TetanusPhase 3NCT06635798
A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
A Phase 3 study testing GR2001 and HTIG in people with Tetanus, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 20 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetanus
- What is being tested?
- GR2001 and HTIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 20 sitesChina
- Study dates
- 3 Sep 2024to 4 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese male or female adults aged ≥ 18 years；
- Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
- Participants who provide signed written informed consent form.
Who cannot join
- Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
- 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;
- Females who are pregnant or with pregnancy test positive.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Si Liu, 86+13501220344, docleo@pku.edu.cn
- Recruiting
Peking University People Hospital
Beijing, Beijing Municipality, 100044
Chuanlin Wang, 86+13911883012, wangchuanlinvip@163.com
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Fen Xu, 86+13683527280, icexubin@aliyun.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Zijing Liang, 86+13719337897, 13719337897@163.com
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
Junyan Hu, 86+18926197810, hujunyan001@163.com
- Recruiting
Zhujiang Hospital Affiliated to Southern Medical University
Guangzhou, Guangdong, 510280
Bin Liu, 86+13302380009, nysylb@163.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Wenwei Cai, 86+13588760325, wwcai@139.com
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Chunlin Yin, 86+18919633593, ycldoctor@163.com
- Recruiting
Nanhua Hospital Affiliated to University of south China
Hengyang, Hunan, 421010
Wenkai Bin, 86+15307340263, SYYBWK@163.COM
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 041000
Hongguo Dai, 86+15935767592, daihongguo3199@163.com
- Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Tao Gan, 86+13977230809, Gantao11@sina.com
- Recruiting
Liuzhou Workers's Hospital
Liuzhou, Guangxi, 545025
Haiding Ruan, 86+13978027516, hailinruan@126.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Lidong Wu, 86+13807095219, dongguawu89@163.com
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Mingquan Chen, 86+18018695670, mingquanchen@fudan.edu.cn
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518037
Zhe Deng, 86+15815520928, dengz163@163.com
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Qinghao Guo, 86+13476845755, Qinghaoguo2390@sina.com
- Recruiting
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030
Zhanfei Li, 86+13986297138, lezhfei@163.com
- Recruiting
The Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225009
Junling Len, 86+13401291473, china_ljl@sina.com
- Recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000
Dapeng Cheng, 86+13903481326, 13903481326@163.com
- Recruiting
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Anyong Yu, 86+13511897722, 2360298076@qq.com
About this study
Official title: 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.
- Conditions
- Tetanus
- Being tested
- GR2001, HTIG
- Keywords
- Tetanus, Human Tetanus Immunoglobulin, GR2001 Injection
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR2001Biological
The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial.
HTIGBiological
The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form.
| Study group | Role | What they receive |
|---|---|---|
| GR2001 | Experimental | If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001 Receives: Biological: GR2001 |
| HTIG | Active comparator | If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG Receives: Biological: HTIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Measured: Baseline up to 12 hours after receipt of Investigational medicinal product.
Secondary outcomes (5)
The incidence of tetanus
Measured: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the safety of GR2001
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Measured: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the peak plasma concentration(Cmax) of GR2001
Measured: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
Measured: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the immunogenicity of GR2001
Measured: Up to 105 days after receipt of Investigational medicinal product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start3 Sep 2024
- Primary completion4 Dec 2024 (estimated)
- Study completion4 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chuanlin Wang, MD, Principal investigator, Peking University People's HospitalZhanfei Li, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635798
- Sponsor's protocol ID
- GR2001-002
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06635798
- Acronym / sponsor ID
- GR2001-002
- Conditions
- Tetanus
- Keywords
- Tetanus, Human Tetanus Immunoglobulin, GR2001 Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 4 Dec 2024 (estimated)
- Study completion
- 4 Mar 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GR2001 | Experimental | Biological: GR2001If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001 |
| HTIG | Active comparator | Biological: HTIGIf randomized to HTIG, participant will receive a single IM gluteal injection of HTIG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese male or female adults aged ≥ 18 years；
- Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
- Participants who provide signed written informed consent form.
Key exclusion criteria (5 listed)
- Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
- 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;
- Females who are pregnant or with pregnancy test positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR2001The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial. | Biological | GR2001 |
| HTIGThe HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form. | Biological | HTIG |
Primary outcome
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
Time frame: Baseline up to 12 hours after receipt of Investigational medicinal product.
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
5 secondary outcomes
The incidence of tetanus
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the safety of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the peak plasma concentration(Cmax) of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the immunogenicity of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanlin Wang, MD principal investigator
Peking University People's Hospital
Zhanfei Li, MD principal investigator
Tongji Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GR2001 and HTIG in people with Tetanus, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanlin Wang, MD (86+13911883012, wangchuanlinvip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The increase of anti-tetanus neutralizing antibody titers (∆ titers) (time frame: Baseline up to 12 hours after receipt of Investigational medicinal product.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.