Tetanus
Conditions
Keywords
Tetanus, Prophylaxis
Brief summary
TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.
Interventions
DRUGTNM002
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
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 dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus; 3. Participants who provide signed written informed consent form.
Exclusion criteria
1. Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins; 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. Current alcohol abuse, drug abuse or drug addiction Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose | Baseline up to 12 hours after receipt of study drug | The change of anti-tetanus neutralizing antibody titers from baseline were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters ≥0.01 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tetanus Protection Rate on Day 28 Post-dose | Up to 28 days after receipt of study drug | The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChuanlin Wang, MD
Peking University People's Hospital
STUDY_DIRECTORShengyi Wang
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Participant flow
Recruitment details
A total of 675 adult participants were recruited from 22 December 2022 to 23 March 2023.
Pre-assignment details
Of 715 screened participants, 675 met eligibility criteria and were randomized to treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 12.43 |
| Age, Customized Age, categorical > 65 to ≤ 75 years | 15 Participants |
| Age, Customized Age, categorical ≤65 years | 644 Participants |
| Age, Customized Age, categorical > 75 years | 1 Participants |
| Baseline anti-tetanus antibody titers | 0.00812 IU/mL |
| Race/Ethnicity, Customized Ethnicity Han Chinese | 635 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 11 Participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 440 | 1 / 221 |
| other Total, other adverse events | 131 / 440 | 49 / 221 |
| serious Total, serious adverse events | 6 / 440 | 2 / 221 |
Outcome results
None listed