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

NCT ID: NCT01173302

Last Updated: 2010-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rabies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Post vaccination

All the subjects had been vaccinated with antirabies vaccine.

Group Type EXPERIMENTAL

Rabies vaccine, manufactured by ChengDa

Intervention Type BIOLOGICAL

1 dose before the antibody is tested

Interventions

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Rabies vaccine, manufactured by ChengDa

1 dose before the antibody is tested

Intervention Type BIOLOGICAL

Other Intervention Names

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ChengDa Speeda

Eligibility Criteria

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Inclusion Criteria

* 20 to 60 years old
* Healthy
* Given ChengDa rabies vaccine
* Good compliance
* Obtained informed consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 21752947 (View on PubMed)

Other Identifiers

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PKUPH-ER-1

Identifier Type: -

Identifier Source: org_study_id

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