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NCT01733056 · ClinicalTrials.gov registry record · NA
Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT01733056 is a NA study that has completed, run by Emory University. The registered enrollment target is 43 participants.
The verdict
NCT01733056, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto 1. Problem of Interest We are proposing to study the effectiveness of vaccines in people who are taking drugs that affect the immune system. There are many populations of people who have chronic medical conditions that require them to have long-term treatment with immunosuppressive medications (drugs that decrease the function of the immune system). Examples of these patients include organ transplant recipients, patients with immune cell cancers such as leukemia and lymphoma, patients with inflammatory disorders such as lupus or scleroderma, and patients with skin conditions requiring steroid-based creams, ointments, pills, or injections. Patients who are taking these medications should receive appropriate vaccinations such as tetanus boosters, influenza vaccines, and pneumonia vaccines. The effectiveness of vaccinations depends in large part on a strong response to the vaccine by the immune system. Drugs that decrease immune system function therefore, may also decrease the effectiveness of vaccines. 2. How the Problem of Interest will be studied We plan to give three different groups of participants influenza vaccinations and measure each participant's immune system response through blood tests. The three groups will be: 1. Healthy people taking no immunosuppressive medications 2. Patients with skin conditions requiring treatment with azathioprine and currently taking no other immunosuppressive agents 3. Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis factor-alpha) and currently taking no other immunosuppressive medications. All participants will be between 18 - 89 years old and will not have had influenza vaccination within the previous six months. We will administer
Interventions
- BIOLOGICAL Flu Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01733056
The ClinicalTrials.gov registry entry for NCT01733056 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flu Vaccine is the first listed.
NCT01733056 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01733056 about?
NCT01733056 is a clinical study titled "Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression". Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto 1. Problem of Interest We ar...
What is the current status of trial NCT01733056?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2011-01. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01733056?
The interventions under investigation include: Flu Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01733056?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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