Humoral and cellular immune responses after 6 months of a heterologous SARS-CoV-2 booster with the protein-based PHH-1V vaccine in a phase IIb trial

The HIPRA-HH-2 was a multicentre, randomized, active-controlled, double-blind, non-inferiority phase IIb clinical trial comparing the immunogenicity and safety of the PHH-1V adjuvanted recombinant vaccine as a heterologous booster against homologous booster with BNT162b2. Interim results demonstrate...

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Detalles Bibliográficos
Autores: Corominas, J, Garriga, C, Prenafeta, A, Moros, A, Cañete, M, Barreiro, A, González-González, L, Madrenas, L, Güell, I, Clotet, B, Izquierdo-Useros, N, Raïch-Regué, D, Gallemí, M, Blanco, J, Pradenas, E, Trinité, B, Prado, JG, Pérez-Caballero, R, Bernad, L, Plana, M, Esteban, I, Aurrecoechea, E, Abu Taleb, R, Mcskimming, P, Soriano, A, Nava, J, Anagua, JO, Ramos, R, Lluch, RM, Comes, AC, Romero, SO, Martínez-Gómez, X, Camacho-Arteaga, L, Molto, J, Benet, S, Bailón, L, Arribas, JR, Borobia, AM, Parada, JQ, Navarro-Pérez, J, Giner, MJF, Lucas, RO, Jiménez, MDV, Fernández, MJL, Alvarez-Mon, M, Troncoso, D, Arana-Arri, E, Meijide, S, Imaz-Ayo, N, García, PM, de la Villa, S, Fernandez, SR, Prat, T, Torroella,É, Ferrer, L
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:dnet:incliva_____::a18d20c222ba1e87621d3e360fb0752b
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/20967
Access Level:acceso abierto
Palabra clave:Covid-19
SARS-CoV-2
Protein-based vaccine
Heterologous booster
Descripción
Sumario:The HIPRA-HH-2 was a multicentre, randomized, active-controlled, double-blind, non-inferiority phase IIb clinical trial comparing the immunogenicity and safety of the PHH-1V adjuvanted recombinant vaccine as a heterologous booster against homologous booster with BNT162b2. Interim results demonstrated strong humoral and cellular immune response against the SARS-CoV-2 Wuhan-Hu-1 strain and the Beta, Delta, and Omicron BA.1 variants up to day 98 post-dosing. Here we report that these responses with PHH-1V are sustained up to 6 months, including in participants over 65 years, despite their smaller sample size. The PHH-1V booster was non- inferior in eliciting neutralizing antibodies for SARS-CoV-2 Omicron XBB.1.5 variant compared to BNT162b2 after 6 months. No severe COVID-19 cases occurred in any group, and mild cases were similar (50.4 % for PHH1V vs. 47.8 % for BNT162b2). While both groups may have reached comparable immunity levels, these findings suggest that the PHH-1V vaccine provides long-lasting immunity against various of SARS-CoV-2 variants. ClinicalTrials.gov Identifier: NCT05142553

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