RabiesPreventionPhase 1NCT07338786
A Phase I Clinical Trial to Evaluate the Safety of Different Immunization Schedules of a Lyophilized Human Rabies Vaccine (Human Diploid Cell)
A Phase 1 study testing Lyophilized Human Rabies Vaccine (Human Diploid Cell) in people with RabiesPrevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- RabiesPrevention
- What is being tested?
- Lyophilized Human Rabies Vaccine (Human Diploid Cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2025to May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
- Conditions
- RabiesPrevention
- Being tested
- Lyophilized Human Rabies Vaccine (Human Diploid Cell)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized Human Rabies Vaccine (Human Diploid Cell)Drug
Each human dose is 0.5 ml.
| Study group | Role | What they receive |
|---|---|---|
| Lyophilized Human Rabies Vaccine (Human Diploid Cell) | Experimental | Not described Receives: Drug: Lyophilized Human Rabies Vaccine (Human Diploid Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints
Incidence of Adverse Events within 30 Days After last Vaccination
Measured: within 30 Days After last Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start13 Sep 2025
- Primary completion4 Jan 2026
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesPreventionStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338786
- Sponsor's protocol ID
- B1901-F20230313-1
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07338786
- Acronym / sponsor ID
- B1901-F20230313-1
- Conditions
- RabiesPrevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2025 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lyophilized Human Rabies Vaccine (Human Diploid Cell) | Experimental | Drug: Lyophilized Human Rabies Vaccine (Human Diploid Cell) |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized Human Rabies Vaccine (Human Diploid Cell)Each human dose is 0.5 ml. | Drug | Lyophilized Human Rabies Vaccine (Human Diploid Cell) |
Primary outcome
Safety Endpoints
Time frame: within 30 Days After last Vaccination
Incidence of Adverse Events within 30 Days After last Vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lyophilized Human Rabies Vaccine (Human Diploid Cell) in people with RabiesPrevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints (time frame: within 30 Days After last Vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.