학술논문
GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial
Document Type
Article
Author
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; Ziviani, Luigi; Malescio, Feliciana; Turrini, Irene; Lawlor, Rita; Romano, Annamaria; Nunziata, Mariagrazia; Armato, Salvatore; Mazzeo, Nicole; Carleo, Maria Aurora; Dell’Isola, Chiara; Pisapia, Raffaella; Pontarelli, Agostina; Olivani, Andrea; Grasselli, Sara; Laccabue, Diletta; Leoni, Maria Cristina; Paolillo, Franco; Mancini, Annalisa; Ruaro, Barbara; Confalonieri, Marco; Salton, Francesco; Mancarella, Giulia; Marocco, Raffaella; De Masi, Margherita; Belvisi, Valeria; Lamonica, Silvia; Cingolani, Antonella; Seguiti, Cristina; Brambilla, Paola; Ferraresi, Alice; Lupi, Matteo; Ludovisi, Serena; Renisi, Giulia; Massafra, Roberta; Pellicciotta, Martina; Armiento, Luciana; Vimercati, Stefania; Piacenza, Mariagrazia; Bonfanti, Paolo; Columpsi, Paola; Cazzaniga, Marina Elena; Rovelli, Cristina; Ceresini, Mariaelena; Previtali, Letizia; Trentini, Laura; Alcantarini, Chiara; Rugge, Walter; Biffi, Stefano; Poletti, Federica; Rostagno, Roberto; Moglia, Roberta; De Negri, Ferdinando; Fini, Elisabetta; Cangialosi, Alice; Bruno, Serena Rita; Rizzo, Marianna; Niglio, Mariangela; Stritto, Anna Dello; Matano, Alfredo; Petruzziello, Arnolfo; Valsecchi, Pietro; Pieri, Teresa; Altamura, Mauro; Calamo, Angela; Giannelli, Anna; Menolascina, Stefania; Di Bari, Silvia; Mauro, Vera; Aronica, Raissa; Segala, Daniela; Cultrera, Rosario; Sighinolfi, Laura; Abbott, Michelle; Gizzi, Andrea; Marascia, Federica Guida; Valenti, Giacomo; Feasi, Marcello; Bobbio, Nicoletta; Del Puente, Filippo; Nicosia, Alfredo; Frascà, Martina; Mazzoleni, Miriam; Garofalo, Nadia; Ammendola, Virginia; Grazioli, Fabiana; Napolitano, Federico; Vitelli, Alessandra; Marcellini, Valentina
Source
Cell Reports Medicine; June 2023, Vol. 4 Issue: 6
Subject
Language
ISSN
26663791
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 genetic vaccine development, especially when robust CD8 response is needed.