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

Phase 4

Completed

• Conditions: Antibody; Rabies
• Interventions: Biological: 5 doses program

• Registration Number: NCT05547815
• Lead Sponsor: Changchun Zhuoyi Biological Co., Ltd

Brief Summary

Evaluation of immune persistence after rabies vaccination in 150 people.

Detailed Description

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 Timeline

• Study Start: 2019-11-11
• Primary Completion: 2020-12-17
• Study Completion: 2021-11-08
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-18
• Last Update Submitted: 2022-09-18
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	5 doses program	5 doses of rabies vaccine

Primary Outcome Measures

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

Trial Locations

Locations (1)

Changchun Zhuoyi Biological Co., Ltd; 🇨🇳 Changchun, Jilin, China