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

NCT07624461 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-06-11

No results posted yet for this 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.

Conditions

  • Rabies Post-exposure Prophylaxis
  • Rabies

Interventions

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.

Sponsors & Collaborators

  • Synermore Biologics (Suzhou) Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2026-03-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624461 on ClinicalTrials.gov