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

NCT05664750 | Completed Phase 3 FDA Drug

• 1 other identifier: TNM002-301
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 28

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.

Conditions

Tetanus

Keywords

Tetanus; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.

  Baseline up to 12 hours after receipt of study drug

Secondary Outcomes (1)

• Tetanus protection rate (1 - tetanus incidence)

  Up to 28 days after receipt of study drug

Other Outcomes (9)

• Incidence of adverse events (AEs)

  Up to 105 days after receipt of study drug

• Incidence of treatment related adverse events (AEs)

  Up to 105 days after receipt of study drug

• Incidence of serious adverse events (SAEs)

  Up to 105 days after receipt of study drug

Study Arms (2)

TNM002

EXPERIMENTAL

If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002

Drug: TNM002

Human tetanus immunoglobulin (HTIG)

ACTIVE COMPARATOR

If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG

Drug: Human tetanus immunoglobulin (HTIG)

Interventions

TNM002 DRUG

Dosage Form: Injection, solution Route of administration: IM gluteal injection

TNM002

Human tetanus immunoglobulin (HTIG) DRUG

Dosage Form: Injection, solution Route of administration: IM gluteal injection

Human tetanus immunoglobulin (HTIG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (28)

Hefei First People's Hospital

Hefei, Anhui, 230061, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 511407, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518025, China

Location

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

Liuchow, Guangxi, 545007, China

Location

Affiliated Hospital of Zunyi Medical College

Zunyi, Guizhou, 563000, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Hangzhou, 310014, China

Location

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

Wuhan, Hubei, 430014, China

Location

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

Wuhan, Hubei, 430030, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Affiliated Nanhua Hospital, University of South China

Hengyang, Hunan, 421010, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750003, China

Location

PKUCare Luzhong Hospital

Zibo, Shandong, 255499, China

Location

The First People's Hospital of Jinzhong

Jinzhong, Shanxi, 030602, China

Location

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

Taiyuan, Shanxi, 030032, China

Location

Yuncheng Central Hospital - East Campus

Yuncheng, Shanxi, 044099, China

Location

Related Publications (9)

• Wang CL, Liu S, Shao ZJ, Yin ZD, Chen QJ, Ma X, Ma C, Wang Q, Wang LH, Deng JK, Li YX, Zhao ZX, Wu D, Wu J, Zhang L, Yao KH, Gao Y, Xie X. [Guidelines for the use of post-traumatic tetanus vaccines and passive immune preparation]. Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Dec 6;53(12):1212-1217. doi: 10.3760/cma.j.issn.0253-9624.2019.12.005. Chinese.

  PMID: 31795577 BACKGROUND

• Roper MH, Vandelaer JH, Gasse FL. Maternal and neonatal tetanus. Lancet. 2007 Dec 8;370(9603):1947-59. doi: 10.1016/S0140-6736(07)61261-6.

  PMID: 17854885 BACKGROUND

• Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French.

  PMID: 28185446 BACKGROUND

• Yu Chao, Xu Yuming, Xu Jin, et al. Progress of clinical application and safety of tetanus antitoxin. Chinese Journal of Pharmacovigilance, 2016, 13 (1): 36-41.

  BACKGROUND

• Perey BJ. Progress in tetanus prophylaxis: the advent of human antitoxin. Can Med Assoc J. 1966 Feb 26;94(9):437-41.

  PMID: 5902706 BACKGROUND

• Plotkin, S.A., W.A. Orenstein and P.A. Offit, Plotkin's vaccines. Seventh edition. ed. 2018. 1691.

  BACKGROUND

• Ortiz JR, Hombach J. Announcing the publication of the WHO immunological basis for immunization series module on influenza vaccines. Vaccine. 2018 Sep 5;36(37):5504-5505. doi: 10.1016/j.vaccine.2017.09.010. Epub 2017 Oct 16.

  PMID: 29042200 BACKGROUND

• Forrat R, Dumas R, Seiberling M, Merz M, Lutsch C, Lang J. Evaluation of the safety and pharmacokinetic profile of a new, pasteurized, human tetanus immunoglobulin administered as sham, postexposure prophylaxis of tetanus. Antimicrob Agents Chemother. 1998 Feb;42(2):298-305. doi: 10.1128/AAC.42.2.298.

  PMID: 9527776 BACKGROUND

• Liang Z, Liu S, Guo W, Deng Z, Bin W, Yu A, Hu J, Wu L, Li Z, Huang W, Li H, Cheng D, Li S, Guo Q, Zhang D, Yan X, Wang C, Cai W, Ding B, Li W, Li X, Xu B, He L, Ouyang Y, Zhan H, Wang J, Zhao Y, Liu X, Xiang W, Zhang M, Zhang Z, Ding J, Kuang X, Zheng W, Liao H, Wang W, Wang C. Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial. Nat Med. 2025 Aug;31(8):2673-2681. doi: 10.1038/s41591-025-03791-8. Epub 2025 Jul 8.

  PMID: 40628965 DERIVED

Related Links

• Srivastava P, B.K.C.J., Trends in tetanus epidemiology in the United States, 1972-2001. 39th National Immunization Conference Workshop 27, 2005. Available at: \<http://cdc.confex.com/cdc/nic2005/techprogram/paper\_7813.htm\>. 2005.

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

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

Study Officials

• Chuanlin Wang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Shengyi Wang

  Zhuhai Trinomab Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 27, 2022
• Study Start: December 22, 2022
• Primary Completion: March 24, 2023
• Study Completion: July 7, 2023
• Last Updated: March 8, 2024

Record last verified: 2023-10

Locations

CN (28)