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CompletedNCT00611611Updated Apr 28, 2011

BLYS and IFN in SLE

An observational study in Systemic Lupus Erythematosus, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-28.

Sponsored by University of Alabama at Birmingham · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
39
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 39 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
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

Exclusion Criteria:

  • chronic infection or cancer
  • pregnancy
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
39 participants (actual)

Groups and cohorts

  • 1

    SLE

    Biological: fluzone · Biological: pneumovax

  • 2

    healthy controls

    Biological: fluzone · Biological: pneumovax

Interventions

  • Biologicalfluzone

    once

  • Biologicalpneumovax

    once

06

What researchers measure

Primary outcomes

  1. change in specific antibodies in response to vaccine

    Time frame: 2 weeks

Secondary outcomes

  1. change in BLyS after vaccination

    Time frame: 2 weeks

  2. change in IFN after vaccination

    Time frame: 2 weeks

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00611611
Lead sponsor
University of Alabama at Birmingham
Collaborators
Hospital for Special Surgery, New York
First posted
Feb 11, 2008
Start date
Oct 2007
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Apr 28, 2011

Study contacts

Robert H Carter, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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