Real World Evidence Study of SYN023 in Children Exposed to Rabies

A Real-World Registry Study to Evaluate Clinical Protection Outcomes Following Post-Exposure Prophylaxis With Zamerovimab and Mazorelvimab Injection in Combination With Rabies Vaccine in Pediatric With Category III Rabies Exposure

This observational study is an open-label, prospective, multi-center design. The goal is to evaluate the long-term clinical survival outcomes at 3 months and 1 year in individuals under 18 years of age with WHO Category III rabies exposure who have received real-world Post-Exposure Prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection / other passive immunization products combined with the rabies vaccine.

Participants will: (1) Have their clinical protection outcomes (rabies-free survival status) registered and evaluated on Day 90 and Day 365. (2) Have the option to provide a blood sample on Day 7 for Rabies Virus Neutralizing Antibody (RVNA) testing. (3) Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.

Study Overview

• Status: Recruiting
• Conditions: Rabies Post-exposure Prophylaxis

• Study Type: Observational
• Enrollment (Estimated): 232

Contacts and Locations

• Study Contact: Name: Xiangjun Li; Phone Number: +86 0512-8765807; Email: xjli@synermore.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University First Hospital
      • Contact: Si Liu; Phone Number: +86 13501220344; Email: DocLeo@vip.sina.com
      • Principal Investigator: Si Liu
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Second People's Hospital
      • Contact: Zhe Deng; Phone Number: +86 0755 83366388
      • Principal Investigator: Zhe Deng
    • Shenzhen, Guangdong, China
      • Recruiting
      • The University of Hong Kong - Shenzhen Hospital
      • Contact: Haibing Xiao
      • Principal Investigator: Haibing Xiao
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Xiaotong Han
      • Principal Investigator: Xiaotong Han
    • Hengyang, Hunan, China
      • Recruiting
      • Affiliated Nanhua Hospital, University of South China
      • Contact: Wenkai Bin
      • Principal Investigator: Wenkai Bin
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Provincial Chest Hospital
      • Principal Investigator: Qilong Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals under 18 years of age with category III rabies exposure who have received post-exposure prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection /other passive immunization products combined rabies vaccine in the real world

Description

Inclusion Criteria:

1. Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity;
2. Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is <7 days;
3. Have completed standardized wound management, injection of Zamerovimab and Mazorelvimab Injection /other passive immunization products, and the first dose of rabies vaccination within 24 hours prior to screening;
4. The volunteer's guardian voluntarily agrees to their participation in the study and signs the informed consent form. Specifically: for volunteers under 8 years old, the guardian signs the informed consent form with the child's assent fully respected; for volunteers aged 8-17, the guardian signs the informed consent form, and the minor volunteer signs the minor assent form;
5. Willing and able to comply with all study procedures, and is expected to be able to complete the full course of rabies vaccination and the 1-year follow-up as required (with no plans for long-term absence or relocation from the study area).

Exclusion Criteria:

1. Based on inquiry, besides the current Category III rabies exposure, there is a history of bites by dogs, cats, mongooses, foxes, ferrets, skunks, bats, or raccoons within the past year;
2. Other conditions considered by the investigator as unsuitable for participation in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
SYN023 combined with rabies vaccine
Other rabies passive immunization products combined with rabies vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rabies-free survival rate	WHO's Classification of Rabies Cases: Suspected case: refers to a case that satisfies the definition of clinical case; Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.	3 months and 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse reactions and adverse events	42 days
Incidence of serious adverse reactions and serious adverse events	126 days
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)	Day 7
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL	Day 7

Collaborators and Investigators

• Sponsor: Synermore Biologics (Suzhou) Co., Ltd.
• Collaborators: Peking University First Hospital; Hunan Provincial People's Hospital; Shenzhen Second People's Hospital; The University of Hong Kong-Shenzhen Hospital; University of South China Affiliated Nanhua Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; rabies; SYN023
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Mononegavirales Infections; Rhabdoviridae Infections; Rabies
• Other Study ID Numbers: SYN023-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No