Safety and immunogenicity of a recombinant protein RBD fusion heterodimer vaccine against SARS-CoV-2
Leal, Lorna (Universitat de Barcelona)
Pich, Judit (Hospital Clínic i Provincial de Barcelona)
Ferrer, Laura (HIPRA (Amer, Girona))
Nava, Jocelyn (Hospital Clínic i Provincial de Barcelona)
Martí-Lluch, Ruth (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Esteban, Ignasi (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Pradenas, Edwards (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Raïch-Regué, Dàlia (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Prenafeta, Antoni (HIPRA (Amer, Girona))
Nava, Jocelyn (Hospital Clínic i Provincial de Barcelona)
Escobar, Karla (Hospital Clínic i Provincial de Barcelona)
Pastor, Carmen (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Ribas-Aulinas, Marc (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Trinité, Benjamin (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Muñoz-Basagoiti, Jordana (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Domenech, Gemma (Institut d'Investigacions Biomédiques August Pi i Sunyer)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Corominas, Júlia (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Corpes-Comes, Aida (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Garriga, Carme (HIPRA (Amer, Girona))
Barreiro Vázquez, Antonio (HIPRA (Amer, Girona))
Izquierdo Useros, Nuria (Instituto de Salud Carlos III)
Arnaiz, Joan Albert (Hospital Clínic i Provincial de Barcelona)
Soriano, A (Instituto de Salud Carlos III)
Ríos, José (Universitat Autònoma de Barcelona)
Nadal, Marga (Instituto de Investigación Biomédica de Girona Josep Trueta)
Plana, Montserrat (Instituto de Salud Carlos III)
Blanco, Julià (Institut Germans Trias i Pujol)
Prat, Teresa (HIPRA (Amer, Girona))
Torroella, Elia (HIPRA (Amer, Girona))
Ramos, Rafel (Universitat de Girona. Departament de Ciències Mèdiques)

Date:	2023
Abstract:	In response to COVID-19 pandemic, we have launched a vaccine development program against SARS-CoV-2. Here we report the safety, tolerability, and immunogenicity of a recombinant protein RBD fusion heterodimeric vaccine against SARS-CoV-2 (PHH-1V) evaluated in a phase 1-2a dose-escalation, randomized clinical trial conducted in Catalonia, Spain. 30 young healthy adults were enrolled and received two intramuscular doses, 21 days apart of PHH-1V vaccine formulations [10 µg (n = 5), 20 µg (n = 10), 40 µg (n = 10)] or control [BNT162b2 (n = 5)]. Each PHH-1V group had one safety sentinel and the remaining participants were randomly assigned. The primary endpoint was solicited events within 7 days and unsolicited events within 28 days after each vaccination. Secondary endpoints were humoral and cellular immunogenicity against the variants of concern (VOCs) alpha, beta, delta and gamma. All formulations were safe and well tolerated, with tenderness and pain at the site of injection being the most frequently reported solicited events. Throughout the study, all participants reported having at least one mild to moderate unsolicited event. Two unrelated severe adverse events (AE) were reported and fully resolved. No AE of special interest was reported. Fourteen days after the second vaccine dose, all participants had a >4-fold change in total binding antibodies from baseline. PHH-1V induced robust humoral responses with neutralizing activities against all VOCs assessed (geometric mean fold rise at 35 days p < 0. 0001). The specific T-cell response assessed by ELISpot was moderate. This initial evaluation has contributed significantly to the further development of PHH-1V, which is now included in the European vaccine portfolio. ClinicalTrials. gov Identifier NCT05007509 EudraCT No. 2021-001411-82.
Rights:	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, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Translational research ; Randomized controlled trials ; Drug development
Published in:	NPJ Vaccines, Vol. 8 (september 2023) , ISSN 2059-0105

DOI: 10.1038/s41541-023-00736-5
PMID: 37775521

12 p, 2.3 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles