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NCT05547815 Clinical Trial

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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05547815
Other study ID # ZY201909001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 11, 2019
Est. completion date November 8, 2021

Study information
Verified date September 2022
Source Changchun Zhuoyi Biological Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of immune persistence after rabies vaccination in 150 people.

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.

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date November 8, 2021
Est. primary completion date December 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Changchun Zhuoyi Biological Co., Ltd Changchun Jilin

Sponsors (1)
Lead Sponsor Collaborator
Changchun Zhuoyi Biological Co., Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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