<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/NCT01698866</url>
  </required_header>
  <id_info>
    <org_study_id>2011-004968-30</org_study_id>
    <nct_id>NCT01698866</nct_id>
  </id_info>
  <brief_title>Low Grade Lymphoma</brief_title>
  <acronym>EVACC-B</acronym>
  <official_title>Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the seroconversion rate and the cellular immune&#xD;
      response after vaccination against hepatitis B virus in patients with lymphoproliferative&#xD;
      syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of&#xD;
      treatment criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rituximab is a human-mouse chimeric monoclonal antibody that targets the B-cell CD20. It is&#xD;
      an indispensible drug for the treatment of B-cell lymphoproliferative syndrome which induced&#xD;
      immunosuppression. So, the infectious complications increase. Reactivation of hepatitis B&#xD;
      virus is one such complication that can lead in asymptomatic hepatitis to death. Prevention&#xD;
      of hepatitis B reactivation is recommended like using nucleoside analog for patients with&#xD;
      chronic hepatitis B or occult hepatitis and vaccination against virus for seronegative&#xD;
      patients. The published data about efficacy of hepatitis b vaccination in onco-haematology&#xD;
      are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis B&#xD;
      vaccination in patients with lymphoproliferative disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab&gt; 10 IU / L.</measure>
    <time_frame>Month 7</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab&gt; 10 IU / L.</measure>
    <time_frame>Month 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the cellular immune response post vaccination at M2 and M7.</measure>
    <time_frame>Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the influence of age on the rate of seroconversion.</measure>
    <time_frame>Month 0, Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe vaccine-tolerance at M2 and M7.</measure>
    <time_frame>Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the influence of sex on the rate of seroconversion.</measure>
    <time_frame>Month 0, Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the influence of lymphocyte count on the rate of seroconversion.</measure>
    <time_frame>Month 0, Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the influence of total immunoglobulin on the rate of seroconversion.</measure>
    <time_frame>Month 0, Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To study the influence of immunoglobulin M on the rate of seroconversion.</measure>
    <time_frame>Month 0, Month 2 and Month 7</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Indolent Lymphoproliferative Disorders</condition>
  <arm_group>
    <arm_group_label>vaccin GenHevac B Pasteur</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vaccin GenHevac B Pasteur (Suspension for injection in pre-filled syringe / 20 μg microgram(s)Per day). In total, 3 injections at M0, M1 and M6</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaccin GenHevac B Pasteur</intervention_name>
    <arm_group_label>vaccin GenHevac B Pasteur</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low tumor&#xD;
             burden&#xD;
&#xD;
          -  No indication of chemotherapy during the seven months of the vaccination protocol.&#xD;
&#xD;
        HBV serology negative for HBsAg / Ab HBs / HBc Ab.&#xD;
&#xD;
          -  No history of vaccination against hepatitis B.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication of immediate chemotherapy.&#xD;
&#xD;
          -  At least one HBV positive serologic marker .&#xD;
&#xD;
          -  History of vaccination against HBV.&#xD;
&#xD;
          -  Known neurodegenerative disease.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Febrile infection untreated.&#xD;
&#xD;
          -  Known allergy to any vaccine component.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre FEUGIER, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre FEUGIER, MD, PhD</last_name>
    <phone>+33 3 83 15 32 82</phone>
    <email>p.feugier@chu-nancy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jessica MICHEL, MD</last_name>
    <phone>+33 3 83 15 53 49</phone>
    <email>je.michel@chu-nancy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Pôle Hématologie CHU Nancy Brabois</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre FEUGIER, MD, PhD</last_name>
      <phone>+33 3 83 15 32 82</phone>
      <email>p.feugier@chu-nancy.fr</email>
    </contact>
    <contact_backup>
      <last_name>Jessica MICHEL, MD</last_name>
      <phone>+33 3 83 15 53 49</phone>
      <email>je.michel@chu-nancy.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Pierre FEUGIER, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>June 15, 2016</last_update_submitted>
  <last_update_submitted_qc>June 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low grade lymphoma</keyword>
  <keyword>follicular lymphoma</keyword>
  <keyword>indolent lymphoproliferative disorders</keyword>
  <keyword>Vaccin GenHevac B Pasteur</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoproliferative Disorders</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/NCT01698866
org study id: 2011-004968-30
nct id: NCT01698866
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the seroconversion rate and the cellular immune
      response after vaccination against hepatitis B virus in patients with lymphoproliferative
      syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of
      treatment criteria.
Rituximab is a human-mouse chimeric monoclonal antibody that targets the B-cell CD20. It is
      an indispensible drug for the treatment of B-cell lymphoproliferative syndrome which induced
      immunosuppression. So, the infectious complications increase. Reactivation of hepatitis B
      virus is one such complication that can lead in asymptomatic hepatitis to death. Prevention
      of hepatitis B reactivation is recommended like using nucleoside analog for patients with
      chronic hepatitis B or occult hepatitis and vaccination against virus for seronegative
      patients. The published data about efficacy of hepatitis b vaccination in onco-haematology
      are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis B
      vaccination in patients with lymphoproliferative disorder.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
time frame: Month 7
measure: - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
time frame: Month 2
measure: Describe the cellular immune response post vaccination at M2 and M7.
time frame: Month 2 and Month 7
measure: To study the influence of age on the rate of seroconversion.
time frame: Month 0, Month 2 and Month 7
measure: Describe vaccine-tolerance at M2 and M7.
time frame: Month 2 and Month 7
measure: To study the influence of sex on the rate of seroconversion.
time frame: Month 0, Month 2 and Month 7
measure: To study the influence of lymphocyte count on the rate of seroconversion.
time frame: Month 0, Month 2 and Month 7
measure: To study the influence of total immunoglobulin on the rate of seroconversion.
time frame: Month 0, Month 2 and Month 7
measure: To study the influence of immunoglobulin M on the rate of seroconversion.
time frame: Month 0, Month 2 and Month 7
arm group label: vaccin GenHevac B Pasteur
arm group type: Experimental
description: vaccin GenHevac B Pasteur (Suspension for injection in pre-filled syringe / 20 μg microgram(s)Per day). In total, 3 injections at M0, M1 and M6
intervention type: Biological
intervention name: Vaccin GenHevac B Pasteur
arm group label: vaccin GenHevac B Pasteur
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre FEUGIER, MD, PhD
role: Principal Investigator
affiliation: Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
last name: Pierre FEUGIER, MD, PhD
phone: +33 3 83 15 32 82
email: p.feugier@chu-nancy.fr
last name: Jessica MICHEL, MD
phone: +33 3 83 15 53 49
email: je.michel@chu-nancy.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Lymphoproliferative Disorders