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

Author

Lanini, Simone, primary, Capone, Stefania, additional, Antinori, Andrea, additional, Milleri, Stefano, additional, Nicastri, Emanuele, additional, Camerini, Roberto, additional, Agrati, Chiara, additional, Castilletti, Concetta, additional, Mori, Federica, additional, Sacchi, Alessandra, additional, Matusali, Giulia, additional, Gagliardini, Roberta, additional, Ammendola, Virginia, additional, Cimini, Eleonora, additional, Grazioli, Fabiana, additional, Scorzolini, Laura, additional, Napolitano, Federico, additional, Plazzi, Maria M., additional, Soriani, Marco, additional, De Luca, Aldo, additional, Battella, Simone, additional, Sommella, Andrea, additional, Contino, Alessandra M., additional, Barra, Federica, additional, Gentile, Michela, additional, Raggioli, Angelo, additional, Shi, Yufang, additional, Girardi, Enrico, additional, Maeurer, Markus, additional, Capobianchi, Maria R., additional, Vaia, Francesco, additional, Piacentini, Mauro, additional, Kroemer, Guido, additional, Vitelli, Alessandra, additional, Colloca, Stefano, additional, Folgori, Antonella, additional, and Ippolito, Giuseppe, additional

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

Author

Lanini, Simone, primary, Capone, Stefania, additional, Antinori, Andrea, additional, Milleri, Stefano, additional, Nicastri, Emanuele, additional, Camerini, Roberto, additional, Agrati, Chiara, additional, Castilletti, Concetta, additional, Mori, Federica, additional, Sacchi, Alessandra, additional, Matusali, Giulia, additional, Gagliardini, Roberta, additional, Ammendola, Virginia, additional, Cimini, Eleonora, additional, Grazioli, Fabiana, additional, Scorzolini, Laura, additional, Napolitano, Federico, additional, Piazzi, Maria Maddalena, additional, Soriani, Marco, additional, De Luca, Aldo, additional, Battella, Simone, additional, Sommella, Andrea, additional, Contino, Alessandra M., additional, Barra, Federica, additional, Gentile, Michela, additional, Raggioli, Angelo, additional, Shi, Yufang, additional, Girardi, Enrico, additional, Maeurer, Markus, additional, Capobianchi, Maria R., additional, Vaia, Francesco, additional, Piacentini, Mauro, additional, Kroemer, Guido, additional, Vitelli, Alessandra, additional, Colloca, Stefano, additional, Folgori, Antonella, additional, and Ippolito, Giuseppe, additional

Published
2021
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14. 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

20. Internment Camps and their Shameful Legacy.

Author

Contino, Jennifer M.

Abstract

On December 7, 1941, the Japanese Imperial Navy bombed the U.S. Pacific Fleet at a naval base in Pearl Harbor, Hawaii. More than 2,300 Americans were killed, and many ships and airplanes were destroyed. This action prompted President Franklin Roosevelt to declare war on Japan. Within hours of the bombing of Pearl Harbor, members of the Federal Bureau of Investigation (FBI) arrested many prominent members of Japanese-American communities along the West Coast. A day later, on December 8, 1941, the U.S. officially declared war on Japan. The Japanese living in the U.S. and those of Japanese ancestry were removed from their homes and placed in internment camps without a trial or hearing. In order to prove their loyalty, many Japanese Americans joined the military and helped to staff and run the bases on the Hawaiian mainlands. INSET: INTERNMENT CAMPS.

Published
2003

21. Working Toward Acceptance.

Author

Contino, Jennifer M.

Abstract

Japanese emigration to the U.S. nearly came to a halt during the 1920s. In 1921, several anti-Japanese land laws were passed in California and Washington. On May 21, 1921, a law was passed that put limitations on the number of immigrants who could enter the U.S. from different countries. Japanese was one of the ethnic backgrounds singled out for exclusion. As a result of the prejudice and discrimination that immigrants faced on a daily basis, the Issei and Nisei created another economy and culture besides that of their white American counterparts. The Issei were loyal to the Japan-owned stores, and many sent their children to Japanese-run segregated schools. In fact, some Issei did not believe in the American education system and sent their children to Japan for schooling. The Nisei were different from most children because they lived in two worlds. The Nisei wanted to fight against the racism and prejudice that they were experiencing from white people, so they organized many clubs and organizations with this aim in mind. They created the Japanese American Citizens League (JACL), a civil rights group that fought to ensure that no immigrants' rights were violated and that all people were treated fairly.

Published
2003

22. Starting a Family in America.

Author

Contino, Jennifer M.

Abstract

Japanese immigrants arriving in the mainland U.S. faced all sorts of problems. The teens who hoped to study in U.S. schools and universities often had to take jobs as domestic servants and go to school at night. The students were not the only ones having problems. Some Japanese immigrants were tricked into signing labor contracts that did not pay or deliver what the worker was promised. Most of the first jobs that the Japanese immigrants took in the U.S. were as migrant farm workers. They lived in railroad cars and moved from place to place. They got jobs helping to harvest crops and then moved on to the next farm. Some Japanese lost all their belongings when crops failed, but many more became successful farmers. Many Californians were jealous of the success that the Japanese experienced. Their feelings of jealousy were an important motivation behind the Alien Land Act, which was passed by the California State Legislature in 1913. The Act prohibited "aliens ineligible for citizenship" from purchasing land or leasing it for a period longer than three years. INSET: SCHOOLBOYS.

Published
2003

23. Making a Living: Japanese Labor in Hawaii and the United States.

Author

Contino, Jennifer M.

Abstract

The first Japanese immigrants in Hawaii worked mainly on sugarcane plantations. Once a laborer arrived on a plantation, he or she usually signed a contract that bound them to work for a period of time — usually three years. The contracts set the wages and amount of time a worker would stay at a particular job. Each worker had to wear an identification number on a brass tag with which they were identified. The bosses were cruel and whipped anyone not working fast enough. Furthermore, the Japanese were being paid less than Puerto Rican or Portuguese workers. This angered many of the Issei. However, despite all these unfair conditions the Japanese worked hard for the plantation owners, and more and more immigrants began to settle in Hawaii. The hard work and skill of the Japanese in Hawaii was not limited to plantation work. Many of the Japanese immigrants also found work with the fishing industry. However, Hawaii was not the only place these new immigrants settled. Many made their homes in West Coast cities in the United States, and some made homes in Mexico and Canada. INSETS: JAPANESE EMIGRATION COMPANIES;THE GENTLEMEN'S AND LADIES' AGREEMENTS.

Published
2003

24. The Journey to a New Life.

Author

Contino, Jennifer M.

Abstract

Most people who thought about immigrating during the 19th century believed that there were economic and social opportunities in North America that were not available to them in their native lands. Japanese thought that in North America you could work and, in a few years, save enough money to live comfortably for the rest of your life back home in Japan. A majority of the Japanese immigrants were males between the ages of 15 and 39 who hoped to start a business, earn money, and then return home wealthy. It was not easy to emigrate. The Japanese government screened potential emigrants at quarantine, or isolation, stations. Before an emigrant received a passport, he or she had to be tested for syphilis, hookworm, trachoma and other illnesses. After the decision was made to go to North America and a passport was granted, a long, slow, and hazardous journey lay ahead. Most of the first Japanese emigrants went to Hawaii to work on sugarcane plantations, where the pay was supposed to be high. Other immigrants found their way to West Coast states like California and Washington, where they worked as migrant workers, moving from farm to farm.

Published
2003

25. Japan Steps into the Modern Era.

Author

Contino, Jennifer M.

Abstract

Unlike many countries, which consist of a large landmass, Japan is made up of nearly 3,000 islands. Before people began emigrating from Japan to North America, the island nation had isolated itself from the rest of the world. For over 250 years, the leaders of Japan shut off the country to foreign trade and influence by closing its shipping ports so that ships from other nations could not enter Japan. The Edo government of Japan also made it against the law for people to read foreign books and learn about other religions, customs, or beliefs. The government did not want anyone or anything to challenge traditional Japanese values, such as obedience and harmony, especially within the family unit. Japan might have remained isolated even longer were it not for the U.S. Navy. In 1853, U.S. naval officer Commodore Matthew C. Perry arrived in Edo Harbor. He had a letter from U.S. president Millard Fillmore. The letter requested permission for American ships to stop at Japanese ports for supplies.

Published
2003

26. Can lease contracts block your reorganization?

Author

Contino, Richard M.

Subjects
LEASE or buy decisions, CORPORATE reorganizations, INDUSTRIAL equipment leases, EQUIPMENT financing, LEASES
Abstract

Should your reorganization due diligence include a review of your equipment leases? The author of this article—an expert in equipment leasing and financing—warns that an equipment lease can restrict your company's ability to reorganize. He explains how to avoid these problems and offers a handy checklist to help you stay out of trouble. © 2007 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Published
2007
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27. America's Ethnic Heritage.

Author

Contino, Jennifer M. and Moreno, Barry

Abstract

Ethnic diversity is one of the most striking characteristics of the American identity. In the U.S. the Bureau of the Census officially recognizes 122 different ethnic groups. Population of North America has grown by leaps and bounds, starting with the American Indian tribes and nations and increasing with the arrival of the European colonial migrants who came to these shores during the 16th and 17th centuries. Since then, millions of immigrants have come to America from every corner of the world. It was not so easy to become part of America's culture. The most striking changes occurred among the children of immigrants, whose hopes and dreams were different from those of their parents. They began breaking away from the Old World customs, perhaps as a reaction to the embarrassment of being labeled "foreigner." Today, the pride that Americans have in their ethnic roots is one of the abiding strengths of both the U.S. and Canada.

Published
2003

28. LARRY YOUNG.

Author

Contino, Jennifer M.

Subjects
*AUTHORS
Abstract

Interviews comic book author Larry Young. His ambition to be an astronaut; His fascination with outer space; Information on his comic book miniseries 'Astronauts in Trouble.'

Published
2002

33. THE JAPANESE AMERICAN CITIZEN LEAGUE.

Author

Contino, Jennifer M.

Abstract

The Japanese American Citizens League (JACL) was founded in 1929 to address issues of discrimination against the Issei and Nisei in the U.S. The JACL was established to fight primarily for the civil rights of Japanese Americans but also for the benefit of other immigrants. Although still a small, California-based organization, the JACL was one of only a few organizations in the 1920s and 1930s willing to challenge the racist policies of the state and federal governments. The true test of the JACL came in the 1940s when Japan attacked the U.S. Naval base at Pearl Harbor and launched America into World War II. During the war, the JACL continued its efforts to ensure some measure of protection and comfort for Japanese Americans imprisoned in government detention camps. The organization argued for and won the right of Japanese Americans to serve in the U.S. military, resulting in the creation of a segregated unit, the famous 442nd Regimental Combat Team, which joined with the 100th Battalion from Hawaii and became the most highly decorated unit in U.S. military history, despite having only served in combat for a little over a year in the European theater of the war.

Published
2003

34. Further Reading.

Author

Contino, Jennifer M.

Abstract

This article presents a list of books that can be referred for further reading on Japanese Americans.

Published
2003

35. Glossary.

Author

Contino, Jennifer M.

Abstract

A glossary of terms used in the book 'Japanese Americans' is given in this article.

Published
2003

36. Famous Japanese Americans.

Author

Contino, Jennifer M.

Abstract

This article presents information about famous Japanese Americans. Leo Esaki was the winner of the 1973 Nobel Prize for Physics for his work on electron tunneling theories. Harvey Itano won the Reverend Dr. Martin Luther King Medical Achievement Award for his outstanding contributions to research on sickle cell anemia, a disease that targets African Americans. George Takei played Sulu in the 'Star Trek' series on television and in films. Ronald Takaki was a Pulitzer Prize nominee for his work on 'A Different Mirror,' 'Iron Cages: Race and Culture in the 19th Century.' He is the Caldecott Award-nominated writer of the children's books Crow Boy, Umbrella, and Seashore Story. She is an attorney, the founder of a multicultural children's book publishing company, and author of Ashok by Any Other Name and Char Siu Bad Boy.

Published
2003

37. Contributors.

Author

Contino, Jennifer M.

Abstract

This article presents information about contributors of the book 'Japanese Americans.' Barry Moreno has been librarian and historian at the Ellis Island Immigration Museum and the Statue of Liberty National Monument since 1988. He is the author of 'The Statue of Liberty Encyclopedia,' which was published by Simon&Schuster in October 2000. After graduation from California State University at Los Angeles, where he earned a degree in history, he joined the National Park Service as a seasonal park ranger at the Statue of Liberty; he eventually became the monument's librarian. In his spare time, Barry enjoys reading, writing, and studying foreign languages and grammar. Jennifer M. Contino is a freelance writer for several magazines, including 'Sequential Tart,' 'Wizard,' 'Comicology,' and 'In Power.' She has a teaching degree in elementary education and also works with abused children as a mental health worker.

Published
2003

38. Photo Credits.

Author

Contino, Jennifer M.

Abstract

This article presents information related to photographs that appear in the book 'Japanese Americans.'

Published
2003

39. Immigration Figures.

Author

Contino, Jennifer M.

Abstract

This article presents statistics of the number of people of Japanese descent living in the U.S.

Published
2003

40. Internet Resources.

Author

Contino, Jennifer M.

Abstract

This article presents a list of Web sites that can be referred for further information related to Japanese Americans. The official Web site of the U.S. Bureau of the Census contains information about the most recent census taken in 2000. The Web site for Canada's Bureau of Statistics, includes population information updated for the most recent census in July 2001. The Web site for the Japanese-American Network is designed to exchange information about Japanese Americans — art, culture, community, history, news, events, social services, and other issues.

Published
2003

41. ANNE * FREAKS, VOL. 1.

Author

Contino, Jennifer M.

Subjects
*COMIC books, strips, etc., *FICTION
Abstract

The article reviews the comic book "Anne * Freaks," volume 1, by Yua Kotegawa.

Published
2006

42. 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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43. 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

44. 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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