<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/NCT01713855</url>
  </required_header>
  <id_info>
    <org_study_id>CHB 04-10-143</org_study_id>
    <nct_id>NCT01713855</nct_id>
  </id_info>
  <brief_title>Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura</brief_title>
  <official_title>Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neufeld, Ellis J, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Terrana ITP Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neufeld, Ellis J, MD, PhD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how children with a history of severe, chronic&#xD;
      Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to&#xD;
      vaccines. Eligible patients are previously or currently enrolled in a study entitled &quot;Open&#xD;
      Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura&#xD;
      in Children and Adolescents&quot; and have decided to obtain an inactivated influenza vaccination.&#xD;
      These patients will be invited to provide one blood sample prior to vaccination and a second&#xD;
      sample following vaccination to quantify immune response to vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this ancillary, pilot-phase study is to determine how children with a history&#xD;
      of severe, chronic ITP who were treated with rituximab might respond to vaccines. Eligible&#xD;
      patients are previously or currently enrolled in a study entitled &quot;Open Label, Phase I/II&#xD;
      Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura in Children and&#xD;
      Adolescents&quot; (CHB 02-12-160) and have decided to obtain the trivalent, inactivated influenza&#xD;
      vaccination. These patients will be invited to provide one blood sample prior to vaccination&#xD;
      and a second sample 4-8 weeks after vaccination to quantify immune response to vaccination.&#xD;
      Additionally, if patients are scheduled to receive a tetanus booster vaccination within one&#xD;
      month before or after the influenza vaccination, response to tetanus will also be quantified.&#xD;
      This sample will be collected during the same phlebotomy as the influenza sample. In some&#xD;
      cases, a blood sample was stored prior to rituximab treatment and will be used for baseline&#xD;
      assessment. The primary and secondary objectives for this study are as follows:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
        -  To determine the portion of patients who will respond adequately to influenza&#xD;
           vaccination, with adequacy defined as a titer greater than 1:32 for each strain of virus&#xD;
           in the vaccine, measured 4-8 weeks after administration of the vaccine OR greater than a&#xD;
           four-fold increase in titers measured 4-8 weeks after administration of the vaccine&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the ability to mount a response to the influenza vaccine, with response&#xD;
           defined as any increase in influenza antibody titer for each strain of virus between&#xD;
           samples before and 4-8 weeks after vaccination.&#xD;
&#xD;
        -  To evaluate the ability to mount an adequate response to tetanus toxoid, with adequacy&#xD;
           defined as in the primary objective.&#xD;
&#xD;
        -  To evaluate the ability to mount a response to tetanus toxoid, with response defined as&#xD;
           above.&#xD;
&#xD;
        -  To compare response to influenza vaccination received less than one year after rituximab&#xD;
           and greater than one year after rituximab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2004</start_date>
  <completion_date type="Actual">March 2006</completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of patients with any increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients with any increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination.</measure>
  </secondary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Idiopathic Thrombocytopenic Purpura</condition>
  <condition>Immune Thrombocytopenic Purpura</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Inactivated Trivalent Influenza vaccine</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously or currently enrolled in parent study, see CHB 02-12-160&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Baseline immunodeficiency (i.e. DiGeorge syndrome, Common Variable Immunodeficiency)&#xD;
&#xD;
          -  Contraindications for influenza vaccine, including: hypersensitivity to egg products;&#xD;
             history of Guillain-Barre syndrome; history of adverse reaction to flu vaccine&#xD;
&#xD;
          -  Contraindications for tetanus toxoid, including: hypersensitivity to prior tetanus&#xD;
             vaccination; concurrent moderate to severe illness&#xD;
&#xD;
          -  Subjects meeting any of the following criteria will be temporarily excluded from the&#xD;
             study: high-dose corticosteroid therapy (5-30 mg/kg/day) during the 24 hours&#xD;
             immediately prior to the vaccine; IVIG (intravenous immunoglobulin) within 4 months&#xD;
             prior to vaccine; platelet count of less than 20,000/ml within one month of&#xD;
             vaccination with evidence of grade II or higher skin bleeding, assessed at vaccine&#xD;
             administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellis J Neufeld, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2012</last_update_posted>
  <responsible_party>
    <name_title>Ellis J. Neufeld, MD, PhD</name_title>
    <organization>Children's Hospital Boston</organization>
  </responsible_party>
  <keyword>ITP</keyword>
  <keyword>Rituximab</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Immune Reconstitution</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01713855
org study id: CHB 04-10-143
nct id: NCT01713855
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine how children with a history of severe, chronic
      Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to
      vaccines. Eligible patients are previously or currently enrolled in a study entitled "Open
      Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
      in Children and Adolescents" and have decided to obtain an inactivated influenza vaccination.
      These patients will be invited to provide one blood sample prior to vaccination and a second
      sample following vaccination to quantify immune response to vaccination.
The purpose of this ancillary, pilot-phase study is to determine how children with a history
      of severe, chronic ITP who were treated with rituximab might respond to vaccines. Eligible
      patients are previously or currently enrolled in a study entitled "Open Label, Phase I/II
      Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura in Children and
      Adolescents" (CHB 02-12-160) and have decided to obtain the trivalent, inactivated influenza
      vaccination. These patients will be invited to provide one blood sample prior to vaccination
      and a second sample 4-8 weeks after vaccination to quantify immune response to vaccination.
      Additionally, if patients are scheduled to receive a tetanus booster vaccination within one
      month before or after the influenza vaccination, response to tetanus will also be quantified.
      This sample will be collected during the same phlebotomy as the influenza sample. In some
      cases, a blood sample was stored prior to rituximab treatment and will be used for baseline
      assessment. The primary and secondary objectives for this study are as follows:

      Primary:

        -  To determine the portion of patients who will respond adequately to influenza
           vaccination, with adequacy defined as a titer greater than 1:32 for each strain of virus
           in the vaccine, measured 4-8 weeks after administration of the vaccine OR greater than a
           four-fold increase in titers measured 4-8 weeks after administration of the vaccine

      Secondary Objectives:

        -  To evaluate the ability to mount a response to the influenza vaccine, with response
           defined as any increase in influenza antibody titer for each strain of virus between
           samples before and 4-8 weeks after vaccination.

        -  To evaluate the ability to mount an adequate response to tetanus toxoid, with adequacy
           defined as in the primary objective.

        -  To evaluate the ability to mount a response to tetanus toxoid, with response defined as
           above.

        -  To compare response to influenza vaccination received less than one year after rituximab
           and greater than one year after rituximab.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination
measure: The number of patients with any increase in titer for each strain of virus in the influenza vaccine at 4-8 weeks after vaccination
measure: The number of patients with a titer greater than 1:32 OR greater than 4-fold increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination
measure: The number of patients with any increase in titer for each strain of virus in the tetanus vaccine at 4-8 weeks after vaccination.
intervention type: Biological
intervention name: Inactivated Trivalent Influenza vaccine
criteria: 
gender: All
minimum age: 18 Months
maximum age: 18 Years
healthy volunteers: No
last name: Ellis J Neufeld, MD, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
facility: 
facility: 
country: United States
name title: Ellis J. Neufeld, MD, PhD
organization: Children's Hospital Boston
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic
mesh term: Purpura, Thrombocytopenic, Idiopathic