Safety,immunogenicity,and preliminary efficacy of a randomized clinical trial ofomicron XBB.1.5-containing bivalent mRNA vaccine  

作　　者：Xuanjing Yu Wei Yang Wei Li Na Wan Guanghong Yan Zumi Zhou Xiao Zhu Wei Su Yani Li Chenyu Xing Sifan Duan Houze Yu Xinshuai Zhao Chunmei Li Taicheng Zhou Dingyun You Jia Wei Zijie Zhang 

机构地区：[1]State Key Laboratory for Conservation and Utilization of Bio-Resource and School of Life Sciences,Yunnan University,Yunnan,China [2]Southwest United Graduate School,Yunnan,China [3]State Key Laboratory of Genetic Engineering,School of Life Sciences,Zhongshan Hospital,Fudan University,Shanghai,China [4]Yunnan Vaccine Laboratory,Yunnan,China [5]School of Public Health,Kunming Medical University,Yunnan,China [6]Yunnan Genvoo Biotech Ltd.,Yunnan,China [7]Central Lab and Liver Disease Research Center,The Affiliated Hospital of Yunnan University,Yunnan University,Yunnan,China

出　　处：《hLife》2024年第3期113-125,共13页健康科学（英文）

基　　金：supported by a grant(2023YFC2307600,to Z.J.Z.)from the Na-tional Key Research and Development Program of China;a grant(202102AA100051,to Z.J.Z.)from the Yunnan Provincial Sci-ence and Technology Department,China;a grant(H-2018102,to J.W.)from the High-level Health Technical Personnel Project of Yunnan Province,China;a grant(2022SCP001,to Z.J.Z.)from the Spring City Plan:The High-level Talent Promotion and Training Project of Kunming;and a grant(32371000,to C.M.L.)from the National Natural Science Foundation of China.

摘　　要：Periodically updating coronavirus disease 19(COVID-19)vaccines that offer broad-spectrum protection is needed giventhe strong immune evasion by the circulating omicron sublineages.The effectiveness of prototype and BA.4/5-containing bivalent mRNA vaccines is reduced when XBB subvariants predominate.We initiated an observer-blinded,threearms study in 376 patients in Chinese individuals aged from 18 to 55 years old who had previously received three dosesCOVID-19 vaccine.Immunogenicity in terms of neutralizing antibodies elicited by a 30-mg dose of XBB.1.5-containingbivalent vaccine(RQ3027),a 30-mg dose of BA.2/BA.5-Alpha/Beta bivalent vaccine(RQ3025)and their precedent 30-mg Alpha/Beta(combined mutations)monovalent mRNA vaccine(RQ3013)and safety are primary and secondary endpoints,respectively.We recorded prescribed COVID-19 cases to explore the preliminary efficacy of three vaccines.RQ3027 and RQ3025 boosters elicited superior neutralizing antibodies(NAbs)against XBB.1.5,XBB.1.16,XBB.1.9.1,and JN.1 compared to RQ3013 at day 14 in participants without SARS-CoV-2 infection.All study vaccines were welltolerated without serious adverse reactions identified.The incidence rates per 1000 person-years of COVID-19 casesduring the 2nd-19th week after randomization were lowest in RQ3027.Overall,our data show that XBB.1.5-containingbivalent booster generated superior immunogenicity and better protection against newer severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)variants compared to BA.2/BA.5-containing bivalent and Alpha/Beta monovalentwith no new safety concerns.

关 键 词：severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) JN.1 XBB lineages coronavirus disease19(COVID-19)vaccine mRNA bivalent vaccine randomized clinical trial 

分 类 号：R186[医药卫生—流行病学]