Clinical trial NCT05664750: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Keywords: Tetanus
Prophylaxis
Lead sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
timeFrame: Baseline up to 12 hours after receipt of study drug
Secondary outcomes:
measure: Tetanus protection rate (1 - tetanus incidence)
timeFrame: Up to 28 days after receipt of study drug
Other outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 105 days after receipt of study drug
measure: Incidence of treatment related adverse events (AEs)
timeFrame: Up to 105 days after receipt of study drug
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 105 days after receipt of study drug
measure: The number and percentage of subjects with abnormal hematology tests
timeFrame: Up to 90 days after receipt of study drug
measure: The number and percentage of subjects with abnormal serum chemistry tests
timeFrame: Up to 90 days after receipt of study drug
measure: The number and percentage of subjects with abnormal urinalysis tests
timeFrame: Up to 90 days after receipt of study drug
measure: The number and percentage of subjects with abnormal vital signs
timeFrame: Up to 90 days after receipt of study drug
measure: The number and percentage of subjects with abnormal physical examination
timeFrame: Up to 90 days after receipt of study drug
measure: The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG)
timeFrame: Up to 90 days after receipt of study drug
Locations:
city: Hefei
country: China
facility: Hefei First People's Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Hangzhou
city: Wuhan
country: China
facility: The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: Affiliated Nanhua Hospital, University of South China
state: Hunan
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shandong
city: Jinzhong
country: China
facility: The First People's Hospital of Jinzhong
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital - East Campus
state: Shanxi
Study officials:
affiliation: Peking University People's Hospital
name: Chuanlin Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhuhai Trinomab Pharmaceutical Co., Ltd.
name: Shengyi Wang
role: STUDY_DIRECTOR
References:
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.
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.
citation: Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French.
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.
citation: Perey BJ. Progress in tetanus prophylaxis: the advent of human antitoxin. Can Med Assoc J. 1966 Feb 26;94(9):437-41.
citation: Plotkin, S.A., W.A. Orenstein and P.A. Offit, Plotkin's vaccines. Seventh edition. ed. 2018. 1691.
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.
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.