Rabies Post-exposure ProphylaxisPhase 3NCT05846568
Study to Evaluate GR1801's Efficacy and Safety
A Phase 3 study testing GR1801, Human Rabies Immunoglobulin(HRIG) and Rabies Vaccine in people with Rabies Post-exposure Prophylaxis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure. Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rabies Post-exposure Prophylaxis
- What is being tested?
- GR1801, Human Rabies Immunoglobulin(HRIG) and Rabies Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2022to 6 Sep 2024
- 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 males or females aged 18 years or above on Study Day 0 with legal identification documents and plan to live in the local area during the study;
- WHO Category III rabies exposure；
- Those who have an armpit temperature ≤ 37.0 °C；
- Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups.
Who cannot join
- WHO Category III rabies exposure but received wound suture treatment;
- WHO Category III rabies exposure over 72 hours;
- Previous receipt of rabies vaccination or rabies passive immunization;
- History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0;
- History of any severe allergy for vaccination;
- Had fever (armpit temperature ≥ 38.5 °C) or received any antipyretic, analgesic or anti-allergic drug within 3 days before Study Day 0;
Show all 12Show fewer
- History of severe autoimmune diseases;
- History of any severe neurological disease；
- History of receiving any immunoglobulin or vaccine within 30 days before Study Day 0, or plan to use any such product during the study;
- History of addiction to any narcotic, alcohol or drugs;
- Previous receipt of any study product (drug, vaccine, biological product or device) within 6 months before Study Day 0, or plan to participate in any other clinical study during this study period;
- Females who are pregnant or with urine pregnancy test positive.
Trial locations and contacts
1 site in 1 country.
China1 site
Center for Disease Control and Prevention (CDC)
Kunming, Yunnan, 650000
About this study
Official title: A Phase III Clinical Trail to Evaluate the Efficacy,safety,pharmacokinetics and Immunogenicity Characteristics of GR1801 Injection for the Post-exposure Prophylaxis (PEP) of WHO Category 3 Rabies Exposure Patients.
The goal of this clinical trial is to compare the efficacy and safety of GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure.
Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug.
Read the detailed description
This is a randomized, double-blind, Human Rabies Immunoglobulin(HRIG) controlled Phase III clinical trial evaluating the efficacy, safety, pharmacokinetic and immunogenicity of GR1801 injection as a part of post-exposure prophylaxis (PEP) in patients with WHO Category 3 rabies exposure who have met all inclusion/exclusion criteria for their treatment group.
1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3: 1. The random stratification factors include time of exposure (within or beyond 24 hours), bite location (above or below the neck), and number of bites (1 or more).
All the patients should receive wound infiltration injection of GR1801 or HRIG on Study Day 0 (wound conditions should be described and recorded both before and post injection by photos, including diameter, depth, expansion treatment, etc.), and should also receive intramuscular injection of one dose of the freeze-dried rabies vaccine for human use (Vero cells) into the deltoid muscle after the infiltration injection. Patients should also be given one dose of the freeze-dried rabies vaccine for human use (Vero cells) on Study Days 3, 7, 14, and 28 respectively according to the WHO Essen regime.
Rabies virus neutralizing antibodies (RVNA) should be collected 9 times from each subject prior to administration and on Study Day1, 3, 5, 7, 14, 42, 90, 365 post administration of Study Drug. RVNA should be assayed through rapid fluorescence focus inhibition test (RFFIT). The occurrence of rabies and survival conditions should be collected through every follow-up visit.
Adverse events should be classified in accordance with solicited adverse events and unsolicited adverse events. Solicited adverse events include local adverse events (such as injection sites pain, induration, swelling, redness, rash and pruritus) and systemic adverse events (such as fever, hypersensitivity, headache, fatigue, nausea, vomiting, arthralgia and myalgia). Unsolicited adverse events are those except solicited adverse events or solicited adverse events beyond 7 days after the first administration.
Solicited adverse events should be collected 7 days after the first administration. Unsolicited adverse events should be collected in 3 months after the first administration and serious adverse events(SAE) should be collected throughout the trial.
- Conditions
- Rabies Post-exposure Prophylaxis
- Being tested
- GR1801, Human Rabies Immunoglobulin(HRIG), Rabies Vaccine
- Keywords
- Rabies, Rabies virus neutralizing antibodies, Post-exposure prophylaxis
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1801Biological
The injection solution GR1801 does not contain preservatives. The excipients include histidine/histidine hydrochloride (20mM), trehalose (90 mg/mL), disodium EDTA (0.372mg/mL) and polysorbate 80 (0.5 mg/mL). The pH value is 5.8 and each bottle contains 2mg of GR1801 protein. The packaging material is a borosilicate glass tube injection bottle (2mL) with a halogenated butyl rubber stopper for injection and an aluminum-plastic composite cap for antibiotic bottles.
Human Rabies Immunoglobulin(HRIG)Biological
The HRIG is a Chinese licensed Human Rabies Immunoglobulin produced by BOYA-BIO, which are derived from human plasma, and then purified and filled in the injectable vial form.
Rabies VaccineBiological
The Chinese licensed freeze-dried rabies vaccine produced by CHENGDA PHARMACEUTICALS for human use (Vero Cells) which is indicated for the rabies Post-exposure Prophylaxis (PEP) .
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS) | Experimental | GR1801 injections are administered by wound infiltration injection or by intramuscular injection.GR1801 injections are a bispecific monoclonal antibody that exhibit a wide spectrum of activity against various wild-type rabies strains in vitro.
Dosage form:2mg/1mL/vial, liquid, Dosage: 0.05mg/kg of GR1801 Frequency/duration: at Day 0.
Rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28. Receives: Biological: GR1801; Biological: Rabies Vaccine |
| Control Group:HRIG（BOYA-BIO）+Rabies vaccine(CHENGDA PHARMACEUTICALS) | Active comparator | HRIG is administered by wound infiltration injection or by intramuscular injection. Dosage form: 200 IU/2mL/vial, liquid, Dosage: 20 IU/kg, Frequency/duration: at Day 0.
Rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28. Receives: Biological: Human Rabies Immunoglobulin(HRIG); Biological: Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Geometric mean RVNA Concentration (accessd by Rapid Fluorescent Foci Inhibition Test(RIFFIT)) for GR1801 recipients is non-inferior to the Geometric mean RVNA Concentration for HRIG recipients on Study Day 7.
RVNA（Rabies Virus Neutralizing Antibodies） geometric mean concentration of GR1801 recipients and HRIG recipients in combination with rabies vaccines.
Measured: 7 days
To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL on Study Day 14 in GR1801 recipients is non-inferior to the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL for HRIG.
The percentage of subjects with the RVNA geometric mean concentration ≥ 0.5 IU/mL in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
Measured: 14 days
To evaluate the rabies post-exposure protection rate for GR1801 recipients is non-inferior to the protection rate for HRIG recipients on Study Day 365.
The percentage of subjects with no case of rabies death in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
Measured: 365 days
Secondary outcomes (10)
To evaluate the rabies post-exposure morbidity of GR1801 compared to HRIG within 90 days and 365 days after administration.
The percentage of subjects with probable or confirmed cases of rabies.
Measured: 365 days
To evaluate the rabies post-exposure mortality of GR1801 compared to HRIG within 90 days and 365 days after administration.
The percentage of subjects with cases of rabies death.
Measured: 365 days
To evaluate the rabies post-exposure survival rate of GR1801 compared to HRIG within 90 days and 365 days after administration.
The percentage of subjects with rabies-free survival.
Measured: 365 days
To evaluate the Geometric mean RVNA Concentration of GR1801 compared to HRIG within 1,3,5,14,42,90 and 365 days after administration.
RVNA geometric mean concentration.
Measured: 365 days
To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL of GR1801 compared to HRIG within 1,3,5,7,42,90 and 365 days after administration.
The percentage of subjects with RVNA geometric mean concentration ≥ 0.5 IU/mL.
Measured: 365 days
To evaluate the detection rate of RVNA concentration of GR1801 compared to HRIG within 1,3,5,7,14,42,90 and 365 days after administration.
The percentage of subjects whose RVNA geometric mean concentration are below the quantization limit.
Measured: 365 days
To evaluate the safety of GR1801 compared to HRIG within 365 days.
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Measured: 365 days
To evaluate the peak plasma concentration(Cmax) of GR1801 within 365 days.
The peak plasma concentration of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis.
Measured: 365 days
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 within 365 days.
The Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis.
Measured: 365 days
To evaluate the immunogenicity of GR1801 within 365 days.
To assess the anti-drug-antibodies (ADA) and neutralizing antibodies (NAb) of GR1801.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Oct 2022
- Primary completion6 Sep 2023
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rabies Post-exposure ProphylaxisStudies of the same condition, open and under way.
- 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
- Model description
- 1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the GR1801 injection group and the HRIG group based on a ratio of 3: 1. The random stratification factors include time of exposure (within or beyond 24 hours), bite location (above or below the neck), and number of bites (1 or more).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Liu, PHD, Principal investigator, Yunnan Province Center for Disease Control and Prevention (CDC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846568
- Sponsor's protocol ID
- GR1801-003
- Status last verified
- Sep 2023
- First submitted
- 6 Apr 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, He J, Zha Y, Jiang Y, Tan S, Li Q, Zhao R, Su H, Shi Y, Yang Z, Zhang S, Zhou Y, Yi X, Pu R, He X, Chang R, Ma Y, Chen Y, Yang G, Zhang Y, Yang Y, Li X, Li M, Li S, Bao W, Li T, Liu X. Comparison of Silevimig, a Novel Bispecific Anti-Rabies Monoclonal Antibody, with Human Rabies Immunoglobulin for Post-Exposure Prophylaxis: A Phase III, Randomized, Double-Blind, Non-Inferiority Trial. Clin Infect Dis. 2026 Sep 21:ciag551. doi: 10.1093/cid/ciag551. Online ahead of print.
PubMed 42764163
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trail to Evaluate the Efficacy,safety,pharmacokinetics and Immunogenicity Characteristics of GR1801 Injection for the Post-exposure Prophylaxis (PEP) of WHO Category 3 Rabies Exposure Patients.
- ClinicalTrials.gov ID
- NCT05846568
- Acronym / sponsor ID
- GR1801-003
- Conditions
- Rabies Post-exposure Prophylaxis
- Keywords
- Rabies, Rabies virus neutralizing antibodies, Post-exposure prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 6 May 2023 (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 GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure.
Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug.
Detailed description
This is a randomized, double-blind, Human Rabies Immunoglobulin(HRIG) controlled Phase III clinical trial evaluating the efficacy, safety, pharmacokinetic and immunogenicity of GR1801 injection as a part of post-exposure prophylaxis (PEP) in patients with WHO Category 3 rabies exposure who have met all inclusion/exclusion criteria for their treatment group.
1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3: 1. The random stratification factors include time of exposure (within or beyond 24 hours), bite location (above or below the neck), and number of bites (1 or more).
All the patients should receive wound infiltration injection of GR1801 or HRIG on Study Day 0 (wound conditions should be described and recorded both before and post injection by photos, including diameter, depth, expansion treatment, etc.), and should also receive intramuscular injection of one dose of the freeze-dried rabies vaccine for human use (Vero cells) into the deltoid muscle after the infiltration injection. Patients should also be given one dose of the freeze-dried rabies vaccine for human use (Vero cells) on Study Days 3, 7, 14, and 28 respectively according to the WHO Essen regime.
Rabies virus neutralizing antibodies (RVNA) should be collected 9 times from each subject prior to administration and on Study Day1, 3, 5, 7, 14, 42, 90, 365 post administration of Study Drug. RVNA should be assayed through rapid fluorescence focus inhibition test (RFFIT). The occurrence of rabies and survival conditions should be collected through every follow-up visit.
Adverse events should be classified in accordance with solicited adverse events and unsolicited adverse events. Solicited adverse events include local adverse events (such as injection sites pain, induration, swelling, redness, rash and pruritus) and systemic adverse events (such as fever, hypersensitivity, headache, fatigue, nausea, vomiting, arthralgia and myalgia). Unsolicited adverse events are those except solicited adverse events or solicited adverse events beyond 7 days after the first administration.
Solicited adverse events should be collected 7 days after the first administration. Unsolicited adverse events should be collected in 3 months after the first administration and serious adverse events(SAE) should be collected throughout the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the GR1801 injection group and the HRIG group based on a ratio of 3: 1. The random stratification factors include time of exposure (within or beyond 24 hours), bite location (above or below the neck), and number of bites (1 or more).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS) | Experimental | Biological: GR1801, Biological: Rabies VaccineGR1801 injections are administered by wound infiltration injection or by intramuscular injection.GR1801 injections are a bispecific monoclonal antibody that exhibit a wide spectrum of activity against various wild-type rabies strains in vitro. Dosage form:2mg/1mL/vial, liquid, Dosage: 0.05mg/kg of GR1801 Frequency/duration: at Day 0. Rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28. |
| Control Group:HRIG（BOYA-BIO）+Rabies vaccine(CHENGDA PHARMACEUTICALS) | Active comparator | Biological: Human Rabies Immunoglobulin(HRIG), Biological: Rabies VaccineHRIG is administered by wound infiltration injection or by intramuscular injection. Dosage form: 200 IU/2mL/vial, liquid, Dosage: 20 IU/kg, Frequency/duration: at Day 0. Rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese males or females aged 18 years or above on Study Day 0 with legal identification documents and plan to live in the local area during the study;
- WHO Category III rabies exposure；
- Those who have an armpit temperature ≤ 37.0 °C；
- Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups.
Key exclusion criteria (12 listed)
- WHO Category III rabies exposure but received wound suture treatment;
- WHO Category III rabies exposure over 72 hours;
- Previous receipt of rabies vaccination or rabies passive immunization;
- History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0;
- History of any severe allergy for vaccination;
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 |
|---|---|---|
| GR1801The injection solution GR1801 does not contain preservatives. The excipients include histidine/histidine hydrochloride (20mM), trehalose (90 mg/mL), disodium EDTA (0.372mg/mL) and polysorbate 80 (0.5 mg/mL). The pH value is 5.8 and each bottle contains 2mg of GR1801 protein. The packaging material is a borosilicate glass tube injection bottle (2mL) with a halogenated butyl rubber stopper for injection and an aluminum-plastic composite cap for antibiotic bottles. | Biological | Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS) |
| Human Rabies Immunoglobulin(HRIG)The HRIG is a Chinese licensed Human Rabies Immunoglobulin produced by BOYA-BIO, which are derived from human plasma, and then purified and filled in the injectable vial form. | Biological | Control Group:HRIG（BOYA-BIO）+Rabies vaccine(CHENGDA PHARMACEUTICALS) |
| Rabies VaccineThe Chinese licensed freeze-dried rabies vaccine produced by CHENGDA PHARMACEUTICALS for human use (Vero Cells) which is indicated for the rabies Post-exposure Prophylaxis (PEP) . | Biological | Control Group:HRIG（BOYA-BIO）+Rabies vaccine(CHENGDA PHARMACEUTICALS), Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS) |
Primary outcome
To evaluate the Geometric mean RVNA Concentration (accessd by Rapid Fluorescent Foci Inhibition Test(RIFFIT)) for GR1801 recipients is non-inferior to the Geometric mean RVNA Concentration for HRIG recipients on Study Day 7.
Time frame: 7 days
RVNA（Rabies Virus Neutralizing Antibodies） geometric mean concentration of GR1801 recipients and HRIG recipients in combination with rabies vaccines.
To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL on Study Day 14 in GR1801 recipients is non-inferior to the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL for HRIG.
Time frame: 14 days
The percentage of subjects with the RVNA geometric mean concentration ≥ 0.5 IU/mL in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
To evaluate the rabies post-exposure protection rate for GR1801 recipients is non-inferior to the protection rate for HRIG recipients on Study Day 365.
Time frame: 365 days
The percentage of subjects with no case of rabies death in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
10 secondary outcomes
To evaluate the rabies post-exposure morbidity of GR1801 compared to HRIG within 90 days and 365 days after administration.
Time frame: 365 days
To evaluate the rabies post-exposure mortality of GR1801 compared to HRIG within 90 days and 365 days after administration.
Time frame: 365 days
To evaluate the rabies post-exposure survival rate of GR1801 compared to HRIG within 90 days and 365 days after administration.
Time frame: 365 days
To evaluate the Geometric mean RVNA Concentration of GR1801 compared to HRIG within 1,3,5,14,42,90 and 365 days after administration.
Time frame: 365 days
To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL of GR1801 compared to HRIG within 1,3,5,7,42,90 and 365 days after administration.
Time frame: 365 days
To evaluate the detection rate of RVNA concentration of GR1801 compared to HRIG within 1,3,5,7,14,42,90 and 365 days after administration.
Time frame: 365 days
To evaluate the safety of GR1801 compared to HRIG within 365 days.
Time frame: 365 days
To evaluate the peak plasma concentration(Cmax) of GR1801 within 365 days.
Time frame: 365 days
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 within 365 days.
Time frame: 365 days
To evaluate the immunogenicity of GR1801 within 365 days.
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 42764163Wang X, He J, Zha Y, Jiang Y, Tan S, Li Q, Zhao R, Su H, Shi Y, Yang Z, Zhang S, Zhou Y, Yi X, Pu R, He X, Chang R, Ma Y, Chen Y, Yang G, Zhang Y, Yang Y, Li X, Li M, Li S, Bao W, Li T, Liu X. Comparison of Silevimig, a Novel Bispecific Anti-Rabies Monoclonal Antibody, with Human Rabies Immunoglobulin for Post-Exposure Prophylaxis: A Phase III, Randomized, Double-Blind, Non-Inferiority Trial. Clin Infect Dis. 2026 Sep 21:ciag551. doi: 10.1093/cid/ciag551. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Xiaoqiang Liu, PHD principal investigator
Yunnan Province Center for Disease Control and Prevention (CDC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GR1801, Human Rabies Immunoglobulin(HRIG) and Rabies Vaccine in people with Rabies Post-exposure Prophylaxis, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the Geometric mean RVNA Concentration (accessd by Rapid Fluorescent Foci Inhibition Test(RIFFIT)) for GR1801 recipients is non-inferior to the Geometric mean RVNA Concentration for HRIG recipients on Study Day 7. (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846568, which also lists 1 linked publication.
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 25 Sep 2024.