Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
- Registration Number
- NCT05664750
- Lead Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 675
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TNM002 TNM002 If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002 Human tetanus immunoglobulin (HTIG) Human tetanus immunoglobulin (HTIG) If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Tetanus protection rate (1 - tetanus incidence) Up to 28 days after receipt of study drug
Trial Locations
- Locations (28)
PKUCare Luzhong Hospital
🇨🇳Zibo, Shandong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Hangzhou, China
The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Affiliated Nanhua Hospital, University of South China
🇨🇳Hengyang, Hunan, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First People's Hospital of Jinzhong
🇨🇳Jinzhong, Shanxi, China
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
🇨🇳Taiyuan, Shanxi, China
Yuncheng Central Hospital - East Campus
🇨🇳Yuncheng, Shanxi, China
Hefei First People's Hospital
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
🇨🇳Liuzhou, Guangxi, China
Affiliated Hospital of Zunyi Medical College
🇨🇳Zunyi, Guizhou, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China