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Completed

NCT Number: NCT05664750

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

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.

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Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hefei First People's Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese male or female adults aged ≥ 18 years;
  • Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;
  • Participants who provide signed written informed consent form.

Exclusion criteria

  • 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;
  • 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;
  • Current alcohol abuse, drug abuse or drug addiction

Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

TNM002

Drug

Dosage Form: Injection, solution

Route of administration: IM gluteal injection

Human tetanus immunoglobulin (HTIG)

Drug

Dosage Form: Injection, solution

Route of administration: IM gluteal injection

Primary outcomes

  1. Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose

    Time frame: 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 outcomes

  1. Tetanus Protection Rate on Day 28 Post-dose

    Time frame: 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.

Other outcomes

  1. Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.

    Time frame: Up to 90 days 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.

  2. ∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose

    Time frame: At 12 hours, and on Days 3, 7, 28 and 90 post-dose

    The change of anti-tetanus neutralizing antibody titers 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.

  3. Tetanus Protection Rate on Days 90 and 105 Post-dose

    Time frame: Up to 105 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.

  4. TNM002 Serum Concentration

    Time frame: pre-dose, 12h, and Days 3, 7, 28, 90 post-dose

    Arithmetic mean concentrations of TNM002 at each specified timepoint

  5. Anti-drug Antibodies (ADA) Against TNM002

    Time frame: pre-dose, and Days 7, 28, and 90 post-dose

    The positive rate of ADA in the TNM002 group at each specified timepoint

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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