<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01733056</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00044264</org_study_id>
    <secondary_id>5-31040</secondary_id>
    <nct_id>NCT01733056</nct_id>
  </id_info>
  <brief_title>Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression</brief_title>
  <official_title>Characterization of Immune Response to Vaccination in Patients Receiving Single-Drug Immunosuppressive Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Biomedical Lay Summary Title: Characterization of immune response to vaccination in patients&#xD;
      receiving single-drug immunosuppressive therapy Principal Investigator: Robert Swerlick, MD&#xD;
      Other Investigators: Rafi Ahmed, PhD Suephy Chen, MD Jens Wrammert, PhD Adam Sperduto&#xD;
&#xD;
        1. Problem of Interest We are proposing to study the effectiveness of vaccines in people&#xD;
           who are taking drugs that affect the immune system. There are many populations of people&#xD;
           who have chronic medical conditions that require them to have long-term treatment with&#xD;
           immunosuppressive medications (drugs that decrease the function of the immune system).&#xD;
           Examples of these patients include organ transplant recipients, patients with immune&#xD;
           cell cancers such as leukemia and lymphoma, patients with inflammatory disorders such as&#xD;
           lupus or scleroderma, and patients with skin conditions requiring steroid-based creams,&#xD;
           ointments, pills, or injections. Patients who are taking these medications should&#xD;
           receive appropriate vaccinations such as tetanus boosters, influenza vaccines, and&#xD;
           pneumonia vaccines. The effectiveness of vaccinations depends in large part on a strong&#xD;
           response to the vaccine by the immune system. Drugs that decrease immune system function&#xD;
           therefore, may also decrease the effectiveness of vaccines.&#xD;
&#xD;
        2. How the Problem of Interest will be studied&#xD;
&#xD;
      We plan to give three different groups of participants influenza vaccinations and measure&#xD;
      each participant's immune system response through blood tests. The three groups will be:&#xD;
&#xD;
        1. Healthy people taking no immunosuppressive medications&#xD;
&#xD;
        2. Patients with skin conditions requiring treatment with azathioprine and currently taking&#xD;
           no other immunosuppressive agents&#xD;
&#xD;
        3. Patients with psoriasis requiring treatment with TNF-alpha (tumor necrosis factor-alpha)&#xD;
           and currently taking no other immunosuppressive medications.&#xD;
&#xD;
      All participants will be between 18 - 89 years old and will not have had influenza&#xD;
      vaccination within the previous six months. We will administer the vaccination on day 0. We&#xD;
      will take blood samples on days 0, 7, and 28 following vaccination. We will use these blood&#xD;
      samples to measure the amount of antibodies produced to the vaccine and the response of&#xD;
      specific immune system cells known as B-lymphocytes. Using statistical methods, we will&#xD;
      compare these findings between the three groups of participants to determine if differences&#xD;
      in response to the vaccination exist.&#xD;
&#xD;
      3. How the research will advance scientific knowledge and/or human health To our knowledge&#xD;
      there is no scientific data available regarding the effectiveness of vaccinations in patients&#xD;
      receiving only one specific immunosuppressive medication. We will also be using new&#xD;
      techniques developed at Emory to measure the B-lymphocyte response to the vaccine. This&#xD;
      research could potentially help guide vaccination strategies for people requiring&#xD;
      immunosuppressive medications and prevent infectious disease in these populations as well as&#xD;
      the general population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination</measure>
    <time_frame>28 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination</measure>
    <time_frame>28 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy volunteers without skin disease that received administration of Fluzone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Azathioprine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with skin diseases taking azathioprine that received administration of Fluzone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TNF alpha blocker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with skin diseases taking azathioprine that received administration of Fluzone</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Flu Vaccine</intervention_name>
    <description>Administration of Fluzone (Influenza Vaccine)</description>
    <arm_group_label>Azathioprine</arm_group_label>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <arm_group_label>TNF alpha blocker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 89 years of age&#xD;
&#xD;
          -  Patient Taking azathioprine, Humira, Enbrel or Remicade&#xD;
&#xD;
          -  Willing to participate in the healthy volunteer arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received flu vaccine in past year&#xD;
&#xD;
          -  Taking systemic corticosteroids or any other immunosuppressive drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Swerlick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University, Department of Dermatology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>July 16, 2013</results_first_submitted>
  <results_first_submitted_qc>June 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 21, 2014</results_first_posted>
  <last_update_submitted>June 19, 2014</last_update_submitted>
  <last_update_submitted_qc>June 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Robert A Swerlick MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dermatology</keyword>
  <keyword>Influenza Vaccine</keyword>

  <clinical_results>

    <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.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy Volunteer</title>
        </group>
        <group group_id="P2">
          <title>Azathioprine</title>
        </group>
        <group group_id="P3">
          <title>TNF Alpha Blockers</title>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Volunteer</title>
          <description>Healthy volunteers without skin disease prior to influenza vaccination</description>
        </group>
        <group group_id="B2">
          <title>Azathioprine</title>
          <description>Patients with skin diseases taking azathioprine</description>
        </group>
        <group group_id="B3">
          <title>TNF Alpha Blocker</title>
          <description>Patients with skin diseases taking TNF alpha blockers</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" spread="9.5"/>
                    <measurement group_id="B2" value="57" spread="7.3"/>
                    <measurement group_id="B3" value="40" spread="11.6"/>
                    <measurement group_id="B4" value="38.1" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination</title>
        <description>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.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Volunteer</title>
            <description>Healthy volunteers without skin disease prior to influenza vaccination</description>
          </group>
          <group group_id="O2">
            <title>Azathioprine</title>
            <description>Patients with skin diseases taking azathioprine</description>
          </group>
          <group group_id="O3">
            <title>TNF Alpha Blockers</title>
            <description>Patients with skin diseases taking TNF alpha blockers</description>
          </group>
        </group_list>
        <measure>
          <title>Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination</title>
          <description>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.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination</title>
        <description>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.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Volunteer</title>
            <description>Healthy volunteers without skin disease prior to influenza vaccination</description>
          </group>
          <group group_id="O2">
            <title>Azathioprine</title>
            <description>Patients with skin diseases taking azathioprine</description>
          </group>
          <group group_id="O3">
            <title>TNF Alpha Blockers</title>
            <description>Patients with skin diseases taking TNF alpha blockers</description>
          </group>
        </group_list>
        <measure>
          <title>Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination</title>
          <description>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.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Healthy Volunteer Pre-vaccination</title>
          <description>Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine</description>
        </group>
        <group group_id="E2">
          <title>Healthy Volunteer Post-vaccination</title>
          <description>Healthy volunteers who had blood drawn after vaccination with influenza vaccine</description>
        </group>
        <group group_id="E3">
          <title>Azathioprine Pre-vaccination</title>
          <description>Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine</description>
        </group>
        <group group_id="E4">
          <title>Azathioprine Post-vaccination</title>
          <description>Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine</description>
        </group>
        <group group_id="E5">
          <title>TNF Alpha Blocker Pre-vaccination</title>
          <description>Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine</description>
        </group>
        <group group_id="E6">
          <title>TNF Alpha Blocker Post-vaccination</title>
          <description>Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Robert Swerlick</name_or_title>
      <organization>Emory University</organization>
      <phone>404-727-3669</phone>
      <email>rswerli@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733056
org study id: IRB00044264
secondary id: 5-31040
nct id: NCT01733056
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination
time frame: 28 days
description: 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.
measure: Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination
time frame: 28 days
description: 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.
arm group label: Healthy Volunteer
arm group type: Placebo Comparator
description: Healthy volunteers without skin disease that received administration of Fluzone
arm group label: Azathioprine
arm group type: Experimental
description: Patients with skin diseases taking azathioprine that received administration of Fluzone
arm group label: TNF alpha blocker
arm group type: Experimental
description: Patients with skin diseases taking azathioprine that received administration of Fluzone
intervention type: Biological
intervention name: Flu Vaccine
description: Administration of Fluzone (Influenza Vaccine)
arm group label: Azathioprine
arm group label: Healthy Volunteer
arm group label: TNF alpha blocker
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Swerlick, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Robert A Swerlick MD
investigator title: Professor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 