Immunogenicity, Reactogenicity, and Safety of AS01E-adjuvanted RSV Prefusion F Protein-based Candidate Vaccine (RSVPreF3 OA) When Co-administered With a Seasonal Quadrivalent Influenza Vaccine in Older Adults: Results of a Phase 3, Open-Label, Randomized Controlled Trial.

Autor:	Chandler R; CAENSA Clinical Trials, Panamá City, Panamá., Montenegro N; Centro de Vacunación e Investigación CEVAXIN S.A., Avenida México, Panamá City, Panamá., Llorach C; Unidad Local de Atención Primaria de Salud de San Cristóbal, Caja de Seguro Social, Panamá.; Instituto de Investigaciones Científicas y Servicios de Alta Tecnología AIP (INDICASAT AIP), Panamá., Aguirre LN; Centro de diagnóstico y tratamiento de enfermedades respiratorias, CEDITER, Panamá City, Panamá., Germain S; GSK, Wavre, Belgium., Kuriyakose SO; GSK, Bangalore, India., Lambert A; GSK, Wavre, Belgium., Descamps D; GSK, Wavre, Belgium., Olivier A; GSK, Wavre, Belgium., Hulstrøm V; GSK, Wavre, Belgium.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 Jan 08. Date of Electronic Publication: 2024 Jan 08.
DOI:	10.1093/cid/ciad786
Abstrakt:	Background: Co-administration of vaccines against respiratory syncytial virus (RSV) and influenza can be considered given their overlapping seasonality, and may increase vaccine uptake and compliance. In this phase 3, open-label, randomized study, we evaluated the immunogenicity, reactogenicity, and safety of the AS01E-adjuvanted RSV prefusion F protein-based candidate vaccine (RSVPreF3 OA) when co-administered with a seasonal quadrivalent influenza vaccine (FLU-QIV) in older adults. Methods: Participants aged ≥60 years (randomized 1:1) received either RSVPreF3 OA and FLU-QIV simultaneously on day 1 (Co-Ad group) or FLU-QIV on day 1 followed by RSVPreF3 OA on day 31 (sequential administration [SA] group). The co-primary objectives were to demonstrate noninferiority of RSVPreF3 OA in terms of RSV-A neutralization geometric mean titer (GMT) ratio and FLU-QIV in terms of hemagglutination inhibition GMT ratio for each FLU-QIV strain, when co-administered versus when administered alone at 1-month post-vaccination. Noninferiority was demonstrated if the upper limit of the 95% confidence interview of the group GMT ratio (SA/Co-Ad) was ≤1.5. Secondary descriptive objectives comprised additional immunogenicity assessments, reactogenicity, and safety. Results: Of the 885 participants who received one dose of the study vaccines, 837 were included in the per protocol set. Demographic and baseline characteristics were balanced between the groups. Both co-primary objectives were met for both vaccines. Reported adverse events in both groups were mild-to-moderate, with a low frequency of grade 3 events. Conclusions: Data from this study demonstrate that RSVPreF3 OA can be co-administered with FLU-QIV. Co-administration is well tolerated, with an acceptable safety profile. Clinicaltrials.gov Registration: NCT04841577. (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze:	MEDLINE
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