Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Feb 15:47:126685.
doi: 10.1016/j.vaccine.2024.126685. Epub 2025 Jan 13.

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

Júlia Corominas  1 , Carme Garriga  1 , Antoni Prenafeta  1 , Alexandra Moros  2 , Manuel Cañete  1 , Antonio Barreiro  1 , Luis González-González  1 , Laia Madrenas  1 , Irina Güell  1 , Bonaventura Clotet  3 , Nuria Izquierdo-Useros  4 , Dàlia Raïch-Regué  5 , Marçal Gallemí  5 , Julià Blanco  6 , Edwards Pradenas  5 , Benjamin Trinité  4 , Julia G Prado  7 , Raúl Pérez-Caballero  8 , Laia Bernad  5 , Montserrat Plana  9 , Ignasi Esteban  10 , Elena Aurrecoechea  10 , Rachel Abu Taleb  11 , Paula McSkimming  10 , Alex Soriano  12 , Jocelyn Nava  13 , Jesse Omar Anagua  13 , Rafel Ramos  14 , Ruth Martí Lluch  14 , Aida Corpes Comes  15 , Susana Otero Romero  16 , Xavier Martínez-Gómez  17 , Lina Camacho-Arteaga  18 , Jose Molto  19 , Susana Benet  19 , Lucía Bailón  19 , Jose R Arribas  20 , Alberto M Borobia  21 , Javier Queiruga Parada  22 , Jorge Navarro-Pérez  23 , Maria José Forner Giner  23 , Rafael Ortí Lucas  23 , María Del Mar Vázquez Jiménez  24 , María Jesús López Fernández  24 , Melchor Alvarez-Mon  25 , Daniel Troncoso  25 , Eunate Arana-Arri  26 , Susana Meijide  26 , Natale Imaz-Ayo  26 , Patricia Muñoz García  27 , Sofía de la Villa  28 , Sara Rodríguez Fernández  28 , Teresa Prat  1 , Èlia Torroella  1 , Laura Ferrer  1
Affiliations
Free article
Clinical Trial

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

Júlia Corominas et al. Vaccine. .
Free article

Abstract

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.

Keywords: Covid-19; Heterologous booster; Protein-based vaccine; SARS-CoV-2.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: J Blanco has received institutional grants from HIPRA, Grifols, Nesapor Europe and MSD. Outside of this work he is the CEO and founder of AlbaJuna Therapeutics, S.L. A Soriano has received grants from Pfizer and Gilead Sciences and honoraria for lectures for Pfizer, MSD, Gilead Sciences, Shionogi, Angelini, Roche and Menarini. N Izquierdo-Useros declares institutional grants from HIPRA, Pharma Mar, Grifols, and Amassence. J R Arribas has received honoraria for lectures and advisory boards from Janssen, Gilead, MSD, Lilly, Roche, and Pfizer. S Otero-Romero has received speaking and consulting honoraria from Genzyme, Biogen-Idec, Novartis, Roche, Excemed and MSD. J G Prado declares institutional grants from HIPRA and Grifols. AM Borobia is principal investigator of clinical trials sponsored by GlaxoSmithKline, Daiichi-Sankyo and Janssen, outside of the submitted work. J Molto has received honoraria for lectures and advisory boards from Johnson & Johnson, Gilead, and MSD. X Martínez-Gómez has received speaking and consulting honoraria from GSK, Pfizer, and AstraZeneca. J Corominas, C Garriga, A Prenafeta, A Moros, M Cañete, A Barreiro, L González-González, L Madrenas, I Güell, T Prat, E Torroella and L Ferrer are employees of HIPRA. Some of these authors may have shares of HIPRA. Several patent applications have been filed by HIPRA SCIENTIFIC S.L.U. and Laboratorios HIPRA, S.A. on different SARS-CoV-2 vaccine candidates and SARS-CoV-2 subunit vaccines, including the novel recombinant RBD fusion heterodimer PHH-1V. A Barreiro, A Prenafeta, L González-González, L Ferrer, T Prat and C Garriga are the inventors of these patent applications.

References

Publication types

MeSH terms

Supplementary concepts

Associated data