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

Author

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

Published
2022
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2. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial

Author

Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, Stefania, Fusco, Francesco M, Milleri, Stefano, Borrè, Silvio, Carbonara, Sergio, Lo Caputo, Sergio, Leone, Sebastiano, Gori, Giovanni, Maggi, Paolo, Cascio, Antonio, Lichtner, Miriam, Cauda, Roberto, Dal Zoppo, Sarah, Cossu, Maria V, Gori, Andrea, Roda, Silvia, Confalonieri, Paola, Bonora, Stefano, Missale, Gabriele, Codeluppi, Mauro, Mezzaroma, Ivano, Capici, Serena, Pontali, Emanuele, Libanore, Marco, Diani, Augusta, Lanini, Simone, Battella, Simone, Contino, Alessandra M, Piano Mortari, Eva, Genova, Francesco, Parente, Gessica, Dragonetti, Rosella, Colloca, Stefano, Visani, Luigi, Iannacone, Claudio, Carsetti, Rita, Folgori, Antonella, Camerini, Roberto, Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, and Marcellini, V

Subjects
immunological memory, phase 2 clinical trial, safety, Sars-CoV-2 vaccine, COVID-19, CD8, T cell response, simian adenoviral vector, General Biochemistry, Genetics and Molecular Biology, CD4, neutralizing antibodie
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 3weeks. 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 Tcell response peaks after the first dose and is characterized by high frequencies of CD8s. Tcells 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.

Published
2023

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

Author

Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., Marcellini V., Capone, S, Fusco, F, Milleri, S, Borre, S, Carbonara, S, Lo Caputo, S, Leone, S, Gori, G, Maggi, P, Cascio, A, Lichtner, M, Cauda, R, Dal Zoppo, S, Cossu, M, Gori, A, Roda, S, Confalonieri, P, Bonora, S, Missale, G, Codeluppi, M, Mezzaroma, I, Capici, S, Pontali, E, Libanore, M, Diani, A, Lanini, S, Battella, S, Contino, A, Piano Mortari, E, Genova, F, Parente, G, Dragonetti, R, Colloca, S, Visani, L, Iannacone, C, Carsetti, R, Folgori, A, Camerini, R, Ziviani, L, Malescio, F, Turrini, I, Lawlor, R, Romano, A, Nunziata, M, Armato, S, Mazzeo, N, Carleo, M, Dell'Isola, C, Pisapia, R, Pontarelli, A, Olivani, A, Grasselli, S, Laccabue, D, Leoni, M, Paolillo, F, Mancini, A, Ruaro, B, Confalonieri, M, Salton, F, Mancarella, G, Marocco, R, De Masi, M, Belvisi, V, Lamonica, S, Cingolani, A, Seguiti, C, Brambilla, P, Ferraresi, A, Lupi, M, Ludovisi, S, Renisi, G, Massafra, R, Pellicciotta, M, Armiento, L, Vimercati, S, Piacenza, M, Bonfanti, P, Columpsi, P, Cazzaniga, M, Rovelli, C, Ceresini, M, Previtali, L, Trentini, L, Alcantarini, C, Rugge, W, Biffi, S, Poletti, F, Rostagno, R, Moglia, R, De Negri, F, Fini, E, Cangialosi, A, Bruno, S, Rizzo, M, Niglio, M, Stritto, A, Matano, A, Petruzziello, A, Valsecchi, P, Pieri, T, Altamura, M, Calamo, A, Giannelli, A, Menolascina, S, Di Bari, S, Mauro, V, Aronica, R, Segala, D, Cultrera, R, Sighinolfi, L, Abbott, M, Gizzi, A, Marascia, F, Valenti, G, Feasi, M, Bobbio, N, Del Puente, F, Nicosia, A, Frasca, M, Mazzoleni, M, Garofalo, N, Ammendola, V, Grazioli, F, Napolitano, F, Vitelli, A, Marcellini, V, Capone S., Fusco F. M., Milleri S., Borre S., Carbonara S., Lo Caputo S., Leone S., Gori G., Maggi P., Cascio A., Lichtner M., Cauda R., Dal Zoppo S., Cossu M. V., Gori A., Roda S., Confalonieri P., Bonora S., Missale G., Codeluppi M., Mezzaroma I., Capici S., Pontali E., Libanore M., Diani A., Lanini S., Battella S., Contino A. M., Piano Mortari E., Genova F., Parente G., Dragonetti R., Colloca S., Visani L., Iannacone C., Carsetti R., Folgori A., Camerini R., Ziviani L., Malescio F., Turrini I., Lawlor R., Romano A., Nunziata M., Armato S., Mazzeo N., Carleo M. A., Dell'Isola C., Pisapia R., Pontarelli A., Olivani A., Grasselli S., Laccabue D., Leoni M. C., Paolillo F., Mancini A., Ruaro B., Confalonieri M., Salton F., Mancarella G., Marocco R., De Masi M., Belvisi V., Lamonica S., Cingolani A., Seguiti C., Brambilla P., Ferraresi A., Lupi M., Ludovisi S., Renisi G., Massafra R., Pellicciotta M., Armiento L., Vimercati S., Piacenza M., Bonfanti P., Columpsi P., Cazzaniga M. E., Rovelli C., Ceresini M., Previtali L., Trentini L., Alcantarini C., Rugge W., Biffi S., Poletti F., Rostagno R., Moglia R., De Negri F., Fini E., Cangialosi A., Bruno S. R., Rizzo M., Niglio M., Stritto A. D., Matano A., Petruzziello A., Valsecchi P., Pieri T., Altamura M., Calamo A., Giannelli A., Menolascina S., Di Bari S., Mauro V., Aronica R., Segala D., Cultrera R., Sighinolfi L., Abbott M., Gizzi A., Marascia F. G., Valenti G., Feasi M., Bobbio N., Del Puente F., Nicosia A., Frasca M., Mazzoleni M., Garofalo N., Ammendola V., Grazioli F., Napolitano F., Vitelli A., and Marcellini V.

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.

Published
2023

4. Corrigendum: Improved memory CD8 T cell response to delayed vaccine boost is associated with a distinct molecular signature

Author

Natalini, Ambra, primary, Simonetti, Sonia, additional, Favaretto, Gabriele, additional, Lucantonio, Lorenzo, additional, Peruzzi, Giovanna, additional, Muñoz-Ruiz, Miguel, additional, Kelly, Gavin, additional, Contino, Alessandra M., additional, Sbrocchi, Roberta, additional, Battella, Simone, additional, Capone, Stefania, additional, Folgori, Antonella, additional, Nicosia, Alfredo, additional, Santoni, Angela, additional, Hayday, Adrian C., additional, and Di Rosa, Francesca, additional

Published
2023
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5. GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomised placebo-controlled phase 2 trial (COVITAR)

Author

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

Published
2023
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7. Improved memory CD8 T cell response to delayed vaccine boost is associated with a distinct molecular signature

Author

Natalini, Ambra, primary, Simonetti, Sonia, additional, Favaretto, Gabriele, additional, Lucantonio, Lorenzo, additional, Peruzzi, Giovanna, additional, Muñoz-Ruiz, Miguel, additional, Kelly, Gavin, additional, Contino, Alessandra M., additional, Sbrocchi, Roberta, additional, Battella, Simone, additional, Capone, Stefania, additional, Folgori, Antonella, additional, Nicosia, Alfredo, additional, Santoni, Angela, additional, Hayday, Adrian C., additional, and Di Rosa, Francesca, additional

Published
2023
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8. MHC class II invariant chain–adjuvanted viral vectored vaccines enhances T cell responses in humans

Author

Esposito I., Cicconi P., D'Alise A. M., Brown A., Esposito M., Swadling L., Holst P. J., Bassi M. R., Stornaiuolo M., Mori F., Vassilev V., Li W., Donnison T., Gentile C., Turner B., von Delft A., Del Sorbo M., Barra F., Contino A. M., Abbate A., Novellino E., Thomsen A. R., Christensen J. P., Lahm A., Grazioli F., Ammendola V., Siani L., Colloca S., Klenerman P., Nicosia A., Dorrell L., Folgori A., Capone S., Barnes E., Bliss C., Ghaffari E., Hartnell F., Kopycinski J., Makvandi-Nejad S., Nevin V., Borys D., Boutriau D., Cochard L., Lin L., Struyf F., Hanke T., Bannan C., Bergin C., Hoffman M., Schmid P., Vernazza P., Gardiner C., Woods E., Esposito, I., Cicconi, P., D'Alise, A. M., Brown, A., Esposito, M., Swadling, L., Holst, P. J., Bassi, M. R., Stornaiuolo, M., Mori, F., Vassilev, V., Li, W., Donnison, T., Gentile, C., Turner, B., von Delft, A., Del Sorbo, M., Barra, F., Contino, A. M., Abbate, A., Novellino, E., Thomsen, A. R., Christensen, J. P., Lahm, A., Grazioli, F., Ammendola, V., Siani, L., Colloca, S., Klenerman, P., Nicosia, A., Dorrell, L., Folgori, A., Capone, S., Barnes, E., Bliss, C., Ghaffari, E., Hartnell, F., Kopycinski, J., Makvandi-Nejad, S., Nevin, V., Borys, D., Boutriau, D., Cochard, L., Lin, L., Struyf, F., Hanke, T., Bannan, C., Bergin, C., Hoffman, M., Schmid, P., Vernazza, P., Gardiner, C., Woods, E., and Consortium, PEACHI

Subjects
0301 basic medicine, T cell, Antigen presentation, Hepacivirus, CD8-Positive T-Lymphocytes, Biology, Major histocompatibility complex, Article, Epitope, 03 medical and health sciences, 0302 clinical medicine, Immune system, Antigen, medicine, Humans, MHC class II, Histocompatibility Antigens Class II, Viral Vaccines, General Medicine, Virology, Antigens, Differentiation, B-Lymphocyte, 030104 developmental biology, medicine.anatomical_structure, biology.protein, CD8, 030215 immunology
Abstract

Strategies to enhance the induction of high magnitude T cell responses through vaccination are urgently needed. Major histocompatibility complex (MHC) class II–associated invariant chain (Ii) plays a critical role in antigen presentation, forming MHC class II peptide complexes for the generation of CD4+ T cell responses. Preclinical studies evaluating the fusion of Ii to antigens encoded in vector delivery systems have shown that this strategy may enhance T cell immune responses to the encoded antigen. We now assess this strategy in humans, using chimpanzee adenovirus 3 and modified vaccinia Ankara vectors encoding human Ii fused to the nonstructural (NS) antigens of hepatitis C virus (HCV) in a heterologous prime/boost regimen. Vaccination was well tolerated and enhanced the peak magnitude, breadth, and proliferative capacity of anti-HCV T cell responses compared to non-Ii vaccines in humans. Very high frequencies of HCV-specific T cells were elicited in humans. Polyfunctional HCV-specific CD8+ and CD4+ responses were induced with up to 30% of CD3+CD8+ cells targeting single HCV epitopes; these were mostly effector memory cells with a high proportion expressing T cell activation and cytolytic markers. No volunteers developed anti-Ii T cell or antibody responses. Using a mouse model and in vitro experiments, we show that Ii fused to NS increases HCV immune responses through enhanced ubiquitination and proteasomal degradation. This strategy could be used to develop more potent HCV vaccines that may contribute to the HCV elimination targets and paves the way for developing class II Ii vaccines against cancer and other infections.

Published
2020
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9. AMOUNT OF ERBITUX USED IN THE HOSPITAL 'CIVICO - DI CRISTINA - BENFRATELLI', PALERMO

Author

VENTURELLA, Fabio, Benanti M., Mariottini G. L., Contino V. M., Amari P., Venturella F., Benanti M., Mariottini G.L, Contino V.M, and Amari P.

Subjects
Settore BIO/14 - Farmacologia, Cetuximab
Abstract

Erbitux (Cetuximab) is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)- expressing, KRAS wild-type metastatic colorectal cancer and without KRAS mutations (wild type). Cetuximab is a chimeric monoclonal IgG1 antibody directed against the EGFR. It blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor and induces the internalization of EGFR, which can lead to down-regulation of EGFR. Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump. The first administration should be administered in 120 minutes and subsequent over 60 minutes. Precautions:It is stored at a temperature between 2°C and 8°C. Prior to the first infusion, patients must receive premedication (antihistamine and a corticosteroid) at least 1 hour before administration of cetuximab. Due to physico-chemical incompatibility, must not be mixed with other medicines. At the Hospital ARNAS “Civico-Di Cristina-Benfratelli” of Palermo were dispensed in the year 2013 130182 mg, in the 2014 147125 mg, in the 2015 117060 mg and in the 2016 (until November) 71964 mg. The highest consumption has had in the year 2014. Following the discovery of RAS subgroups, it is seen that Erbitux works best on K-RAS subgroup, then, over the years, the SOC has varied according to the state determination mutated or non-mutated K-RAS gene. From 2015, with the marketing of Panitumumab for under K-RAS Group and the use of Bevacizumab for N-RAS, the use of Erbitux it has in fact greatly reduced.

Published
2017

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

Subjects
Pharmacology, Infectious Diseases, Immunology, Pharmacology (medical)
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

13. A next generation vaccine against human rabies based on a single dose of a chimpanzee adenovirus vector serotype C

Author

Federico Napolitano, Rossella Merone, Adele Abbate, Virginia Ammendola, Emma Horncastle, Francesca Lanzaro, Marialuisa Esposito, Alessandra Maria Contino, Roberta Sbrocchi, Andrea Sommella, Joshua D. Duncan, Jospeh Hinds, Richard A. Urbanowicz, Armin Lahm, Stefano Colloca, Antonella Folgori, Jonathan K. Ball, Alfredo Nicosia, Benjamin Wizel, Stefania Capone, Alessandra Vitelli, Napolitano, F., Merone, R., Abbate, A., Ammendola, V., Horncastle, E., Lanzaro, F., Esposito, M., Contino, A. M., Sbrocchi, R., Sommella, A., Duncan, J. D., Hinds, J., Urbanowicz, R. A., Lahm, A., Colloca, S., Folgori, A., Ball, J. K., Nicosia, A., Wizel, B., Capone, S., and Vitelli, A.

Subjects
RNA viruses, Viral Diseases, Physiology, RC955-962, Post-Exposure Prophylaxi, Rabbit, Pathology and Laboratory Medicine, Biochemistry, Mice, Zoonoses, Immune Physiology, Arctic medicine. Tropical medicine, Medicine and Health Sciences, Public and Occupational Health, Enzyme-Linked Immunoassays, Antigens, Viral, Vaccines, Synthetic, Vaccines, Immune System Proteins, Pan troglodyte, Vaccination, Vaccination and Immunization, Infectious Diseases, Medical Microbiology, Viral Pathogens, Viruses, Female, Genetic Vector, Rabbits, Pathogens, Public aspects of medicine, RA1-1270, Post-Exposure Prophylaxis, Human, Research Article, Neglected Tropical Diseases, Pan troglodytes, Infectious Disease Control, Rabies, Genetic Vectors, Immunology, Serogroup, Research and Analysis Methods, Microbiology, Antibodies, Rabies viru, Rabies Virus, Virology, Animals, Humans, Immunoassays, Microbial Pathogens, Macaca fasciculari, Biology and life sciences, Animal, Public Health, Environmental and Occupational Health, Organisms, Correction, Proteins, Viral Vaccines, Tropical Diseases, Rabies Vaccine, Macaca fascicularis, Rabies Vaccines, Immunologic Techniques, Adenoviruses, Simian, Rabie, Lyssavirus, Preventive Medicine
Abstract

Rabies, caused by RNA viruses in the Genus Lyssavirus, is the most fatal of all infectious diseases. This neglected zoonosis remains a major public health problem in developing countries, causing the death of an estimated 25,000–159,000 people each year, with more than half of them in children. The high incidence of human rabies in spite of effective vaccines is mainly linked to the lack of compliance with the complicated administration schedule, inadequacies of the community public health system for local administration by the parenteral route and the overall costs of the vaccine. The goal of our work was the development of a simple, affordable and effective vaccine strategy to prevent human rabies virus infection. This next generation vaccine is based on a replication-defective chimpanzee adenovirus vector belonging to group C, ChAd155-RG, which encodes the rabies glycoprotein (G). We demonstrate here that a single dose of this vaccine induces protective efficacy in a murine model of rabies challenge and elicits strong and durable neutralizing antibody responses in vaccinated non-human primates. Importantly, we demonstrate that one dose of a commercial rabies vaccine effectively boosts the neutralizing antibody responses induced by ChAd155-RG in vaccinated monkeys, showing the compatibility of the novel vectored vaccine with the current post-exposure prophylaxis in the event of rabies virus exposure. Finally, we demonstrate that antibodies induced by ChAd155-RG can also neutralize European bat lyssaviruses 1 and 2 (EBLV-1 and EBLV-2) found in bat reservoirs., Author summary Rabies still remains a neglected zoonosis after a long history of vaccination. Considering the severity of the disease and its continued high incidence in low-income countries, the development of a next generation vaccine is warranted. We utilized a group C, replication-defective chimpanzee adenovirus vector to develop a novel vaccine against rabies. Mice vaccinated with ChAd155-RG survived after rabies infection and non-human primates injected with a single dose of this vaccine developed strong and durable neutralizing antibody responses which could be effectively boosted with a licensed vaccine, demonstrating the compatibility of the novel vectored vaccine with the current post-exposure prophylaxis in the event of rabies virus exposure. Importantly, we show that ChAd155-RG induced neutralizing antibodies can neutralize also lyssavirus species (EBLV-1 and EBLV-2) found in bat reservoirs. These studies paved the way to the clinical testing of the ChAd155-RG based rabies vaccine as a single-dose, low cost, preventative rabies vaccine candidate.

Published
2020

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