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Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results

Authors :
Chiara Agrati
Concetta Castilletti
Simone Battella
Eleonora Cimini
Giulia Matusali
Andrea Sommella
Alessandra Sacchi
Francesca Colavita
Alessandra M. Contino
Veronica Bordoni
Silvia Meschi
Giulia Gramigna
Federica Barra
Germana Grassi
Licia Bordi
Daniele Lapa
Stefania Notari
Rita Casetti
Aurora Bettini
Massimo Francalancia
Federica Ciufoli
Alessandra Vergori
Serena Vita
Michela Gentile
Angelo Raggioli
Maria M. Plazzi
Antonella Bacchieri
Emanuele Nicastri
Andrea Antinori
Stefano Milleri
Simone Lanini
Stefano Colloca
Enrico Girardi
Roberto Camerini
Giuseppe Ippolito
Francesco Vaia
Antonella Folgori
Stefania Capone
Agrati, Chiara
Castilletti, Concetta
Battella, Simone
Cimini, Eleonora
Matusali, Giulia
Sommella, Andrea
Sacchi, Alessandra
Colavita, Francesca
Contino, Alessandra M
Bordoni, Veronica
Meschi, Silvia
Gramigna, Giulia
Barra, Federica
Grassi, Germana
Bordi, Licia
Lapa, Daniele
Notari, Stefania
Casetti, Rita
Bettini, Aurora
Francalancia, Massimo
Ciufoli, Federica
Vergori, Alessandra
Vita, Serena
Gentile, Michela
Raggioli, Angelo
Plazzi, Maria M
Bacchieri, Antonella
Nicastri, Emanuele
Antinori, Andrea
Milleri, Stefano
Lanini, Simone
Colloca, Stefano
Girardi, Enrico
Camerini, Roberto
Ippolito, Giuseppe
Vaia, Francesco
Folgori, Antonella
Capone, Stefania
Publication Year :
2022

Abstract

Despite the successful deployment of efficacious vaccines and therapeutics, the development of novel vaccines for SARS-CoV-2 remains a major goal to increase vaccine doses availability and accessibility for lower income setting. We report here on the kinetics of Spike-specific humoral and T-cell response in young and old volunteers over 6 months follow-up after a single intramuscular administration of GRAd-COV2, a gorilla adenoviral vector-based vaccine candidate currently in phase-2 of clinical development. At all three tested vaccine dosages, Spike binding and neutralizing antibodies were induced and substantially maintained up to 3 months, to then contract at 6 months. Potent T-cell responses were readily induced and sustained throughout the study period, with only minor decline. No major differences in immune response to GRAd-COV2 vaccination were observed in the two age cohorts. In light of its favorable safety and immunogenicity, GRAd-COV2 is a valuable candidate for further clinical development and potential addition to the COVID-19 vaccine toolbox to help fighting SARS-CoV-2 pandemic.

Details

Language :
English
Database :
OpenAIRE
Accession number :
edsair.doi.dedup.....c0ba91407a43fa2ff9a00fb3cc03bbb1