학술논문
Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results
Document Type
Original Paper
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; Capone, Stefania
Source
npj Vaccines. 7(1)
Subject
Language
English
ISSN
2059-0105
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.