<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/NCT04446832</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL19_0752</org_study_id>
    <nct_id>NCT04446832</nct_id>
  </id_info>
  <brief_title>VACcination of LIver Transplantation Candidates</brief_title>
  <acronym>VacLit</acronym>
  <official_title>VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of&#xD;
      the immune system. Liver transplantation represents the only replacement therapy for&#xD;
      end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but&#xD;
      required immunosuppressive treatment to limit the risk of rejection. Candidates for liver&#xD;
      transplantation are at an increased risk for severe infections, some of which can be&#xD;
      prevented by vaccination. With regard to vaccine preventable diseases, these patients share&#xD;
      the same pitfalls than all immunocompromised individuals: i) a theoretical or proven&#xD;
      increased incidence and severity of certain infections warranting specific vaccine&#xD;
      recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing&#xD;
      vaccine disease after administration of live attenuated vaccines. It is therefore recommended&#xD;
      for all patients awaiting liver transplantation: i) updating the vaccinations recommended in&#xD;
      general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the&#xD;
      risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and&#xD;
      chickenpox more common and more serious in this population. However, these recommendations&#xD;
      are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination&#xD;
      in cirrhotic patients and persistence of post-transplant protection had been poorly assessed&#xD;
      as well as their determinants; ii) there are only a few data regarding the tolerance of&#xD;
      vaccinations in this population; iii) vaccination coverage of patients with end-stage liver&#xD;
      disease is poorly known in France and; iv) the perception and acceptability of vaccinations&#xD;
      have not been evaluated in this population.&#xD;
&#xD;
      Investigators hypothesis is that: the vaccination schedule currently recommended for liver&#xD;
      transplantation does not provide adequate protection against vaccine targets 6 months after&#xD;
      liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">July 6, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 6, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of vaccine &quot; responder &quot; according to serological results measured 6 months after liver transplantation</measure>
    <time_frame>6 months after liver transplantation</time_frame>
    <description>Vaccine immunogenicity will be assess by titration of specific antibodies by standard approved serological tests and patients will be considered if their antibody title exceed protection threshold defined by the WHO and support by the literature when available (for example for tetanus or diphtheria vaccines), or a 4-fold increase in antibody titers compared to antibodies titers measures before vaccination when a protection threshold is not formally defined (for example for pneumococcus vaccination)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Liver Transplant; Complications</condition>
  <condition>Vaccination; Complications</condition>
  <condition>Cirrhosis</condition>
  <condition>Chronic Hepatitis</condition>
  <arm_group>
    <arm_group_label>Liver transplantation candidates</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vaccine immunogenicity</intervention_name>
    <description>Evaluation of the vaccine immunogenicity by standard approved serological tests</description>
    <arm_group_label>Liver transplantation candidates</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Liver transplantation candidates&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years old&#xD;
&#xD;
          -  patients waiting for liver transplantation referred by hepato-gastroenterology&#xD;
             department as part of the pre-transplant evaluation to the infectiology consultation&#xD;
&#xD;
          -  patient who were informed of the study and did not object to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient candidate for multi-organ transplant&#xD;
&#xD;
          -  patient who received immunosuppressive therapy, biotherapy and/ or corticosteroid&#xD;
             therapy at a dose greater than 10 mg / day of prednisone equivalent for more than 2&#xD;
             weeks within 3 months before vaccination (6 months of rituximab)&#xD;
&#xD;
          -  patient who received polyvalent immunoglobulins within the 6 months before the&#xD;
             serological evaluation&#xD;
&#xD;
          -  patient who received systemic anti-cancer chemotherapy for solid tumor or hemopathy&#xD;
             within 6 months preceding the start of vaccination&#xD;
&#xD;
          -  splenectomized patients&#xD;
&#xD;
          -  asplenic patients for a reason other than liver disease&#xD;
&#xD;
          -  chronic infection with the human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  patient with any other hereditary immune deficiency or acquired which could compromise&#xD;
             the vaccine response or interpretation of serological results&#xD;
&#xD;
          -  patient under legal protection measure or unable to consent to the study&#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_contact>
    <last_name>Florent VALOUR, Dr</last_name>
    <phone>04 72 07 11 07</phone>
    <phone_ext>+33</phone_ext>
    <email>florent.valour@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florent VALOUR, Dr</last_name>
      <phone>04 72 07 11 07</phone>
      <phone_ext>+33</phone_ext>
      <email>florent.valour@chu-lyon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446832
org study id: 69HCL19_0752
nct id: NCT04446832
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of
      the immune system. Liver transplantation represents the only replacement therapy for
      end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but
      required immunosuppressive treatment to limit the risk of rejection. Candidates for liver
      transplantation are at an increased risk for severe infections, some of which can be
      prevented by vaccination. With regard to vaccine preventable diseases, these patients share
      the same pitfalls than all immunocompromised individuals: i) a theoretical or proven
      increased incidence and severity of certain infections warranting specific vaccine
      recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing
      vaccine disease after administration of live attenuated vaccines. It is therefore recommended
      for all patients awaiting liver transplantation: i) updating the vaccinations recommended in
      general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the
      risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and
      chickenpox more common and more serious in this population. However, these recommendations
      are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination
      in cirrhotic patients and persistence of post-transplant protection had been poorly assessed
      as well as their determinants; ii) there are only a few data regarding the tolerance of
      vaccinations in this population; iii) vaccination coverage of patients with end-stage liver
      disease is poorly known in France and; iv) the perception and acceptability of vaccinations
      have not been evaluated in this population.

      Investigators hypothesis is that: the vaccination schedule currently recommended for liver
      transplantation does not provide adequate protection against vaccine targets 6 months after
      liver transplantation.
observational model: Cohort
time perspective: Prospective
measure: Proportion of vaccine " responder " according to serological results measured 6 months after liver transplantation
time frame: 6 months after liver transplantation
description: Vaccine immunogenicity will be assess by titration of specific antibodies by standard approved serological tests and patients will be considered if their antibody title exceed protection threshold defined by the WHO and support by the literature when available (for example for tetanus or diphtheria vaccines), or a 4-fold increase in antibody titers compared to antibodies titers measures before vaccination when a protection threshold is not formally defined (for example for pneumococcus vaccination)
arm group label: Liver transplantation candidates
intervention type: Other
intervention name: Vaccine immunogenicity
description: Evaluation of the vaccine immunogenicity by standard approved serological tests
arm group label: Liver transplantation candidates
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Florent VALOUR, Dr
phone: 04 72 07 11 07
phone ext: +33
email: florent.valour@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis, Chronic
sharing ipd: No