Author:
Corominas Júlia,Garriga Carme,Prenafeta Antoni,Moros Alexandra,Cañete Manuel,Barreiro Antonio,González-González Luis,Madrenas Laia,Güell Irina,Clotet Bonaventura,Izquierdo-Useros Nuria,Raïch-Regué Dàlia,Gallemí Marçal,Blanco Julià,Pradenas Edwards,Trinité Benjamin,Prado Julia G,Pérez-Caballero Raúl,Bernad Laia,Plana Montserrat,Esteban Ignasi,Aurrecoechea Elena,Taleb Rachel Abu,McSkimming Paula,Soriano Alex,Nava Jocelyn,Anagua Jesse Omar,Ramos Rafel,Lluch Ruth Martí,Comes Aida Corpes,Romero Susana Otero,Martínez-Gómez Xavier,Camacho-Arteaga Lina,Molto Jose,Benet Susana,Bailón Lucía,Arribas Jose R,Borobia Alberto M,Parada Javier Queiruga,Navarro-Pérez Jorge,Giner Maria José Forner,Lucas Rafael Ortí,Jiménez María del Mar Vázquez,Fernández María Jesús López,Alvarez-Mon Melchor,Troncoso Daniel,Arana-Arri Eunate,Meijide Susana,Imaz-Ayo Natale,García Patricia Muñoz,de la Villa Sofía,Fernández Sara Rodríguez,Prat Teresa,Torroella Èlia,Ferrer Laura
Abstract
SummaryThe HIPRA-HH-2 was a multicentre, randomized, active-controlled, double-blind, non-inferiority phase IIb clinical trial to compare the immunogenicity and safety of a heterologous booster with PHH-1V adjuvanted recombinant vaccine versus a homologous booster with mRNA vaccine. Interim results showed a 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 after dosing. Here we report that these humoral and cellular responses after PHH-1V dosing are sustained up to 6 months. These results are observed both when including or not participants who reported SARS-CoV-2 infection and in a high-risk population (≥65 years). Additional analysis revealed a non-inferiority of PHH-1V booster in eliciting neutralizing antibodies also for SARS-CoV-2 Omicron XBB.1.5 when compared to mRNA vaccine after 6 months. The PHH-1V vaccine provides long-lasting protection against a wide variety of SARS-CoV-2 emerging variants to prevent severe COVID-19.ClinicalTrials.govIdentifierNCT05142553
Publisher
Cold Spring Harbor Laboratory