Safety and immunogenicity of a recombinant protein RBD fusion heterodimer vaccine against SARS-CoV-2

Lorna Leal, Judit Pich, Laura Ferrer, Jocelyn Nava, Ruth Martí-Lluch, Ignasi Esteban, Edwards Pradenas, Dàlia Raïch-Regué, Antoni Prenafeta, Karla Escobar, Carmen Pastor, Marc Ribas-Aulinas, Benjamin Trinitè, Jordana Muñoz-Basagoiti, Gemma Domenech, Bonaventura Clotet, Júlia Corominas, Aida Corpes-Comes, Carme Garriga, Antonio BarreiroNuria Izquierdo-Useros, Joan Albert Arnaiz, Alex Soriano, José Ríos, Marga Nadal, Montserrat Plana, Julià Blanco, Teresa Prat, Elia Torroella, Rafel Ramos, Eva Bonfill, Omar Anagua, Faisury Caicedo, Clara Castán, Fauno Guazina, Sara Messeguer, Marta Aldea, Anna Vilella, Sandra Serrano, Lorna Leal, Judit Pich, Jocelyn Nava, Karla Escobar, Joan Albert Arnaiz, Alex Soriano, José Ríos, Teresa Botta, Ignasi Esteban, Carmen Pastor, Montserrat Plana, Gemma Domenech, Silvia Marfil, Carla Rovirosa, Raquel Ortiz, Daniel Perez-Zsolt, Marçal Gallemí, Edwards Pradenas, Dàlia Raïch-Regué, Benjamin Trinité, Jordana Muñoz-Basagoiti, Bonaventura Clotet, Nuria Izquierdo-Useros, Julià Blanco, Marina González del Río, Ruth Martí-Lluch, Marc Ribas-Aulinas, Aida Corpes-Comes, Marga Nadal, Rafel Ramos, Luís González, Manuel Cañete, Laia Madrenas, Alexandra Moros, Irina Güell, Laura Ferrer, Antoni Prenafeta, Júlia Corominas, Carme Garriga, Antonio Barreiro, Teresa Prat, Elia Torroella

Producció científica: Article en revista indexadaArticleAvaluat per experts


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. Identifier NCT05007509 EudraCT No. 2021-001411-82.

Idioma originalAnglès
Número d’article147
Nombre de pàgines12
Revistanpj Vaccines
Estat de la publicacióPublicació electrònica prèvia a la impressió - 29 de set. 2023
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