BLYS and IFN in SLE

Systemic Lupus Erythematosus Clinical Trial

Official title:

BLyS and IFN Responses to Antigen Challenge in Human SLE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611611
• Other study ID #: F060217005
• Secondary ID: NIH R21 AI069363
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: April 27, 2011
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• ACR lupus criteria

• 18<age<65

Exclusion Criteria:

• chronic infection or cancer

• pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• fluzone
once
• pneumovax
once

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in specific antibodies in response to vaccine		2 weeks	No
Secondary	change in BLyS after vaccination		2 weeks	No
Secondary	change in IFN after vaccination		2 weeks	No