tetano
Editor, Senior Moderator
Cell Rep Med
. 2023 May 29;101084.
doi: 10.1016/j.xcrm.2023.101084. Online ahead of print. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial
Stefania Capone[SUP] 1 [/SUP], Francesco M Fusco[SUP] 2 [/SUP], Stefano Milleri[SUP] 3 [/SUP], Silvio Borrè[SUP] 4 [/SUP], Sergio Carbonara[SUP] 5 [/SUP], Sergio Lo Caputo[SUP] 6 [/SUP], Sebastiano Leone[SUP] 7 [/SUP], Giovanni Gori[SUP] 8 [/SUP], Paolo Maggi[SUP] 9 [/SUP], Antonio Cascio[SUP] 10 [/SUP], Miriam Lichtner[SUP] 11 [/SUP], Roberto Cauda[SUP] 12 [/SUP], Sarah Dal Zoppo[SUP] 13 [/SUP], Maria V Cossu[SUP] 14 [/SUP], Andrea Gori[SUP] 15 [/SUP], Silvia Roda[SUP] 16 [/SUP], Paola Confalonieri[SUP] 17 [/SUP], Stefano Bonora[SUP] 18 [/SUP], Gabriele Missale[SUP] 19 [/SUP], Mauro Codeluppi[SUP] 20 [/SUP], Ivano Mezzaroma[SUP] 21 [/SUP], Serena Capici[SUP] 22 [/SUP], Emanuele Pontali[SUP] 23 [/SUP], Marco Libanore[SUP] 24 [/SUP], Augusta Diani[SUP] 25 [/SUP], Simone Lanini[SUP] 26 [/SUP], Simone Battella[SUP] 27 [/SUP], Alessandra M Contino[SUP] 27 [/SUP], Eva Piano Mortari[SUP] 28 [/SUP], Francesco Genova[SUP] 27 [/SUP], Gessica Parente[SUP] 27 [/SUP], Rosella Dragonetti[SUP] 27 [/SUP], Stefano Colloca[SUP] 27 [/SUP], Luigi Visani[SUP] 29 [/SUP], Claudio Iannacone[SUP] 30 [/SUP], Rita Carsetti[SUP] 28 [/SUP], Antonella Folgori[SUP] 27 [/SUP], Roberto Camerini[SUP] 27 [/SUP]; COVITAR study group
Collaborators, Affiliations
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.
Keywords: CD4; CD8; COVID-19; Sars-CoV-2 vaccine; T cell response; immunological memory; neutralizing antibodies; phase 2 clinical trial; safety; simian adenoviral vector.
. 2023 May 29;101084.
doi: 10.1016/j.xcrm.2023.101084. Online ahead of print. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial
Stefania Capone[SUP] 1 [/SUP], Francesco M Fusco[SUP] 2 [/SUP], Stefano Milleri[SUP] 3 [/SUP], Silvio Borrè[SUP] 4 [/SUP], Sergio Carbonara[SUP] 5 [/SUP], Sergio Lo Caputo[SUP] 6 [/SUP], Sebastiano Leone[SUP] 7 [/SUP], Giovanni Gori[SUP] 8 [/SUP], Paolo Maggi[SUP] 9 [/SUP], Antonio Cascio[SUP] 10 [/SUP], Miriam Lichtner[SUP] 11 [/SUP], Roberto Cauda[SUP] 12 [/SUP], Sarah Dal Zoppo[SUP] 13 [/SUP], Maria V Cossu[SUP] 14 [/SUP], Andrea Gori[SUP] 15 [/SUP], Silvia Roda[SUP] 16 [/SUP], Paola Confalonieri[SUP] 17 [/SUP], Stefano Bonora[SUP] 18 [/SUP], Gabriele Missale[SUP] 19 [/SUP], Mauro Codeluppi[SUP] 20 [/SUP], Ivano Mezzaroma[SUP] 21 [/SUP], Serena Capici[SUP] 22 [/SUP], Emanuele Pontali[SUP] 23 [/SUP], Marco Libanore[SUP] 24 [/SUP], Augusta Diani[SUP] 25 [/SUP], Simone Lanini[SUP] 26 [/SUP], Simone Battella[SUP] 27 [/SUP], Alessandra M Contino[SUP] 27 [/SUP], Eva Piano Mortari[SUP] 28 [/SUP], Francesco Genova[SUP] 27 [/SUP], Gessica Parente[SUP] 27 [/SUP], Rosella Dragonetti[SUP] 27 [/SUP], Stefano Colloca[SUP] 27 [/SUP], Luigi Visani[SUP] 29 [/SUP], Claudio Iannacone[SUP] 30 [/SUP], Rita Carsetti[SUP] 28 [/SUP], Antonella Folgori[SUP] 27 [/SUP], Roberto Camerini[SUP] 27 [/SUP]; COVITAR study group
Collaborators, Affiliations
- PMID: 37315558
- DOI: 10.1016/j.xcrm.2023.101084
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.
Keywords: CD4; CD8; COVID-19; Sars-CoV-2 vaccine; T cell response; immunological memory; neutralizing antibodies; phase 2 clinical trial; safety; simian adenoviral vector.