Omicron XBB.1.16-Adapted Vaccine for COVID-19: Interim Immunogenicity and Safety Clinical Trial Results.

Autor:	López Fernández MJ; Servicio de Medicina Preventiva y Salud Pública, Hospital Regional Universitario de Málaga, 29010 Málaga, Spain., Narejos S; Centro de Atención Primaria Centelles, 08540 Centelles, Spain., Castro A; Hospital Universitari de Girona Doctor Josep Trueta, 17007 Girona, Spain., Echave-Sustaeta JM; Hospital Universitario Quirónsalud Madrid, 28223 Madrid, Spain., Forner MJ; Hospital Clínico Universitario Valencia, 46010 Valencia, Spain., Arana-Arri E; Unidad de Coordinación Científica, Biocruces Bizkaia, Osakidetza, 48903 Barakaldo, Spain., Molto J; Centro de Investigación Biomédica en Red-Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain.; Department of Infectious Diseases, Fundació Lluita Contra les Infeccions, Hospital Universitari Germans Trias i Pujol, 08916 Badalona, Spain., Bernad L; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain., Pérez-Caballero R; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain.; Institut de Recerca Germans Trias i Pujol (IGTP), 08916 Badalona, Spain., Prado JG; Centro de Investigación Biomédica en Red-Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain.; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain.; Institut de Recerca Germans Trias i Pujol (IGTP), 08916 Badalona, Spain., Raïch-Regué D; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain., Boreika R; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain., Izquierdo-Useros N; Centro de Investigación Biomédica en Red-Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain.; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain., Trinité B; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain., Blanco J; Centro de Investigación Biomédica en Red-Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain.; IrsiCaixa, Can Ruti Campus, 08916 Badalona, Spain.; Institut de Recerca Germans Trias i Pujol (IGTP), 08916 Badalona, Spain.; Càtedra de Malalties Infeccioses i Immunitat, Facultat de Medicina, Universitat de Vic-Universitat Central de Catalunya (UVic-UCC), 08500 Vic, Spain., Puig-Barberà J; Área de Investigación en Vacunas, Fundació per al Foment de la Investigació Sanitària i Biomèdica de la Comunitat Valenciana (FISABIO), 46020 Valencia, Spain., Natalini Martínez S; Unidad de Investigación de Vacunas, Instituto de Investigación Sanitaria HM, 28938 Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Vaccines [Vaccines (Basel)] 2024 Jul 25; Vol. 12 (8). Date of Electronic Publication: 2024 Jul 25.
DOI:	10.3390/vaccines12080840
Abstrakt:	(1) Background: The global coronavirus disease 2019 vaccination adapts to protect populations from emerging variants. This communication presents interim findings from the new Omicron XBB.1.16-adapted PHH-1V81 protein-based vaccine compared to an XBB.1.5-adapted mRNA vaccine against various acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains. (2) Methods: In a Phase IIb/III pivotal trial, adults previously vaccinated with a primary scheme and at least one booster dose of an EU-approved mRNA vaccine randomly received either the PHH-1V81 or BNT162b2 XBB.1.5 vaccine booster as a single dose. The primary efficacy endpoint assessed neutralization titers against the Omicron XBB.1.16 variant at day 14. Secondary endpoints evaluated neutralization titers and cellular immunity against different variants. Safety endpoints comprised solicited reactions up to day 7 post-vaccination and serious adverse events until the cut-off date of the interim analysis. Changes in humoral responses were assessed by pseudovirion-based or virus neutralization assays. (3) Results: At the cut-off date, immunogenicity assessments included 599 participants. Both boosters elicited neutralizing antibodies against XBB.1.16, XBB.1.5, and JN.1, with PHH-1V81 inducing a higher response for all variants. The PHH-1V8 booster triggers a superior neutralizing antibody response against XBB variants compared to the mRNA vaccine. A subgroup analysis consistently revealed higher neutralizing antibody responses with PHH-1V81 across age groups, SARS-CoV-2 infection history, and the number of prior vaccination shots. A safety analysis (n = 607) at the day 14 visit revealed favorable safety profiles without any serious vaccine-related adverse events. (4) Conclusions: PHH-1V81 demonstrates superiority on humoral immunogenicity compared to the mRNA vaccine against XBB variants and non-inferiority against JN.1 with a favorable safety profile and lower reactogenicity, confirming its potential as a vaccine candidate.
Databáze:	MEDLINE
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