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NCT01506661 · ClinicalTrials.gov registry record · Phase 1
Safety of Zostavax Vaccination in Rheumatoid Arthritis
A Phase 1 study, sponsored by Oklahoma Medical Research Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01506661 is a Phase 1 study that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 20 participants.
The verdict
NCT01506661, a Phase 1 study, has completed, sponsored by Oklahoma Medical Research Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Shingles presents as a painful, itchy blistering rash that usually involves a single portion of the skin and lasts about 7-10 days. The risk of developing shingles increases with age in healthy people, and has been shown in some studies to be increased in people with rheumatoid arthritis and other autoimmune diseases. Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by the FDA for the prevention of Shingles among people 60 years and older, and is now approved for use in people aged 50 years and older. Because rheumatoid arthritis and some of the medications used to treat rheumatoid arthritis can impair the body's immune system, it is not known how much of an immune response can be generated in people with rheumatoid arthritis. The goals of this study are to measure the immune response after standard vaccination with Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune systems. All participants will be 50 years old or older, and subjects with rheumatoid arthritis will not be eligible if they are taking certain biologic medications, including TNF inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid arthritis will all receive a single vaccination with Zostavax, then will be followed for 12 weeks to assess the immune response and for the development of local rash or other potential side effects.
Interventions
- DRUG Zostavax (varicella zoster virus) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-01 |
| Est. Completion | 2018-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01506661
The ClinicalTrials.gov registry entry for NCT01506661 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. The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zostavax (varicella zoster virus) vaccine is the first listed.
NCT01506661 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01506661 about?
NCT01506661 is a clinical study titled "Safety of Zostavax Vaccination in Rheumatoid Arthritis". Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV) that usually occurs decades following initial exposure. The risk of developing shingles increases with age. Shingles presents as a painful, itchy blistering rash that usually involves a single portion of the sk...
What is the current status of trial NCT01506661?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-01. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01506661?
The interventions under investigation include: Zostavax (varicella zoster virus) vaccine (DRUG).
Who is sponsoring clinical trial NCT01506661?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
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