Rabies Post-exposure Prophylaxis
Conditions
Keywords
rabies, SYN023, pediatric
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.
Interventions
None listed
Sponsors
Synermore Biologics (Suzhou) Co., Ltd.
Peking University First Hospital
Shenzhen Second People's Hospital
Hunan Provincial People's Hospital
The University of Hong Kong-Shenzhen Hospital
University of South China Affiliated Nanhua Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rabies-free survival rate | 3 months and 1 year | 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. |
Secondary
| 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 |
Countries
China
Contacts
CONTACTXiangjun Li
Outcome results
None listed