Rabies Virus Neutralizing Activity, Safety, and Immunogenicity of Recombinant Human Rabies Antibody Compared with Human Rabies Immunoglobulin in Healthy Adults

• Published in: Biomedical and environmental sciences Vol. 35; no. 9; pp. 782 - 791
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 20.09.2022; 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
• Subjects: Human rabies immunoglobulin; Immunogenicity; NM57; Rabies virus neutralizing activity; Recombinant human rabies antibody; Safety; Recombinant human rabies antibody; Human rabies immunoglobulin; Safety; Rabies virus neutralizing activity; Immunogenicity; NM57
• DOI: 10.3967/bes2022.103
• ISSN: 0895-3988; 2214-0190

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. 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. 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. 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.