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

Changchun Zhuoyi Biological Co., Ltd149 enrolled

Overview

Evaluation of immune persistence after rabies vaccination in 150 people.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

149

Conditions

Rabies Antibody

Interventions

5 doses programBIOLOGICAL

Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody

Eligibility

Sex: ALLMin age: 10 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months

Data from ClinicalTrials.gov

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