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2. Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection

Author

Page, Kimberly, Melia, Michael T, Veenhuis, Rebecca T, Winter, Matthew, Rousseau, Kimberly E, Massaccesi, Guido, Osburn, William O, Forman, Michael, Thomas, Elaine, Thornton, Karla, Wagner, Katherine, Vassilev, Ventzislav, Lin, Lan, Lum, Paula J, Giudice, Linda C, Stein, Ellen, Asher, Alice, Chang, Soju, Gorman, Richard, Ghany, Marc G, Liang, T Jake, Wierzbicki, Michael R, Scarselli, Elisa, Nicosia, Alfredo, Folgori, Antonella, Capone, Stefania, and Cox, Andrea L

Subjects
Vaccine Related, Liver Disease, Clinical Trials and Supportive Activities, Clinical Research, Hepatitis, Emerging Infectious Diseases, Digestive Diseases, HIV/AIDS, Hepatitis - C, Immunization, Chronic Liver Disease and Cirrhosis, Infectious Diseases, Prevention, Biotechnology, Prevention of disease and conditions, and promotion of well-being, 6.1 Pharmaceuticals, 3.4 Vaccines, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Infection, Good Health and Well Being, Adenoviruses, Simian, Adolescent, Adult, Animals, Double-Blind Method, Female, Genetic Vectors, Hepatitis C Antibodies, Hepatitis C, Chronic, Humans, Immunogenicity, Vaccine, Incidence, Male, Middle Aged, Pan troglodytes, Substance Abuse, Intravenous, T-Lymphocytes, Vaccines, Synthetic, Viral Hepatitis Vaccines, Young Adult, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundA safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of efforts to eliminate the disease.MethodsIn this phase 1-2 randomized, double-blind, placebo-controlled trial, we evaluated a recombinant chimpanzee adenovirus 3 vector priming vaccination followed by a recombinant modified vaccinia Ankara boost; both vaccines encode HCV nonstructural proteins. Adults who were considered to be at risk for HCV infection on the basis of a history of recent injection drug use were randomly assigned (in a 1:1 ratio) to receive vaccine or placebo on days 0 and 56. Vaccine-related serious adverse events, severe local or systemic adverse events, and laboratory adverse events were the primary safety end points. The primary efficacy end point was chronic HCV infection, defined as persistent viremia for 6 months.ResultsA total of 548 participants underwent randomization, with 274 assigned to each group. There was no significant difference in the incidence of chronic HCV infection between the groups. In the per-protocol population, chronic HCV infection developed in 14 participants in each group (hazard ratio [vaccine vs. placebo], 1.53; 95% confidence interval [CI], 0.66 to 3.55; vaccine efficacy, -53%; 95% CI, -255 to 34). In the modified intention-to-treat population, chronic HCV infection developed in 19 participants in the vaccine group and 17 in placebo group (hazard ratio, 1.66; 95% CI, 0.79 to 3.50; vaccine efficacy, -66%; 95% CI, -250 to 21). The geometric mean peak HCV RNA level after infection differed between the vaccine group and the placebo group (152.51×103 IU per milliliter and 1804.93×103 IU per milliliter, respectively). T-cell responses to HCV were detected in 78% of the participants in the vaccine group. The percentages of participants with serious adverse events were similar in the two groups.ConclusionsIn this trial, the HCV vaccine regimen did not cause serious adverse events, produced HCV-specific T-cell responses, and lowered the peak HCV RNA level, but it did not prevent chronic HCV infection. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT01436357.).

Published
2021

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

Author

Ziviani, Luigi, Malescio, Feliciana, Turrini, Irene, Lawlor, Rita, Romano, Annamaria, Nunziata, Mariagrazia, Armato, Salvatore, Mazzeo, Nicole, Carleo, Maria Aurora, Dell’Isola, Chiara, Pisapia, Raffaella, Pontarelli, Agostina, Olivani, Andrea, Grasselli, Sara, Laccabue, Diletta, Leoni, Maria Cristina, Paolillo, Franco, Mancini, Annalisa, Ruaro, Barbara, Confalonieri, Marco, Salton, Francesco, Mancarella, Giulia, Marocco, Raffaella, De Masi, Margherita, Belvisi, Valeria, Lamonica, Silvia, Cingolani, Antonella, Seguiti, Cristina, Brambilla, Paola, Ferraresi, Alice, Lupi, Matteo, Ludovisi, Serena, Renisi, Giulia, Massafra, Roberta, Pellicciotta, Martina, Armiento, Luciana, Vimercati, Stefania, Piacenza, Mariagrazia, Bonfanti, Paolo, Columpsi, Paola, Cazzaniga, Marina Elena, Rovelli, Cristina, Ceresini, Mariaelena, Previtali, Letizia, Trentini, Laura, Alcantarini, Chiara, Rugge, Walter, Biffi, Stefano, Poletti, Federica, Rostagno, Roberto, Moglia, Roberta, De Negri, Ferdinando, Fini, Elisabetta, Cangialosi, Alice, Bruno, Serena Rita, Rizzo, Marianna, Niglio, Mariangela, Stritto, Anna Dello, Matano, Alfredo, Petruzziello, Arnolfo, Valsecchi, Pietro, Pieri, Teresa, Altamura, Mauro, Calamo, Angela, Giannelli, Anna, Menolascina, Stefania, Di Bari, Silvia, Mauro, Vera, Aronica, Raissa, Segala, Daniela, Cultrera, Rosario, Sighinolfi, Laura, Abbott, Michelle, Gizzi, Andrea, Marascia, Federica Guida, Valenti, Giacomo, Feasi, Marcello, Bobbio, Nicoletta, Del Puente, Filippo, Nicosia, Alfredo, Frascà, Martina, Mazzoleni, Miriam, Garofalo, Nadia, Ammendola, Virginia, Grazioli, Fabiana, Napolitano, Federico, Vitelli, Alessandra, Marcellini, Valentina, 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, and Camerini, Roberto

Published
2023
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7. 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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8. Adenovirus Encoded Adjuvant (AdEnA) anti-CTLA-4, a novel strategy to improve Adenovirus based vaccines against infectious diseases and cancer

Author

D’Alise, Anna Morena, primary, Nocchi, Linda, additional, Garzia, Irene, additional, Seclì, Laura, additional, Infante, Luigia, additional, Troise, Fulvia, additional, Cotugno, Gabriella, additional, Allocca, Simona, additional, Romano, Giuseppina, additional, Lahm, Armin, additional, Leoni, Guido, additional, Sasso, Emanuele, additional, Scarselli, Elisa, additional, and Nicosia, Alfredo, additional

Published
2023
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9. Table S1 from A Genetic Vaccine Encoding Shared Cancer Neoantigens to Treat Tumors with Microsatellite Instability

Author

Leoni, Guido, primary, D'Alise, Anna Morena, primary, Cotugno, Gabriella, primary, Langone, Francesca, primary, Garzia, Irene, primary, De Lucia, Maria, primary, Fichera, Imma, primary, Vitale, Rosa, primary, Bignone, Veronica, primary, Tucci, Fabio Giovanni, primary, Mori, Federica, primary, Leuzzi, Adriano, primary, Di Matteo, Elena, primary, Troise, Fulvia, primary, Abbate, Adele, primary, Merone, Rossella, primary, Ruzza, Valentino, primary, Diodoro, Maria Grazia, primary, Yadav, Mahesh, primary, Gordon-Alonso, Monica, primary, Vanhaver, Cristophe, primary, Panigada, Maddalena, primary, Soprana, Elisa, primary, Siccardi, Antonio, primary, Folgori, Antonella, primary, Colloca, Stefano, primary, van der Bruggen, Pierre, primary, Nicosia, Alfredo, primary, Lahm, Armin, primary, Catanese, Maria Teresa, primary, and Scarselli, Elisa, primary

Published
2023
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10. Data from A Genetic Vaccine Encoding Shared Cancer Neoantigens to Treat Tumors with Microsatellite Instability

Author

Leoni, Guido, primary, D'Alise, Anna Morena, primary, Cotugno, Gabriella, primary, Langone, Francesca, primary, Garzia, Irene, primary, De Lucia, Maria, primary, Fichera, Imma, primary, Vitale, Rosa, primary, Bignone, Veronica, primary, Tucci, Fabio Giovanni, primary, Mori, Federica, primary, Leuzzi, Adriano, primary, Di Matteo, Elena, primary, Troise, Fulvia, primary, Abbate, Adele, primary, Merone, Rossella, primary, Ruzza, Valentino, primary, Diodoro, Maria Grazia, primary, Yadav, Mahesh, primary, Gordon-Alonso, Monica, primary, Vanhaver, Cristophe, primary, Panigada, Maddalena, primary, Soprana, Elisa, primary, Siccardi, Antonio, primary, Folgori, Antonella, primary, Colloca, Stefano, primary, van der Bruggen, Pierre, primary, Nicosia, Alfredo, primary, Lahm, Armin, primary, Catanese, Maria Teresa, primary, and Scarselli, Elisa, primary

Published
2023
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11. Supplementary Data from A Genetic Vaccine Encoding Shared Cancer Neoantigens to Treat Tumors with Microsatellite Instability

Author

Leoni, Guido, primary, D'Alise, Anna Morena, primary, Cotugno, Gabriella, primary, Langone, Francesca, primary, Garzia, Irene, primary, De Lucia, Maria, primary, Fichera, Imma, primary, Vitale, Rosa, primary, Bignone, Veronica, primary, Tucci, Fabio Giovanni, primary, Mori, Federica, primary, Leuzzi, Adriano, primary, Di Matteo, Elena, primary, Troise, Fulvia, primary, Abbate, Adele, primary, Merone, Rossella, primary, Ruzza, Valentino, primary, Diodoro, Maria Grazia, primary, Yadav, Mahesh, primary, Gordon-Alonso, Monica, primary, Vanhaver, Cristophe, primary, Panigada, Maddalena, primary, Soprana, Elisa, primary, Siccardi, Antonio, primary, Folgori, Antonella, primary, Colloca, Stefano, primary, van der Bruggen, Pierre, primary, Nicosia, Alfredo, primary, Lahm, Armin, primary, Catanese, Maria Teresa, primary, and Scarselli, Elisa, primary

Published
2023
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14. Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade

Author

D’Alise, Anna Morena, Leoni, Guido, Cotugno, Gabriella, Troise, Fulvia, Langone, Francesca, Fichera, Imma, De Lucia, Maria, Avalle, Lidia, Vitale, Rosa, Leuzzi, Adriano, Bignone, Veronica, Di Matteo, Elena, Tucci, Fabio Giovanni, Poli, Valeria, Lahm, Armin, Catanese, Maria Teresa, Folgori, Antonella, Colloca, Stefano, Nicosia, Alfredo, and Scarselli, Elisa

Published
2019
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15. 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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16. Evaluation of the Efficacy of ChAd63-MVA Vectored Vaccines Expressing Circumsporozoite Protein and ME-TRAP Against Controlled Human Malaria Infection in Malaria-Naive Individuals

Author

Hodgson, Susanne H., Ewer, Katie J., Bliss, Carly M., Edwards, Nick J., Rampling, Thomas, Anagnostou, Nicholas A., de Barra, Eoghan, Havelock, Tom, Bowyer, Georgina, Poulton, Ian D., de Cassan, Simone, Longley, Rhea, Illingworth, Joseph J., Douglas, Alexander D., Mange, Pooja B., Collins, Katharine A., Roberts, Rachel, Gerry, Stephen, Berrie, Eleanor, Moyle, Sarah, Colloca, Stefano, Cortese, Riccardo, Sinden, Robert E., Gilbert, Sarah C., Bejon, Philip, Lawrie, Alison M., Nicosia, Alfredo, Faust, Saul N., and Hill, Adrian V. S.

Published
2015

18. Supplemental Materials for Safety and Immunogenicity of Chimpanzee Adenovirus Vector Ebola Vaccine

Author

Ledgerwood, Julie E., DeZure, Adam D., Stanley, Daphne A., Novik, Laura, Enama, Mary E., Berkowitz, Nina M., Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J., Plummer, Sarah A., Holman, LaSonji A., Hendel, Cynthia S., Yamshchikov, Galina, Roman, Francois, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T., Schwartz, Richard M., Roederer, Mario, Mascola, John R., Koup, Richard A., Sullivan, Nancy J., and Graham, Barney S.

Published
2017

19. 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 Maria, 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
2022
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20. Chimpanzee Adenovirus Vector Ebola Vaccine

Author

Ledgerwood, Julie E., DeZure, Adam D., Stanley, Daphne A., Coates, Emily E., Novik, Laura, Enama, Mary E., Berkowitz, Nina M., Hu, Zonghui, Joshi, Gyan, Ploquin, Aurélie, Sitar, Sandra, Gordon, Ingelise J., Plummer, Sarah A., Holman, LaSonji A., Hendel, Cynthia S., Yamshchikov, Galina, Roman, Francois, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Bailer, Robert T., Schwartz, Richard M., Roederer, Mario, Mascola, John R., Koup, Richard A., Sullivan, Nancy J., and Graham, Barney S.

Published
2017
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22. Antigen expression determines adenoviral vaccine potency independent of IFN and sting signaling

Author

Quinn, Kylie M., Zak, Daniel E., Costa, Andreia, Yamamoto, Ayako, Kastenmuller, Kathrin, Hill, Brenna J., Lynn, Geoffrey M., Darrah, Patricia A., Lindsay, Ross W.B., Wang, Lingshu, Cheng, Cheng, Nicosia, Alfredo, Folgori, Antonella, Colloca, Stefano, Cortese, Riccardo, Gostick, Emma, Price, David A., Gall, Jason G.D., Roederer, Mario, Aderem, Alan, and Seder, Robert A.

Subjects
T cells -- Physiological aspects, Antigens -- Physiological aspects, Vaccines -- Dosage and administration, Health care industry
Abstract

Recombinant adenoviral vectors (rAds) are lead vaccine candidates for protection against a variety of pathogens, including Ebola, HIV, tuberculosis, and malaria, due to their ability to potently induce T cell immunity in humans. However, the ability to induce protective cellular immunity varies among rAds. Here, we assessed the mechanisms that control the potency of CD8 T cell responses in murine models following vaccination with human-, chimpanzee-, and simian-derived rAds encoding SIV-Gag antigen (Ag). After rAd vaccination, we quantified Ag expression and performed expression profiling of innate immune response genes in the draining lymph node. Human-derived rAd5 and chimpanzee- derived chAd3 were the most potent rAds and induced high and persistent Ag expression with low innate gene activation, while less potent rAds induced less Ag expression and robustly induced innate immunity genes that were primarily associated with IFN signaling. Abrogation of type I IFN or stimulator of IFN genes (STING) signaling increased Ag expression and accelerated CD8 T cell response kinetics but did not alter memory responses or protection. These findings reveal that the magnitude of rAd-induced memory CD8 T cell immune responses correlates with Ag expression but is independent of IFN and STING and provide criteria for optimizing protective CD8 T cell immunity with rAd vaccines., Introduction CD8 T cells play a critical role in mediating protection to a variety of intracellular pathogens, including Ebola, HIV, tuberculosis, and malaria. Replication-defective recombinant adenoviral vectors (rAds) are promising [...]

Published
2015
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24. Clinical Assessment of a Recombinant Simian Adenovirus ChAd63: A Potent New Vaccine Vector

Author

O'Hara, Geraldine A., Duncan, Christopher J. A., Ewer, Katie J., Collins, Katharine A., Elias, Sean C., Halstead, Fenella D., Goodman, Anna L., Edwards, Nick J., Reyes-Sandoval, Arturo, Bird, Prudence, Rowland, Rosalind, Sheehy, Susanne H., Poulton, Ian D., Hutchings, Claire, Todryk, Stephen, Andrews, Laura, Folgori, Antonella, Berrie, Eleanor, Moyle, Sarah, Nicosia, Alfredo, Colloca, Stefano, Cortese, Riccardo, Siani, Loredana, Lawrie, Alison M., Gilbert, Sarah C., and Hill, Adrian V. S.

Published
2012
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27. Chimpanzee adenovirus vaccine generates acute and durable protective immunity against ebolavirus challenge

Author

Stanley, Daphne A., Honko, Anna N., Asiedu, Clement, Trefry, John C., Lau-Kilby, Annie W., Johnson, Joshua C., Hensley, Lisa, Ammendola, Virginia, Abbate, Adele, Grazioli, Fabiana, Foulds, Kathryn E., Cheng, Cheng, Wang, Lingshu, Donaldson, Mitzi M., Colloca, Stefano, Folgori, Antonella, Roederer, Mario, Nabel, Gary J., Mascola, John, Nicosia, Alfredo, Cortese, Riccardo, Koup, Richard A., and Sullivan, Nancy J.

Subjects
Viral vaccines -- Research -- Analysis -- Physiological aspects, Ebola virus -- Research -- Analysis, Biological sciences, Health
Abstract

Ebolavirus disease causes high mortality, and the current outbreak has spread unabated through West Africa. Human adenovirus type 5 vectors (rAd5) encoding ebolavirus glycoprotein (GP) generate protective immunity against acute lethal Zaire ebolavirus (EBOV) challenge in macaques, but fail to protect animals immune to Ad5, suggesting natural Ad5 exposure may limit vaccine efficacy in humans. Here we show that a chimpanzee-derived replication-defective adenovirus (ChAd) vaccine also rapidly induced uniform protection against acute lethal EBOV challenge in macaques. Because protection waned over several months, we boosted ChAd3 with modified vaccinia Ankara (MVA) and generated, for the first time, durable protection against lethal EBOV challenge., Human-derived rAd vectors have undergone extensive development in preclinical and human trials as vaccines for multiple pathogens (1-6). For ebolavirus, rAd vaccines that confer protection against acute EBOV challenge generate [...]

Published
2014
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28. Chronic hepatitis C viral infection subverts vaccine-induced T-cell immunity in humans

Author

Kelly, Christabel, Swadling, Leo, Capone, Stefania, Brown, Anthony, Richardson, Rachel, Halliday, John, von Delft, Annette, Oo, Ye, Mutimer, David, Kurioka, Ayako, Hartnell, Felicity, Collier, Jane, Ammendola, Virginia, Sorbo, Mariarosaria Del, Grazioli, Fabiana, Esposito, Maria Luisa, Marco, Stefania Di, Siani, Loredana, Traboni, Cinzia, Hill, Adrian V.S., Colloca, Stefano, Nicosia, Alfredo, Cortese, Riccardo, Folgori, Antonella, Klenerman, Paul, and Barnes, Eleanor

Published
2016
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30. A Monovalent Chimpanzee Adenovirus Ebola Vaccine Boosted with MVA

Author

Ewer, Katie, Rampling, Tommy, Venkatraman, Navin, Bowyer, Georgina, Wright, Danny, Lambe, Teresa, Imoukhuede, Egeruan B., Payne, Ruth, Fehling, Sarah Katharina, Strecker, Thomas, Biedenkopf, Nadine, Krähling, Verena, Tully, Claire M., Edwards, Nick J., Bentley, Emma M., Samuel, Dhanraj, Labbé, Geneviève, Jin, Jing, Gibani, Malick, Minhinnick, Alice, Wilkie, Morven, Poulton, Ian, Lella, Natalie, Roberts, Rachel, Hartnell, Felicity, Bliss, Carly, Sierra-Davidson, Kailan, Powlson, Jonathan, Berrie, Eleanor, Tedder, Richard, Roman, Francois, De Ryck, Iris, Nicosia, Alfredo, Sullivan, Nancy J., Stanley, Daphne A., Mbaya, Olivier T., Ledgerwood, Julie E., Schwartz, Richard M., Siani, Loredana, Colloca, Stefano, Folgori, Antonella, Di Marco, Stefania, Cortese, Riccardo, Wright, Edward, Becker, Stephan, Graham, Barney S., Koup, Richard A., Levine, Myron M., Volkmann, Ariane, Chaplin, Paul, Pollard, Andrew J., Draper, Simon J., Ballou, Ripley W., Lawrie, Alison, Gilbert, Sarah C., and Hill, Adrian V.S.

Published
2016
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32. Maximizing cancer therapy via complementary mechanisms of immune activation: PD-1 blockade, neoantigen vaccination, and Tregs depletion

Author

D'Alise, Anna Morena, primary, Leoni, Guido, additional, De Lucia, Maria, additional, Langone, Francesca, additional, Nocchi, Linda, additional, Tucci, Fabio Giovanni, additional, Micarelli, Elisa, additional, Cotugno, Gabriella, additional, Troise, Fulvia, additional, Garzia, Irene, additional, Vitale, Rosa, additional, Bignone, Veronica, additional, Di Matteo, Elena, additional, Bartolomeo, Rosa, additional, Charych, Deborah H, additional, Lahm, Armin, additional, Zalevsky, Jonathan, additional, Nicosia, Alfredo, additional, and Scarselli, Elisa, additional

Published
2021
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36. VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction

Author

Leoni, Guido, primary, D’Alise, Anna Morena, additional, Tucci, Fabio Giovanni, additional, Micarelli, Elisa, additional, Garzia, Irene, additional, De Lucia, Maria, additional, Langone, Francesca, additional, Nocchi, Linda, additional, Cotugno, Gabriella, additional, Bartolomeo, Rosa, additional, Romano, Giuseppina, additional, Allocca, Simona, additional, Troise, Fulvia, additional, Nicosia, Alfredo, additional, Lahm, Armin, additional, and Scarselli, Elisa, additional

Published
2021
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39. Successful anti-scavenger receptor class B type I (SR-BI) monoclonal antibody therapy in humanized mice after challenge with HCV variants with in vitro resistance to SR-BI-targeting agents

Author

Vercauteren, Koen, Van Den Eede, Naomi, Mesalam, Ahmed Atef, Belouzard, Sandrine, Catanese, Maria Teresa, Bankwitz, Dorothea, Wong-Staal, Flossie, Cortese, Riccardo, Dubuisson, Jean, Rice, Charles M., Pietschmann, Thomas, Leroux-Roels, Geert, Nicosia, Alfredo, and Meuleman, Philip

Published
2014
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40. Correction: A next generation vaccine against human rabies based on a single dose of a chimpanzee adenovirus vector serotype C

Author

Napolitano, Federico, primary, Merone, Rossella, additional, Abbate, Adele, additional, Ammendola, Virginia, additional, Horncastle, Emma, additional, Lanzaro, Francesca, additional, Esposito, Marialuisa, additional, Contino, Alessandra Maria, additional, Sbrocchi, Roberta, additional, Sommella, Andrea, additional, Duncan, Joshua D., additional, Hinds, Joseph, additional, Urbanowicz, Richard A., additional, Lahm, Armin, additional, Colloca, Stefano, additional, Folgori, Antonella, additional, Ball, Jonathan K., additional, Nicosia, Alfredo, additional, Wizel, Benjamin, additional, Capone, Stefania, additional, and Vitelli, Alessandra, additional

Published
2021
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42. A Genetic Vaccine Encoding Shared Cancer Neoantigens to Treat Tumors with Microsatellite Instability.

Author

UCL - SSS/DDUV/GECE - Génétique cellulaire, Leoni, Guido, D'Alise, Anna Morena, Cotugno, Gabriella, Langone, Francesca, Garzia, Irene, De Lucia, Maria, Fichera, Imma, Vitale, Rosa, Bignone, Veronica, Tucci, Fabio Giovanni, Mori, Federica, Leuzzi, Adriano, Di Matteo, Elena, Troise, Fulvia, Abbate, Adele, Merone, Rossella, Ruzza, Valentino, Diodoro, Maria Grazia, Yadav, Mahesh, Gordon-Alonso, Monica, Vanhaver, Christophe, Panigada, Maddalena, Soprana, Elisa, Siccardi, Antonio, Folgori, Antonella, Colloca, Stefano, Van Der Bruggen, Pierre, Nicosia, Alfredo, Lahm, Armin, Catanese, Maria Teresa, Scarselli, Elisa, UCL - SSS/DDUV/GECE - Génétique cellulaire, Leoni, Guido, D'Alise, Anna Morena, Cotugno, Gabriella, Langone, Francesca, Garzia, Irene, De Lucia, Maria, Fichera, Imma, Vitale, Rosa, Bignone, Veronica, Tucci, Fabio Giovanni, Mori, Federica, Leuzzi, Adriano, Di Matteo, Elena, Troise, Fulvia, Abbate, Adele, Merone, Rossella, Ruzza, Valentino, Diodoro, Maria Grazia, Yadav, Mahesh, Gordon-Alonso, Monica, Vanhaver, Christophe, Panigada, Maddalena, Soprana, Elisa, Siccardi, Antonio, Folgori, Antonella, Colloca, Stefano, Van Der Bruggen, Pierre, Nicosia, Alfredo, Lahm, Armin, Catanese, Maria Teresa, and Scarselli, Elisa

Abstract

Tumors with microsatellite instability (MSI) are caused by a defective DNA mismatch repair system that leads to the accumulation of mutations within microsatellite regions. Indels in microsatellites of coding genes can result in the synthesis of frameshift peptides (FSP). FSPs are tumor-specific neoantigens shared across patients with MSI. In this study, we developed a neoantigen-based vaccine for the treatment of MSI tumors. Genetic sequences from 320 MSI tumor biopsies and matched healthy tissues in The Cancer Genome Atlas database were analyzed to select shared FSPs. Two hundred nine FSPs were selected and cloned into nonhuman Great Ape Adenoviral and Modified Vaccinia Ankara vectors to generate a viral-vectored vaccine, referred to as Nous-209. Sequencing tumor biopsies of 20 independent patients with MSI colorectal cancer revealed that a median number of 31 FSPs out of the 209 encoded by the vaccine was detected both in DNA and mRNA extracted from each tumor biopsy. A relevant number of peptides encoded by the vaccine were predicted to bind patient HLA haplotypes. Vaccine immunogenicity was demonstrated in mice with potent and broad induction of FSP-specific CD8 and CD4 T-cell responses. Moreover, a vaccine-encoded FSP was processed by human antigen-presenting cells and was subsequently able to activate human CD8 T cells. Nous-209 is an "off-the-shelf" cancer vaccine encoding many neoantigens shared across sporadic and hereditary MSI tumors. These results indicate that Nous-209 can induce the optimal breadth of immune responses that might achieve clinical benefit to treat and prevent MSI tumors. SIGNIFICANCE: These findings demonstrate the feasibility of an "off-the-shelf" vaccine for treatment and prevention of tumors harboring frameshift mutations and neoantigenic peptides as a result of microsatellite instability.

Published
2020

43. MHC class II invariant chain-adjuvanted viral vectored vaccines enhances T cell responses in humans

Author

Esposito, Ilaria, Cicconi, Paola, D'Alise, Anna Morena, Brown, Anthony, Esposito, Marialuisa, Swadling, Leo, Holst, Peter Johannes, Bassi, Maria Rosaria, Stornaiuolo, Mariano, Mori, Federica, Vassilev, Ventzislav, Li, Wenqin, Donnison, Timothy, Gentile, Chiara, Turner, Bethany, von Delft, Annette, Del Sorbo, Mariarosaria, Barra, Federica, Contino, Alessandra Maria, Abbate, Adele, Novellino, Ettore, Thomsen, Allan Randrup, Christensen, Jan Pravsgaard, Lahm, Armin, Grazioli, Fabiana, Ammendola, Virginia, Siani, Loredana, Colloca, Stefano, Klenerman, Paul, Nicosia, Alfredo, Dorrell, Lucy, Folgori, Antonella, Capone, Stefania, Barnes, Eleanor, Esposito, Ilaria, Cicconi, Paola, D'Alise, Anna Morena, Brown, Anthony, Esposito, Marialuisa, Swadling, Leo, Holst, Peter Johannes, Bassi, Maria Rosaria, Stornaiuolo, Mariano, Mori, Federica, Vassilev, Ventzislav, Li, Wenqin, Donnison, Timothy, Gentile, Chiara, Turner, Bethany, von Delft, Annette, Del Sorbo, Mariarosaria, Barra, Federica, Contino, Alessandra Maria, Abbate, Adele, Novellino, Ettore, Thomsen, Allan Randrup, Christensen, Jan Pravsgaard, Lahm, Armin, Grazioli, Fabiana, Ammendola, Virginia, Siani, Loredana, Colloca, Stefano, Klenerman, Paul, Nicosia, Alfredo, Dorrell, Lucy, Folgori, Antonella, Capone, Stefania, and Barnes, Eleanor

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

44. Generation of a Novel Mesothelin-Targeted Oncolytic Herpes Virus and Implemented Strategies for Manufacturing

Author

Froechlich, Guendalina, primary, Gentile, Chiara, additional, Infante, Luigia, additional, Caiazza, Carmen, additional, Pagano, Pasqualina, additional, Scatigna, Sarah, additional, Cotugno, Gabriella, additional, D’Alise, Anna Morena, additional, Lahm, Armin, additional, Scarselli, Elisa, additional, Nicosia, Alfredo, additional, Mallardo, Massimo, additional, Sasso, Emanuele, additional, and Zambrano, Nicola, additional

Published
2021
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46. Retargeted and Multi-cytokine-Armed Herpes Virus Is a Potent Cancer Endovaccine for Local and Systemic Anti-tumor Treatment

Author

De Lucia, Maria, primary, Cotugno, Gabriella, additional, Bignone, Veronica, additional, Garzia, Irene, additional, Nocchi, Linda, additional, Langone, Francesca, additional, Petrovic, Biljana, additional, Sasso, Emanuele, additional, Pepe, Simona, additional, Froechlich, Guendalina, additional, Gentile, Chiara, additional, Zambrano, Nicola, additional, Campadelli-Fiume, Gabriella, additional, Nicosia, Alfredo, additional, Scarselli, Elisa, additional, and D’Alise, Anna Morena, additional

Published
2020
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