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

NCT07275645 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Phase 3

Started

2026-02-26

Last updated

2026-10-28

Condition(s) studied

Rabies

Investigational drug(s) / intervention(s)

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

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

10 Years

Max age

60 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose. — Day 14 after the first dose.
Seroconversion rate of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose. — Day 14 after the last dose.
Incidence of adverse events within different timeframes (30 minutes, 0-7 days, 0-30 days) after each vaccine dose. — Within 30 minutes, 0-7 days, and 0-30 days after each dose
All serious adverse events (SAEs) occurring from the first dose of primary immunization to 6 months after completion of the primary immunization. — From the first dose of primary immunization to 6 months after completion

Trial sites (5)

Facility	City	Region
Qichun County Center for Disease Control and Prevention	Huanggang	Hubei
Yunyang District Center for Disease Control and Prevention	Shiyan	Hubei
Zhushan county Center for Disease control and Prevention	Shiyan	Hubei
Gucheng county Center for Disease control and Prevention	Xiangyang	Hubei
Xiangzhou District Center for Disease Control and Prevention	Xiangyang	Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07275645 on ClinicalTrials.gov ↗ ← All trials in China