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


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.

SUBMITTER: Capone S 

PROVIDER: S-EPMC10243192 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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

Capone Stefania S   Fusco Francesco M FM   Milleri Stefano S   Borrè Silvio S   Carbonara Sergio S   Lo Caputo Sergio S   Leone Sebastiano S   Gori Giovanni G   Maggi Paolo P   Cascio Antonio A   Lichtner Miriam M   Cauda Roberto R   Dal Zoppo Sarah S   Cossu Maria V MV   Gori Andrea A   Roda Silvia S   Confalonieri Paola P   Bonora Stefano S   Missale Gabriele G   Codeluppi Mauro M   Mezzaroma Ivano I   Capici Serena S   Pontali Emanuele E   Libanore Marco M   Diani Augusta A   Lanini Simone S   Battella Simone S   Contino Alessandra M AM   Piano Mortari Eva E   Genova Francesco F   Parente Gessica G   Dragonetti Rosella R   Colloca Stefano S   Visani Luigi L   Iannacone Claudio C   Carsetti Rita R   Folgori Antonella A   Camerini Roberto R  

Cell reports. Medicine 20230529 6


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 rand  ...[more]

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