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NCT07624461
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Conditions: Rabies Post-exposure Prophylaxis, Rabies
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 80
Sponsor: Synermore Biologics (Suzhou) Co., Ltd.
Location: The Disease Prevention and Control Center of Nanyang Nanyang Henan
Summary
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.
1. The study primarily aims to assess:
2. The 3-month rabies-free survival rate following PEP initiation.
3. The 1-year long-term rabies-free survival rate.
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.
Eligibility Criteria
Inclusion Criteria:
1. Adults aged $\\ge 18$ years at the time of screening.
2. Sustained a verified WHO Grade III rabies exposure from a traceable offending dog involved in a multi-person canine attack incident (defined as a single animal attacking multiple individuals within a clustered timeframe/location) in Nanyang City.
3. Time interval from Grade III exposure to post-exposure prophylaxis (PEP) initiation is less than 7 days.
4. Successfully completed standard wound debridement, anatomical infiltration of zamerovimab/mazorelvimab injection (0.3 mg/kg single full dose), and the first dose of rabies vaccine within 24 hours prior to screening.
5. Voluntarily provides signed written informed consent.
6. Patient is willing and able to comply with all sequential follow-up procedures (including serum collections if applicable) and intends to reside locally for the full 1-year study duration.
Exclusion Criteria:
1. Documented history of any separate animal bite or scratch (e.g., dog, cat, bat, or wild carnivore) within the past 12 months prior to the current exposure.
2. Documented complete pre-exposure or post-exposure rabies vaccination history within the past 12 months.
3. Concurrent presentation with life-threatening traumatic injuries requiring intensive care, or severe systemic immunodeficiency disorders that could impede immunogenicity or follow-up compliance.
4. Any other clinical or psychological condition deemed by the investigator as unsuitable for safe participation or reliable data registry.
Source: ClinicalTrials.gov (NCT07624461). StuddyBuddy aggregates publicly available trial information.
