Evaluating GR2001 Injection for Tetanus Prevention

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

This study is testing a new injection called GR2001 to see if it can effectively prevent tetanus in adults who might have been exposed, compared to the standard treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 582 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. (industry)
• Locations: 20 sites (Hefei, Anhui and 19 other locations)
• Trial ID: NCT06635798 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of GR2001 injection against Human Tetanus Immunoglobulin (HTIG) for preventing tetanus in adults with suspected exposure. Participants will receive either GR2001 or HTIG on the first day of the study. The trial focuses on assessing the pharmacokinetics and immunogenicity of GR2001 in this context. The study is designed to provide insights into the effectiveness of GR2001 as a potential alternative to HTIG.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese adults aged 18 and older who have suspected tetanus exposure due to contaminated wounds.

Not a fit: Patients who are already diagnosed with tetanus or have severe allergies to the investigational product may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new and effective option for tetanus prophylaxis.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have not been widely reported, indicating that this may be a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Chinese male or female adults aged ≥ 18 years；
2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
3. Participants who provide signed written informed consent form.

Exclusion Criteria:

1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
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. Females who are pregnant or with pregnancy test positive.

Where this trial is running

Hefei, Anhui and 19 other locations

• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Peking University People Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
• Zhujiang Hospital Affiliated to Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (RECRUITING)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (RECRUITING)
• Liuzhou Workers's Hospital — Liuzhou, Guangxi, China (RECRUITING)
• The Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (RECRUITING)
• The Central Hospital of Wuhan — Wuhan, Hubei, China (RECRUITING)
• Tongji Hospital, Tongji Medical College of HUST — Wuhan, Hubei, China (RECRUITING)
• Nanhua Hospital Affiliated to University of south China — Hengyang, Hunan, China (RECRUITING)
• The Affiliated Hospital of Yangzhou University — Yangzhou, Jiangsu, China (RECRUITING)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
• Linfen Central Hospital — Linfen, Shanxi, China (RECRUITING)
• Yuncheng Central Hospital — Yuncheng, Shanxi, China (RECRUITING)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Chuanlin Wang, MD — Peking University People's Hospital
• Study coordinator: Chuanlin Wang, MD

Conditions: Tetanus, Human Tetanus Immunoglobulin, GR2001 Injection