RabiesPhase 1NCT06132789
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10-60 Years
A Phase 1 study testing Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in people with Rabies, run by Ab&B Bio-tech Co., Ltd.JS at 1 site in China.
Trial summary
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 16 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age at enrollment ranged from 10 to 60 years；
- Subjects/subjects and their guardians voluntarily agreed to participate in the study and signed an informed consent form;
- Participants and their families are permitted to participate in study follow-up visits as required by the protocol (no long-term departure or family relocation plan)；
- Female subjects were non-pregnant or lactating (negative urine pregnancy test before vaccination) and had no plans to get pregnant within 2 months after enrollment；
- The axillary temperature was < 37.3 ° C.
Who cannot join
- a Exclusion criteria for the first dose:
- A history of rabies vaccine and specific passive immune preparation injection, and a history of dog or other mammal bite/scratch within the past 1 year;
- Those who are allergic to any component of the trial vaccine, or have had previous allergies to any component of the vaccine, or have had a history of severe allergies requiring medical intervention, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioedema, etc;
- Fever (axillary temperature ≥37.3 ° C) within 3 days before the first dose of vaccination, acute or chronic infectious diseases (active tuberculosis, active viral hepatitis), or acute exacerbation of a chronic disease;
- Received blood/blood-related products or immune globulin within 3 months before the first dose of vaccine, or plan to use such a product after enrollment until 1 month after the last dose of vaccine;
- Vaccinate any vaccine within 14 days before the first dose of vaccine;
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- Asplenia or functional asplenia due to any condition (e.g., splenectomy);
- Have been diagnosed with congenital or acquired immunodeficiency (HIV), or have been on immunosuppressive therapy within 3 months (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2mg/kg/ day or ≥20mg/ day of prednisone or prednisone equivalent);
- Severe congenital malformations or autoimmune (hereditary) diseases, severe chronic diseases (including but not limited to thalassemia, heart disease, kidney disease, diabetes mellitus, hereditary allergies, Guillain-Barre syndrome, etc.);
- People with a medical or family history of seizures, epilepsy, encephalopathy and psychosis;
- Contraindications to intramuscular injection (e.g. having been diagnosed with thrombocytopenia, any coagulopathy, or receiving anticoagulant therapy);
- Drug-uncontrolled hypertension, defined as pre-enrollment systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg (for adults aged 18 years and over);
- Are participating in other investigational or unregistered clinical studies of products (drugs or vaccines), or plan to participate in other clinical studies before the end of this clinical study;
- Patients with clinically significant abnormalities in laboratory tests such as blood routine, blood biochemistry, and urine routine could not be enrolled according to the comprehensive judgment of the investigators;
- The investigator considered the subject to have any condition that might interfere with the assessment of the purpose of the study.
- 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);
- Subject has any other conditions that warrant discontinuation of vaccination as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-arm, Phase Ⅰ Clinical Trial to Evaluate the Safety of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried Vaccinated With Different Immunization Schedule in People Aged 10-60 Years
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies.
Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.
- Conditions
- Rabies
- Being tested
- Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedBiological
This vaccine（1.0ml） is produced by Ab\&b Biotechnology Co., Ltd.JS. Subjects will receive the Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried vaccinated by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Essen Experimental Group (18-60 years old) | Experimental | The subjects received 1 dose of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, 14 and 28, with a total of 5 doses Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Essen Experimental Group (10-17 years old) | Experimental | The subjects received 1 dose of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, 14 and 28, with a total of 5 doses Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Zagreb Experimental Group (18-60 years old) | Experimental | The subjects received 2 doses of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried on day 0, 1 dose on day 7 and 1 dose on day 21, a total of 4 doses. Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Zagreb Experimental Group (10-17 years old) | Experimental | The subjects received 2 doses of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried on day 0, 1 dose on day 7 and 1 dose on day 21, a total of 4 doses. Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of adverse events/reactions within 1 month from the first dose to full immunization;
The occurrence of adverse events/reactions within 1 month from the first dose to full immunization;
Measured: Within 1 month from the first dose to full immunization
The occurrence of serious adverse events/reactions within 6 month from the first dose to full immunization;
The occurrence of serious adverse events/reactions within 6 month from the first dose to full immunization;
Measured: Within 6 month from the first dose to full immunization
The abnormal occurrence of laboratory indicators (blood biochemistry, blood routine and urine routine) 3 days after the first dose of vaccination
The abnormal occurrence of laboratory indicators (blood biochemistry, blood routine and urine routine) 3 days after the first dose of vaccination
Measured: 3 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start27 Nov 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Xianfeng Zhang, Master, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132789
- Sponsor's protocol ID
- HDCV-ZHSW-03
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-arm, Phase Ⅰ Clinical Trial to Evaluate the Safety of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried Vaccinated With Different Immunization Schedule in People Aged 10-60 Years
- ClinicalTrials.gov ID
- NCT06132789
- Acronym / sponsor ID
- HDCV-ZHSW-03
- Conditions
- Rabies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 15 Nov 2023 (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.
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies.
Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Essen Experimental Group (18-60 years old) | Experimental | Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe subjects received 1 dose of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, 14 and 28, with a total of 5 doses |
| Essen Experimental Group (10-17 years old) | Experimental | Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe subjects received 1 dose of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, 14 and 28, with a total of 5 doses |
| Zagreb Experimental Group (18-60 years old) | Experimental | Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe subjects received 2 doses of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried on day 0, 1 dose on day 7 and 1 dose on day 21, a total of 4 doses. |
| Zagreb Experimental Group (10-17 years old) | Experimental | Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe subjects received 2 doses of 1mL Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried on day 0, 1 dose on day 7 and 1 dose on day 21, a total of 4 doses. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age at enrollment ranged from 10 to 60 years；
- Subjects/subjects and their guardians voluntarily agreed to participate in the study and signed an informed consent form;
- Participants and their families are permitted to participate in study follow-up visits as required by the protocol (no long-term departure or family relocation plan)；
- Female subjects were non-pregnant or lactating (negative urine pregnancy test before vaccination) and had no plans to get pregnant within 2 months after enrollment；
- The axillary temperature was < 37.3 ° C.
Key exclusion criteria (21 listed)
- A history of rabies vaccine and specific passive immune preparation injection, and a history of dog or other mammal bite/scratch within the past 1 year;
- Those who are allergic to any component of the trial vaccine, or have had previous allergies to any component of the vaccine, or have had a history of severe allergies requiring medical intervention, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, angioedema, etc;
- Fever (axillary temperature ≥37.3 ° C) within 3 days before the first dose of vaccination, acute or chronic infectious diseases (active tuberculosis, active viral hepatitis), or acute exacerbation of a chronic disease;
- Received blood/blood-related products or immune globulin within 3 months before the first dose of vaccine, or plan to use such a product after enrollment until 1 month after the last dose of vaccine;
- Vaccinate any vaccine within 14 days before the first dose of vaccine;
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 |
|---|---|---|
| Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThis vaccine（1.0ml） is produced by Ab\&b Biotechnology Co., Ltd.JS. Subjects will receive the Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried vaccinated by intramuscular injection. | Biological | Essen Experimental Group (10-17 years old), Essen Experimental Group (18-60 years old), Zagreb Experimental Group (10-17 years old), Zagreb Experimental Group (18-60 years old) |
Primary outcome
The occurrence of adverse events/reactions within 1 month from the first dose to full immunization;
Time frame: Within 1 month from the first dose to full immunization
The occurrence of adverse events/reactions within 1 month from the first dose to full immunization;
The occurrence of serious adverse events/reactions within 6 month from the first dose to full immunization;
Time frame: Within 6 month from the first dose to full immunization
The occurrence of serious adverse events/reactions within 6 month from the first dose to full immunization;
The abnormal occurrence of laboratory indicators (blood biochemistry, blood routine and urine routine) 3 days after the first dose of vaccination
Time frame: 3 days after the first dose
The abnormal occurrence of laboratory indicators (blood biochemistry, blood routine and urine routine) 3 days after the first dose of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xianfeng Zhang, Master principal investigator
Hubei Provincial Center for Disease Control and Prevention
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 Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in people with Rabies, run by Ab&B Bio-tech Co., Ltd.JS 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The occurrence of adverse events/reactions within 1 month from the first dose to full immunization; (time frame: Within 1 month from the first dose to full immunization). The study lists 3 primary outcomes in all. 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 2 Jan 2026.