Rabies Virus Neutralizing Activity, Safety, and Immunogenicity of Recombinant Human Rabies Antibody Compared with Human Rabies Immunoglobulin in Healthy Adults.
- Author:
Jun Nan ZHANG
1
;
Ya Juan MENG
2
;
Yun Hua BAI
1
;
Yu Feng LI
2
;
Li Qing YANG
1
;
Nian Min SHI
3
;
Hui Xia HAN
4
;
Jian GAO
2
;
Li Juan ZHU
4
;
Shu Ping LI
1
;
Jing ZHANG
2
;
Qin Hua ZHAO
2
;
Xiu Qin WANG
2
;
Jing Shuang WEI
2
;
Le Min REN
2
;
Chen Hua CAO
2
;
Chen CHEN
2
;
Wei ZHAO
2
;
Li LI
1
Author Information
- Publication Type:Randomized Controlled Trial
- Keywords: Human rabies immunoglobulin; Immunogenicity; NM57; Rabies virus neutralizing activity; Recombinant human rabies antibody; Safety
- MeSH: Adult; Antibodies, Neutralizing; Antibodies, Viral; Data Collection; Humans; Rabies/prevention & control*; Rabies Vaccines/adverse effects*; Rabies virus/genetics*
- From: Biomedical and Environmental Sciences 2022;35(9):782-791
- CountryChina
- Language:English
-
Abstract:
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.
