tetanus
Conditions
Interventions
Human Tetanus Immunoglobulin Group (Control Group):Administration of tetanus passive immunization agent: Human Tetanus Immunoglobulin (HTIG)
Siltartoxatug Group (Test Group):Administration of tetanus passive immunization agent: Siltartoxatug Injection
Sponsors
The First People's Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participating in this study, with the subject or legal guardian having signed a written informed consent form; 2. Age between 18 and 69 years; 3. Patients with severe trauma (according to the "Polytrauma Medical Records and Diagnosis: Expert Consensus (2023 Edition)" including severe and critical polytrauma patients with ISS >=16); 4. Tetanus risk graded as: high risk; 5. (1) Previous TTCV immunization history unknown, or (2) Previous TTCV immunization history with fewer than 3 doses, or (3) Previous full TTCV immunization history but the last TTCV vaccination was over 10 years ago. 6. Passive immunization is required to prevent tetanus (for the use of passive immunization agents, see Annex 6). Note: (1) The ISS score refers to the international AIS-2005 scoring system and is assessed by the attending physician; (2) Tetanus risk classification refers to the "Diagnosis and Treatment Guidelines for Non-Neonatal Tetanus (2024 Edition)" and is assessed by the attending physician. High risk is defined as meeting any of the following conditions: no medical treatment within 6 hours; wound contaminated with soil, human or animal feces, or mammalian saliva; puncture wound; avulsion injury; crush injury; firearm injury; burn or frostbite; presence of ischemic or necrotic tissue not removed; foreign objects in the wound not removed; wound with signs of existing infection.
Exclusion criteria
Exclusion criteria: 1.Suspected or confirmed tetanus at admission or prior to administration; 2.Body temperature (axillary or ear temperature) >= 38°C within 72 hours prior to administration; 3.Pregnant or lactating females; 4.Known or suspected allergy to siltartoxatug, human tetanus immunoglobulin, or related excipients, or a history of severe systemic allergic reactions; 5.Presence of the following severe underlying diseases: end-stage liver disease (Child-Pugh Grade C), end-stage renal disease (requiring long-term dialysis), high risk of active bleeding (excluding that caused by trauma itself); 6.Use of immunoglobulins, blood products, any tetanus passive immunization agents, or live viral vaccines within 3 months prior to administration; 7.Participation in other clinical trials of investigational drugs or devices (interventional or non-interventional observational studies) within 3 months prior to administration or within 5 half-lives (whichever is longer); 8.History of convulsions, seizures or epilepsy, presence of mental illness, alcoholism, drug addiction or substance abuse; 9.Subjects assessed to have a risk of death within 3 months; 10.Subjects who are investigators related to this study, or have direct family relationship or significant financial interest with investigators; 11.Other conditions judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with anti-tetanus neutralizing antibody titer ?Titer = 0.01 IU/mL at 8 hours after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tetanus protection rate within 90 days after administration;Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR) and adverse events of special interest (AESI) within 90 days after administration;Proportion of subjects with anti-tetanus neutralizing antibody titer ?Titer = 0.01 IU/mL at 12 hours and 28 days after administration; | — |
Countries
China
Contacts
Public ContactDaming Wang?
The First People's Hospital of Changzhou
Outcome results
None listed