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

NCT07021703 | Recruiting Phase 1

• 1 other identifier: AIM2301-Ⅰ-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rabies

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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

  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.

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

Study Arms (2)

Group1

EXPERIMENTAL

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

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

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

Interventions

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

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

Group1

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

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

Group2

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (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 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.
• (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 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Ningbo Rongan Biological Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Zhiqiang Q Xie

CONTACT

+8613526534586; xiezqshang@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 15, 2025
• Study Start: May 23, 2025
• Primary Completion: July 28, 2025
• Study Completion: December 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)