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

NCT07275645 | Active Not Recruiting Phase 3

• 1 other identifier: HDCV-ZHSW-04
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Rabies

Keywords

Rabies; Rabies vaccine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (5)

Essen Control Group

ACTIVE COMPARATOR

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

Essen Experimental Group

EXPERIMENTAL

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

Zagreb Experimental Group

EXPERIMENTAL

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

Simplified Four-Dose Group 1

EXPERIMENTAL

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

Simplified Four-Dose Group 2

EXPERIMENTAL

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

Interventions

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

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.

Essen Experimental Group

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Positive urine pregnancy test；

Sponsors & Collaborators

• Ab&B Bio-tech Co., Ltd.JS: lead

Study Sites (5)

Qichun County Center for Disease Control and Prevention

Huanggang, Hubei, China

Location

Yunyang District Center for Disease Control and Prevention

Shiyan, Hubei, China

Location

Zhushan county Center for Disease control and Prevention

Shiyan, Hubei, China

Location

Gucheng county Center for Disease control and Prevention

Xiangyang, Hubei, China

Location

Xiangzhou District Center for Disease Control and Prevention

Xiangyang, Hubei, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: February 26, 2026
• Primary Completion: April 26, 2026
• Study Completion (Estimated): April 26, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)