Immunogenicity and safety of a recombinant fusion protein vaccine(V-01)against coronavirus disease 2019 in healthy adults:a randomized,double-blind,placebo-controlled,phaseⅡtrial  

作　　者：Ya-Jun Shu Jian-Feng He Rong-Juan Pei Peng He Zhu-Hang Huang Shao-Min Chen Zhi-Qiang Ou Jing-Long Deng Pei-Yu Zeng Jian Zhou Yuan-Qin Min Fei Deng Hua Peng Zheng Zhang Bo Wang Zhong-Hui Xu Wu-Xiang Guan Zhong-Yu Hu Ji-Kai Zhang 

机构地区：[1]Guangdong Provincial Institute of Biological Products and Materia Medica,Guangzhou,Guangdong 510440,China [2]Guangdong Provincial Center for Disease Control and Prevention,Guangzhou,Guangdong 511430,China [3]Wuhan Institute of Virology,Chinese Academy of Sciences,Wuhan,Hubei 430071,China [4]National Institutes for Food and Drug Control,Beijing 100050,China [5]Gaozhou Center for Disease Control and Prevention,Maoming,Guangdong 525000,China [6]Livzon Bio Inc.,Zhuhai,Guangdong 519045,China [7]Key Laboratory of Infection and Immunity,Institute of Biophysics,Chinese Academy of Sciences,Beijing 100101,China [8]Institute for Hepatology,National Clinical Research Center for Infectious Disease,Shenzhen Third People’s Hospital,Shenzhen,Guangdong 518112,China.

出　　处：《Chinese Medical Journal》2021年第16期1967-1976,共10页中华医学杂志（英文版）

基　　金：the Emergency Key Program of Guangzhou Laboratory(No.EKPG21-21)。

摘　　要：Background:Innovative coronavirus disease 2019(COVID-19)vaccines,with elevated global manufacturing capacity,enhanced safety and efficacy,simplified dosing regimens,and distribution that is less cold chain-dependent,are still global imperatives for tackling the ongoing pandemic.A previous phase I trial indicated that the recombinant COVID-19 vaccine(V-01),which contains a fusion protein(IFN-PADRE-RBD-Fc dimer)as its antigen,is safe and well tolerated,capable of inducing rapid and robust immune responses,and warranted further testing in additional clinical trials.Herein,we aimed to assess the immunogenicity and safety of V-01,providing rationales of appropriate dose regimen for further efficacy study.Methods:A randomized,double-blind,placebo-controlled phaseⅡclinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention(Guangdong,China)in March 2021.Both younger(n=440;18–59 years of age)and older(n=440;≥60 years of age)adult participants in this trial were sequentially recruited into two distinct groups:two-dose regimen group in which participants were randomized either to follow a 10 or 25 mg of V-01 or placebo given intramuscularly 21 days apart(allocation ratio,3:3:1,n=120,120,40 for each regimen,respectively),or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 mg of V-01 or placebo(allocation ratio,3:1,n=120,40,respectively).The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2,and specific binding antibodies to the receptor binding domain(RBD).The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events(AEs)within 30 days after full immunization.Results:V-01 provoked substantial immune responses in the two-dose group,achieving encouragingly high titers of neutralizing antibody and anti-RBDimmunoglobulin,which peaked at day 35(161.9[95%confidence interval[CI]:133.3–196.7]and

关 键 词：COVID-19 PhaseⅡ Clinical trial Recombinant fusion protein vaccine SAFETY IMMUNOGENICITY 

分 类 号：R392-33[医药卫生—免疫学]