Omicron XBB.1.16-Adapted Vaccine for COVID-19 : Interim Immunogenicity and Safety Clinical Trial Results
López Fernández, María Jesús (Hospital Regional Universitario de Málaga)
Narejos, Silvia (Centro de Atención Primaria Centelles)
Castro, Antoni (Hospital Universitari de Girona Doctor Josep Trueta)
Echave-Sustaeta, José María (Grupo Quirónsalud (Madrid, Espanya))
Forner, Maria Jose (Hospital Clínic Universitari (València))
Arana-Arri, Eunate (Unidad de Coordinación Científica. Biocruces Bizkaia. Osakidetza)
Moltó, José (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Bernard Rosa, Laia (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Pérez-Caballero, Raúl (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Prado, Julia G. (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Raïch-Regué, Dàlia (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Boreika, Rytis (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Izquierdo Useros, Nuria (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Trinité, Benjamin (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Blanco, Julià (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Puig-Barberà, Joan (Fundación para la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO))
Natalini Martínez, Silvina (Unidad de Investigación de Vacunas, Instituto de Investigación Sanitaria HM)

Data:	2024
Resum:	(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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	JN.1 ; XBB.1.16 ; Adapted vaccine ; SARS-CoV-2 vaccine ; Adjuvanted protein vaccine ; Booster vaccine ; COVID-19
Publicat a:	Vaccines (Basel), Vol. 12 Núm. 8 (July 2024) , ISSN 2076-393X

DOI: 10.3390/vaccines12080840
PMID: 39203967

16 p, 3.4 MB

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