Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)

NCT05969626 | Unknown Phase 3

• 1 other identifier: AIM1813-III
• Study Type: interventional
• Target: 2,460
• Locations: 1 country
• Sites: 4

Brief Summary

This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.

Conditions

Rabies

Outcome Measures

Primary Outcomes (6)

• Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine

  Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine

  Day 14

• Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine

  Antibody Geometric Mean Concentration in 5-dose groups of test vaccine and 5-dose groups of control vaccine

  Day 14

• Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine

  Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine

  Day 14

• Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine

  Antibody Geometric Mean Concentration in 4-dose groups of test vaccine and 5-dose groups of control vaccine

  Day 14

• Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine

  Antibody Seroconversion rate in 5-dose groups of test vaccine and 5-dose groups of control vaccine

  Day 42

• Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine

  Antibody Seroconversion rate in 4-dose groups of test vaccine and 5-dose groups of control vaccine

  Day 42

Study Arms (4)

5-dose group of test vaccine

EXPERIMENTAL

Biological: 5-dose group of test vaccine

5-dose group of control vaccine

ACTIVE COMPARATOR

Biological: 5-dose group of control vaccine

4-dose A group of test vaccine

EXPERIMENTAL

Biological: 4-dose A group of test vaccine

4-dose B group of test vaccine

EXPERIMENTAL

Biological: 4-dose B group of test vaccine

Interventions

5-dose group of test vaccine BIOLOGICAL

Subjects will be vaccinated on days 0, 3, 7, 14, and 28

5-dose group of test vaccine

5-dose group of control vaccine BIOLOGICAL

Subjects will be vaccinated on days 0, 3, 7, 14, and 28

5-dose group of control vaccine

4-dose A group of test vaccine BIOLOGICAL

Subjects will be vaccinated on days 0, 3, 7, 14

4-dose A group of test vaccine

4-dose B group of test vaccine BIOLOGICAL

Subjects will be vaccinated on days 0, 3, 7, 28

4-dose B group of test vaccine

Eligibility Criteria

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

You may qualify if:

• The age of the subject is 10-60 years old (≥10 years old, \<61 years old);
• Subjects aged 10-17 and their guardians can provide valid identification; subjects aged 18-60 can provide valid identification;
• Subjects aged 10-17 and at least one of their guardians voluntarily participate with informed consent, and sign the Informed Consent for minors and adults respectively; Subjects aged 18-60 voluntarily participate with informed consent and sign the adult version of Informed Consent; Basic reading and writing skills are required;
• If the subjects are WOCBP (women of childbearing potential), they should not be pregnant or breastfeeding, have a negative urine pregnancy test before vaccination, and have taken effective contraceptive measures within 2 weeks before being enrolled in this study; From enrollment in the study until 6 months after full exemption, no family planning and consent to use effective contraception during the study period. Effective forms of birth control include: oral contraceptives (excluding emergency contraceptives)Injectable or embedded contraception, sustained release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), isolationMembrane, cervical cap, etc.;
• \* On the day of enrollment, armpit body temperature of subjects \>14 years old was \<37.3℃, and armpit body temperature of subjects \<14 years old was \<37.5℃;
• Adult subjects or minor subjects and their guardians shall comply with the requirements of the clinical study protocol.

You may not qualify if:

• A history of rabies vaccine immunization or rabies virus passive immunization was asked;
• A history of grade 2 or 3 injury in animals susceptible to rabies virus (cats, dogs, etc.) within 12 months prior to the first dose of vaccination (the assessment criteria was the Technical Guidelines for Rabies Prevention and Control (2016));
• Plan to participate in other clinical trials during the clinical study;
• Allergic to any component of the test vaccine; History of severe allergies that require medical intervention, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, allergic necrosis reaction (Arthus reaction), severe urticaria, dyspnea, angioneurotic edema, etc.;
• Have been diagnosed with a congenital or acquired immunodeficiency disease, such as HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other immune disease that the investigator has determined may affect the evaluation of the trial;
• Known or suspected serious medical conditions upon inquiry include: severe respiratory diseases, poorly controlled chronic diseases, severe liver and kidney diseases, severe cardiovascular diseases, malignant tumors, etc.;
• \* Medically unmanageable hypertension, such as systolic blood pressure \>120mmHg and/or diastolic blood pressure \>80mmHg in subjects 10 to 17 years of age prior to enrollment, systolic blood pressure of 140mmHg and/or diastolic blood pressure of 90mmHg in subjects 18 years of age and older;
• Coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by a physician;
• Asplenia, functional asplenia, and any condition resulting in asplenia or splenectomy;
• Have received immunosuppressive therapy within 3 months prior to vaccination or plan to receive immunosuppressive therapy throughout the study period;
• Plan to receive such treatment within 30 days after the first dose to the full dose, such as long-term systemic glucocorticoid therapy (2 weeks or more at a dose of \>2mg/kg/ day or \>20mg/ day of prednisone or equivalent); Allow topical use (such as ointment, eye drops, inhalants or nasal sprays);
• \* Received immunoglobulins or blood-related products within 3 months prior to vaccination or plan to receive them throughout the study period;
• \* Acute illness or acute onset of chronic disease within 3 days prior to vaccination;
• \* Antipyretic, analgesic and anti-allergic drugs were used within 3 days prior to vaccination;
• \* Have received COVID-19 vaccine or live attenuated vaccine within 28 days prior to vaccination, and have received inactivated vaccines other than COVID-19 inactivated vaccines within 14 days prior to vaccination;

Sponsors & Collaborators

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

Study Sites (4)

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, 610041, China

Location

Center for Disease Control and Prevention, Mianyang City

Mianyang, Sichuan, 621000, China

Location

Shizhong District, Neijiang City Center for Disease Control and Prevention

Neijiang, Sichuan, 511002, China

Location

Rongxian Center for Disease Control and Prevention

Zigong, Sichuan, 643199, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ting Huang

CONTACT

13330993324; cocoht@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: July 23, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-07

Locations

CN (4)