New rabies antibody shot tested in kids – could replace current treatment?
NCT ID NCT07342257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new combination of lab-made antibodies (SYN023) given alongside the rabies vaccine to healthy children under 18. The goal was to see if it is safe and how well it works compared to the standard treatment. A total of 108 children received either a low or high dose of SYN023 or the usual rabies immune globulin, plus the vaccine over 28 days. The trial is now complete, and results will help decide if larger studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Zamerovimab and Mazorelvimab injection (SYN023), a combination of two lab-made antibodies
- What this could lead to
- If successful, this could provide a safer or more effective option for preventing rabies after an animal bite in children.
- What could go wrong
- This is an early Phase 1 trial with only 108 participants, so safety and effectiveness are not yet proven. The results may not apply to all children or real-world bite scenarios.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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108 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Under 18 years of age at enrollment, male or female, with legal identification available. 2. Legal guardians of the volunteers voluntarily agree to participate in the study and sign the Informed Consent Form (ICF). Specifically, for volunteers under 8 years old, ICF is signed by legal guardians while fully respecting the child's opinion; for volunteers aged 8-17 years, legal guardians sign the ICF while volunteers themselves sign the ICF for minor volunteers; 3. Willing and able to comply with all study procedures, expected to be able to complete all follow-up visits and maintain contact throughout the study period; 4. Female volunteers of childbearing potential must have a negative urine pregnancy test prior to investigational product/vaccine administration, be non-lactating, and agree to use effective contraception during the study; 5. In good general health with normal physical examination findings, vital signs measurements, and axillary temperature ≤ 37.0℃. Exclusion Criteria: 1. Subjects with history of injection of rabies vaccine and/or rabies virus passive immunization agents such as equine immunoglobulin, equine purified F (ab') 2 fragment products and HRIG; 2. Subjects with history of being bitten by a dog, cat, ferret, fox, ferret, skunk, bat or raccoon (wound with skin damage) in the past 6 months; 3. Subjects who have had pyrexia (≥ 37.3℃) or other acute illness within 7 days before enrollment, or are in acute exacerbation of chronic diseases; 4. History or current presence of any autoimmune or immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, HIV infection, etc.); 5. Subjects with loss of splenic function or functional impairment, such as asplenia due to any condition (e.g., splenectomy); 6. Subjects with a history of severe allergy to previous vaccination requiring medical intervention, such as generalized urticaria, allergic laryngeal edema, Henoch-Schonlein purpura, local allergic necrosis reaction (Arthus reaction), angioneurotic edema and anaphylactic shock; or known hypersensitivity to any component contained in the investigational products/vaccine; 7. History or current presence of any systemic disease or poorly controlled chronic condition that may interfere with safety or efficacy evaluations as determined by the investigator, including but not limited to hematologic disorders, hepatic/renal diseases, gastrointestinal disorders, respiratory diseases, malignancies, or history of major organ transplantation, etc.; 8. History or current presence of severe neurological disorders (e.g., epilepsy, convulsions or seizures \[excluding febrile seizures\], encephalopathy) or psychiatric illness, or family history of psychiatric disorders; 9. Presence of coagulation abnormalities (e.g., coagulation factor deficiency, platelet disorders); 10. Administration of immunoglobulins or blood products within 3 months prior to enrollment, or planned use during the study; 11. Receipt of systemic immunosuppressants or other immunomodulatory therapies within 3 months prior to enrollment, including but not limited to systemic corticosteroids (e.g., prednisone ≥ 2 mg/kg/day for \> 2 weeks), or cytotoxic therapy, or planned administration during the trial; 12. Participation in other clinical trials within 3 months prior to enrollment, or planned participation during the study; 13. Administration of live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment; 14. Presence of skin lesions, inflammation, ulcers, rashes, or scars at the intended injection site that may interfere with administration or local reaction assessment; 15. Any other condition considered by the investigator to render the participant unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yuping Dong Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, 554000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.