Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression
Characterization of Immune Response to Vaccination in Patients Receiving Single-Drug Immunosuppressive Therapy
2 other identifiers
interventional
43
1 country
2
Brief 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
- 3.Healthy people taking no immunosuppressive medications
- 4.Patients with skin conditions requiring treatment with azathioprine and currently taking no other immunosuppressive agents
- 5.Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis factor-alpha) and currently taking no other immunosuppressive medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
November 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
July 21, 2014
CompletedJuly 21, 2014
June 1, 2014
2 years
November 20, 2012
July 16, 2013
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination
Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.
28 days
Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination
Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.
28 days
Study Arms (3)
Healthy Volunteer
PLACEBO COMPARATORHealthy volunteers without skin disease that received administration of Fluzone
Azathioprine
EXPERIMENTALPatients with skin diseases taking azathioprine that received administration of Fluzone
TNF alpha blocker
EXPERIMENTALPatients with skin diseases taking azathioprine that received administration of Fluzone
Interventions
Administration of Fluzone (Influenza Vaccine)
Eligibility Criteria
You may qualify if:
- to 89 years of age
- Patient Taking azathioprine, Humira, Enbrel or Remicade
- Willing to participate in the healthy volunteer arm
You may not qualify if:
- Has received flu vaccine in past year
- Taking systemic corticosteroids or any other immunosuppressive drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (2)
Emory University, Department of Dermatology
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Swerlick
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Swerlick, MD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 20, 2012
First Posted
November 26, 2012
Study Start
January 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
July 21, 2014
Results First Posted
July 21, 2014
Record last verified: 2014-06