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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
History of Changes
  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:

MedlinePlus related topics: Lupus
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 28, 2008
Last Updated: April 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013