典型文献
Rabies Virus Neutralizing Activity, Safety, and Immunogenicity of Recombinant Human Rabies Antibody Compared with Human Rabies Immunoglobulin in Healthy Adults
文献摘要：
Objective Preliminary assessment of rabies virus neutralizing activity, safety and immunogenicity of a recombinant human rabies antibody (NM57) compared with human rabies immunoglobulin (HRIG) in Chinese healthy adults.Methods Subjects were randomly (1:1:1) allocated to Groups A (20 IU/kg NM57), B (40 IU/kg NM57), or C (20 IU/kg HRIG). One injection was given on the day of enrollment. Blood samples were collected on days ?7 to 0 (pre-injection), 3, 7, 14, 28, and 42. Adverse events (AEs) and serious AEs (SAEs) were recorded over a period of 42 days after injection. Results All 60 subjects developed detectable rabies virus neutralizing antibodies (RVNAs) (>0.05 IU/mL) on days 3, 7, 14, 28, and 42. The RVNA levels peaked on day 3 in all three groups, with a geometric mean concentration (GMC) of 0.2139 IU/mL in Group A, 0.3660 IU/mL in Group B, and 0.1994 IU/mL in Group C. At each follow-up point, the GMC in Group B was significantly higher than that in Groups A and C. The areas under the antibody concentration curve over 0–14 days and 0–42 days in Group B were significantly larger than those in Groups A and C. Fifteen AEs were reported. Except for one grade 2 myalgia in Group C, the other 14 were all grade 1. No SAEs were observed. Conclusion The rabies virus neutralizing activity of 40 IU/kg NM57 was superior to that of 20 IU/kg NM57 and 20 IU/kg HRIG, and the rabies virus neutralizing activity of 20 IU/kg NM57 and 20 IU/kg HRIG were similar. Safety was comparable between NM57 and HRIG.
文献关键词：
中图分类号：
作者姓名：
ZHANG Jun Nan;MENG Ya Juan;BAI Yun Hua;LI Yu Feng;YANG Li Qing;SHI Nian Min;HAN Hui Xia;GAO Jian;ZHU Li Juan;LI Shu Ping;ZHANG Jing;ZHAO Qin Hua;WANG Xiu Qin;WEI Jing Shuang;REN Le Min;CAO Chen Hua;CHEN Chen;ZHAO Wei;LI Li
作者机构：
Center for Disease Control and Prevention of Chaoyang District,Beijing 100021,China;NCPC New Drug Research and Development Co.,Ltd.,State Key Laboratory of Antibody Research&Development,Shijiazhuang 050015,Hebei,China;Beijing Institute of Biological Products,Beijing 100021,China;Xiaohongmen Community Healthcare Center,Beijing 100023,China
文献出处：
引用格式：
[1]ZHANG Jun Nan;MENG Ya Juan;BAI Yun Hua;LI Yu Feng;YANG Li Qing;SHI Nian Min;HAN Hui Xia;GAO Jian;ZHU Li Juan;LI Shu Ping;ZHANG Jing;ZHAO Qin Hua;WANG Xiu Qin;WEI Jing Shuang;REN Le Min;CAO Chen Hua;CHEN Chen;ZHAO Wei;LI Li-.Rabies Virus Neutralizing Activity, Safety, and Immunogenicity of Recombinant Human Rabies Antibody Compared with Human Rabies Immunoglobulin in Healthy Adults)[J].生物医学与环境科学（英文版）,2022(09):782-791
A类：
NM57,HRIG,RVNAs,RVNA
B类：
Rabies,Virus,Neutralizing,Activity,Safety,Immunogenicity,Recombinant,Human,Antibody,Compared,Immunoglobulin,Healthy,Adults,Objective,Preliminary,assessment,rabies,virus,neutralizing,activity,safety,immunogenicity,recombinant,human,antibody,compared,immunoglobulin,Chinese,healthy,adults,Methods,Subjects,were,randomly,allocated,Groups,IU,One,injection,was,given,enrollment,Blood,samples,collected,days,pre,Adverse,events,serious,SAEs,recorded,over,period,after,Results,All,subjects,developed,detectable,antibodies,levels,peaked,three,groups,geometric,mean,concentration,GMC,At,each,follow,point,significantly,higher,than,that,areas,under,curve,larger,those,Fifteen,reported,Except,one,grade,myalgia,other,No,observed,Conclusion,superior,similar,comparable,between
AB值：
0.443159
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