Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
28. maj 2026 opdateret af: Synermore Biologics (Suzhou) Co., Ltd.
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
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.
- The study primarily aims to assess:
- The 3-month rabies-free survival rate following PEP initiation.
- 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This prospective, multicenter registry study evaluates the real-world deployment, clinical protection, and safety profile of zamerovimab and mazorelvimab injection (ZM cocktail)- containing two non-overlapping human monoclonal antibodies-in community emergency settings.
Rabies presents a near 100% case-fatality rate upon symptom onset, making immediate and high-potency passive immunization essential during the active-vaccine immunity window (Days 0-7).
Recent regional epidemic resurgences underscore the public health urgency of handling single-dog multiple-bite clusters, where furious rabid animals carry high viral loads and inflict multiple deep lesions.Approximately 80 patients receiving routine post-exposure care will be enrolled.
Participants will receive standard-of-care wound debridement, anatomical infiltration of the ZM cocktail, and a full rabies vaccine regimen.
Joining this registry involves no additional clinical interventions beyond standard medical care; investigators will actively maintain follow-up contacts at 3 months and 1 year to document survival outcomes.
Concurrently, trapped offending dogs will undergo molecular verification via reverse transcription polymerase chain reaction (RT-PCR) and next-generation sequencing (NGS) to map localized viral ecology, providing crucial real-world data to optimize outbreak emergency response frameworks.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
80
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Henan
-
Nanyang, Henan, Kina, 473000
- The Disease Prevention and Control Center of Nanyang
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
People aged 18 or older who were bitten by a dog that also bit others, have a serious (Grade III) rabies exposure, and already received wound cleaning, the antibody injection, and the first rabies shot within 24 hours can join.
Beskrivelse
Inclusion Criteria:
- Adults aged $\ge 18$ years at the time of screening.
- Sustained a verified WHO Grade III rabies exposure from a traceable offending dog involved in a multi-person canine attack incident (defined as a single animal attacking multiple individuals within a clustered timeframe/location) in Nanyang City.
- Time interval from Grade III exposure to post-exposure prophylaxis (PEP) initiation is less than 7 days.
- Successfully completed standard wound debridement, anatomical infiltration of zamerovimab/mazorelvimab injection (0.3 mg/kg single full dose), and the first dose of rabies vaccine within 24 hours prior to screening.
- Voluntarily provides signed written informed consent.
- Patient is willing and able to comply with all sequential follow-up procedures (including serum collections if applicable) and intends to reside locally for the full 1-year study duration.
Exclusion Criteria:
- Documented history of any separate animal bite or scratch (e.g., dog, cat, bat, or wild carnivore) within the past 12 months prior to the current exposure.
- Documented complete pre-exposure or post-exposure rabies vaccination history within the past 12 months.
- Concurrent presentation with life-threatening traumatic injuries requiring intensive care, or severe systemic immunodeficiency disorders that could impede immunogenicity or follow-up compliance.
- Any other clinical or psychological condition deemed by the investigator as unsuitable for safe participation or reliable data registry.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Grade III rabies exposure cohort
Adults (≥18 years) who sustained verified WHO Grade III rabies exposure from a traceable dog involved in a tracked multi-person attack incident, and who initiated standardized PEP within the protocolized window.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
3-month rabies-free survival rate
Tidsramme: 90 days (±3 days) post-enrollment
|
The proportion of participants alive and free of clinical rabies symptoms at 90 days following post-exposure prophylaxis (PEP) initiation.
|
90 days (±3 days) post-enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
1-year rabies-free survival rate
Tidsramme: 365 days (±7 days) post-enrollment
|
The proportion of participants alive and free of clinical rabies symptoms at 1 year following post-exposure prophylaxis (PEP) initiation.
|
365 days (±7 days) post-enrollment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. juni 2025
Primær færdiggørelse (Faktiske)
31. marts 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
28. maj 2026
Først indsendt, der opfyldte QC-kriterier
28. maj 2026
Først opslået (Faktiske)
3. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SYN023-RWE-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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