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

Author

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, and Capone, Stefania

Published
2022
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2. Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results

Author

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, and Capone, Stefania

Subjects
Pharmacology, Infectious Diseases, Immunology, Pharmacology (medical)
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.

Published
2022

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