A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years

Ab&B Bio-tech Co., Ltd.JS

Status and phase: Not yet enrolling; Phase 3

Conditions: Rabies

Treatments: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Study type: Interventional

Funder types: Other

Identifiers

NCT07275645

HDCV-ZHSW-04

Details and patient eligibility

About

A total of 3,000 participants will be enrolled, stratified by age into two groups: 600 participants aged 10-17 years and 2,400 participants aged 18-60 years. Within each age group, participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five vaccination schedule groups: Essen Control Group (Group A), Essen Experimental Group (Group B), Zagreb Experimental Group (Group C), Simplified Four-Dose Group 1 (Group D), and Simplified Four-Dose Group 2 (Group E).

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged between 10 and 60 years at the time of enrollment.
• 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

a Exclusion criteria for the first dose:

• Axillary body temperature ≥37.3°C at screening.
• 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.

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);
• Participant has any other conditions that warrant discontinuation of vaccination as determined by the investigator.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,000 participants in 5 patient groups

Essen Control Group

Active Comparator group

Treatment:

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Essen Experimental Group

Experimental group

Treatment:

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Zagreb Experimental Group

Experimental group

Treatment:

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Simplified Four-Dose Group 1

Experimental group

Treatment:

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Simplified Four-Dose Group 2

Experimental group

Treatment:

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried

Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried