%0 Journal Article
%A Ferguson, Murdo
%A Schwarz, Tino F
%A Núñez, Sebastián A
%A Rodriguez-Garcia, Juan
%A Mital, Marek
%A Zala, Carlos
%A Schmitt, Bernhard
%A Toursarkissian, Nicole
%A Mazarro, Dolores Ochoa
%A Großkopf, Josef
%A Voors-Pette, Christine
%A Mehta, Hemalini
%A Hailemariam, Hiwot Amare
%A de Heusch, Magali
%A Salaun, Bruno
%A Damaso, Silvia
%A David, Marie-Pierre
%A Descamps, Dominique
%A Hill, Judith
%A Vandermeulen, Corinne
%A Hulstrøm, Veronica
%T Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age
%D 2024
%U https://hdl.handle.net/20.500.13003/20943
%X The adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) is approved in adults aged ≥60 years. We evaluated RSVPreF3 OA immunogenicity and safety in adults aged 50-59 years without or with increased risk for RSV disease due to specific chronic medical conditions.This observer-blind, phase 3, noninferiority trial included adults aged 50-59 years, stratified into 2 subcohorts: those with and those without predefined, stable, chronic medical conditions leading to an increased risk for RSV disease. Participants in both subcohorts were randomized 2:1 to receive RSVPreF3 OA or placebo. A control group of adults aged ≥60 years received RSVPreF3 OA. Primary outcomes were RSV-A and RSV-B neutralization titers (geometric mean titer ratios and sero-response rate differences) 1 month post-vaccination in 50-59-year-olds versus ≥60-year-olds. Cell-mediated immunity and safety were also assessed.The exposed population included 1152 participants aged 50-59 years and 381 participants aged ≥60 years. RSVPreF3 OA was immunologically noninferior in 50-59-year-olds versus ≥60-year-olds; noninferiority criteria were met for RSV-A and RSV-B neutralization titers in those with and those without increased risk for RSV disease. Frequencies of RSVPreF3-specific polyfunctional CD4+ T cells increased substantially from pre- to 1 month post-vaccination. Most solicited adverse events had mild-to-moderate intensity and were transient. Unsolicited and serious adverse event rates were similar in all groups.RSVPreF3 OA was immunologically noninferior in 50-59-year-olds compared to ≥60-year-olds, in whom efficacy was previously demonstrated. The safety profile in 50-59-year-olds was consistent with that in ≥60-year-olds.ClinicalTrials.gov: NCT05590403.
%~