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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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01173302
First received: July 19, 2010
Last updated: July 30, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Rabies
 Biological: Rabies vaccine, manufactured by ChengDa
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:

MedlinePlus related topics: Rabies
U.S. FDA Resources

Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • Rabies antibody titer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We test the antirabies antibody titer before and after the single booster dose


Estimated Enrollment: 160
Study Start Date: May 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post vaccination
All the subjects had been vaccinated with antirabies vaccine.
 Biological: Rabies vaccine, manufactured by ChengDa
1 dose before the antibody is tested
Other Name: ChengDa Speeda

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 to 60 years old
  • Healthy
  • Given ChengDa rabies vaccine
  • Good compliance
  • Obtained informed consent

Exclusion Criteria:

  • Other than inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173302

Locations
China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
  More Information

Additional Information:
Peking University People's Hospital  This link exits the ClinicalTrials.gov site

No publications provided by Peking University People's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Wang Chuanlin, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01173302     History of Changes
Other Study ID Numbers: PKUPH-ER-1
Study First Received: July 19, 2010
Last Updated: July 30, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University People's Hospital:
Rabies
Anti-rabies antibody
Persistence

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
 Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013