@article{20.500.13003/20943,
year = {2024},
month = {8},
url = {https://hdl.handle.net/20.500.13003/20943},
abstract = {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.},
publisher = {Oxford},
title = {Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age},
doi = {10.1093/cid/ciae364},
journal = {Clinical infectious diseases : an official publication of the Infectious Diseases Society of America},
author = {Ferguson, Murdo and Schwarz, Tino F and Núñez, Sebastián A and Rodriguez-Garcia, Juan and Mital, Marek and Zala, Carlos and Schmitt, Bernhard and Toursarkissian, Nicole and Mazarro, Dolores Ochoa and Großkopf, Josef and Voors-Pette, Christine and Mehta, Hemalini and Hailemariam, Hiwot Amare and de Heusch, Magali and Salaun, Bruno and Damaso, Silvia and David, Marie-Pierre and Descamps, Dominique and Hill, Judith and Vandermeulen, Corinne and Hulstrøm, Veronica},
}