RENOIR Trial — RSVpreF Vaccine Efficacy over Two Seasons
Edward E. Walsh, Gonzalo Pérez Marc, Ann R. Falsey, Qin Jiang, Daniel Eiras, Michael Quinn Patton, Fernando P. Polack, Conrado J. Llapur, Pablo A. Doreski, Agnieszka Zareba, Kumar Ilangovan, Mika Rämet, Yasushi Fukushima, Nazreen Hussen, Louis Bont, Jose F Cardona, Elliot DeHaan, Tarek Mikati, Rupal N. Shah, Katherine Schneider, David Cooper, Kenneth Koury, Maria-Maddalena Lino, Annaliesa S. Anderson, Kathrin U. Jansen, Kena A. Swanson, William C. Gruber, Beate Schmöele-Thoma, Alejandra Gurtman
Abstract
In the international phase 3 RSV Vaccine Efficacy Study in Older Adults Immunized against RSV Disease (RENOIR) trial, conducted in seven countries in the Northern and Southern Hemispheres among participants 60 years of age or older, bivalent RSVpreF (respiratory syncytial virus prefusion F protein-based) vaccine was efficacious in preventing RSV-associated lower respiratory tract illness with at least two or at least three symptoms (the primary efficacy end points) through a single RSV season (August 31, 2021, through July 8, 2022). 1 Predominantly on the basis of these results, RSVpreF vaccine is now approved for the prevention of RSV-associated lower respiratory tract illness in persons 60 years of age or older. 2 An analysis of vaccine efficacy in a second RSV season in the Northern and Southern Hemispheres was conducted to understand the duration of protection provided by RSVpreF vaccine.Details of the ethical considerations and statistical analysis are provided in the Supplementary Appendix, available with the full text of this letter at NEJM.org.A post hoc regression model did not show any heterogeneity in vaccine efficacy between seasons one and two; therefore, vaccine efficacy across both seasons was pooled for analysis.Surveillance for acute respiratory illness was performed from July 12, 2022, through November 6, 2023; the total mean duration of surveillance from vaccination to analysis at the end of season two was 16.4 months.Among participants who underwent follow-up in season two, the mean duration of surveillance in season two was 7.6 months; the mean duration of surveillance from vaccination to the end of the season-two surveillance period was 17.6 months.RSVpreF vaccine maintained efficacy against RSV-associated lower respiratory tract illness with at least three symptoms in season two (vaccine efficacy, 77.8%; 95% confidence interval [CI], 51.4 to 91.1) and across two seasons (vaccine efficacy, 81.5%; 95% CI, 63.3 to 91.6) (Table 1).Among participants with RSV-associated lower respiratory tract illness with at least three symptoms, vaccine efficacy against RSV A and RSV B (the cocirculating antigenic subgroups) persisted across two seasons: efficacy against RSV A was 80.6% (95% CI, 52.9 to 93.4), and efficacy against RSV B was 86.4% (95% CI, 54.6 to 97.4).As observed in RSV season one, vaccine efficacy trended lower with regard to less severe disease end points (RSV-associated lower respiratory tract illness with at least two symptoms and RSV-associated acute respiratory illness) in season two.Vaccine efficacy against RSV-associated lower respiratory tract illness with at least three sympthis week's letters