Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine

作     者：Chalkias, Spyros Pragalos, Antionette Akinsola, Adebayo Berman, Gary Ampajwala, Madhavi Meyer, Jay Schoch, Lorraine Zhou, Wen Paila, Yamuna D. Deng, Weiping Feng, Jing de Windt, Elizabeth Edwards, Darin Miller, Jacqueline Das, Rituparna 

作者机构：Moderna Inc Infect Dis Dev 325 Binney St Cambridge MA 02142 USA CTI Clin Trial & Consulting Serv Covington KY USA Tekton Res Atlanta GA USA Clin Res Inst Inc Minneapolis MN USA Univ N Texas Plano TX USA Veloc Clin Res Lincoln NE USA Moderna Inc Clin Operat Infect Dis Cambridge MA USA Moderna Inc Biostat Cambridge MA USA Moderna Inc Clin Biomarkers Infect Dis Cambridge MA USA Moderna Inc Clin Safety Cambridge MA USA Moderna Inc Infect Dis Cambridge MA USA Moderna Inc Res & Dev Infect Dis 325 Binney St Cambridge MA 02142 USA 

出 版 物：《JOURNAL OF INFECTIOUS DISEASES》 (J. Infect. Dis.)

年 卷 期：2025年第231卷第4期

页      面：e754-e763页

核心收录：

学科分类：0710[理学-生物学] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：Moderna  Inc 

主　　题：COVID-19 SARS-CoV-2 mRNA vaccines mRNA-1283 mRNA-1273 booster vaccination clinical study 

摘      要：Background mRNA-1283 is an investigational coronavirus disease 2019 (COVID-19) mRNA vaccine encoding the receptor-binding and N-terminal domains of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in contrast to the original mRNA-1273 vaccine, which encodes the full-length spike *** A phase 2a, dose-ranging, observer-blind, randomized study conducted in adults (aged = 18 years) previously vaccinated with mRNA-1273 evaluated the safety and immunogenicity of a single dose of mRNA-1283 (2.5, 5, and 10 mu g) and its bivalent formulation, mRNA-1283.211 (5 and 10 mu g;encoding original SARS-CoV-2 and Beta) against the comparator mRNA-1273 vaccine, 50 mu g (part A). A subsequent, open-label study (part B) evaluated the safety and immunogenicity of a monovalent Omicron BA.1 vaccine, mRNA-1283.529 (5 and 10 mu g).Results A total of 340 participants were randomized in part A, and 200 participants were enrolled in part B. All dose levels of mRNA-1283 vaccines were well tolerated and increased the neutralizing antibody (nAb) responses at day 29 compared to baseline against SARS-CoV-2 D614G and Beta. The nAb responses elicited by mRNA-1283 were higher than those elicited by mRNA-1273. mRNA-1283.529 (part B) increased nAb at day 29 against Omicron BA.1. Antibody responses remained detectable for a year *** mRNA-1283 was well tolerated and exhibited improved immunogenicity compared to *** Trials Registration NCT05137236. The mRNA-1283 vaccine encoding the RBD and NTD of the SARS-CoV-2 spike protein was well tolerated and had improved immunogenicity compared with mRNA-1273, regardless of the vaccine valency (monovalent, bivalent) or the variant sequence tested (SARS-CoV-2 D614G, Beta, Omicron BA.1).