Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• 3-month rabies-free survival rate — 90 days (±3 days) post-enrollment
  The proportion of participants alive and free of clinical rabies symptoms at 90 days following post-exposure prophylaxis (PEP) initiation.

Trial sites (1)

More Synermore Biologics (Suzhou) Co., Ltd. trials in China

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