A Phase I Clinical Trial to Evaluate the Safety of Different Immunization Schedules of a Lyophilized Human Rabies Vaccine (Human Diploid Cell)

January 4, 2026 updated by: Changchun BCHT Biotechnology Co.

A Single-Center, Open-Label, Single-Arm, Phase I Clinical Trial to Evaluate the Safety of a Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered in Different Immunization Schedules.

This clinical trial employed a single-center, open-label, single-arm design. A total of 80 participants aged 10 to 60 years were enrolled and divided into two age groups: 40 in the 18-60 years cohort and 40 in the 10-17 years cohort. All participants received the lyophilized human rabies vaccine (human diploid cell)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Jiangsu CDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants aged 10 to 60 years;
  • Informed consent can be obtained from the participant and/or their guardian;
  • The participant and/or guardian 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 use of rabies virus passive immunization preparations
  • History of dog or other mammalian bites or scratches (with skin laceration) within 1 year prior to the first vaccination
  • Abnormalities in laboratory tests such as complete blood count (CBC), blood biochemistry, and urinalysis before the first vaccination are clinically significant and cannot be excluded based on the investigator's comprehensive assessment.
  • Suffering from acute illness or acute exacerbation of chronic disease within 3 days prior to the first vaccination
  • Urinary pregnancy test results were positive in female participants of childbearing age, or they were in the lactation period, or female participants of childbearing age, male participants, or their partners had fertility plans during the trial period.
  • History of severe allergic reactions requiring medical intervention or severe adverse reactions to vaccines (e.g., severe urticaria, anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, localized allergic necrotic reaction (Arthus reaction), angioedema, etc.), or allergy to any component of the trial vaccine, such as human serum albumin, dextran 40, sucrose, glycine, disodium hydrogen phosphate, or potassium dihydrogen phosphate.
  • Known or suspected malignancy, autoimmune disease, immunodeficiency, or immunosuppression (e.g., human immunodeficiency virus (HIV) infection, organ transplantation, systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.)
  • Within 6 months prior to the first dose or with a planned long-term use of immunosuppressants and/or immunomodulators (e.g., systemic glucocorticoids, continuous use of targeted immunomodulators for more than 14 days), cytotoxic therapy, etc.
  • Patients with congenital malformations or developmental disorders affecting organ function, uncontrolled hypertension (limited to 18-60 years of age) [maintained with medication at systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg], severe hepatic or renal diseases (critical cases, e.g., with concomitant diabetes), etc.
  • Contraindications to intramuscular injection, such as local infection or skin lesions at the injection site, severe thrombocytopenia, coagulation dysfunction, or a history of coagulation disorders
  • History or family history of psychiatric and neurological disorders such as convulsions, epilepsy, encephalopathy, and psychosis
  • Individuals who have received or plan to use blood products or immunoglobulin products during the trial period within the past 3 months
  • Received other investigational drugs within 1 month prior to trial vaccine administration or was participating in other clinical trials
  • Received a live attenuated vaccine within 14 days prior to enrollment, or a subunit or inactivated vaccine within 7 days prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lyophilized Human Rabies Vaccine (Human Diploid Cell)
Drug: Lyophilized Human Rabies Vaccine (Human Diploid Cell)
Each human dose is 0.5 ml.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Endpoints
Time Frame: within 30 Days After last Vaccination
Incidence of Adverse Events within 30 Days After last Vaccination
within 30 Days After last Vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changchun BCHT Biotechnology Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1901-F20230313-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lyophilized Human Rabies Vaccine (Human Diploid Cell)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings