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NCT01173302 Clinical 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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01173302
Other study ID # PKUPH-ER-1
Secondary ID
Status Unknown status
Phase Phase 4
First received July 19, 2010
Last updated July 30, 2010
Start date May 2010
Est. completion date September 2010

Study information
Verified date July 2010
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 160
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- 20 to 60 years old

- Healthy

- Given ChengDa rabies vaccine

- Good compliance

- Obtained informed consent

Exclusion Criteria:

- Other than inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Rabies vaccine, manufactured by ChengDa
1 dose before the antibody is tested

Locations
Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rabies antibody titer We test the antirabies antibody titer before and after the single booster dose 6 months
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