An observational study in Rabies Post-exposure Prophylaxis and Rabies, sponsored by Synermore Biologics (Suzhou) Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Synermore Biologics (Suzhou) Co., Ltd. · Observational
The objective of this real-world, prospective observational study is to evaluate the clinical effectiveness of zamerovimab and mazorelvimab injection (a human rabies monoclonal antibody cocktail) administered in combination with a standard rabies vaccine for post-exposure prophylaxis (PEP) in individuals with WHO Grade III rabies exposure in Nanyang City, China.
The rabies virus (RABV) carrying rate and genomic epidemiology among offending dogs involved in single-dog multiple-bite incidents.
Eligible participants aged 18 years or older who have sustained a Grade III exposure from a tracked multi-person canine attack event, and have completed wound debridement and initial passive/active immunization within 24 hours prior to screening, will be followed for up to 1 year via telephone or clinic visits to monitor clinical survival.
This prospective, multicenter registry study evaluates the real-world deployment, clinical protection, and safety profile of zamerovimab and mazorelvimab injection (ZM cocktail)- containing two non-overlapping human monoclonal antibodies-in community emergency settings. Rabies presents a near 100% case-fatality rate upon symptom onset, making immediate and high-potency passive immunization essential during the active-vaccine immunity window (Days 0-7). Recent regional epidemic resurgences underscore the public health urgency of handling single-dog multiple-bite clusters, where furious rabid animals carry high viral loads and inflict multiple deep lesions.Approximately 80 patients receiving routine post-exposure care will be enrolled. Participants will receive standard-of-care wound debridement, anatomical infiltration of the ZM cocktail, and a full rabies vaccine regimen. Joining this registry involves no additional clinical interventions beyond standard medical care; investigators will actively maintain follow-up contacts at 3 months and 1 year to document survival outcomes. Concurrently, trapped offending dogs will undergo molecular verification via reverse transcription polymerase chain reaction (RT-PCR) and next-generation sequencing (NGS) to map localized viral ecology, providing crucial real-world data to optimize outbreak emergency response frameworks.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
Browse Rabies studies →Synermore Biologics (Suzhou) Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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People aged 18 or older who were bitten by a dog that also bit others, have a serious (Grade III) rabies exposure, and already received wound cleaning, the antibody injection, and the first rabies shot within 24 hours can join.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults (≥18 years) who sustained verified WHO Grade III rabies exposure from a traceable dog involved in a tracked multi-person attack incident, and who initiated standardized PEP within the protocolized window.
Drug: Zamerovimab and Mazorelvimab Injection plus Rabies Vaccine
Standard-of-care wound debridement, followed by anatomical infiltration of zamerovimab/mazorelvimab injection at a single dose of 0.3 mg/kg around the wound sites on Day 0, combined with a standard intramuscular rabies vaccine regimen.
3-month rabies-free survival rate
The proportion of participants alive and free of clinical rabies symptoms at 90 days following post-exposure prophylaxis (PEP) initiation.
Time frame: 90 days (±3 days) post-enrollment
1-year rabies-free survival rate
The proportion of participants alive and free of clinical rabies symptoms at 1 year following post-exposure prophylaxis (PEP) initiation.
Time frame: 365 days (±7 days) post-enrollment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Mar 2026, 9 months.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Synermore Biologics (Suzhou) Co., Ltd.