
• Van der Wielen, Marie
• Descamps, Dominique

Titel

Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons

Ist Teil von

• Clinical infectious diseases, 2024-06, Vol.78 (6), p.1732-1744

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2024

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Abstract Background The adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post–dose 1. Methods In this phase 3, blinded trial, ≥60-year-olds were randomized (1:1) to receive RSVPreF3 OA or placebo pre–season 1. RSVPreF3 OA recipients were re-randomized (1:1) to receive a second RSVPreF3 OA dose (RSV_revaccination group) or placebo (RSV_1dose group) pre–season 2; participants who received placebo pre–season 1 received placebo pre–season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary objective, success criterion: lower limits of 2-sided CIs around efficacy estimates >20%). Results The efficacy analysis comprised 24 967 participants (RSV_1dose: 6227; RSV_revaccination: 6242; placebo: 12 498). Median efficacy follow-up was 17.8 months. Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6–92.0%) against severe RSV-LRTD. Efficacy over 2 seasons of a first dose followed by revaccination was 67.1% (97.5% CI: 48.1–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.5–92.0%) against severe RSV-LRTD. Reactogenicity/safety of the revaccination dose were similar to dose 1. Conclusions One RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post–dose 1 was well tolerated but did not seem to provide additional efficacy benefit in the overall study population. Clinical Trials Registration ClinicalTrials.gov: NCT04886596. One RSVPreF3 OA dose was efficacious against respiratory syncytial virus (RSV)–related lower respiratory tract disease during at least 2 RSV seasons in ≥60-year-olds. RSVPreF3 OA revaccination 1 year post–dose 1 did not seem to provide additional efficacy benefit. Optimal timing of revaccination remains to be determined.