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

Júlia Corominas, Carme Garriga, Antoni Prenafeta, Alexandra Moros*, Manuel Cañete, Antonio Barreiro, Luis González-González, Laia Madrenas, Irina Güell, Bonaventura Clotet, Nuria Izquierdo-Useros, Dàlia Raïch-Regué, Marçal Gallemí, Julià Blanco, Edwards Pradenas, Benjamin Trinité, Julia G. Prado, Raúl Pérez-Caballero, Laia Bernad, Montserrat PlanaIgnasi Esteban, Elena Aurrecoechea, Rachel Abu Taleb, Paula McSkimming, Alex Soriano, Jocelyn Nava, Jesse Omar Anagua, Rafel Ramos, Ruth Martí Lluch, Aida Corpes Comes, Susana Otero Romero, Xavier Martínez-Gómez, Lina Camacho-Arteaga, Jose Molto, Susana Benet, Lucía Bailón, Jose R. Arribas, Alberto M. Borobia, Javier Queiruga Parada, Jorge Navarro-Pérez, Maria José Forner Giner, Rafael Ortí Lucas, María del Mar Vázquez Jiménez, María Jesús López Fernández, Melchor Alvarez-Mon, Daniel Troncoso, Eunate Arana-Arri, Susana Meijide, Natale Imaz-Ayo, Patricia Muñoz García, Sofía de la Villa, Sara Rodríguez Fernández, Teresa Prat, Èlia Torroella, Laura Ferrer

*Autor corresponent d’aquest treball

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Resum

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 PHH-1V 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

Idioma originalAnglès
Número d’article126685
RevistaVaccine
Volum47
DOIs
Estat de la publicacióPublicada - 15 de febr. 2025
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