18~59岁健康人群接种重组新型冠状病毒蛋白疫苗(CHO细胞)后的血清抗体分析  

Serum antibodies of healthy people aged 18-59 years after inoculation with recombinant novel coronavirus protein vaccine(CHO cells)

作　　者：赵俊仕[1] 滕笑雪 黄涛[1] 杨世龙 周敏 李放军[1] 张尚孝 夏伟[1] 鄢廷栋 高立冬[1] ZHAO Junshi;TENG Xiaoxue;HUANG Tao;YANG Shilong;ZHOU Min;LI Fangjun;ZHANG Shangxiao;XIA Wei;YAN Tingdong;GAO Lidong(Hunan Provincial Center for Disease Control and Prevention,Changsha,Hunan 410153,China;Anhui Zhifei Longcom Biopharmaceutical Co.Ltd.,Hefei,Anhui 230088,China;Xiangtan County Center for Disease Control and Prevention,Xiangtan,Hunan 411228,China)

机构地区：[1]湖南省疾病预防控制中心,湖南长沙410153 [2]安徽智飞龙科马生物制药有限公司,安徽合肥230088 [3]湘潭县疾病预防控制中心,湖南湘潭411228

出　　处：《实用预防医学》2024年第9期1025-1029,共5页Practical Preventive Medicine

基　　金：湖南省自然科学基金项目(2021JJ70011)。

摘　　要：目的评价不同剂量、不同免疫程序的重组新型冠状病毒蛋白疫苗(CHO细胞)(ZF2001)在18~59岁健康人群中的免疫原性和持久性。方法本研究为Ⅱ期临床试验,采用随机、盲法、安慰剂对照的研究设计,纳入900例18~59岁健康人群,按1∶1∶1∶1∶1∶1比例随机分配至低剂量2剂组、高剂量2剂组、安慰剂2剂组、低剂量3剂组、高剂量3剂组、安慰剂3剂组,接种ZF2001或安慰剂。采集所有研究对象不同时间节点血样进行新冠病毒原型株中和抗体、受体结合区域(receptor binding domain,RBD)蛋白结合抗体检测。结果低剂量2剂组、高剂量2剂组、安慰剂2剂组全程接种后14 d和6个月中和抗体几何平均滴度(geometric mean titer,GMT)分别为17.7、14.1、2.0和3.6、3.7、2.0;RBD蛋白结合抗体GMT分别为439.82、338.04、5.98和63.62、50.42、5.67。低剂量3剂组、高剂量3剂组、安慰剂3剂组全程接种后14 d、6和12个月中和抗体GMT分别为97.3、68.4、2.0及19.3、16.7、2.0和7.4、7.3、2.0;全程接种后14 d、6个月RBD蛋白结合抗体GMT分别为1745.67、1107.36、5.84和281.31、212.41、5.80。结论ZF2001在健康人群中可诱导较高的中和抗体及RBD蛋白结合抗体滴度,接种3剂次的免疫持久性优于2剂次,接种低剂量的免疫原性和免疫持久性优于高剂量,全程接种后6个月中和抗体呈现下降趋势。建议使用低剂量3剂接种程序,且在全程接种后6个月考虑加强接种。Objective To evaluate the immunogenicity and immune persistence of recombinant novel coronavirus protein vaccine(CHO cells),ZF2001,at different doses and immunization procedures in healthy people aged 18-59 years.Methods We conducted a randomized,blind,placebo-controlled and phase II clinical trial.A total of 900 healthy participants aged 18-59 years were randomly assigned to two-doses of low-dose group,two-doses of high-dose group,two-doses of placebo group,three-doses of low-dose group,three-doses of high-dose group,and three-doses of placebo group at a ratio of 1:1:1:1:1:1 and received ZF2001 or placebo.All the participants’blood samples were collected for SARS-CoV-2 neutralizing and receptor binding domain(RBD)protein-binding antibodies detection before vaccination,14 days,six months,and 12 months after full vaccination.Results The geometric mean titers(GMTs)of neutralizing antibodies of two-doses of low-dose group,two-doses of high-dose group,two-doses of placebo group at 14 days after full vaccination were 17.7,14.1 and 2.0 respectively,and those at 6 months after full vaccination were 3.6,3.7 and 2.0 respectively.The GMTs of RBD protein-binding antibodies of the above-mentioned three groups at 14 days after full vaccination were 439.82,338.04 and 5.98 respectively,and those at 6 months after full vaccination were 63.62,50.42,and 5.67 respectively.The GMTs of neutralizing antibodies of three-doses of low-dose group,three-doses of high-dose group,and three-doses of placebo group at 14 days after full vaccination were 97.3,68.4 and 2.0 respectively,those at 6 months after full vaccination were 19.3,16.7 and 2.0 respectively,and those at 12 months after full vaccination were 7.4,7.3 and 2.0 respectively.The GMTs of RBD protein-binding antibodies of the above-mentioned three groups at 14 days after full vaccination were 1,745.67,1,107.36 and 5.84 respectively,and those at 6 months after full vaccination were 281.31,212.41 and 5.80 respectively.Conclusion ZF2001 can induce high levels of neutralizing and RBD p

关 键 词：新型冠状病毒 疫苗 中和抗体 免疫原性 免疫持久性 

分 类 号：R563.1[医药卫生—呼吸系统] R446.6[医药卫生—内科学]