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

Author:

Agrati ChiaraORCID,Castilletti ConcettaORCID,Battella Simone,Cimini Eleonora,Matusali Giulia,Sommella Andrea,Sacchi Alessandra,Colavita Francesca,Contino Alessandra M.,Bordoni Veronica,Meschi Silvia,Gramigna Giulia,Barra FedericaORCID,Grassi Germana,Bordi Licia,Lapa Daniele,Notari Stefania,Casetti Rita,Bettini Aurora,Francalancia Massimo,Ciufoli Federica,Vergori AlessandraORCID,Vita Serena,Gentile Michela,Raggioli AngeloORCID,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 StefaniaORCID

Abstract

AbstractDespite 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.

Funder

Regione Lazio,Italian Ministry of research

Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute

Regione Lazio, Italian Ministry of research

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Infectious Diseases,Pharmacology,Immunology

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