The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.
Chinese male or female adults aged ≥ 18 years；
Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
Participants who provide signed written informed consent form.
Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
Suspect or diagnosed as tetanus;
Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
Parallel
GR2001
Biological/VaccineThe packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial.
HTIG
Biological/VaccineThe HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form.
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
The incidence of tetanus
To evaluate the safety of GR2001
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
To evaluate the peak plasma concentration(Cmax) of GR2001
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
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