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

被引：1

作者：

Corominas, Julia ^{[1
]}

Garriga, Carme ^{[1
]}

Prenafeta, Antoni ^{[1
]}

Moros, Alexandra ^{[1
]}

Canete, Manuel ^{[1
]}

Barreiro, Antonio ^{[1
]}

Gonzalez-Gonzalez, Luis ^{[1
]}

Madrenas, Laia ^{[1
]}

Guell, Irina ^{[1
]}

Clotet, Bonaventura ^{[2
,3
]}

Izquierdo-Useros, Nuria ^{[2
,4
]}

Raich-Regue, Dalia ^{[2
]}

Gallemi, Marcal ^{[2
]}

Blanco, Julia ^{[2
,3
,4
,5
]}

Pradenas, Edwards ^{[2
]}

Trinite, Benjamin ^{[2
,4
]}

Prado, Julia G. ^{[2
,4
,5
]}

Perez-Caballero, Raul ^{[2
,5
]}

Bernad, Laia ^{[2
]}

Plana, Montserrat ^{[4
,6
]}

Esteban, Ignasi ^{[6
]}

Aurrecoechea, Elena ^{[6
]}

Abu Taleb, Rachel ^{[7
]}

Mcskimming, Paula ^{[6
]}

Soriano, Alex ^{[4
,8
]}

Nava, Jocelyn ^{[8
]}

Anagua, Jesse Omar ^{[8
]}

Ramos, Rafel ^{[9
]}

Lluch, Ruth Marti ^{[9
,10
]}

Comes, Aida Corpes ^{[9
]}

Romero, Susana Otero ^{[11
,12
,13
]}

Martinez-Gomez, Xavier ^{[11
]}

Camacho-Arteaga, Lina ^{[11
]}

Molto, Jose ^{[14
]}

Benet, Susana ^{[14
]}

Bailon, Lucia ^{[14
]}

Arribas, Jose R. ^{[4
,15
]}

Borobia, Alberto M. ^{[4
,16
,17
]}

Parada, Javier Queiruga ^{[16
,17
]}

Navarro-Perez, Jorge ^{[18
]}

Giner, Maria Jose Forner ^{[18
]}

Lucas, Rafael Orti ^{[18
]}

Jimenez, Maria del Mar Vazquez ^{[19
]}

Fernandez, Maria Jesus Lopez ^{[19
]}

Alvarez-Mon, Melchor ^{[20
]}

Troncoso, Daniel ^{[20
]}

Arana-Arri, Eunate ^{[21
]}

Meijide, Susana ^{[21
]}

Imaz-Ayo, Natale ^{[21
]}

Garcia, Patricia Munoz ^{[22
,23
]}

机构：

[1] HIPRA, Girona, Spain

[2] IrsiCaixa AIDS Res Inst, Can Ruti Campus, Badalona 08916, Spain

[3] Univ Vic, Univ Cent Catalunya UV UCC, Fac Med, Infect Dis & Immun, Vic, Spain

[4] Inst Salud Carlos III, CIBER Enfermedades Infecciosas CIBERINFEC, Madrid, Spain

[5] Germans Trias i Pujol Res Inst IGTP, Badalona, Spain

[6] Inst Invest Biomed August Pi & Sunyer IDIBAPS, AIDS Res Grp, Barcelona, Spain

[7] Veristat LLC, Barcelona, Spain

[8] Hosp Clin Barcelona, Inst Invest Biomed August Pi I Sunyer IDIBAPS, Barcelona, Spain

[9] Catalan Inst Hlth, Biomed Res Inst Girona IdIBGi, Inst Univ Invest Atencio Primaria Jordi Gol IDIAP, Catalonia, Spain

[10] Univ Girona, Sch Med, Dept Med Sci, Girona, Spain

[11] Hosp Univ Vall dHebron, Barcelona, Spain

[12] Univ Autonoma Barcelona, Unitat Docent Vall dHebron, Bellaterra, Spain

[13] Hosp Univ Vall dHebron, Ctr Esclerosis Multiple Catalunya Cemcat, Dept Neurol Neuroimmunol, Vall dHebron Barcelona Hosp Campus, Barcelona, Spain

[14] Hosp Univ Germans Trias i Pujol, Dept Infect Dis, Badalona, Spain

[15] La Paz Univ Hosp, Internal Med Dept, Infect Dis Unit, IdiPAZ, Madrid, Spain

[16] La Paz Univ Hosp, Clin Pharmacol Dept, IdiPAZ, Madrid, Spain

[17] Spanish Clin Res Network SCReN, Madrid, Spain

[18] Hosp Clin Univ, Valencia, Spain

[19] Hosp Reg Univ Malaga, Malaga, Spain

[20] Hosp Univ Principe Asturias, Madrid, Spain

[21] Osakidetza, Biocruces Bizkaia HRI, Sci Coordinat, Baracaldo, Spain

[22] Inst Invest Sanitaria Hosp Gregorio Maranon, Madrid, Spain

[23] CIBER Enfermedades Resp CIBERES CB06 06 0058, Madrid, Spain

来源：

VACCINE | 2025年 / 47卷

关键词：

Covid-19; SARS-CoV-2; Protein-based vaccine; Heterologous booster; INFECTION;

D O I：

10.1016/j.vaccine.2024.126685

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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

引用

页数：9

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