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BLYS and IFN in SLE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00611611
First Posted: February 11, 2008
Last Update Posted: April 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital for Special Surgery, New York
Information provided by:
University of Alabama at Birmingham
  Purpose
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.

Condition Intervention
Systemic Lupus Erythematosus Biological: fluzone Biological: pneumovax

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: BLyS and IFN Responses to Antigen Challenge in Human SLE

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • change in specific antibodies in response to vaccine [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • change in BLyS after vaccination [ Time Frame: 2 weeks ]
  • change in IFN after vaccination [ Time Frame: 2 weeks ]

Enrollment: 39
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
SLE
Biological: fluzone
once
Biological: pneumovax
once
2
healthy controls
Biological: fluzone
once
Biological: pneumovax
once

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
lupus and healthy controls
Criteria

Inclusion Criteria:

  • ACR lupus criteria
  • 18<age<65

Exclusion Criteria:

  • chronic infection or cancer
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611611


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Robert H Carter, MD University of Alabama at Birmingham
  More Information

Responsible Party: W Winn Chatham, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00611611     History of Changes
Other Study ID Numbers: F060217005
NIH R21 AI069363
First Submitted: January 28, 2008
First Posted: February 11, 2008
Last Update Posted: April 28, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases