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

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...

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Published in:Cell reports. Medicine 2023-06, Vol.4 (6), p.101084-101084, Article 101084
Main Authors: Capone, Stefania, Fusco, Francesco M., Borrè, Silvio, Carbonara, Sergio, Lo Caputo, Sergio, Leone, Sebastiano, Gori, Giovanni, Maggi, Paolo, Cascio, Antonio, Lichtner, Miriam, Cauda, Roberto, Cossu, Maria V., Roda, Silvia, Confalonieri, Paola, Missale, Gabriele, Codeluppi, Mauro, Capici, Serena, Pontali, Emanuele, Libanore, Marco, Diani, Augusta, Lanini, Simone, Battella, Simone, Contino, Alessandra M., Piano Mortari, Eva, Genova, Francesco, Parente, Gessica, Dragonetti, Rosella, Visani, Luigi, Iannacone, Claudio, Carsetti, Rita, Ziviani, Luigi, Malescio, Feliciana, Turrini, Irene, Lawlor, Rita, Romano, Annamaria, Nunziata, Mariagrazia, Armato, Salvatore, Mazzeo, Nicole, Carleo, Maria Aurora, Dell’Isola, Chiara, Olivani, Andrea, Grasselli, Sara, Laccabue, Diletta, Leoni, Maria Cristina, Paolillo, Franco, Ruaro, Barbara, Confalonieri, Marco, Salton, Francesco, Mancarella, Giulia, Marocco, Raffaella, De Masi, Margherita, Belvisi, Valeria, Lamonica, Silvia, Cingolani, Antonella, Seguiti, Cristina, Ferraresi, Alice, Lupi, Matteo, Ludovisi, Serena, Massafra, Roberta, Pellicciotta, Martina, Armiento, Luciana, Piacenza, Mariagrazia, Bonfanti, Paolo, Columpsi, Paola, Cazzaniga, Marina Elena, Rovelli, Cristina, Ceresini, Mariaelena, Previtali, Letizia, Rugge, Walter, Biffi, Stefano, Poletti, Federica, Rostagno, Roberto, De Negri, Ferdinando, Fini, Elisabetta, Cangialosi, Alice, Bruno, Serena Rita, Rizzo, Marianna, Niglio, Mariangela, Matano, Alfredo, Petruzziello, Arnolfo, Pieri, Teresa, Calamo, Angela, Giannelli, Anna, Menolascina, Stefania, Di Bari, Silvia, Mauro, Vera, Aronica, Raissa, Cultrera, Rosario, Sighinolfi, Laura, Abbott, Michelle, Marascia, Federica Guida, Valenti, Giacomo, Feasi, Marcello, Bobbio, Nicoletta, Nicosia, Alfredo, Mazzoleni, Miriam, Garofalo, Nadia, Ammendola, Virginia, Grazioli, Fabiana, Marcellini, Valentina
Format: Article
Language:English
Subjects:
CD4
CD8
COVID-19
COVID-19 - prevention & control
COVID-19 Vaccines
Humans
Immunity, Cellular
immunological memory
neutralizing antibodies
phase 2 clinical trial
safety
SARS-CoV-2
Sars-CoV-2 vaccine
simian adenoviral vector
T cell response
Vaccines
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Summary: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. [Display omitted] •GRAd-COV2 vaccine based on a recently developed group C gorilla adenoviral vector•Phase 2 trial confirms favorable safety profile for single- and double-dose regimens•SARS-CoV-2 binding/neutralizing Ab boosted by homologous or heterologous vaccine•Potent, VOC cross-reactive, functional, and durable CD4 and CD8 T cell responses Capone et al. show that GRAd-COV2 vaccine is well tolerated and immunogenic in phase 2 trial; as an alternative Ad serotype, GRAd represents a valid addition to the SARS-CoV-2 vaccine toolbox for heterologous prime/boost regimens and a promising platform for genetic vaccines, particularly when T cell response is key.
ISSN:2666-3791
2666-3791
DOI:10.1016/j.xcrm.2023.101084