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DOI 10.1016/j.vaccine.2024.126685

Медицинская библиотека · Vaccine · 2025

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.

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, G Prado Julia, 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, Martí Lluch Ruth, Corpes Comes Aida, Otero Romero Susana, Martínez-Gómez Xavier, Camacho-Arteaga Lina, Molto Jose, Benet Susana, Bailón Lucía, Arribas Jose R, Borobia Alberto M, Queiruga Parada Javier, Navarro-Pérez Jorge, Forner Giner Maria José, Lucas Rafael Ortí, Vázquez Jiménez María Del Mar, López Fernández María Jesús, Alvarez-Mon Melchor, Troncoso Daniel, Arana-Arri Eunate, Meijide Susana, Imaz-Ayo Natale, García Patricia Muñoz, de la Villa Sofía, Rodríguez Fernández Sara, Prat Teresa, Torroella Èlia, Ferrer Laura

СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАEquivalence TrialПеревод пока не подготовлен

Аннотация

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 Identifier: NCT05142553.

Для цитирования: 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, G Prado Julia, 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, Martí Lluch Ruth, Corpes Comes Aida, Otero Romero Susana, Martínez-Gómez Xavier, Camacho-Arteaga Lina, Molto Jose, Benet Susana, Bailón Lucía, Arribas Jose R, Borobia Alberto M, Queiruga Parada Javier, Navarro-Pérez Jorge, Forner Giner Maria José, Lucas Rafael Ortí, Vázquez Jiménez María Del Mar, López Fernández María Jesús, Alvarez-Mon Melchor, Troncoso Daniel, Arana-Arri Eunate, Meijide Susana, Imaz-Ayo Natale, García Patricia Muñoz, de la Villa Sofía, Rodríguez Fernández Sara, Prat Teresa, Torroella Èlia, Ferrer Laura. 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.. Vaccine. 2025. DOI: 10.1016/j.vaccine.2024.126685.

Предметные рубрики MeSH

HumansImmunization, SecondarySARS-CoV-2COVID-19MaleFemaleAntibodies, ViralCOVID-19 VaccinesImmunity, CellularImmunity, HumoralMiddle AgedAntibodies, NeutralizingAgedDouble-Blind MethodBNT162 VaccineAdultVaccines, SyntheticImmunogenicity, Vaccine
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