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RecruitingNCT07021703Updated Jun 15, 2025

A Clinical Trial of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried

A Phase 1 interventional study of Freeze-dried Human Rabies Vaccine(Human Diploid Cell), Essen and Freeze-dried Human Rabies Vaccine(Human Diploid Cell),Zagreb in Rabies, sponsored by Ningbo Rongan Biological Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Rabies

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03

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

This study's planned enrollment of 60 is below the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Ningbo Rongan Biological Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (1) The participants' ages range from 10 to 60 years old (≥10 years old and \<61 years old).

    (2) 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.

    (3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the 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.

    (4) 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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

    1. After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
    2. There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
    3. The axillary body temperature of the participants on the day of enrollment was ≥37.3℃*;
    4. Those whose various examination results during the screening period are abnormal and are determined by clinicians to be of clinical significance;
    5. 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;
    6. 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;
    7. Allergy to any component of the vaccine used in the test, such as human albumin, sucrose, or maltose;
    8. 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.
    9. Has been diagnosed with congenital or acquired immune system diseases Such as (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;
    10. 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.
    11. Abnormal coagulation function (such as deficiency of coagulation factors, coagulation disorders, abnormal ) or coagulation disorders diagnosed by a doctor;
    12. Anplenia or functional anplenia, as well as anplenia or splenectomy caused by any circumstances;
    13. 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;
    14. 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 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;
    15. Have received or plan to receive immunoenhancers or inhibitors, immunoglobulins or blood-related products throughout the trial period within 3 months prior to enrollment;
    16. Have received attenuated within 14 days before enrollment, and subunit vaccines or inactivated vaccines within 7 days *;
    17. Within 3 days before enrollment, have suffered from acute diseases or be in the acute attack stage of chronic diseases *;
    18. Antipyretic, analgesic and antihistamine drugs were used within 3 days before enrollment.
    19. Currently participating in or planning to participate in other clinical trials during this clinical trial;
    20. 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group1

    The Participants received 1 dose of AIM2301 on day 0, 3, 7, 14 and 28, a total of 5 doses

    Biological: Freeze-dried Human Rabies Vaccine(Human Diploid Cell), Essen

  • Experimental
    Group2

    The Participants received 2 dose of AIM2301 on day 0, 1 dose of AIM2301 on day7 and 21, a total of 4 doses

    Biological: Freeze-dried Human Rabies Vaccine(Human Diploid Cell),Zagreb

Interventions

  • BiologicalFreeze-dried Human Rabies Vaccine(Human Diploid Cell), Essen

    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

    Also known as: AIM2301

  • BiologicalFreeze-dried Human Rabies Vaccine(Human Diploid Cell),Zagreb

    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.

    Also known as: AIM2301

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 30 minutes after each dose of vaccination

  2. 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.

    Time frame: within 7 days after each dose of vaccination

  3. 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.

    Time frame: within 30 days from the first dose of vaccination to the full course of vaccination

  4. 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

    Time frame: the third day after the first dose of vaccination

  5. 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.

    Time frame: within 6 months from the first dose of vaccination to the full course of vaccination.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2025 (actual). Primary completion is estimated for Jul 2025, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2025
First posted
Jun 15, 2025
StartActual
May 23, 2025
Primary completionEst.
Jul 28, 2025
CompletionEst.
Dec 31, 2025
Last update
Jun 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07021703
Lead sponsor
Ningbo Rongan Biological Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 15, 2025
Start date
May 23, 2025
Primary completion
Jul 28, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 15, 2025

Study contacts

Zhiqiang Q Xie
Contact
xiezqshang@163.com
+8613526534586

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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