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Active, not recruitingNCT07624461Updated Jun 11, 2026

Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang

An observational study in Rabies Post-exposure Prophylaxis and Rabies, sponsored by Synermore Biologics (Suzhou) Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Synermore Biologics (Suzhou) Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.

  1. The study primarily aims to assess:
  2. The 3-month rabies-free survival rate following PEP initiation.
  3. 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.

Read the detailed description

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.

02

Conditions studied

  • Rabies Post-exposure Prophylaxis
  • Rabies

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Keywords

  • Single-dog Multiple-bite Incidents
  • Grade III rabies exposures
03

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

Browse Rabies studies →

Lead sponsor

Synermore Biologics (Suzhou) Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults aged ≥18 years at the time of screening.
  2. 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.
  3. Time interval from Grade III exposure to post-exposure prophylaxis (PEP) initiation is less than 7 days.
  4. 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.
  5. Voluntarily provides signed written .
  6. 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

Exclusion Criteria:

  1. 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.
  2. Documented complete pre-exposure or post-exposure rabies vaccination history within the past 12 months.
  3. Concurrent presentation with life-threatening traumatic injuries requiring intensive care, or severe systemic immunodeficiency disorders that could impede immunogenicity or follow-up compliance.
  4. Any other clinical or psychological condition deemed by the investigator as unsuitable for safe participation or reliable data registry.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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.

    Drug: Zamerovimab and Mazorelvimab Injection plus Rabies Vaccine

Interventions

  • DrugZamerovimab and Mazorelvimab Injection plus Rabies Vaccine

    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.

06

What researchers measure

Primary outcomes

  1. 3-month rabies-free survival rate

    The proportion of participants alive and free of clinical rabies symptoms at 90 days following post-exposure prophylaxis (PEP) initiation.

    Time frame: 90 days (±3 days) post-enrollment

Secondary outcomes

  1. 1-year rabies-free survival rate

    The proportion of participants alive and free of clinical rabies symptoms at 1 year following post-exposure prophylaxis (PEP) initiation.

    Time frame: 365 days (±7 days) post-enrollment

07

Study locations

1 site
  • The Disease Prevention and Control Center of Nanyang
    Nanyang, Henan 473000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2025 to primary completion in Mar 2026, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2026
First posted
Jun 3, 2026
StartActual
Jun 6, 2025
Primary completionActual
Mar 31, 2026
CompletionEst.
Dec 2026
Last update
Jun 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07624461
Lead sponsor
Synermore Biologics (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Jun 6, 2025
Primary completion
Mar 31, 2026
Completion
Dec 2026 (estimated)
Last update
Jun 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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