BLYS and IFN in SLE

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: fluzone; Biological: pneumovax

• Registration Number: NCT00611611
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-11
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• ACR lupus criteria
• 18<age<65

Exclusion Criteria

• chronic infection or cancer
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	fluzone	SLE
1	pneumovax	SLE
2	fluzone	healthy controls
2	pneumovax	healthy controls

Primary Outcome Measures

Name	Time	Method
change in specific antibodies in response to vaccine	2 weeks

Secondary Outcome Measures

Name	Time	Method
change in BLyS after vaccination	2 weeks
change in IFN after vaccination	2 weeks

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States