Immunosuppression
Conditions
Keywords
Dermatology, Influenza Vaccine
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.
Interventions
BIOLOGICALFlu Vaccine
Administration of Fluzone (Influenza Vaccine)
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination | 28 days | 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 | 28 days | 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. |
Countries
United States
Participant flow
Recruitment details
43 subjects enrolled from Dept of dermatology, including 21 normal controls, 12 patients on TNF blockers for the treatment of skin diseases, and 10 patients treated with azathioprine for the treatment of skin diseases. Both serologic and cell based assays were completed before and after vaccination on all subjects.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteer Healthy volunteers without skin disease prior to influenza vaccination | 21 |
| Azathioprine Patients with skin diseases taking azathioprine | 10 |
| TNF Alpha Blocker Patients with skin diseases taking TNF alpha blockers | 12 |
| Total | 43 |
Baseline characteristics
| Characteristic | Azathioprine | TNF Alpha Blocker | Healthy Volunteer | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 21 Participants | 42 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 7.3 | 40 years STANDARD_DEVIATION 11.6 | 33 years STANDARD_DEVIATION 9.5 | 38.1 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment United States | 10 participants | 12 participants | 21 participants | 43 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination
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.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Volunteer | Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination | 19 participants |
| Azathioprine | Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination | 5 participants |
| TNF Alpha Blockers | Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination | 6 participants |
Primary
Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination
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.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Volunteer | Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination | 15 participants |
| Azathioprine | Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination | 3 participants |
| TNF Alpha Blockers | Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination | 6 participants |