TY - JOUR
T1 - 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
AU - Corominas, Júlia
AU - Garriga, Carme
AU - Prenafeta, Antoni
AU - Moros, Alexandra
AU - Cañete, Manuel
AU - Barreiro, Antonio
AU - González-González, Luis
AU - Madrenas, Laia
AU - Güell, Irina
AU - Clotet, Bonaventura
AU - Izquierdo-Useros, Nuria
AU - Raïch-Regué, Dàlia
AU - Gallemí, Marçal
AU - Blanco, Julià
AU - Pradenas, Edwards
AU - Trinité, Benjamin
AU - G. Prado, Julia
AU - Pérez-Caballero, Raúl
AU - Bernad, Laia
AU - Plana, Montserrat
AU - Esteban, Ignasi
AU - Aurrecoechea, Elena
AU - Taleb, Rachel Abu
AU - McSkimming, Paula
AU - Soriano, Alex
AU - Nava, Jocelyn
AU - Anagua, Jesse Omar
AU - Ramos, Rafel
AU - Martí Lluch, Ruth
AU - Corpes Comes, Aida
AU - Otero Romero, Susana
AU - Martínez-Gómez, Xavier
AU - Camacho-Arteaga, Lina
AU - Molto, Jose
AU - Benet, Susana
AU - Bailón, Lucía
AU - Arribas, Jose R.
AU - Borobia, Alberto M.
AU - Queiruga Parada, Javier
AU - Navarro-Pérez, Jorge
AU - Forner Giner, Maria José
AU - Lucas, Rafael Ortí
AU - Vázquez Jiménez, María del Mar
AU - López Fernández, María Jesús
AU - Alvarez-Mon, Melchor
AU - Troncoso, Daniel
AU - Arana-Arri, Eunate
AU - Meijide, Susana
AU - Imaz-Ayo, Natale
AU - García, Patricia Muñoz
AU - de la Villa, Sofía
AU - Rodríguez Fernández, Sara
AU - Prat, Teresa
AU - Torroella, Èlia
AU - Ferrer, Laura
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/2/15
Y1 - 2025/2/15
N2 - 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
AB - 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
KW - Covid-19
KW - Heterologous booster
KW - Protein-based vaccine
KW - SARS-CoV-2
UR - https://www.scopus.com/pages/publications/85214563036
U2 - 10.1016/j.vaccine.2024.126685
DO - 10.1016/j.vaccine.2024.126685
M3 - Article
AN - SCOPUS:85214563036
SN - 0264-410X
VL - 47
JO - Vaccine
JF - Vaccine
M1 - 126685
ER -
