[Translation] A randomized, double-blind, tetanus immunoglobulin-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of intramuscular GR2001 injection in patients with suspected tetanus exposure

主要目的：评价GR2001注射液在疑似破伤风暴露者中的有效性。次要目的：比较GR2001注射液与HTIG在疑似破伤风暴露者中的临床结局；比较GR2001注射液与HTIG的安全性；评价GR2001注射液在疑似破伤风暴露者中的药代动力学（PK）特征；评价GR2001注射液在疑似破伤风暴露者中的免疫原性。

[Translation]

Primary objective: To evaluate the effectiveness of GR2001 injection in patients with suspected tetanus exposure. Secondary objectives: To compare the clinical outcomes of GR2001 injection and HTIG in patients with suspected tetanus exposure; To compare the safety of GR2001 injection and HTIG; To evaluate the pharmacokinetic (PK) characteristics of GR2001 injection in patients with suspected tetanus exposure; To evaluate the immunogenicity of GR2001 injection in patients with suspected tetanus exposure.

Start Date03 Sep 2024

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

NCT06635798

/ RecruitingPhase 3

A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus

The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.

Start Date03 Sep 2024

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

CTR20241199

/ RecruitingPhase 1

多中心、随机、盲法、对照评价全人源抗破伤风毒素单克隆抗体A82/B86注射液组合制剂的安全性、耐受性、药动学、药效学和免疫原性的I/II期临床试验

[Translation] A multicenter, randomized, blinded, controlled phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of a combination of fully human anti-tetanus toxin monoclonal antibodies A82/B86 injection

Ia（单独给药阶段）主要目的：评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的安全性、耐受性。次要目的：（1）评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的药代动力学特征；（2）评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的药效学特征；（3）评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的免疫原性特征。 Ib（药物相互作用阶段）主要目的：评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的安全性、耐受性。次要目的：（1）评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的药效学特征，评估药物相互作用；（2）评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的药代动力学特征；（3）评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的免疫原性特征。

[Translation]

Ia (single administration phase) Main objective: To evaluate the safety and tolerability of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers. Secondary objectives: (1) To evaluate the pharmacokinetic characteristics of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers; (2) To evaluate the pharmacodynamic characteristics of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers; (3) To evaluate the immunogenicity characteristics of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers. Ib (drug interaction phase) Main objective: To evaluate the safety and tolerability of intramuscular injection of CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers. Secondary objectives: (1) To evaluate the pharmacodynamic characteristics of intramuscular CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers and assess drug interactions; (2) To evaluate the pharmacokinetic characteristics of intramuscular CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers; (3) To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers.

Start Date30 Apr 2024

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

100 Clinical Results associated with Tetanus toxin

100 Translational Medicine associated with Tetanus toxin

0 Patents (Medical) associated with Tetanus toxin

1,896

Literatures (Medical) associated with Tetanus toxin

01 Feb 2025·Transfusion and Apheresis Science

Case report: Plasma exchange treatment in a patient with severe tetanus

Article

Author: Gao, Kai ; Zhang, Qishuo ; Xie, Yang ; Huang, Shijie ; Hu, WeiHao ; Han, Fei

Tetanus, a severe illness caused by Clostridium tetani, entails symptoms such as muscle spasms and tissue necrosis due to the production of tetanus toxin and hemolysin, posing a grave risk to life. Plasma exchange is infrequently used in tetanus treatment due to limited reported cases, guidelines, the relative rarity of tetanus cases, the high cost and technical complexity of the treatment, and the need to carefully balance risks and benefits. In this case study, a 57-year-old male with a recent foot injury presented with classical tetanus symptoms, including lockjaw, neck stiffness, and lower limb hypertonicity. Upon admission, his condition deteriorated rapidly, leading to cardiac arrest. Following successful resuscitation, he was admitted to the ICU. The patient underwent plasma exchange due to persistent symptoms, ultimately showing partial functional recovery and being discharged for rehabilitation. Clinical evidence supports plasma exchange's ability to eliminate macromolecules, autoantibodies, immune complexes, cytokines, and inflammatory mediators from the body. Despite its uncommon use in tetanus infections, our patient's treatment with plasma exchange facilitated toxin removal and alleviated persistent symptoms. This case contributes to expanding our understanding and offers a novel therapeutic option for severe tetanus cases.

01 Jan 2025·Carbohydrate Research

Carboxymethylation of β-Glucan from Pythium insidiosum: Structural characterization and preliminary adsorption evaluation of DON and T2 toxin

Article

Author: Loreto, Erico S ; Sassaki, Guilherme L ; Tondolo, Juliana S M ; Zeni, Gilson ; Santurio, Janio M ; Santurio, Janio M. ; Tondolo, Juliana S.M. ; Sassaki, Guilherme L. ; Loreto, Erico S.

This study aimed to evaluate the impact of carboxymethylation on the structural and functional properties of β-glucan derived from the pathogenic oomycete Pythium insidiosum. β-Glucan was extracted and subjected to carboxymethylation (CM-glucan), with structural changes analyzed using ¹³C and ¹H NMR spectroscopy. The modified β-glucan's ability to adsorb mycotoxins, specifically deoxynivalenol (DON) and T2 toxin, was assessed through in vitro adsorption assays. Results demonstrated that the adsorption of DON by CM-glucan increased from 0 % to 59.11 %, corresponding to the adsorption of approximately 1.18 μg of DON from the initial concentration (2 μg/mL). Similarly, the adsorption of T2 toxin increased slightly from 0 % to 4.54 %, corresponding to 0.09 μg of T2 toxin adsorbed from the initial concentration (2 μg/mL). These findings underscore the potential of chemical modifications to enhance the functional properties of natural polysaccharides, suggesting future applications in mycotoxin adsorption and other biological properties across various areas.

01 Jan 2025·Biosensors and Bioelectronics

Nanometal surface energy transfer-based lateral flow immunoassay for T2 toxin detection

Article

Author: Ding, Mingyue ; Huang, Xianqing ; Mao, Yexuan ; Zhang, Xiya ; Wang, Zhanhui ; Song, Lianjun ; Li, Zizhe ; Bu, Tong ; Dang, Meng ; Dou, Leina

In this study, we incorporated nanometal surface energy transfer (NSET) in lateral flow immunoassay (LFIA) and explored the relationship between fluorescence quenching efficiency and detection sensitivity to improve sensitivity of NSET-LFIA system. We developed nine gold nanoparticles (GNPs) with absorption spectrum in the range of 520-605 nm as acceptors and quantum dot microspheres (QDMs) with emission spectrum of 530, 570, and 610 nm as donors. By analyzing the overlap integral area, fluorescence quenching efficiency, and detection sensitivity of 27 donor-acceptor pairs, we observed that the larger overlap integral area led to higher fluorescence quenching efficiency and detection sensitivity. A maximum fluorescence quenching efficiency of 91.0% was obtained from the combination of GNPs at 605 nm and QDMs at 610 nm, achieving the highest detection sensitivity. We developed NSET-LFIA for the detection of T2 toxin with a limit of detection of 0.04 ng/mL, which was 10-times higher than that obtained via conventional GNP-LFIA. NSET-LFIA represents a versatile, ultrasensitive and valuable screening tool for small molecules in real samples.

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