Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Study Overview
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Brief Summary
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A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

Detailed Description
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It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination. To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.

Official Title
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Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)

Conditions
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Antibody Titer, Rabies Human

Intervention / Treatment
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* Biological: rabies vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age is 10-60 years old; Underarm temperature ≤ 37.0 ℃. Exclusion Criteria: Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； Has been diagnosed with congenital or acquired immunodeficiency disease； Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 4 doses<br>Inoculate experimental vaccine according to 2-1-1 immunization procedure | Biological: rabies vaccine<br>* The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared<br>|
| Experimental: Experimental 5 doses<br>Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure | Biological: rabies vaccine<br>* The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared<br>|
| Active Comparator: SPEEDA® 4 doses<br>Inoculate SPEEDA® according to 2-1-1 immunization procedure | Biological: rabies vaccine<br>* The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody positive conversion rate of experimental groups | - Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation. | 3 months | 
| Antibody positive conversion rate of 4 doses groups | -Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation. | 3 months | 
| Compare the GMT between two experimental groups | - Compare the GMT between two experimental groups 14 days after the first dose of inoculation. | 3 months | 
| Geometric Mean Titer (GMT) of 4 doses groups | - Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation. | 3 months | 
| Safety within 30 minutes | - Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation; | 3 months | 
| Safety within 0-7 days | - Incidence rate of collected AE within 0-7 days after each dose of inoculation; | 3 months | 
| Safety within 6 months | - Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation. | 9months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody test of 7 days. | - Antibody test 7 days after the first dose of inoculation. | 3 months | 
| Antibody test after whole vaccination. | - Antibody test 14days after the whole vaccination. | 3 months | 
| Persistent observation within 12 months | - Antibody test in different points within 12 months after the whole vaccination. | 16 months |