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NCT07624461

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

Sponsor: Synermore Biologics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: Post-Exposure Prophylaxis Outcome of Zamerovimab and Mazorelvimab Injection and Rabies Vaccine in Grade III Rabies Exposure Cases From Single-Dog Multiple-Bite Incidents: A Real-World Prospective Study

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2025-06-06

Completion Date

2026-12

Last Updated

2026-06-03

Healthy Volunteers

No

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.

Locations (1)

The Disease Prevention and Control Center of Nanyang

Nanyang, Henan, China