Reactogenicity and immunogenicity against MPXV of the intradermal administration of Modified V 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 Galli', 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
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Abstract

The recent resurgence of Mpox in central Africa has been declared again a 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 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. Here, we compare the two vaccine administration routes according to reactogenicity and immunogenicity based on data from 943 vaccine recipients during the 2022 vaccination campaign in Rome, Italy. We found that the intradermal route elicited slightly higher titers of MPXV-specific IgG and nAbs than the subcutaneous one. At the same time, no differences in cellular response were detected. MVA-BN was globally well tolerated despite higher reactogenicity for the intradermal than the subcutaneous route, especially for the reactions at the local injection site. The intradermal dose-sparing strategy was proven safe and immunogenic and would make vaccination available to more people.
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与标准皮下注射途径相比,皮内注射改良 V 型安卡拉疫苗对 MPXV 的致反应性和免疫原性。
最近,非洲中部再次出现麻风腮疫情,已再次被宣布为国际关注的公共卫生紧急事件(PHEIC),需要国际社会协调应对。接种疫苗是扩大保护范围和加强控制策略的当务之急,但疫苗的需求量超过了现有剂量。在 2022 年 "公共卫生突发事件"(PHEIC)期间,临时授权皮下注射五分之一的标准改良疫苗-安卡拉(MVA-BN)剂量。2022 年之前进行的研究提供了接种疫苗后针对 Vaccinia 病毒 (VACV) 的体液反应证据,但未提供针对 Mpox 病毒 (MPXV) 的体液反应证据。此外,目前还没有关于皮下或皮内注射 MVA-BN 所引起的 T 细胞反应的数据。在此,我们根据 2022 年意大利罗马疫苗接种活动中 943 名疫苗接种者的数据,根据反应原性和免疫原性对两种疫苗接种途径进行了比较。我们发现,皮内接种途径引起的 MPXV 特异性 IgG 和 nAbs 滴度略高于皮下接种途径。同时,在细胞反应方面没有发现差异。尽管皮内途径的致反应性比皮下途径高,尤其是局部注射部位的反应,但MVA-BN的耐受性总体良好。事实证明,皮内节省剂量的策略既安全又有免疫原性,可以让更多的人接种疫苗。
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