A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
NCT ID: NCT07275645
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
3000 participants
INTERVENTIONAL
2025-12-18
2027-02-18
Brief Summary
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Among participants in the four experimental groups-Essen Experimental Group, Zagreb Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2-stratified block randomization will be applied. Within each age group and each vaccination schedule group, participants will be further randomized in a 1:1:1 ratio into three subgroups: those receiving a booster dose at Day 90 after completion of the primary immunization, those receiving a booster dose at Day 180, and those undergoing assessment of immune persistence at Day 360 after completion of the primary immunization.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Simplified Four-Dose Group 1
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7 and 14. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Simplified Four-Dose Group 2
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Essen Control Group
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28.
Essen Experimental Group
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Zagreb Experimental Group
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. Two doses will be administered on Day 0, followed by one dose each on Days 7 and 21, for a total of 4 doses. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Interventions
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Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. Two doses will be administered on Day 0, followed by one dose each on Days 7 and 21, for a total of 4 doses. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7 and 14. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 4 doses will be administered at Day 0, 3, 7, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28.
Eligibility Criteria
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Inclusion Criteria
* The participant and/or their legal guardian voluntarily agrees to participate in the trial and signs the informed consent form.
* The participant and their family are able to comply with the trial follow-up schedule as required by the protocol (no plans for extended absence or relocation from the study site).
* Female participants are neither pregnant nor lactating (negative urine pregnancy test prior to vaccination), and have no plans to become pregnant within 2 months after enrollment.
Exclusion Criteria
* History of rabies vaccination or administration of rabies-specific passive immunization products, or history of bites/scratches by dogs or other mammals within the past year.
* History of severe allergic reactions requiring medical intervention to any vaccine or vaccine components, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, Arthus reaction, severe urticaria, or angioedema.
* Fever, acute or chronic infectious diseases (e.g., active tuberculosis, viral hepatitis), or acute exacerbation of chronic illness within 3 days before the first vaccine dose.
* Receipt of blood, blood products, or immunoglobulins within 3 months prior to the first vaccine dose, or planned use of such products within 1 month after the final vaccine dose.
* Receipt of any other vaccines within 14 days prior to the first vaccine dose.
* Asplenia or functional asplenia due to any condition (e.g., splenectomy).
* Diagnosed congenital or acquired immunodeficiency (including HIV infection), or treatment with immunosuppressive agents within the past 3 months (e.g., systemic corticosteroids for ≥14 days at doses ≥2 mg/kg/day or ≥20 mg/day of prednisone or equivalent).
* Presence of severe congenital malformations, autoimmune (hereditary) diseases, or severe chronic conditions (including but not limited to: thalassemia, heart disease, kidney disease, diabetes, hereditary allergic constitution, Guillain-Barré syndrome, etc.)
* Personal or family history of convulsions, epilepsy, encephalopathy, or psychiatric disorders.
* Contraindications to intramuscular injection (e.g., diagnosed thrombocytopenia, any coagulation disorder, or current use of anticoagulant therapy).
* Uncontrolled hypertension (e.g., systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at screening for adults aged 18 years and above).
* Currently participating in another clinical trial involving investigational or unregistered products (drugs or vaccines), or planning to participate in another clinical trial before completion of this study.
* Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
* 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);
* Participant has any other conditions that warrant discontinuation of vaccination as determined by the investigator.
10 Years
60 Years
ALL
Yes
Sponsors
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Ab&B Bio-tech Co., Ltd.JS
OTHER
Responsible Party
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Locations
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Qichun County Center for Disease Control and Prevention
Huanggang, Hubei, China
Yunyang District Center for Disease Control and Prevention
Shiyan, Hubei, China
Zhushan county Center for Disease control and Prevention
Shiyan, Hubei, China
Gucheng county Center for Disease control and Prevention
Xiangyang, Hubei, China
Xiangzhou District Center for Disease Control and Prevention
Xiangyang, Hubei, China
Countries
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Central Contacts
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Other Identifiers
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HDCV-ZHSW-04
Identifier Type: -
Identifier Source: org_study_id