Back to resultsObservation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
Primary Purpose
Rabies, Antibody
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
5 doses program
Sponsored by
About this trial
This is an interventional prevention trial for Rabies focused on measuring rabies vaccine, antibody, persistence
Eligibility Criteria
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.
Sites / Locations
- Changchun Zhuoyi Biological Co., Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
5 doses of rabies vaccine
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05547815
First Posted
September 13, 2022
Last Updated
September 18, 2022
Sponsor
Changchun Zhuoyi Biological Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05547815
Brief Title
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
November 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun Zhuoyi Biological Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies, Antibody
Keywords
rabies vaccine, antibody, persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
5 doses of rabies vaccine
Intervention Type
Biological
Intervention Name(s)
5 doses program
Intervention Description
Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody
Primary Outcome Measure Information:
Title
positive conversion rate evaluation (6 months)
Description
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
Time Frame
6 months
Title
antibody titer evaluation (6 months)
Description
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
Title
positive conversion rate evaluation (12 months)
Description
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
Time Frame
12 months
Title
antibody titer evaluation (12 months)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Miao, Dr
Organizational Affiliation
Changchun Zhuoyi Biological Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Changchun Zhuoyi Biological Co., Ltd
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all data of antibody titer .
IPD Sharing Time Frame
before December 2022.
IPD Sharing Access Criteria
public for all.
Learn more about this trial
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
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