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