Clinical trial NCT01733056: Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression
Official title: Characterization of Immune Response to Vaccination in Patients Receiving Single-Drug Immunosuppressive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunosuppression
Keywords: Dermatology
Influenza Vaccine
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.


Eligibility 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

Primary outcomes:
measure: Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination
timeFrame: 28 days
measure: Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Department of Dermatology
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Robert Swerlick, MD
role: PRINCIPAL_INVESTIGATOR
References: