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 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.