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1. Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results

Author

Chiara Agrati, Concetta Castilletti, Simone Battella, Eleonora Cimini, Giulia Matusali, Andrea Sommella, Alessandra Sacchi, Francesca Colavita, Alessandra M. Contino, Veronica Bordoni, Silvia Meschi, Giulia Gramigna, Federica Barra, Germana Grassi, Licia Bordi, Daniele Lapa, Stefania Notari, Rita Casetti, Aurora Bettini, Massimo Francalancia, Federica Ciufoli, Alessandra Vergori, Serena Vita, Michela Gentile, Angelo Raggioli, Maria M. Plazzi, Antonella Bacchieri, Emanuele Nicastri, Andrea Antinori, Stefano Milleri, Simone Lanini, Stefano Colloca, Enrico Girardi, Roberto Camerini, Giuseppe Ippolito, Francesco Vaia, Antonella Folgori, and Stefania Capone

Subjects
Immunologic diseases. Allergy, RC581-607, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Despite the successful deployment of efficacious vaccines and therapeutics, the development of novel vaccines for SARS-CoV-2 remains a major goal to increase vaccine doses availability and accessibility for lower income setting. We report here on the kinetics of Spike-specific humoral and T-cell response in young and old volunteers over 6 months follow-up after a single intramuscular administration of GRAd-COV2, a gorilla adenoviral vector-based vaccine candidate currently in phase-2 of clinical development. At all three tested vaccine dosages, Spike binding and neutralizing antibodies were induced and substantially maintained up to 3 months, to then contract at 6 months. Potent T-cell responses were readily induced and sustained throughout the study period, with only minor decline. No major differences in immune response to GRAd-COV2 vaccination were observed in the two age cohorts. In light of its favorable safety and immunogenicity, GRAd-COV2 is a valuable candidate for further clinical development and potential addition to the COVID-19 vaccine toolbox to help fighting SARS-CoV-2 pandemic.

Published
2022
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2. GRAd-COV2, a gorilla adenovirus-based candidate vaccine against COVID-19, is safe and immunogenic in younger and older adults

Author

Alessandra Vitelli, Germana Grassi, Yufang Shi, Erminia Masone, Alessandra D’Abramo, Francesca Cocca, Aldo De Luca, Francesco Vaia, Laura Scorzolini, Luigi Ziviani, Dorian Bardhi, Flavia Mazzaferri, Daniele Lapa, Sandrine Ottou, Rita T. Lawlor, Irene Turrini, Federica Barra, Markus Maeurer, Francesca Colavita, Federica Mori, Alessandra M. Contino, Rita Casetti, Alessandra Vergori, Stefano Milleri, Feliciana Malescio, Marco Soriani, Ottavia Porzio, Federica Martire, Concetta Castilletti, Simone Battella, Maria M. Plazzi, Stefano Colloca, Giulia Matusali, Roberto Camerini, Enrico Girardi, Michela Gentile, Veronica Bordoni, Antonella Petrecchia, Andrea Sommella, Angelo Raggioli, Fabiana Grazioli, Alessandra Sacchi, Elisa Marchioni, Giuseppe Ippolito, Silvia Murachelli, Guido Kroemer, Chiara Agrati, Federico Napolitano, Virginia Ammendola, Roberta Gagliardini, Emanuele Nicastri, Stefania Notari, Serena Vita, Andrea Antinori, Alessandra Grillo, Daniela Zamboni, Silvia Meschi, Simone Lanini, Chiara Montaldo, Federica Poli, Mauro Piacentini, Teresa Tambasco, Emilio Scalise, Antonella Folgori, Eleonora Cimini, Maria R. Capobianchi, Licia Bordi, Stefania Capone, HAL-SU, Gestionnaire, Istituto Nazionale di Malattie Infettive 'Lazzaro Spallanzani' (INMI), ReiThera, Centro Ricerche Cliniche di Verona, Soochow University, University of Chinese Academy of Sciences [Beijing] (UCAS), Champalimaud Centre for the Unknown [Lisbon], University Medical Center of the Johannes Gutenberg-University Mainz, Department of Public Health and Cell Biology, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy, Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Institut Gustave Roussy (IGR), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Karolinska University Hospital [Stockholm], Lanini, S., Capone, S., Antinori, A., Milleri, S., Nicastri, E., Camerini, R., Agrati, C., Castilletti, C., Mori, F., Sacchi, A., Matusali, G., Gagliardini, R., Ammendola, V., Cimini, E., Grazioli, F., Scorzolini, L., Napolitano, F., Plazzi, M. M., Soriani, M., De Luca, A., Battella, S., Sommella, A., Contino, A. M., Barra, F., Gentile, M., Raggioli, A., Shi, Y., Girardi, E., Maeurer, M., Capobianchi, M. R., Vaia, F., Piacentini, M., Kroemer, G., Vitelli, A., Colloca, S., Folgori, A., and Ippolito, G.

Subjects
2019-20 coronavirus outbreak, COVID-19 Vaccines, Settore BIO/06, Coronavirus disease 2019 (COVID-19), COVID-19 Vaccine, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Gorilla, Adenoviridae, Adenovirus Vaccines, biology.animal, Pandemic, Animals, Humans, Medicine, MESH: COVID-19, MESH: Animals, MESH: SARS-CoV-2, Aged, MESH: Adenovirus Vaccines, MESH: Aged, Gorilla gorilla, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, MESH: Humans, biology, Animal, SARS-CoV-2, business.industry, MESH: Gorilla gorilla, COVID-19, MESH: Adenoviridae, General Medicine, Virology, Adenovirus Vaccine, MESH: COVID-19 Vaccines, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Human
Abstract

International audience; Safe and effective vaccines against coronavirus disease 2019 (COVID-19) are essential for ending the ongoing pandemic. Although impressive progress has been made with several COVID-19 vaccines already approved, it is clear that those developed so far cannot meet the global vaccine demand alone. We describe a COVID-19 vaccine based on a replication-defective gorilla adenovirus expressing the stabilized prefusion severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein named GRAd-COV2. We assessed the safety and immunogenicity of a single-dose regimen of this vaccine in healthy younger and older adults to select the appropriate dose for each age group. For this purpose, a phase 1, dose-escalation, open-labeled trial was conducted including 90 healthy participants (45 aged 18 to 55 years old and 45 aged 65 to 85 years old) who received a single intramuscular administration of GRAd-COV2 at three escalating doses. Local and systemic adverse reactions were mostly mild or moderate and of short duration, and no serious adverse events were reported. Four weeks after vaccination, seroconversion to spike protein and receptor binding domain was achieved in 43 of 44 young volunteers and in 45 of 45 older participants. Consistently, neutralizing antibodies were detected in 42 of 44 younger-age and 45 of 45 older-age volunteers. In addition, GRAd-COV2 induced a robust and T helper 1 cell (T H 1)-skewed T cell response against the spike protein in 89 of 90 participants from both age groups. Overall, the safety and immunogenicity data from the phase 1 trial support the further development of this vaccine.

Published
2022
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