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NCT01474720 · ClinicalTrials.gov registry record · Phase 1
Zostavax in Systemic Lupus Erythematosus
A Phase 1 study of Systemic Lupus Erythematosus, sponsored by Oklahoma Medical Research Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01474720 is a Phase 1 study of Systemic Lupus Erythematosus that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 20 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01474720, a Phase 1 study of Systemic Lupus Erythematosus, has completed, sponsored by Oklahoma Medical Research Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox. The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines. Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.
Conditions Studied
Interventions
- DRUG Zostavax vaccine
Study Locations (1)
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01474720
The ClinicalTrials.gov registry entry for NCT01474720 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (95% lower). The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Zostavax vaccine is the first listed.
NCT01474720 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT01474720 about?
NCT01474720 is a clinical study titled "Zostavax in Systemic Lupus Erythematosus". Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox. The investigators propose to study the immune response to commercially available Zostavax vaccine ...
What is the current status of trial NCT01474720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-11. Estimated completion is 2012-10.
What conditions does trial NCT01474720 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT01474720?
The interventions under investigation include: Zostavax vaccine (DRUG).
Who is sponsoring clinical trial NCT01474720?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01474720 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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