Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

NCT ID: NCT01733056

Last Updated: 2014-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Volunteer

Healthy volunteers without skin disease that received administration of Fluzone

Group Type: PLACEBO_COMPARATOR

Flu Vaccine

Intervention Type: BIOLOGICAL

Administration of Fluzone (Influenza Vaccine)

Azathioprine

Patients with skin diseases taking azathioprine that received administration of Fluzone

Group Type: EXPERIMENTAL

Flu Vaccine

Intervention Type: BIOLOGICAL

Administration of Fluzone (Influenza Vaccine)

TNF alpha blocker

Patients with skin diseases taking azathioprine that received administration of Fluzone

Group Type: EXPERIMENTAL

Flu Vaccine

Intervention Type: BIOLOGICAL

Administration of Fluzone (Influenza Vaccine)

Interventions

Flu Vaccine

Administration of Fluzone (Influenza Vaccine)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Robert A Swerlick MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Swerlick, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University, Department of Dermatology

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

5-31040

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00044264

Identifier Type: -

Identifier Source: org_study_id