Real World Evidence Study of SYN023 in Children Exposed to Rabies

Официальное название

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

Обзор

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.

Первичные конечные точки

• Rabies-free survival rate [Срок оценки: 3 months and 1 year]

Вторичные конечные точки (4)

• Incidence of adverse reactions and adverse events [Срок оценки: 42 days]
• Incidence of serious adverse reactions and serious adverse events [Срок оценки: 126 days]
• Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) [Срок оценки: Day 7]
• Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL [Срок оценки: Day 7]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 6 центров

• Peking University First Hospital — Пекин
• Shenzhen second people's hospital — Шэньчжэнь
• The University of Hong Kong - Shenzhen Hospital — Шэньчжэнь
• Hunan Provincial People's Hospital — Чанша
• Affiliated Nanhua Hospital, University of South China — Hengyang
• Jiangxi Provincial Chest Hospital — Nanchang

Идентификаторы

NCT: NCT07327307 · SYN023-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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