Vaccines (Dec 2024)
Reactogenicity and Immunogenicity Against MPXV of the Intradermal Administration of Modified Vaccinia Ankara Compared to the Standard Subcutaneous Route
- 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
Affiliations
- Valentina Mazzotta
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Pierluca Piselli
- Clinical Epidemiology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Alessandro Cozzi Lepri
- Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, University College London (UCL), London NW3 2PF, UK
- Giulia Matusali
- Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Eleonora Cimini
- Cellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Rozenn Esvan
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Francesca Colavita
- Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Roberta Gagliardini
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Stefania Notari
- Cellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Alessandra Oliva
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Silvia Meschi
- Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Rita Casetti
- Cellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Giulia Micheli
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Licia Bordi
- Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Alessandro Giacinta
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Germana Grassi
- Cellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Saba Gebremeskel Tekle
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Claudia Cimaglia
- Clinical Epidemiology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Jessica Paulicelli
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Alessandro Caioli
- Clinical Epidemiology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Paola Gallì
- Health Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Giulia Del Duca
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Miriam Lichtner
- Infectious Diseases Unit, NESMOS Department, Santa Maria Goretti Hospital of Latina, Sapienza University of Rome, 04100 Latina, Italy
- Loredana Sarmati
- Infectious Diseases Unit, Tor Vergata University Hospital, 00133 Rome, Italy
- Enrica Tamburrini
- Department of Safety and Bioethics, Catholic University of the Sacred Heart, 00136 Rome, Italy
- Claudio Mastroianni
- Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, Italy
- Alessandra Latini
- STI/HIV Unit, San Gallicano Dermatological Institute IRCCS, 00144 Rome, Italy
- Paolo Faccendini
- Pharmacy Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Carla Fontana
- Laboratory of Microbiology and Biological Bank Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Emanuele Nicastri
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Andrea Siddu
- General Directorate of Prevention, Ministry of Health, 00144 Rome, Italy
- Alessandra Barca
- Unit of Health Promotion and Prevention, Directorate of Health and Integration, Lazio Region, 00145 Rome, Italy
- Francesco Vaia
- General Directorate of Prevention, Ministry of Health, 00144 Rome, Italy
- Enrico Girardi
- Scientific Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Fabrizio Maggi
- Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- Andrea Antinori
- Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy
- DOI
- https://doi.org/10.3390/vaccines13010032
- Journal volume & issue
-
Vol. 13,
no. 1
p. 32
Abstract
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 (n = 943) and immunogenicity (n = 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 log2, p = 0.05) and nAbs (0.24 log2, p = 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.
Keywords
