Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study
SARS-CoV-2 vaccination campaigns on current endemic situation would benefit from vaccine alternatives with easy logistics and accessibility, sustained response and cross-reactivity against emerging variants. Herein, safety and immunogenicity of PHH-1V, adjuvanted recombinant RBD-based vaccine, as fo...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2474775 |
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| author | María Jesús López Maria Del Mar Vazquez Melchor Alvarez-Mon José Ramón Arribas Eunate Arana-Arri Patricia Muñoz Jorge Navarro-Pérez Rafael Ramos José Molto Susana Otero-Romero Elena Aurrecoechea Roc Pomarol Laia Bernad Ignasi Esteban Raúl Pérez-Caballero Montserrat Plana Júlia G. Prado Álex Soriano |
| author_facet | María Jesús López Maria Del Mar Vazquez Melchor Alvarez-Mon José Ramón Arribas Eunate Arana-Arri Patricia Muñoz Jorge Navarro-Pérez Rafael Ramos José Molto Susana Otero-Romero Elena Aurrecoechea Roc Pomarol Laia Bernad Ignasi Esteban Raúl Pérez-Caballero Montserrat Plana Júlia G. Prado Álex Soriano |
| author_sort | María Jesús López |
| collection | DOAJ |
| description | SARS-CoV-2 vaccination campaigns on current endemic situation would benefit from vaccine alternatives with easy logistics and accessibility, sustained response and cross-reactivity against emerging variants. Herein, safety and immunogenicity of PHH-1V, adjuvanted recombinant RBD-based vaccine, as fourth dose for the most prevalent SARS-CoV-2 variants in Spain in subjects ≥18 years was investigated for 6 months in HIPRA-HH-2 open-label extension study. Subjects received a fourth dose of PHH-1V after either two BNT162b2 doses plus one PHH-1V dose (cohort 1) or three BNT162b2 doses (cohort 2). As regulatory endpoint, neutralization titers were investigated for PHH-1 V as fourth dose vs BNT162b2 as third dose in subjects receiving previous BNT162b2-based regimens. PHH-1 V immunogenicity (GMT) was investigated against Beta, Delta, and Omicron BA.1, BA.4/5 and XBB.1.5 on Days 14, 98 and 182 post-immunization. Two hundred and eighty-eight subjects received PHH-1V. Neutralizing antibodies against Omicron BA.1 at Day 14 significantly increased after the PHH-1V as fourth booster vs the third BNT162b2 booster (GMT ratio 0.43 (95% CI: 0.28; 0.65; p-value < .0001)). PHH-1V fourth booster induced a significant increase in neutralizing titers vs baseline (GMFR on Day 14 [95% CI]: Beta 6.96 [5.23, 9.25]; Delta 6.27 [4.79, 8.22]; Omicron BA.1 9.21 [5.57, 15.21]; Omicron BA.4/5 11.80 [8.29, 16.80]; Omicron XBB.1.5 5.22 [3.97, 6.87]), remaining significantly higher up to 6 months. The most frequent adverse events were injection site pain and fatigue. As conclusion, PHH-1V booster induced sustained humoral and cellular immune response against Beta, Delta variants and cross reactivity against distant Omicron subvariants and could be an appropriate strategy for implementing heterologous vaccination campaigns. |
| format | Article |
| id | doaj-art-73d6913c19334bf49de59731bc4bb802 |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-73d6913c19334bf49de59731bc4bb8022025-08-20T01:48:28ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2474775Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension studyMaría Jesús López0Maria Del Mar Vazquez1Melchor Alvarez-Mon2José Ramón Arribas3Eunate Arana-Arri4Patricia Muñoz5Jorge Navarro-Pérez6Rafael Ramos7José Molto8Susana Otero-Romero9Elena Aurrecoechea10Roc Pomarol11Laia Bernad12Ignasi Esteban13Raúl Pérez-Caballero14Montserrat Plana15Júlia G. Prado16Álex Soriano17Preventive Medicine Unit, Hospital Regional Universitario de Málaga, Málaga, SpainPreventive Medicine Unit, Hospital Regional Universitario de Málaga, Málaga, SpainInternal Medicine Unit, Hospital Universitario Príncipe de Asturias, Madrid, SpainInfectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, IdiPAZ, Madrid, SpainScientific Coordinator, Biocruces Bizkaia Health Research Institute, Osakidetza, Barakaldo, Spain.g. Clinical Microbiology, Infectious Diseases and AIDS Group, Instituto de Investigación Sanitaria Hospital Gregorio Marañon, Madrid, SpainClinical Microbiology and Infectious Diseases, Hospital General Universitario Gregorio Marañón, Madrid, SpainHospital Clínico Universitario de Valencia, Valencia, SpainVascular Health Research Group, Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Biomedical Research Institute, Girona (IdIBGi), Catalan Institute of Health, Catalonia, SpainCIBER Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, SpainPreventive Medicine and Epidemiology Department, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainAIDS Research Group, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, SpainAIDS Research Group, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, SpainIrsicaixa, Badalona, SpainAIDS Research Group, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, SpainIrsicaixa, Badalona, SpainCIBER Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, SpainCIBER Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, SpainCIBER Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, SpainSARS-CoV-2 vaccination campaigns on current endemic situation would benefit from vaccine alternatives with easy logistics and accessibility, sustained response and cross-reactivity against emerging variants. Herein, safety and immunogenicity of PHH-1V, adjuvanted recombinant RBD-based vaccine, as fourth dose for the most prevalent SARS-CoV-2 variants in Spain in subjects ≥18 years was investigated for 6 months in HIPRA-HH-2 open-label extension study. Subjects received a fourth dose of PHH-1V after either two BNT162b2 doses plus one PHH-1V dose (cohort 1) or three BNT162b2 doses (cohort 2). As regulatory endpoint, neutralization titers were investigated for PHH-1 V as fourth dose vs BNT162b2 as third dose in subjects receiving previous BNT162b2-based regimens. PHH-1 V immunogenicity (GMT) was investigated against Beta, Delta, and Omicron BA.1, BA.4/5 and XBB.1.5 on Days 14, 98 and 182 post-immunization. Two hundred and eighty-eight subjects received PHH-1V. Neutralizing antibodies against Omicron BA.1 at Day 14 significantly increased after the PHH-1V as fourth booster vs the third BNT162b2 booster (GMT ratio 0.43 (95% CI: 0.28; 0.65; p-value < .0001)). PHH-1V fourth booster induced a significant increase in neutralizing titers vs baseline (GMFR on Day 14 [95% CI]: Beta 6.96 [5.23, 9.25]; Delta 6.27 [4.79, 8.22]; Omicron BA.1 9.21 [5.57, 15.21]; Omicron BA.4/5 11.80 [8.29, 16.80]; Omicron XBB.1.5 5.22 [3.97, 6.87]), remaining significantly higher up to 6 months. The most frequent adverse events were injection site pain and fatigue. As conclusion, PHH-1V booster induced sustained humoral and cellular immune response against Beta, Delta variants and cross reactivity against distant Omicron subvariants and could be an appropriate strategy for implementing heterologous vaccination campaigns.https://www.tandfonline.com/doi/10.1080/21645515.2025.2474775Protein vaccineomicron subvariantsvaccine boosterSARS-CoV-2COVID-19 |
| spellingShingle | María Jesús López Maria Del Mar Vazquez Melchor Alvarez-Mon José Ramón Arribas Eunate Arana-Arri Patricia Muñoz Jorge Navarro-Pérez Rafael Ramos José Molto Susana Otero-Romero Elena Aurrecoechea Roc Pomarol Laia Bernad Ignasi Esteban Raúl Pérez-Caballero Montserrat Plana Júlia G. Prado Álex Soriano Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study Human Vaccines & Immunotherapeutics Protein vaccine omicron subvariants vaccine booster SARS-CoV-2 COVID-19 |
| title | Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study |
| title_full | Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study |
| title_fullStr | Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study |
| title_full_unstemmed | Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study |
| title_short | Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study |
| title_sort | safety and immunogenicity of phh 1v booster against sars cov 2 variants including omicron subvariants results from a phase iib open label extension study |
| topic | Protein vaccine omicron subvariants vaccine booster SARS-CoV-2 COVID-19 |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2474775 |
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