NCT01173302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 2, 2010

Status Verified

July 1, 2010

Enrollment Period

3 months

First QC Date

July 19, 2010

Last Update Submit

July 30, 2010

Conditions

Rabies

Keywords

RabiesAnti-rabies antibodyPersistence

Outcome Measures

Primary Outcomes (1)

  • Rabies antibody titer

    We test the antirabies antibody titer before and after the single booster dose

    6 months

Study Arms (1)

Post vaccination

EXPERIMENTAL

All the subjects had been vaccinated with antirabies vaccine.

Biological: Rabies vaccine, manufactured by ChengDa

Interventions

Rabies vaccine, manufactured by ChengDaBIOLOGICAL

1 dose before the antibody is tested

Also known as: ChengDa Speeda
Post vaccination

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

  • 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.

    PMID: 21752947DERIVED

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2010

First Posted

August 2, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

August 2, 2010

Record last verified: 2010-07

Locations

CN(1)