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BLYS and IFN in SLE

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ClinicalTrials.gov Identifier: NCT00611611
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : April 28, 2011
Sponsor:
Collaborator:
Hospital for Special Surgery, New York
Information provided by:
University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment
Systemic Lupus Erythematosus Biological: fluzone Biological: pneumovax

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: BLyS and IFN Responses to Antigen Challenge in Human SLE
Study Start Date : October 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
SLE
Biological: fluzone
once
Biological: pneumovax
once
2
healthy controls
Biological: fluzone
once
Biological: pneumovax
once



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

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


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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

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

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 Posted: February 11, 2008    Key Record Dates
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