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BLYS and IFN in SLE

This study has been completed.
Sponsor:
Collaborator:
Hospital for Special Surgery, New York
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00611611
First received: January 28, 2008
Last updated: April 27, 2011
Last verified: April 2011

January 28, 2008
April 27, 2011
October 2007
April 2009   (final data collection date for primary outcome measure)
change in specific antibodies in response to vaccine [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611611 on ClinicalTrials.gov Archive Site
  • change in BLyS after vaccination [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • change in IFN after vaccination [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
BLYS and IFN in SLE
BLyS and IFN Responses to Antigen Challenge in Human SLE

This protocol tests whether changes in BLyS or IFN can be detected in a normal immune response to a vaccine and, if so, whether the response differs between those with lupus and healthy controls.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

lupus and healthy controls

Systemic Lupus Erythematosus
  • Biological: fluzone
    once
  • Biological: pneumovax
    once
  • 1
    SLE
    Interventions:
    • Biological: fluzone
    • Biological: pneumovax
  • 2
    healthy controls
    Interventions:
    • Biological: fluzone
    • Biological: pneumovax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ACR lupus criteria
  • 18<age<65

Exclusion Criteria:

  • chronic infection or cancer
  • pregnancy
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611611
F060217005, NIH R21 AI069363
No
W Winn Chatham, University of Alabama at Birmingham
University of Alabama at Birmingham
Hospital for Special Surgery, New York
Principal Investigator: Robert H Carter, MD University of Alabama at Birmingham
University of Alabama at Birmingham
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP