This study has been completed.
Hospital for Special Surgery, New York
Information provided by:
University of Alabama at Birmingham Identifier:
First received: January 28, 2008
Last updated: April 27, 2011
Last verified: April 2011
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 ] [ 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
Biological: fluzone
Biological: pneumovax
healthy controls
Biological: fluzone
Biological: pneumovax


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

Inclusion Criteria:

  • ACR lupus criteria
  • 18<age<65

Exclusion Criteria:

  • chronic infection or cancer
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00611611

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
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 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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases processed this record on November 25, 2015