Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route
Background: The recent resurgence of mpox in central Africa has been declared a new public health emergency of international concern (PHEIC) requiring coordinated international responses. Vaccination is a priority to expand protection and enhance control strategies, but the vaccine’s need exceeds th...
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2024-12-01
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| author | Valentina Mazzotta Pierluca Piselli Alessandro Cozzi Lepri Giulia Matusali Eleonora Cimini Rozenn Esvan Francesca Colavita Roberta Gagliardini Stefania Notari Alessandra Oliva Silvia Meschi Rita Casetti Giulia Micheli Licia Bordi Alessandro Giacinta Germana Grassi Saba Gebremeskel Tekle Claudia Cimaglia Jessica Paulicelli Alessandro Caioli Paola Gallì Giulia Del Duca Miriam Lichtner Loredana Sarmati Enrica Tamburrini Claudio Mastroianni Alessandra Latini Paolo Faccendini Carla Fontana Emanuele Nicastri Andrea Siddu Alessandra Barca Francesco Vaia Enrico Girardi Fabrizio Maggi Andrea Antinori |
| author_facet | Valentina Mazzotta Pierluca Piselli Alessandro Cozzi Lepri Giulia Matusali Eleonora Cimini Rozenn Esvan Francesca Colavita Roberta Gagliardini Stefania Notari Alessandra Oliva Silvia Meschi Rita Casetti Giulia Micheli Licia Bordi Alessandro Giacinta Germana Grassi Saba Gebremeskel Tekle Claudia Cimaglia Jessica Paulicelli Alessandro Caioli Paola Gallì Giulia Del Duca Miriam Lichtner Loredana Sarmati Enrica Tamburrini Claudio Mastroianni Alessandra Latini Paolo Faccendini Carla Fontana Emanuele Nicastri Andrea Siddu Alessandra Barca Francesco Vaia Enrico Girardi Fabrizio Maggi Andrea Antinori |
| author_sort | Valentina Mazzotta |
| collection | DOAJ |
| description | Background: The recent resurgence of mpox in central Africa has been declared a new public health emergency of international concern (PHEIC) requiring coordinated international responses. Vaccination is a priority to expand protection and enhance control strategies, but the vaccine’s need exceeds the currently available doses. Intradermal (ID) administration of one-fifth of the standard modified vaccinia Ankara (MVA-BN) dose was temporarily authorized during the 2022 PHEIC. Studies conducted before 2022 provided evidence about the humoral response against the vaccinia virus (VACV) after vaccination but not against the mpox virus (MPXV). Moreover, no data are available on the T-cell response elicited by MVA-BN administered subcutaneously or intradermally. Methods: We compare the two vaccine administration routes according to reactogenicity (<i>n</i> = 943) and immunogenicity (<i>n</i> = 225) of vaccine recipients attending INMI Spallanzani hospital during the 2022 vaccination campaign in Rome, Italy. Results: We found that the ID route elicited higher titers of MPXV-specific IgG (mean difference of 0.26 log<sub>2</sub>, <i>p</i> = 0.05) and nAbs (0.24 log<sub>2</sub>, <i>p</i> = 0.08) than the subcutaneous (SC) route one month after the complete vaccination cycle. At the same time, no evidence for a difference in cellular response was found. Conclusions: MVA-BN was globally well tolerated despite higher reactogenicity for the ID than the SC route, especially for the reactions at the local injection site. The ID dose-sparing strategy was proven safe and immunogenic and would make vaccination available to more people. Our data support the current WHO recommendation of using the ID route in low–medium-income countries (LMIC), although response data in people infected with the new 1b clade are urgently needed. |
| format | Article |
| id | doaj-art-f265c34bca5540369819edb256c27ff5 |
| institution | Kabale University |
| issn | 2076-393X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-f265c34bca5540369819edb256c27ff52025-01-24T13:51:43ZengMDPI AGVaccines2076-393X2024-12-011313210.3390/vaccines13010032Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous RouteValentina Mazzotta0Pierluca Piselli1Alessandro Cozzi Lepri2Giulia Matusali3Eleonora Cimini4Rozenn Esvan5Francesca Colavita6Roberta Gagliardini7Stefania Notari8Alessandra Oliva9Silvia Meschi10Rita Casetti11Giulia Micheli12Licia Bordi13Alessandro Giacinta14Germana Grassi15Saba Gebremeskel Tekle16Claudia Cimaglia17Jessica Paulicelli18Alessandro Caioli19Paola Gallì20Giulia Del Duca21Miriam Lichtner22Loredana Sarmati23Enrica Tamburrini24Claudio Mastroianni25Alessandra Latini26Paolo Faccendini27Carla Fontana28Emanuele Nicastri29Andrea Siddu30Alessandra Barca31Francesco Vaia32Enrico Girardi33Fabrizio Maggi34Andrea Antinori35Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Epidemiology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyCentre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, University College London (UCL), London NW3 2PF, UKLaboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyCellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyLaboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyCellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyLaboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyCellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyLaboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyCellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Epidemiology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Epidemiology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyHealth Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyInfectious Diseases Unit, NESMOS Department, Santa Maria Goretti Hospital of Latina, Sapienza University of Rome, 04100 Latina, ItalyInfectious Diseases Unit, Tor Vergata University Hospital, 00133 Rome, ItalyDepartment of Safety and Bioethics, Catholic University of the Sacred Heart, 00136 Rome, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, ItalySTI/HIV Unit, San Gallicano Dermatological Institute IRCCS, 00144 Rome, ItalyPharmacy Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyLaboratory of Microbiology and Biological Bank Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyGeneral Directorate of Prevention, Ministry of Health, 00144 Rome, ItalyUnit of Health Promotion and Prevention, Directorate of Health and Integration, Lazio Region, 00145 Rome, ItalyGeneral Directorate of Prevention, Ministry of Health, 00144 Rome, ItalyScientific Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyLaboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyClinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, ItalyBackground: The recent resurgence of mpox in central Africa has been declared a new public health emergency of international concern (PHEIC) requiring coordinated international responses. Vaccination is a priority to expand protection and enhance control strategies, but the vaccine’s need exceeds the currently available doses. Intradermal (ID) administration of one-fifth of the standard modified vaccinia Ankara (MVA-BN) dose was temporarily authorized during the 2022 PHEIC. Studies conducted before 2022 provided evidence about the humoral response against the vaccinia virus (VACV) after vaccination but not against the mpox virus (MPXV). Moreover, no data are available on the T-cell response elicited by MVA-BN administered subcutaneously or intradermally. Methods: We compare the two vaccine administration routes according to reactogenicity (<i>n</i> = 943) and immunogenicity (<i>n</i> = 225) of vaccine recipients attending INMI Spallanzani hospital during the 2022 vaccination campaign in Rome, Italy. Results: We found that the ID route elicited higher titers of MPXV-specific IgG (mean difference of 0.26 log<sub>2</sub>, <i>p</i> = 0.05) and nAbs (0.24 log<sub>2</sub>, <i>p</i> = 0.08) than the subcutaneous (SC) route one month after the complete vaccination cycle. At the same time, no evidence for a difference in cellular response was found. Conclusions: MVA-BN was globally well tolerated despite higher reactogenicity for the ID than the SC route, especially for the reactions at the local injection site. The ID dose-sparing strategy was proven safe and immunogenic and would make vaccination available to more people. Our data support the current WHO recommendation of using the ID route in low–medium-income countries (LMIC), although response data in people infected with the new 1b clade are urgently needed.https://www.mdpi.com/2076-393X/13/1/32mpoximmunogenicityreactogenicitycellular responsehumoral responsevaccine |
| spellingShingle | Valentina Mazzotta Pierluca Piselli Alessandro Cozzi Lepri Giulia Matusali Eleonora Cimini Rozenn Esvan Francesca Colavita Roberta Gagliardini Stefania Notari Alessandra Oliva Silvia Meschi Rita Casetti Giulia Micheli Licia Bordi Alessandro Giacinta Germana Grassi Saba Gebremeskel Tekle Claudia Cimaglia Jessica Paulicelli Alessandro Caioli Paola Gallì Giulia Del Duca Miriam Lichtner Loredana Sarmati Enrica Tamburrini Claudio Mastroianni Alessandra Latini Paolo Faccendini Carla Fontana Emanuele Nicastri Andrea Siddu Alessandra Barca Francesco Vaia Enrico Girardi Fabrizio Maggi Andrea Antinori Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route Vaccines mpox immunogenicity reactogenicity cellular response humoral response vaccine |
| title | Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route |
| title_full | Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route |
| title_fullStr | Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route |
| title_full_unstemmed | Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route |
| title_short | Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route |
| title_sort | reactogenicity and immunogenicity against mpxv of the intradermal administration of modified vaccinia ankara compared to the standard subcutaneous route |
| topic | mpox immunogenicity reactogenicity cellular response humoral response vaccine |
| url | https://www.mdpi.com/2076-393X/13/1/32 |
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