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Can a Lab-Made antibody outperform standard tetanus shots?

NCT ID NCT05664750

Prevention Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This phase 3 trial compares a new lab-made antibody, TNM002, with the standard human tetanus immunoglobulin for preventing tetanus in adults with dirty or contaminated wounds. Participants receive one injection of either treatment, and researchers measure whether their blood reaches protective antibody levels within 12 hours. The study also tracks how many people develop tetanus over the following month. If TNM002 works as well or better, it could provide a safer, more consistent option for tetanus prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TNM002, a lab-made antibody against tetanus toxin
What this could lead to
If it works, TNM002 could offer a reliable, lab-made alternative to human-derived tetanus immunoglobulin, potentially easing supply shortages and reducing infection risk.
What could go wrong
This is an early-stage test in a specific group of injured adults, so results may not apply to everyone. The antibody might not match the effectiveness of the standard treatment, and allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

675 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

tetanus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tetanus

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, 563000, China

  • Affiliated Nanhua Hospital, University of South China

    Hengyang, Hunan, 421010, China

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003, China

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

  • Hefei First People's Hospital

    Hefei, Anhui, 230061, China

  • Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University

    Liuzhou, Guangxi, 545007, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • PKUCare Luzhong Hospital

    Zibo, Shandong, 255499, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060, China

  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)

    Taiyuan, Shanxi, 030032, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518025, China

  • The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology

    Wuhan, Hubei, 430014, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511407, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510062, China

  • The First People's Hospital of Jinzhong

    Jinzhong, Shanxi, 030602, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008, China

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150, China

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Yuncheng Central Hospital - East Campus

    Yuncheng, Shanxi, 044099, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Hangzhou, 310014, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430062, China

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