Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants : Results from a phase IIb open-label extension study
López Fernández, María Jesús (Hospital Regional Universitario de Málaga)
Vazquez, Maria Del Mar (Hospital Regional Universitario de Málaga)
Alvarez-Mon, Melchor (Hospital Universitario Príncipe de Asturias (Alcalá de Henares, Madrid))
Arribas, Jose (Instituto de Salud Carlos III)
Arana-Arri, Eunate (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Munoz, Patricia (Centro de Investigación Biomédica en Red de Enfermedades Respiratorias)
Navarro-Pérez, Jorge (Hospital Clínic Universitari (València))
Ramos, Rafel (Universitat de Girona)
Moltó, José (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Otero-Romero, Susana (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i de Medicina Preventiva i Salut Pública)
Aurrecoechea, Elena (Universitat de Barcelona)
Pomarol, Roc (Universitat de Barcelona)
Bernard Rosa, Laia (Institut Germans Trias i Pujol)
Esteban, Ignasi (Universitat de Barcelona)
Pérez-Caballero, Raúl (Institut Germans Trias i Pujol)
Plana, Montserrat (Universitat de Barcelona)
Prado, Julia G. (Institut Germans Trias i Pujol)
Soriano Viladomiu, Alex (Institut d'Investigacions Biomèdiques August Pi i Sunyer)

Data:	2025
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Protein vaccine ; Omicron subvariants ; Vaccine booster ; SARS-CoV-2 ; COVID-19
Publicat a:	Human vaccines & immunotherapeutics, Vol. 21, Núm. 1 (2025) , ISSN 2164-554X

DOI: 10.1080/21645515.2025.2474775
PMID: 40304691

13 p, 4.3 MB

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