RabiesPhase 3NCT07275645
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
A Phase 3 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 5 sites in China.
Trial 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)… 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
- 3,000 participants
- Where
- 5 sitesChina
- Study dates
- 26 Feb 2026to 26 Apr 2027
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- a Exclusion criteria for the first dose:
- 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.
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- 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.
- 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);
- Participant has any other conditions that warrant discontinuation of vaccination as determined by the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Qichun County Center for Disease Control and Prevention
Huanggang, Hubei
Yunyang District Center for Disease Control and Prevention
Shiyan, Hubei
Zhushan county Center for Disease control and Prevention
Shiyan, Hubei
Gucheng county Center for Disease control and Prevention
Xiangyang, Hubei
Xiangzhou District Center for Disease Control and Prevention
Xiangyang, Hubei
About this study
Official title: A Phase III, Randomized, Blinded, and Homologous Vaccine-Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Rabies Vaccine (Human Diploid Cell), Freeze-dried, Vaccinated With Different Immunization Schedules in a Population Aged 10 to 60 Years
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
- Being tested
- Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
- Keywords
- Rabies, Rabies vaccine
- 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
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.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedBiological
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. Two doses will be administered on Day 0, followed by one dose each on Days 7 and 21, for a total of 4 doses. 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.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedBiological
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 4 doses will be administered at Day 0, 3, 7 and 14. 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.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedBiological
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 4 doses will be administered at Day 0, 3, 7, 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.
Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Essen Control Group | Active comparator | Not described Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Essen Experimental Group | Experimental | Not described Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Zagreb Experimental Group | Experimental | Not described Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Simplified Four-Dose Group 1 | Experimental | Not described Receives: Biological: Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried |
| Simplified Four-Dose Group 2 | Experimental | Not described 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.
Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose.
Measured: Day 14 after the first dose.
Seroconversion rate of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 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 posted10 Dec 2025
- Study start26 Feb 2026
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Apr 2027 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275645
- Sponsor's protocol ID
- HDCV-ZHSW-04
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2025
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Blinded, and Homologous Vaccine-Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Rabies Vaccine (Human Diploid Cell), Freeze-dried, Vaccinated With Different Immunization Schedules in a Population Aged 10 to 60 Years
- ClinicalTrials.gov ID
- NCT07275645
- Acronym / sponsor ID
- HDCV-ZHSW-04
- Conditions
- Rabies
- Keywords
- Rabies, Rabies vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 10 Dec 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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-driedThe 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. | Biological | Essen Experimental Group |
| Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe 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. Two doses will be administered on Day 0, followed by one dose each on Days 7 and 21, for a total of 4 doses. 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. | Biological | Zagreb Experimental Group |
| Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe 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 4 doses will be administered at Day 0, 3, 7 and 14. 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. | Biological | Simplified Four-Dose Group 1 |
| Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe 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 4 doses will be administered at Day 0, 3, 7, 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. | Biological | Simplified Four-Dose Group 2 |
| Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-driedThe 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. | Biological | Essen Control Group |
Primary outcome
Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose.
Time frame: Day 14 after the first dose.
Seroconversion rate of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose.
Time frame: 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.
Time frame: 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.
Time frame: From the first dose of primary immunization to 6 months after completion
3 secondary outcomes
Geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose.
Time frame: 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.
Time frame: 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.
Time frame: Day 7 after the first dose
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 28 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 5 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose. (time frame: Day 14 after the first dose.). The study lists 4 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 28 Oct 2026.