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
Por:
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 and Ferrer, L
Publicada:
15 feb 2025
Ahead of Print:
1 ene 2025
Resumen:
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
Filiaciones:
Corominas, J:
HIPRA, Girona, Spain
Garriga, C:
HIPRA, Girona, Spain
Prenafeta, A:
HIPRA, Girona, Spain
Moros, A:
HIPRA, Girona, Spain
Cañete, M:
HIPRA, Girona, Spain
Barreiro, A:
HIPRA, Girona, Spain
González-González, L:
HIPRA, Girona, Spain
Madrenas, L:
HIPRA, Girona, Spain
Güell, I:
HIPRA, Girona, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Univ Vic, Univ Cent Catalunya UV UCC, Fac Med, Infect Dis & Immun, Vic, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Gallemí, M:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Blanco, J:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Univ Vic, Univ Cent Catalunya UV UCC, Fac Med, Infect Dis & Immun, Vic, Spain
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
Germans Trias i Pujol Res Inst IGTP, Badalona, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Trinité, B:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
Germans Trias i Pujol Res Inst IGTP, Badalona, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Germans Trias i Pujol Res Inst IGTP, Badalona, Spain
:
IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain
Plana, M:
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
Inst Invest Biomed August Pi & Sunyer IDIBAPS, AIDS Res Grp, Barcelona, Spain
Esteban, I:
Inst Invest Biomed August Pi & Sunyer IDIBAPS, AIDS Res Grp, Barcelona, Spain
Aurrecoechea, E:
Inst Invest Biomed August Pi & Sunyer IDIBAPS, AIDS Res Grp, Barcelona, Spain
Abu Taleb, R:
Veristat LLC, Barcelona, Spain
Mcskimming, P:
Inst Invest Biomed August Pi & Sunyer IDIBAPS, AIDS Res Grp, Barcelona, Spain
Soriano, A:
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
Hosp Clin Barcelona, Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain
Nava, J:
Hosp Clin Barcelona, Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain
Anagua, JO:
Hosp Clin Barcelona, Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain
Ramos, R:
Catalan Inst Hlth, Biomed Res Inst Girona IdIBGi, Inst Univ Invest Atencio Primaria Jordi Gol IDIAP, Catalonia, Spain
Lluch, RM:
Catalan Inst Hlth, Biomed Res Inst Girona IdIBGi, Inst Univ Invest Atencio Primaria Jordi Gol IDIAP, Catalonia, Spain
Univ Girona, Sch Med, Dept Med Sci, Girona, Spain
Comes, AC:
Catalan Inst Hlth, Biomed Res Inst Girona IdIBGi, Inst Univ Invest Atencio Primaria Jordi Gol IDIAP, Catalonia, Spain
Romero, SO:
Hosp Univ Vall dHebron, Barcelona, Spain
Univ Autonoma Barcelona, Unitat Docent Vall dHebron, Bellaterra, Spain
Hosp Univ Vall dHebron, Ctr Esclerosis Multiple Catalunya Cemcat, Dept Neurol Neuroimmunol, Vall dHebron Barcelona Hosp Campus, Barcelona, Spain
Martínez-Gómez, X:
Hosp Univ Vall dHebron, Barcelona, Spain
Camacho-Arteaga, L:
Hosp Univ Vall dHebron, Barcelona, Spain
:
Hosp Univ Germans Trias i Pujol, Dept Infect Dis, Badalona, Spain
:
Hosp Univ Germans Trias i Pujol, Dept Infect Dis, Badalona, Spain
Bailón, L:
Hosp Univ Germans Trias i Pujol, Dept Infect Dis, Badalona, Spain
Arribas, JR:
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
La Paz Univ Hosp, Internal Med Dept, Infect Dis Unit, IdiPAZ, Madrid, Spain
Borobia, AM:
Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERInfec, Madrid, Spain
La Paz Univ Hosp, Clin Pharmacol Dept, IdiPAZ, Madrid, Spain
Spanish Clin Res Network SCReN, Madrid, Spain
Parada, JQ:
La Paz Univ Hosp, Clin Pharmacol Dept, IdiPAZ, Madrid, Spain
Spanish Clin Res Network SCReN, Madrid, Spain
Navarro-Pérez, J:
Hosp Clin Univ, Valencia, Spain
Giner, MJF:
Hosp Clin Univ, Valencia, Spain
Lucas, RO:
Hosp Clin Univ, Valencia, Spain
Jiménez, MDV:
Hosp Reg Univ Malaga, Malaga, Spain
Fernández, MJL:
Hosp Reg Univ Malaga, Malaga, Spain
Alvarez-Mon, M:
Hosp Univ Principe Asturias, Madrid, Spain
Troncoso, D:
Hosp Univ Principe Asturias, Madrid, Spain
Arana-Arri, E:
Osakidetza, Biocruces Bizkaia HRI, Sci Coordinat, Baracaldo, Spain
Meijide, S:
Osakidetza, Biocruces Bizkaia HRI, Sci Coordinat, Baracaldo, Spain
Imaz-Ayo, N:
Osakidetza, Biocruces Bizkaia HRI, Sci Coordinat, Baracaldo, Spain
García, PM:
Inst Invest Sanitaria Hosp Gregorio Maranon, Madrid, Spain
CIBER Enfermedades Resp CIBERES CB06 06 0058, Madrid, Spain
de la Villa, S:
Inst Invest Sanitaria Hosp Gregorio Maranon, Madrid, Spain
Fernandez, SR:
Inst Invest Sanitaria Hosp Gregorio Maranon, Madrid, Spain
Prat, T:
HIPRA, Girona, Spain
Torroella,É:
HIPRA, Girona, Spain
Ferrer, L:
HIPRA, Girona, Spain
hybrid, Green Submitted
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