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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05664750
• Other study ID #: TNM002-301
• Status: Completed
• Phase: Phase 3
• Start date: December 22, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: October 2023
• Source: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: July 7, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tetanus

Intervention

Drug:
• TNM002
Dosage Form: Injection, solution Route of administration: IM gluteal injection
• Human tetanus immunoglobulin (HTIG)
Dosage Form: Injection, solution Route of administration: IM gluteal injection

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	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	Hainan General Hospital	Haikou	Hainan
China	Zhejiang Provincial People's Hospital	Hangzhou	Hangzhou
China	Hefei First People's Hospital	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Affiliated Nanhua Hospital, University of South China	Hengyang	Hunan
China	The First People's Hospital of Jinzhong	Jinzhong	Shanxi
China	Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)	Taiyuan	Shanxi
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Yuncheng Central Hospital - East Campus	Yuncheng	Shanxi
China	PKUCare Luzhong Hospital	Zibo	Shandong
China	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Trinomab Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View Citation

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

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events (AEs)		Up to 105 days after receipt of study drug
Other	Incidence of treatment related adverse events (AEs)		Up to 105 days after receipt of study drug
Other	Incidence of serious adverse events (SAEs)		Up to 105 days after receipt of study drug
Other	The number and percentage of subjects with abnormal hematology tests	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	Up to 90 days after receipt of study drug
Other	The number and percentage of subjects with abnormal serum chemistry tests	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	Up to 90 days after receipt of study drug
Other	The number and percentage of subjects with abnormal urinalysis tests	The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell	Up to 90 days after receipt of study drug
Other	The number and percentage of subjects with abnormal vital signs	The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature	Up to 90 days after receipt of study drug
Other	The number and percentage of subjects with abnormal physical examination	The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities.	Up to 90 days after receipt of study drug
Other	The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG)		Up to 90 days after receipt of study drug
Primary	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	Tetanus protection rate (1 - tetanus incidence)		Up to 28 days after receipt of study drug

External 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.