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

Primary Purpose

Tetanus

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TNM002
Human tetanus immunoglobulin (HTIG)
Sponsored by
Zhuhai Trinomab Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetanus focused on measuring Tetanus, Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hefei First People's Hospital
  • The Second Hospital of Anhui Medical University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Beijing Tiantan Hospital Affiliated to Capital Medical University
  • The First Affiliated Hospital, Sun Yat-sen University
  • Guangdong Provincial Hospital of Chinese Medicine
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Guangzhou First People's Hospital
  • Nanfang Hospital of Southern Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Shenzhen Second People's Hospital
  • Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
  • Affiliated Hospital of Zunyi Medical College
  • Hainan General Hospital
  • Zhejiang Provincial People's Hospital
  • The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Renmin Hospital of Wuhan University
  • Zhongnan Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • Affiliated Nanhua Hospital, University of South China
  • The Second Affiliated Hospital of Nanchang University
  • General Hospital of Ningxia Medical University
  • PKUCare Luzhong Hospital
  • The First People's Hospital of Jinzhong
  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
  • Yuncheng Central Hospital - East Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TNM002

Human tetanus immunoglobulin (HTIG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tetanus protection rate (1 - tetanus incidence)

Full Information

First Posted
December 7, 2022
Last Updated
May 17, 2023
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05664750
Brief Title
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
May 28, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus
Keywords
Tetanus, Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
675 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNM002
Arm Type
Experimental
Arm Description
If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
Arm Title
Human tetanus immunoglobulin (HTIG)
Arm Type
Active Comparator
Arm Description
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Intervention Type
Drug
Intervention Name(s)
TNM002
Intervention Description
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Intervention Type
Drug
Intervention Name(s)
Human tetanus immunoglobulin (HTIG)
Intervention Description
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Primary Outcome Measure Information:
Title
Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Time Frame
Baseline up to 12 hours after receipt of study drug
Secondary Outcome Measure Information:
Title
Tetanus protection rate (1 - tetanus incidence)
Time Frame
Up to 28 days after receipt of study drug
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events (AEs)
Time Frame
Up to 105 days after receipt of study drug
Title
Incidence of treatment related adverse events (AEs)
Time Frame
Up to 105 days after receipt of study drug
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 105 days after receipt of study drug
Title
The number and percentage of subjects with abnormal hematology tests
Description
The hemotology tests include red blood cell count, hemoglobin, platelet count, white blood cell count, absolute neutrophil count, neutrophil percentage, absolute lymphocyte count, lymphocytes percentage, absolute monocyte count, and hematocrit
Time Frame
Up to 90 days after receipt of study drug
Title
The number and percentage of subjects with abnormal serum chemistry tests
Description
The serum chemistry tests include total protein, albumin, sodium, potassium, chloride, calcium, glucose, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, urea (blood urea nitrogen) and creatinine
Time Frame
Up to 90 days after receipt of study drug
Title
The number and percentage of subjects with abnormal urinalysis tests
Description
The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell
Time Frame
Up to 90 days after receipt of study drug
Title
The number and percentage of subjects with abnormal vital signs
Description
The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature
Time Frame
Up to 90 days after receipt of study drug
Title
The number and percentage of subjects with abnormal physical examination
Description
The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities.
Time Frame
Up to 90 days after receipt of study drug
Title
The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG)
Time Frame
Up to 90 days after receipt of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuanlin Wang, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shengyi Wang
Organizational Affiliation
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Hefei First People's Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230061
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510062
Country
China
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511407
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518025
Country
China
Facility Name
Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545007
Country
China
Facility Name
Affiliated Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430062
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Affiliated Nanhua Hospital, University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421010
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750003
Country
China
Facility Name
PKUCare Luzhong Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255499
Country
China
Facility Name
The First People's Hospital of Jinzhong
City
Jinzhong
State/Province
Shanxi
ZIP/Postal Code
030602
Country
China
Facility Name
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Facility Name
Yuncheng Central Hospital - East Campus
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044099
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31795577
Citation
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.
Results Reference
background
PubMed Identifier
17854885
Citation
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. Erratum In: Lancet. 2007 Dec 8;370(9603):1906.
Results Reference
background
PubMed Identifier
28185446
Citation
Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
5902706
Citation
Perey BJ. Progress in tetanus prophylaxis: the advent of human antitoxin. Can Med Assoc J. 1966 Feb 26;94(9):437-41.
Results Reference
background
Citation
Plotkin, S.A., W.A. Orenstein and P.A. Offit, Plotkin's vaccines. Seventh edition. ed. 2018. 1691.
Results Reference
background
PubMed Identifier
29042200
Citation
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.
Results Reference
background
PubMed Identifier
9527776
Citation
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.
Results Reference
background
Links:
URL
http://cdc.confex.com/cdc/nic2005/techprogram/paper_7813.htm
Description
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.

Learn more about this trial

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

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