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ANTONIO CASCIO

GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

  • Authors: Capone, Stefania; Fusco, Francesco M; Milleri, Stefano; Borrè, Silvio; Carbonara, Sergio; Lo Caputo, Sergio; Leone, Sebastiano; Gori, Giovanni; Maggi, Paolo; Cascio, Antonio; Lichtner, Miriam; Cauda, Roberto; Dal Zoppo, Sarah; Cossu, Maria V; Gori, Andrea; Roda, Silvia; Confalonieri, Paola; Bonora, Stefano; Missale, Gabriele; Codeluppi, Mauro; Mezzaroma, Ivano; Capici, Serena; Pontali, Emanuele; Libanore, Marco; Diani, Augusta; Lanini, Simone; Battella, Simone; Contino, Alessandra M; Piano Mortari, Eva; Genova, Francesco; Parente, Gessica; Dragonetti, Rosella; Colloca, Stefano; Visani, Luigi; Iannacone, Claudio; Carsetti, Rita; Folgori, Antonella; Camerini, Roberto
  • Publication year: 2023
  • Type: Articolo in rivista
  • OA Link: http://hdl.handle.net/10447/620128

Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose-and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3 weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific T cell response peaks after the first dose and is characterized by high frequencies of CD8s. T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for ge-netic vaccine development, especially when robust CD8 response is needed.