Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

This study is currently recruiting participants.
Verified November 2012 by Emory University
Sponsor:
Information provided by (Responsible Party):
Robert A Swerlick MD, Emory University
ClinicalTrials.gov Identifier:
NCT01733056
First received: November 20, 2012
Last updated: November 25, 2012
Last verified: November 2012
  Purpose

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 connective tissue disorders such as lupus, sarcoidosis, or scleroderma, and patients with skin conditions requiring steroid-based creams, ointments, pills, or injections. Patients who are taking these medications must 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. To our knowledge, there is no data in the scientific literature regarding the effectiveness of vaccines in patients who are taking only one immunosuppressive medication.
  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 40 - 60 years old and will not have had influenza vaccination within the previous six months. We will administer the vaccination on day 0. We will take blood samples on days 0, 7, and 30 following vaccination. We will use these blood samples to measure the amount of antibodies produced to the vaccine and the response of specific immune system cells known as B-lymphocytes. Using statistical methods, we will compare these findings between the three groups of participants to determine if differences in response to the vaccination exist.

3. How the research will advance scientific knowledge and/or human health To our knowledge there is no scientific data available regarding the effectiveness of vaccinations in patients receiving only one specific immunosuppressive medication. We will also be using new techniques developed at Emory to measure the B-lymphocyte response to the vaccine. This research could potentially help guide vaccination strategies for people requiring immunosuppressive medications and prevent infectious disease in these populations as well as the general population.

4. Standard of Care This research study does not propose to treat any of the participants conditions. Therefore, there is no "standard of care." This research study does propose to give influenza vaccinations to all participants.


Condition Intervention
Immunosuppression
Biological: Flu Vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Characterization of Immune Response to Vaccination in Patients Receiving Single-Drug Immunosuppressive Therapy

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Specific Aim 1: Characterize influenza antibody titers before and after vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Specific Aim 1: Characterize influenza antibody titers before and after vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls.


Secondary Outcome Measures:
  • Specific Aim 2: Characterize the B cell responses to influenza vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Specific Aim 2: Characterize the B cell responses to influenza vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls.

    Measure the magnitude and specificity of influenza-specific B cell memory.

    Analyze influenza-specific antibody secreting cells (ASC) appearing in blood after influenza vaccination



Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Volunteer
Characterize influenza antibody titers before and after vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls.
Biological: Flu Vaccine
Fluzone (Influenza Vaccine)
Active Comparator: Azathioprine
Characterize influenza antibody titers before and after vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls.
Biological: Flu Vaccine
Fluzone (Influenza Vaccine)
Active Comparator: TNF alpha
Characterize influenza antibody titers before and after vaccination in patients taking azathioprine, TNF-alpha, or in healthy controls.
Biological: Flu Vaccine
Fluzone (Influenza Vaccine)

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • Patient Taking azathioprine, Humira, Enbrel or Remicade
  • Willing to participate in the healthy volunteer arm

Exclusion Criteria:

  • Has received flu vaccine in past year
  • Taking steroids or any other immunosuppressive drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733056

Locations
United States, Georgia
Emory University, Department of Dermatology Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bridget R Bradley, RN, FNP, CCRC    404-778-3084    brbradl@emory.edu   
Contact: Rachel Sahn, MD    404-778-3158    rsahn@emory.edu   
Principal Investigator: Robert A Swerlick, MD         
Sponsors and Collaborators
Emory University
  More Information

No publications provided

Responsible Party: Robert A Swerlick MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01733056     History of Changes
Other Study ID Numbers: Emory IRB00044264, 5-31040
Study First Received: November 20, 2012
Last Updated: November 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Dermatology
Influenza Vaccine

Additional relevant MeSH terms:
Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014