RabiesPhase 1NCT07021703
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
A Phase 1 study testing Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen and Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb in people with Rabies, run by Ningbo Rongan Biological Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and… 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?
- Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen and Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2025to 31 Dec 2025
- 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
- (1) The participants' ages range from 10 to 60 years old (≥10 years old and <61 years old).
- Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents.
- Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent form voluntarily to participate in the trial, fully understand the trial procedures, the risks of participating in the trial, and other intervention measures that can be chosen if they do not participate in the trial, etc.
- Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with fertility must also meet the following conditions: 1) They have taken effective contraceptive measures within two weeks prior to participating in this trial; 2) Have no plans to have children within 6 months from the start of participating in this trial until the full vaccination. 3) Understand and agree to take effective contraceptive measures during the trial period (from the first dose to within 6 months after the full vaccination). Effective contraceptive measures include: condoms (for men), intrauterine devices, oral contraceptives (excluding emergency contraceptives), sterilization, abstention, injection or implantable contraception, sustained-release local contraceptives, hormone patches, diaphragms, cervical caps, etc. External ejaculation and safe period contraception are not regarded as effective contraceptive measures.
Who cannot join
- For the standards marked with *, if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances
- After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
- There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
- The axillary body temperature of the participants on the day of enrollment was ≥37.3℃*;
- Those whose various examination results during the screening period are abnormal and are determined by clinicians to be of clinical significance;
- Women who have a positive urine pregnancy test before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;
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- Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg for participants aged 18 years and above before enrollment;
- Allergy to any component of the vaccine used in the test, such as human albumin, sucrose, or maltose;
- Those with a history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, allergic bronchitis, acquired angioedema, etc.
- Has been diagnosed with congenital or acquired immune system diseases Such as Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other immune diseases that researchers determine may affect the evaluation of the trial;
- Known or suspected of having serious diseases, including severe respiratory diseases, liver and kidney diseases, cardiovascular and cerebrovascular diseases, malignant tumors, and other chronic diseases that are poorly controlled, etc.
- Abnormal coagulation function (such as deficiency of coagulation factors, coagulation disorders, abnormal platelets) or coagulation disorders diagnosed by a doctor;
- Anplenia or functional anplenia, as well as anplenia or splenectomy caused by any circumstances;
- Previous or current clearly diagnosed neurological or mental disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed epilepsy, convulsions, as well as other neurological or mental disorders that the researcher deems unsuitable for participation in this trial;
- It is planned to receive such treatment within 30 days after the first dose of vaccination and the full course of vaccination, such as long-term systemic glucocorticoid therapy (used continuously for 2 weeks or more, at a dose of 2mg/kg/ day or 20mg/ day prednisone or an equivalent dose); Local medications (such as ointments, eye drops, inhalants or nasal sprays) are allowed;
- Have received or plan to receive immunoenhancers or inhibitors, immunoglobulins or blood-related products throughout the trial period within 3 months prior to enrollment;
- Have received attenuated live vaccines within 14 days before enrollment, and subunit vaccines or inactivated vaccines within 7 days *;
- Within 3 days before enrollment, have suffered from acute diseases or be in the acute attack stage of chronic diseases *;
- Antipyretic, analgesic and antihistamine drugs were used within 3 days before enrollment.
- Currently participating in or planning to participate in other clinical trials during this clinical trial;
- According to the researcher's judgment, due to various medical, psychological, social conditions or other circumstances contrary to the trial protocol, or the participants' inability to comply with the requirements of the trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, 450000
Zhiqiang Xie, +8613526534586, xiezqshang@163.com
About this study
Official title: A Open-label, Randomized Study to Evaluate the Safety and Tolerability of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants With Different Immunization Schedules
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60
Read the detailed description
This trial will adopt a single-arm, randomized, open-label experimental design, with a planned enrollment of 60 participants, comprising 30 individuals aged 10-17 years and 30 aged 18-60 years. Initially, 30 participants in the 18-60 age group will be enrolled and randomly assigned in a 1:1 ratio to either the 5-dose schedule group or the 2-1-1 schedule group. Participants in the 5-dose schedule group will receive five doses of the trial vaccine according to the immunization schedule of days 0, 3, 7, 14, and 28. Those in the 2-1-1 schedule group will receive four doses of the trial vaccine according to the immunization schedule of day 0 (two doses), day 7, and day 21. Following the administration of the first dose, safety will be monitored for 7 days among participants aged 18-60 years. If no criteria for trial suspension/termination are met, an additional 30 participants in the 10-17 age group will be enrolled and randomly assigned in a 1:1 ratio to either the 5-dose schedule group or the 2-1-1 schedule group, following the same immunization schedules as described above.
Adverse events (AEs) that occur from the first dose of vaccination through 30 days post-completion of the full vaccination regimen will be collected. Serious adverse events (SAEs), pregnancy-related events (including pregnancy outcomes, delivery characteristics, neonatal conditions, and growth and development within one month postpartum for female participants), reported from the first dose of vaccination through 6 months post-completion of the full vaccination regimen, will also be recorded.
- Conditions
- Rabies
- Being tested
- Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen, Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, EssenBiological
Also called AIM2301
This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection.
Receive on the day 0, 3, 7, 14 and 28, a total of 5 doses
Freeze-dried Human Rabies Vaccine（Human Diploid Cell），ZagrebBiological
Also called AIM2301
This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection.
Receive 2 doses on day 0, 1 dose on day 7 and day 21, a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | The Participants received 1 dose of AIM2301 on day 0, 3, 7, 14 and 28, a total of 5 doses Receives: Biological: Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen |
| Group2 | Experimental | The Participants received 2 dose of AIM2301 on day 0, 1 dose of AIM2301 on day7 and 21, a total of 4 doses Receives: Biological: Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of AE and AR within 30 minutes after each dose of vaccination
After each dose of the investigational vaccine is administered, participants should be observed on-site for 30 minutes. The contents of safety observation include any medical events occurring in participants.
The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Measured: within 30 minutes after each dose of vaccination
The occurrence of AE and AR within 7 days after each dose of vaccination
After each dose of vaccine is administered, a Diary Card will be issued to participants. Participants and/or their guardians should measure body temperature daily from Day 0 to Day 7 and observe/record all adverse events (AEs) as well as concomitant medications/vaccines according to the requirements of the Diary Card.
The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Measured: within 7 days after each dose of vaccination
The occurrence of AE and AR within 30 days from the first dose of vaccination to the full course of vaccination
Solicited and unsolicited adverse events from the first dose vaccination to 30 days after full-course vaccination shall be collected through diary cards and contact cards.
The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Measured: within 30 days from the first dose of vaccination to the full course of vaccination
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators (blood biochemistry, blood routine and urine routine) on the third day after the first dose of vaccination
Measured: the third day after the first dose of vaccination
The occurrence of serious adverse events
The occurrence of serious adverse events within 6 months from the first dose of vaccination to the full course of vaccination.
SAE assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
Measured: within 6 months from the first dose of vaccination to the full course of vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start23 May 2025
- Primary completion28 Jul 2025 (estimated)
- Study completion31 Dec 2025 (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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021703
- Sponsor's protocol ID
- AIM2301-Ⅰ-01
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 15 Jun 2025
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Randomized Study to Evaluate the Safety and Tolerability of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants With Different Immunization Schedules
- ClinicalTrials.gov ID
- NCT07021703
- Acronym / sponsor ID
- AIM2301-Ⅰ-01
- Conditions
- Rabies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 28 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jun 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.
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60
Detailed description
This trial will adopt a single-arm, randomized, open-label experimental design, with a planned enrollment of 60 participants, comprising 30 individuals aged 10-17 years and 30 aged 18-60 years. Initially, 30 participants in the 18-60 age group will be enrolled and randomly assigned in a 1:1 ratio to either the 5-dose schedule group or the 2-1-1 schedule group. Participants in the 5-dose schedule group will receive five doses of the trial vaccine according to the immunization schedule of days 0, 3, 7, 14, and 28. Those in the 2-1-1 schedule group will receive four doses of the trial vaccine according to the immunization schedule of day 0 (two doses), day 7, and day 21. Following the administration of the first dose, safety will be monitored for 7 days among participants aged 18-60 years. If no criteria for trial suspension/termination are met, an additional 30 participants in the 10-17 age group will be enrolled and randomly assigned in a 1:1 ratio to either the 5-dose schedule group or the 2-1-1 schedule group, following the same immunization schedules as described above.
Adverse events (AEs) that occur from the first dose of vaccination through 30 days post-completion of the full vaccination regimen will be collected. Serious adverse events (SAEs), pregnancy-related events (including pregnancy outcomes, delivery characteristics, neonatal conditions, and growth and development within one month postpartum for female participants), reported from the first dose of vaccination through 6 months post-completion of the full vaccination regimen, will also be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Biological: Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, EssenThe Participants received 1 dose of AIM2301 on day 0, 3, 7, 14 and 28, a total of 5 doses |
| Group2 | Experimental | Biological: Freeze-dried Human Rabies Vaccine（Human Diploid Cell），ZagrebThe Participants received 2 dose of AIM2301 on day 0, 1 dose of AIM2301 on day7 and 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 (4 listed)
- (1) The participants' ages range from 10 to 60 years old (≥10 years old and <61 years old).
Key exclusion criteria (21 listed)
- For the standards marked with *, if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances
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 |
|---|---|---|
| Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, EssenAlso: AIM2301This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive on the day 0, 3, 7, 14 and 28, a total of 5 doses | Biological | Group1 |
| Freeze-dried Human Rabies Vaccine（Human Diploid Cell），ZagrebAlso: AIM2301This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive 2 doses on day 0, 1 dose on day 7 and day 21, a total of 4 doses. | Biological | Group2 |
Primary outcome
The occurrence of AE and AR within 30 minutes after each dose of vaccination
Time frame: within 30 minutes after each dose of vaccination
After each dose of the investigational vaccine is administered, participants should be observed on-site for 30 minutes. The contents of safety observation include any medical events occurring in participants. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
The occurrence of AE and AR within 7 days after each dose of vaccination
Time frame: within 7 days after each dose of vaccination
After each dose of vaccine is administered, a Diary Card will be issued to participants. Participants and/or their guardians should measure body temperature daily from Day 0 to Day 7 and observe/record all adverse events (AEs) as well as concomitant medications/vaccines according to the requirements of the Diary Card. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
The occurrence of AE and AR within 30 days from the first dose of vaccination to the full course of vaccination
Time frame: within 30 days from the first dose of vaccination to the full course of vaccination
Solicited and unsolicited adverse events from the first dose vaccination to 30 days after full-course vaccination shall be collected through diary cards and contact cards. The severity and relevance of AEs shall be determined in accordance with the guidance for adverse event grading criteria and the guidance for relevance determination.
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators
Time frame: the third day after the first dose of vaccination
Abnormal changes /Occurrence of clinically significant abnormal changes in laboratory test indicators (blood biochemistry, blood routine and urine routine) on the third day after the first dose of vaccination
The occurrence of serious adverse events
Time frame: within 6 months from the first dose of vaccination to the full course of vaccination.
The occurrence of serious adverse events within 6 months from the first dose of vaccination to the full course of vaccination. SAE assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
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 15 Jun 2025.
- 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.
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 Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen and Freeze-dried Human Rabies Vaccine（Human Diploid Cell），Zagreb in people with Rabies, run by Ningbo Rongan Biological Pharmaceutical Co., Ltd. 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 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: looking for participants now, as of the sponsor's last update on 15 Jun 2025. 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?
Contact Zhiqiang Q Xie (+8613526534586, xiezqshang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of AE and AR within 30 minutes after each dose of vaccination (time frame: within 30 minutes after each dose of vaccination). The study lists 5 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 15 Jun 2025.