Tetanus
Conditions
Keywords
Tetanus, Human Tetanus Immunoglobulin, GR2001 Injection
Brief summary
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.
Interventions
BIOLOGICALGR2001
The 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.
BIOLOGICALHTIG
The 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.
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Chinese male or female adults aged ≥ 18 years； 2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries); 3. Participants who provide signed written informed consent form.
Exclusion criteria
1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions； 2. Suspect or diagnosed as tetanus; 3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies； 4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine; 5. Females who are pregnant or with pregnancy test positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The increase of anti-tetanus neutralizing antibody titers (∆ titers) | Baseline up to 12 hours after receipt of Investigational medicinal product. | The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of tetanus | Up to 105 days after receipt of Investigational medicinal product. | — |
| To evaluate the safety of GR2001 | Up to 105 days after receipt of Investigational medicinal product. | 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 | Up to 105 days after receipt of Investigational medicinal product. | — |
| To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001 | Up to 105 days after receipt of Investigational medicinal product. | — |
| To evaluate the immunogenicity of GR2001 | Up to 105 days after receipt of Investigational medicinal product. | — |
Countries
China
Contacts
Primary ContactChuanlin Wang, MD
Outcome results
None listed