A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)

NCT06078423 | Completed Phase 3

• 1 other identifier: 2018-Rab01
• Study Type: interventional
• Target: 1,880
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2

Conditions

Rabies Vaccine Adverse Reaction

Keywords

Safety; Efficacy

Outcome Measures

Primary Outcomes (6)

• Antibody positive conversion rate - Immunogenicity endpoint

  Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group

  up to 14 days after the first/full dose of vaccination

• Geometric mean concentration - Immunogenicity endpoint

  GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group

  14 days after the first/full dose of vaccination

• Incidence of Adverse Events [Safety and Tolerability]

  The incidence of any local and systemic adverse events (AEs)

  within 30 minutes after each dose of vaccination

• Incidence of Adverse Events [Safety and Tolerability]

  The incidence of collected AEs

  within 0-7 days after each dose of vaccination

• Incidence of Adverse Events [Safety and Tolerability]

  The incidence of non solicited AE

  within 30 days after the first dose of vaccination to the full course of vaccination

• Incidence of Adverse Events [Safety and Tolerability]

  The incidence of all serious adverse events (SAE)

  within 6 months after the first dose administration and the entire vaccination process

Secondary Outcomes (4)

• Antibody positive conversion rate - Immunogenicity endpoint

  7 days after the first dose of vaccination；3 month after full dose of vaccination；

• Geometric mean concentration - Immunogenicity endpoint

  7 days after the first dose of vaccination;3 month after full dose of vaccination；

• Antibody positive conversion rate - Immunogenicity endpoint

  12 month after full dose of vaccination；

• Geometric mean concentration - Immunogenicity endpoint

  12 month after full dose of vaccination；

Study Arms (4)

Investigational Vaccine - 5-dose program

EXPERIMENTAL

Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.

Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program

Investigational Vaccine - 4-dose program

EXPERIMENTAL

Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 5.24 IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd.

Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program

Control vaccine - 5-dose program

ACTIVE COMPARATOR

Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd

Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program

Control vaccine - 4-dose program

ACTIVE COMPARATOR

Freeze-dried human rabies vaccine (MRC-5 cells), 1.0 ml after reconstitution, with a titer of not less than 4.57 IU, ,Chengdu Kanghua Biological Products Co., Ltd

Biological: Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program

Interventions

Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program BIOLOGICAL

Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm

Investigational Vaccine - 5-dose program

Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program BIOLOGICAL

Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm

Investigational Vaccine - 4-dose program

Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program BIOLOGICAL

Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm

Control vaccine - 5-dose program

Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program BIOLOGICAL

Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm

Control vaccine - 4-dose program

Eligibility Criteria

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

You may qualify if:

• Age range from 10 to 60 years old;
• Willing to participate in this experiment and sign an informed consent or notification form;
• The subjects themselves or/and their guardians promise to comply with the requirements of the clinical research protocol;
• Under the age of 14 (including 14 years old), the axillary body temperature is less than 37.5 ℃, and above the age of 14, the axillary body temperature is less than 37.3 ℃

You may not qualify if:

• Have a history of rabies vaccine immunization or use of rabies virus passive immunity preparations;
• Have a history of injury to dogs or other mammals within 12 months prior to the first vaccination;
• Have used blood products within 4 months before the first vaccination;
• Inoculate any vaccine within 14 days before the first vaccination;
• Have used other research or unregistered products (drugs or vaccines) within one month before the first vaccination, or have planned to participate in other clinical studies after enrollment in this clinical study;
• Suffering from congenital or acquired immune deficiency. Receiving immunosuppressive therapy, such as long-term (oral) systemic glucocorticoid therapy (continuous (oral) systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs);
• Have a history of convulsion, epilepsy, encephalopathy, psychosis or family history;
• Allergic to any component in the study vaccine (such as human albumin, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, sucrose, maltose, etc.); Have a history of severe allergies, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthur reaction);
• Have any previous history of serious side effects from vaccines or drugs, such as urticaria, skin eczema, respiratory difficulties, vascular and neurological edema, etc;
• Individuals with acute febrile diseases (body temperature ≥ 38.5 ℃) and infectious diseases within 3 days before vaccination;
• Having congenital heart disease, developmental disorder or chronic disease, such as asthma, diabetes, thyroid disease;
• Suffering from urticaria within one year before receiving the experimental vaccine;
• Blood pressure: systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg (regardless of medication);
• Suffering from thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection);
• Women of childbearing age who have a positive urine pregnancy test, or have a fertility plan during pregnancy, lactation, or within 2 months;

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 410005, China

Location

Study Officials

• Fangjun Li, Bachelor

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

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

Model Details: Similar vaccine control

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: October 11, 2023
• Study Start: October 19, 2019
• Primary Completion: July 21, 2021
• Study Completion: September 26, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)