Real World Evidence Study of SYN023 in Children Exposed to Rabies

NCT07327307 | Recruiting

• 1 other identifier: SYN023-008
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Rabies Post-exposure Prophylaxis

Keywords

rabies; SYN023; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

SYN023 combined with rabies vaccine

Other rabies passive immunization products combined with rabies vaccine

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity;
• Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is \<7 days;
• 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;
• 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;
• 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).

You may not qualify if:

• 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;
• Other conditions considered by the investigator as unsuitable for participation in this study.

Sponsors & Collaborators

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

Study Sites (6)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Shenzhen second people's hospital

Shenzhen, Guangdong, China

RECRUITING

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

RECRUITING

Affiliated Nanhua Hospital, University of South China

Hengyang, Hunan, China

RECRUITING

Jiangxi Provincial Chest Hospital

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Xiangjun Li

CONTACT

+86 0512-8765807; xjli@synermore.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: August 2, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (6)