RT Journal Article
T1 Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age
A1 Ferguson, Murdo
A1 Schwarz, Tino F
A1 Núñez, Sebastián A
A1 Rodriguez-Garcia, Juan
A1 Mital, Marek
A1 Zala, Carlos
A1 Schmitt, Bernhard
A1 Toursarkissian, Nicole
A1 Mazarro, Dolores Ochoa
A1 Großkopf, Josef
A1 Voors-Pette, Christine
A1 Mehta, Hemalini
A1 Hailemariam, Hiwot Amare
A1 de Heusch, Magali
A1 Salaun, Bruno
A1 Damaso, Silvia
A1 David, Marie-Pierre
A1 Descamps, Dominique
A1 Hill, Judith
A1 Vandermeulen, Corinne
A1 Hulstrøm, Veronica
AB 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.
PB Oxford
YR 2024
FD 2024-08-05
LK https://hdl.handle.net/20.500.13003/20943
UL https://hdl.handle.net/20.500.13003/20943
LA eng
NO Ferguson M, Schwarz TF, Núñez SA, Rodríguez-García J, Mital M, Zala C, et al. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age. Clin Infect Dis. 2024 Aug 5.
DS Docusalut
RD 31 jul. 2026