Systemic Lupus ErythematosusNCT00611611
BLYS and IFN in SLE
An observational study of Systemic Lupus Erythematosus, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- fluzone and pneumovax
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: lupus and healthy controls
Who may be able to join
- ACR lupus criteria
- 18<age<65
Who cannot join
- chronic infection or cancer
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: BLyS and IFN Responses to Antigen Challenge in Human SLE
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- fluzone, pneumovax
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluzoneBiological
once
pneumovaxBiological
once
| Study group | Role | What they receive |
|---|---|---|
| 1 | SLE Receives: Biological: fluzone; Biological: pneumovax | |
| 2 | healthy controls Receives: Biological: fluzone; Biological: pneumovax |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in specific antibodies in response to vaccine
Measured: 2 weeks
Secondary outcomes (2)
change in BLyS after vaccination
Measured: 2 weeks
change in IFN after vaccination
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Investigators
- Robert H Carter, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611611
- Sponsor's protocol ID
- F060217005
- Other IDs
- NIH R21 AI069363
- Status last verified
- Apr 2011
- First submitted
- 28 Jan 2008
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLyS and IFN Responses to Antigen Challenge in Human SLE
- ClinicalTrials.gov ID
- NCT00611611
- Acronym / sponsor ID
- F060217005
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: fluzone, Biological: pneumovaxSLE |
| 2 | – | Biological: fluzone, Biological: pneumovaxhealthy controls |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- lupus and healthy controls
Key inclusion criteria (2 listed)
- ACR lupus criteria
- 18<age<65
Key exclusion criteria (2 listed)
- chronic infection or cancer
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluzoneonce | Biological | 1, 2 |
| pneumovaxonce | Biological | 1, 2 |
Primary outcome
change in specific antibodies in response to vaccine
Time frame: 2 weeks
2 secondary outcomes
change in BLyS after vaccination
Time frame: 2 weeks
change in IFN after vaccination
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Carter, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in specific antibodies in response to vaccine (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.