Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Primary Purpose
Rabies
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rabies vaccine, manufactured by ChengDa
Sponsored by
About this trial
This is an interventional health services research trial for Rabies focused on measuring Rabies, Anti-rabies antibody, Persistence
Eligibility Criteria
Inclusion Criteria:
- 20 to 60 years old
- Healthy
- Given ChengDa rabies vaccine
- Good compliance
- Obtained informed consent
Exclusion Criteria:
- Other than inclusion criteria
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Post vaccination
Arm Description
All the subjects had been vaccinated with antirabies vaccine.
Outcomes
Primary Outcome Measures
Rabies antibody titer
We test the antirabies antibody titer before and after the single booster dose
Secondary Outcome Measures
Full Information
NCT ID
NCT01173302
First Posted
July 19, 2010
Last Updated
July 30, 2010
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01173302
Brief Title
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Official Title
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5 years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. A total of 160 subjects would be enrolled. These subjects were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is obtained, these subjects would be tested for their antirabies antibody titer and given a single booster dose. Seven and 14 days later, the investigators would re-evaluate the antibody titer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
Rabies, Anti-rabies antibody, Persistence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post vaccination
Arm Type
Experimental
Arm Description
All the subjects had been vaccinated with antirabies vaccine.
Intervention Type
Biological
Intervention Name(s)
Rabies vaccine, manufactured by ChengDa
Other Intervention Name(s)
ChengDa Speeda
Intervention Description
1 dose before the antibody is tested
Primary Outcome Measure Information:
Title
Rabies antibody titer
Description
We test the antirabies antibody titer before and after the single booster dose
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
20 to 60 years old
Healthy
Given ChengDa rabies vaccine
Good compliance
Obtained informed consent
Exclusion Criteria:
Other than inclusion criteria
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21752947
Citation
Zhang X, Zhu Z, Wang C. Persistence of rabies antibody 5 years after postexposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. Clin Vaccine Immunol. 2011 Sep;18(9):1477-9. doi: 10.1128/CVI.05090-11. Epub 2011 Jul 13.
Results Reference
derived
Learn more about this trial
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
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