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

Authors :
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
Zyl-Smit, Richard N van
Verheust, Céline
Dezutter, Nancy
Gruselle, Olivier
Fissette, Laurence
David, Marie-Pierre
Kostanyan, Lusine
Hulstrøm, Veronica
Olivier, Aurélie
Wielen, Marie Van der
Descamps, Dominique
Source :
Clinical Infectious Diseases; 6/15/2024, Vol. 78 Issue 6, p1732-1744, 13p
Publication Year :
2024

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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10584838
Volume :
78
Issue :
6
Database :
Complementary Index
Journal :
Clinical Infectious Diseases
Publication Type :
Academic Journal
Accession number :
177926996
Full Text :
https://doi.org/10.1093/cid/ciae010