Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert A Swerlick MD, Emory University
ClinicalTrials.gov Identifier:
NCT01733056
First received: November 20, 2012
Last updated: June 19, 2014
Last verified: June 2014
  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 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 the vaccination on day 0. We will take blood samples on days 0, 7, and 28 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.


Condition Intervention
Immunosuppression
Biological: Flu Vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:
  • Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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.

  • Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Healthy Volunteer
Healthy volunteers without skin disease that received administration of Fluzone
Biological: Flu Vaccine
Administration of Fluzone (Influenza Vaccine)
Experimental: Azathioprine
Patients with skin diseases taking azathioprine that received administration of Fluzone
Biological: Flu Vaccine
Administration of Fluzone (Influenza Vaccine)
Experimental: TNF alpha blocker
Patients with skin diseases taking azathioprine that received administration of Fluzone
Biological: Flu Vaccine
Administration of 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 to 89 years of age
  • 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 systemic corticosteroids or any other immunosuppressive drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733056

Locations
United States, Georgia
Emory University, Department of Dermatology
Atlanta, Georgia, United States, 30322
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Robert Swerlick, MD 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: IRB00044264, 5-31040
Study First Received: November 20, 2012
Results First Received: July 16, 2013
Last Updated: June 19, 2014
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 September 14, 2014