A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)

A Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered Via Different Immunization Schedules Using a Randomized, Blinded, Positive-Controlled Design

Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization.

The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group

Study Overview

• Status: Enrolling by invitation
• Conditions: Rabies Prevention
• Intervention / Treatment: Biological: Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell); Biological: approved Rabies vaccine

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

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Neijiang, Sichuan, China
      • sichuan CDC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants aged 10 to 60 years old;
• Able to obtain informed consent from the participants themselves and/or their guardians;
• The participants themselves and/or their guardians are able to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

• Axillary temperature >37.0°C on the day of vaccination;
• History of rabies vaccination or administration of rabies virus passive immunization preparations;
• History of bites or scratches (with broken skin) by dogs or other mammals within 1 year before the first vaccination;
• Suffering from an acute illness or acute exacerbation of a chronic disease within 3 days before the first vaccination;
• Positive urine pregnancy test result or lactation in female participants of childbearing age, or pregnancy planning for female participants of childbearing age, male participants and their female sexual partners from the start of the trial until 6 months after the completion of the full vaccination course;
• History of severe allergies requiring medical intervention or severe adverse reactions to vaccines (such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrotizing reaction (Arthus reaction), angioedema, etc.), or allergy to any component of the investigational vaccine, such as human albumin, dextran 40, sucrose, glycine, disodium hydrogen phosphate, potassium dihydrogen phosphate;
• Known or suspected malignant tumor, autoimmune disease, immunodeficiency or immunosuppression (e.g., human immunodeficiency virus (HIV) infection, organ transplantation, systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.);
• Use of immunosuppressive agents and/or immunomodulators (e.g., systemic glucocorticoids, targeted immunomodulators used continuously for more than 14 days), cytotoxic therapy, etc., within 6 months before the first vaccination or planned long-term use thereof;
• Congenital malformations or developmental disorders affecting organ function, hypertension not effectively controlled by medication (only for those aged 18-60 years) [systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite maintenance medication], severe liver and kidney diseases (severe cases, e.g., complicated with diabetes), etc.;
• Contraindications to intramuscular injection, such as local infection or skin lesions at the injection site, severe thrombocytopenia, abnormal coagulation function or history of coagulation disorders;
• History or family history of mental and neurological diseases such as convulsions, epilepsy, encephalopathy and psychosis;
• Received blood products or immunoglobulin products within the past 3 months or planned to use them during the trial;
• Received other investigational medicinal products within 1 month before administration of the investigational vaccine or are currently participating in other clinical trials;
• Received live attenuated vaccines within 14 days before enrollment, or subunit or inactivated vaccines within 7 days before enrollment;
• Other conditions that the investigator considers may affect the trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCHT rabies vaccine; Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)	Biological: Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell); Dosage schedule: Five-dose regimen: one dose on days 0, 3, 7, 14, and 28 respectively; 2-1-1 regimen: administration on days 0, 7, and 21, with 2 doses on day 0 and 1 dose on each of the other days; Simplified four-dose regimen: one dose on days 0, 3, 7, and 14, or one dose on days 0, 3, 7, and 28 respectively.
Active Comparator: Approved rabies vaccine; Approved Lyophilized Human Rabies Vaccine (Human Diploid Cell)	Biological: approved Rabies vaccine; One dose shall be administered on days 0, 3, 7, 14, and 28 respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neutralizing antibodies after the first dose	Seroconversion rate and geometric mean concentration of neutralizing antibodies	14 days and 42 day after the first dose

Collaborators and Investigators

• Sponsor: Changchun BCHT Biotechnology Co.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): March 25, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B1901-F20230313-2

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