Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

NCT07028801 | Not Yet Recruiting Phase 3

• 1 other identifier: AIM2301-Ⅲ-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Phase 3 clinical trial of freeze-dried human rabies vaccine (human diploid cells) adopted a randomized, blinded, parallel control,non-inferiority design,and administered vaccines to participants aged 10 to 60 years with different immunization schedules (5-dose schedule group, two simple 4-dose schedule groups, and 2-1-1 schedule group) to evaluate the immunogenicity and safety of the vaccine.

Conditions

Rabies

Outcome Measures

Primary Outcomes (12)

• Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.

  14 days after the first dose

• Antibody GMC for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody Geometric Mean Concentration in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.

  14 days after the first dose

• Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the simple 4-dose schedule group 1 of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after the first dose

• Antibody GMC for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule of the control vaccine

  Antibody Geometric Mean Concentration in the simple 4-dose schedule group 1 of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after the first dose

• Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the simple 4-dose schedule group 2 of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after the first dose

• Antibody GMC for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody Geometric Mean Concentration in the simple 4-dose schedule group 2 of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after the first dose

• Antibody SCR for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after the first dose

• Antibody GMC for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody Geometric Mean Concentration in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after the first dose

• Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the 5-dose schedule group of the trial vaccine and the 5-dose control vaccine group.

  14 days after full vaccination

• Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the simple 4-dose schedule group 1 of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after full vaccination

• Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the simple 4-dose schedule group 2 of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after full vaccination

• Antibody SCR for the 2-1-1 schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

  Antibody seroconversion rates in the 2-1-1 schedule group of the trial vaccine and in the 5-dose group of the control vaccine.

  14 days after full vaccination

Study Arms (5)

group 1

EXPERIMENTAL

The Participants received 1 dose of 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.

Biological: Freeze-dried human rabies vaccine (human diploid cells)

group 2

EXPERIMENTAL

The Participants received 1 dose of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7, and14, with a total of 4 doses.

Biological: Freeze-dried human rabies vaccine (human diploid cells)

group 3

EXPERIMENTAL

The Participants received 1 dose of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried each at day 0, 3, 7 and 28, with a total of 4 doses.

Biological: Freeze-dried human rabies vaccine (human diploid cells)

group 4

EXPERIMENTAL

The Participants received 2 doses of 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.

Biological: Freeze-dried human rabies vaccine (human diploid cells)

group 5

ACTIVE COMPARATOR

The Participants received 1 dose of 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.

Biological: Freeze-dried human rabies vaccine (human diploid cells)

Interventions

Freeze-dried human rabies vaccine (human diploid cells) BIOLOGICAL

This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7, 14 and 28, total 5 doses

group 1

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℃\*;
• Women who have a positive urine pregnancy trial 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 ≥160mmHg and/or diastolic blood pressure ≥100mmHg for participants aged 18 years and above before enrollment;
• Allergy to any component of the vaccine used in the trial, 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 the Human Immunodeficiency Virus. HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other immune diseases that the researcher deems likely to affect the trial assessment;
• 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 from the first dose of vaccination to 30 days after the full vaccination course, such as long-term systemic glucocorticoid therapy (used continuously for 2 weeks or more, at a dose of ³2mg/kg/ day or ³20mg/ day prednisone or equivalent doses); 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;

Sponsors & Collaborators

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

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhiqiang Xie

CONTACT

+8613526534586; xiezqshang@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 19, 2025
• Study Start: July 31, 2025
• Primary Completion: September 30, 2025
• Study Completion: March 31, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CN (1)