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

A Phase III, Randomized, Blinded, and Homologous Vaccine-Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Rabies Vaccine (Human Diploid Cell), Freeze-dried, Vaccinated With Different Immunization Schedules in a Population Aged 10 to 60 Years

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rabies
• Intervention / 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

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Huanggang, Hubei, China
      • Qichun County Center for Disease Control and Prevention
    • Shiyan, Hubei, China
      • Yunyang District Center for Disease Control and Prevention
    • Shiyan, Hubei, China
      • Zhushan county Center for Disease control and Prevention
    • Xiangyang, Hubei, China
      • Gucheng county Center for Disease control and Prevention
    • Xiangyang, Hubei, China
      • Xiangzhou District Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Essen Control Group	Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.
Experimental: Essen Experimental Group	Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.
Experimental: Zagreb Experimental Group	Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.
Experimental: Simplified Four-Dose Group 1	Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.
Experimental: Simplified Four-Dose Group 2	Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.; Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose.	Day 14 after the last dose
Comparison of seroconversion rates and GMCs among baseline seronegative participants in the Essen Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2 at Days 28 and 42 after the first dose.	Days 28 and 42 after the first dose
Comparison of seroconversion rates and GMCs in baseline seronegative participants between the Essen Experimental Group and the Zagreb Experimental Group at Day 7 after the first dose.	Day 7 after the first dose

Other Outcome Measures

Outcome Measure	Time Frame
Seropositivity rate and GMC of rabies virus neutralizing antibodies in a subset of participants at 90 days, 180 days, and 360 days after completion of the primary immunization.	90, 180, and 360 days post-primary immunization
Seropositivity rate and GMC in a subset of participants at 14, 42, 90, and 180 days after the first dose of re-exposure immunization.	14, 42, 90, and 180 days after re-exposure immunization

Collaborators and Investigators

• Sponsor: Ab&B Bio-tech Co., Ltd.JS

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): April 26, 2026
• Study Completion (Estimated): April 26, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rabies; Rabies vaccine
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Mononegavirales Infections; Rhabdoviridae Infections; Rabies
• Other Study ID Numbers: HDCV-ZHSW-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No