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This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG(20 IU/kg)only, rhRIG(40 IU/kg)only,HRIG(20 IU/kg)only, rhRIG(20 IU/kg)in combination with rabies vaccine for human use, rhRIG(40 IU/kg)in combination with rabies vaccine for human use,HRIG(20 IU/kg)in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhRIG(20 IU/kg)only | Experimental | Subjects received rhRIG(20 IU/kg) on day 0 |
|
| rhRIG(40 IU/kg)only | Experimental | Subjects received rhRIG(40 IU/kg) on day 0 |
|
| HRIG(20 IU/kg)only | Active Comparator | Subjects received HRIG(20 IU/kg)on day 0 |
|
| rhRIG(20 IU/kg)+ vaccine | Experimental | Subjects received rhRIG(20 IU/kg)in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
|
| rhRIG(40 IU/kg)+ vaccine | Experimental | Subjects received rhRIG(40 IU/kg)in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
|
| HRIG(20 IU/kg)+ vaccine | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhRIG(20 IU/kg) | Biological |
| ||
| rhRIG(40 IU/kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36123259 | Derived | Li L, Li Y, Bai Y, Li G, Zhang J, Yang L, Zhao W, Zhao W, Luo F, Zhao Q, Zhang Z, Liu Y, Li S, Lu Q, Wang H, Zhang J, Zhang Y, Gao J, Shi N. Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase Ⅱb randomized, double-blind, parallel-controlled study. Vaccine. 2022 Oct 6;40(42):6153-6162. doi: 10.1016/j.vaccine.2022.09.022. Epub 2022 Sep 16. | |
| 36016106 |
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Subjects received HRIG(20 IU/kg)in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
|
| placebo + vaccine | Placebo Comparator | Subjects received placebo in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28 |
|
|
| HRIG(20 IU/kg) | Biological |
|
| rhRIG(20 IU/kg) and vaccine | Biological |
|
| rhRIG(40 IU/kg) and vaccine | Biological |
|
| HRIG(20 IU/kg) and vaccine | Biological |
|
| placebo and vaccine | Biological |
|
| Derived |
| Zhang J, Shi N, Li G, Li L, Bai Y, Yang L, Zhao W, Gao J, Wei J, Zhao W, Zhai L, Huo P, Ren L, Yu L, Li Y. Population Pharmacodynamic Analyses of Human Anti-Rabies Virus Monoclonal Antibody (Ormutivimab) in Healthy Adult Subjects. Vaccines (Basel). 2022 Jul 29;10(8):1218. doi: 10.3390/vaccines10081218. |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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