New rabies vaccine passes first safety check in small trial
NCT ID NCT06132789
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety of a new rabies vaccine in 80 healthy people aged 10 to 60. Participants received one of two different vaccination schedules. Researchers monitored for side effects for up to 6 months. The goal was to see if the vaccine is safe enough to move to larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rabies vaccine (human diploid cell), freeze-dried
- What this could lead to
- If successful, this could confirm a safe way to give a new rabies vaccine, potentially improving rabies prevention.
- What could go wrong
- This is a very early Phase 1 safety trial with only 80 participants. It cannot prove the vaccine works, only that it is safe enough to test further.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
80 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Aug 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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10 to 60 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: * Age at enrollment ranged from 10 to 60 years; * Subjects/subjects and their guardians voluntarily agreed to participate in the study and signed an informed consent form; * Participants and their families are permitted to participate in study follow-up visits as required by the protocol (no long-term departure or family relocation plan); * Female subjects were non-pregnant or lactating (negative urine pregnancy test before vaccination) and had no plans to get pregnant within 2 months after enrollment; * The axillary temperature was \< 37.3 ° C. Exclusion Criteria: a Exclusion criteria for the first dose: * A history of rabies vaccine and specific passive immune preparation injection, and a history of dog or other mammal bite/scratch within the past 1 year; * Those who are allergic to any component of the trial vaccine, or have had previous allergies to any component of the vaccine, or have had a history of severe allergies requiring medical intervention, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioedema, etc; * Fever (axillary temperature ≥37.3 ° C) within 3 days before the first dose of vaccination, acute or chronic infectious diseases (active tuberculosis, active viral hepatitis), or acute exacerbation of a chronic disease; * Received blood/blood-related products or immune globulin within 3 months before the first dose of vaccine, or plan to use such a product after enrollment until 1 month after the last dose of vaccine; * Vaccinate any vaccine within 14 days before the first dose of vaccine; * Asplenia or functional asplenia due to any condition (e.g., splenectomy); * Have been diagnosed with congenital or acquired immunodeficiency (HIV), or have been on immunosuppressive therapy within 3 months (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2mg/kg/ day or ≥20mg/ day of prednisone or prednisone equivalent); * Severe congenital malformations or autoimmune (hereditary) diseases, severe chronic diseases (including but not limited to thalassemia, heart disease, kidney disease, diabetes mellitus, hereditary allergies, Guillain-Barre syndrome, etc.); * People with a medical or family history of seizures, epilepsy, encephalopathy and psychosis; * Contraindications to intramuscular injection (e.g. having been diagnosed with thrombocytopenia, any coagulopathy, or receiving anticoagulant therapy); * Drug-uncontrolled hypertension, defined as pre-enrollment systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg (for adults aged 18 years and over); * Are participating in other investigational or unregistered clinical studies of products (drugs or vaccines), or plan to participate in other clinical studies before the end of this clinical study; * Patients with clinically significant abnormalities in laboratory tests such as blood routine, blood biochemistry, and urine routine could not be enrolled according to the comprehensive judgment of the investigators; * The investigator considered the subject to have any condition that might interfere with the assessment of the purpose of the study. b Exclusion criteria for subsequent doses: * Positive urine pregnancy test; * Severe anaphylaxis after the previous dose; * Grade 4 adverse events associated with trial vaccination after the previous dose; * Exposure during the course (bite or scratch from dogs, cats or other mammals); * Subject has any other conditions that warrant discontinuation of vaccination as determined by the investigator.
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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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Gucheng Center for Disease Control and Prevention
Xiangyang, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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