Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

Study Overview
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Brief Summary
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Evaluation of immune persistence after rabies vaccination in 150 people.

Detailed Description
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150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Official Title
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Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)

Conditions
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Rabies, Antibody

Intervention / Treatment
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* Biological: 5 doses program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10-60 years old； Temperature on the day of admission≤37.0 ° C (axillary temperature). 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>5 doses of rabies vaccine | Biological: 5 doses program<br>* Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive conversion rate evaluation (6 months) | Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program | 6 months | 
| antibody titer evaluation (6 months) | Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program | 6 months | 
| positive conversion rate evaluation (12 months) | Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program | 12 months | 
| antibody titer evaluation (12 months) | Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibody, rabies vaccine, persistence