Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression
Condition: Immunosuppression
Study type: Interventional

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 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.
    


Intervention name(s): Flu Vaccine
Intervention type(s): Biological
Intervention description(s): Administration of Fluzone (Influenza Vaccine)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dermatology; Influenza Vaccine