NCT00611611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

1.5 years

First QC Date

January 28, 2008

Last Update Submit

April 27, 2011

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • change in specific antibodies in response to vaccine

    2 weeks

Secondary Outcomes (2)

  • change in BLyS after vaccination

    2 weeks

  • change in IFN after vaccination

    2 weeks

Study Arms (2)

1

SLE

Biological: fluzoneBiological: pneumovax

2

healthy controls

Biological: fluzoneBiological: pneumovax

Interventions

fluzoneBIOLOGICAL

once

12
pneumovaxBIOLOGICAL

once

12

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lupus and healthy controls

You may qualify if:

  • ACR lupus criteria
  • \<age\<65

You may not qualify if:

  • chronic infection or cancer
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Influenza VaccinesPneumococcal Vaccines

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesStreptococcal VaccinesBacterial Vaccines

Study Officials

  • Robert H Carter, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

US(1)