<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/NCT04456504</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0631</org_study_id>
    <secondary_id>A561000</secondary_id>
    <secondary_id>PHARM/PHARMACY</secondary_id>
    <secondary_id>Protocol Version 6/11/2020</secondary_id>
    <nct_id>NCT04456504</nct_id>
  </id_info>
  <brief_title>HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders</brief_title>
  <official_title>HepB-CpG Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to determine if healthcare workers who have previously failed to&#xD;
      respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant&#xD;
      (hepB-CpG) (Heplisav-B)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Intervention Each individual who has completed at least 5 doses hepB vaccine with&#xD;
      aluminum adjuvant series but is anti-HBs negative will be contacted by EHS staff and invited&#xD;
      to receive the hepB-CpG two dose series on a 0 and 1 month schedule. Antibody to the surface&#xD;
      antigen will be measured after the first dose during the visit for the administration of the&#xD;
      second dose. One month after completion of the series, each immunized individual will have&#xD;
      another anti-HBs measured.&#xD;
&#xD;
      Total Number of Subjects Up to 130 individuals will be recruited and enrolled. Study&#xD;
      Population Healthcare workers who have received at least 5 doses of hepatitis B vaccine with&#xD;
      aluminum adjuvant and have antiHBs &lt; 10mIU/ml.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Number of participants who failed to respond to 5 or more doses of hepatitis B vaccine with aluminum adjuvant who respond to hepatitis B vaccine with CpG adjuvant series</measure>
    <time_frame>one month after dose 2 (up to 84 days on study)</time_frame>
    <description>Response is defined as AntiHBs &gt;10 mIU/ml following two doses of hepB-CpG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who respond to a single dose of hepB-CpG</measure>
    <time_frame>one month after dose 1 (up to 42 days on study)</time_frame>
    <description>Response is defined as AntiHBs &gt;10 mIU/ml following a single dose of hepB-CpG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who are nonresponders with each risk factor</measure>
    <time_frame>one month after dose 2 (up to 84 days on study)</time_frame>
    <description>A multivariate model will be developed by measuring the proportion of participants who are nonresponders with each risk factor. Potential risk factors include including age, smoking status, sex, diabetes, immunosuppression.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Healthcare Worker, Hepatitis B Vaccine, Nonresponder</condition>
  <arm_group>
    <arm_group_label>Healthcare worker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant hepatitis B vaccine with CpG adjuvant</intervention_name>
    <description>Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.</description>
    <arm_group_label>Healthcare worker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Healthcare workers who have received at least 5 doses of hepatitis B vaccine with&#xD;
             aluminum adjuvant and have antiHBs &lt; 10mIU/ml&#xD;
&#xD;
          -  Females of childbearing potential will be asked about the possibility of pregnancy as&#xD;
             is the standard of care for immunization services. If a female indicates that she may&#xD;
             be pregnant, study participation will be postponed until pregnancy is completed or the&#xD;
             female reports that she is not pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or planning on becoming pregnant during the study&#xD;
&#xD;
          -  Allergy to the vaccine or a component of the vaccine&#xD;
&#xD;
          -  Not suitable for study participation due to other reasons, such as inability or&#xD;
             unwillingness to comply with the study procedures, at the discretion of the&#xD;
             investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary S Hayney, PharmD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary S Hayney, PharmD, MPH</last_name>
    <phone>6082654666</phone>
    <email>mary.hayney@wisc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary S Hayney, PharmD</last_name>
      <email>mshayney@pharmacy.wisc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 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 A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</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/NCT04456504
org study id: 2020-0631
secondary id: A561000
secondary id: PHARM/PHARMACY
secondary id: Protocol Version 6/11/2020
nct id: NCT04456504
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is being done to determine if healthcare workers who have previously failed to
      respond to hepatitis B vaccine series will respond to a hepatitis B with CpG adjuvant
      (hepB-CpG) (Heplisav-B)
Study Intervention Each individual who has completed at least 5 doses hepB vaccine with
      aluminum adjuvant series but is anti-HBs negative will be contacted by EHS staff and invited
      to receive the hepB-CpG two dose series on a 0 and 1 month schedule. Antibody to the surface
      antigen will be measured after the first dose during the visit for the administration of the
      second dose. One month after completion of the series, each immunized individual will have
      another anti-HBs measured.

      Total Number of Subjects Up to 130 individuals will be recruited and enrolled. Study
      Population Healthcare workers who have received at least 5 doses of hepatitis B vaccine with
      aluminum adjuvant and have antiHBs < 10mIU/ml.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants who failed to respond to 5 or more doses of hepatitis B vaccine with aluminum adjuvant who respond to hepatitis B vaccine with CpG adjuvant series
time frame: one month after dose 2 (up to 84 days on study)
description: Response is defined as AntiHBs >10 mIU/ml following two doses of hepB-CpG
measure: Number of participants who respond to a single dose of hepB-CpG
time frame: one month after dose 1 (up to 42 days on study)
description: Response is defined as AntiHBs >10 mIU/ml following a single dose of hepB-CpG
measure: Proportion of participants who are nonresponders with each risk factor
time frame: one month after dose 2 (up to 84 days on study)
description: A multivariate model will be developed by measuring the proportion of participants who are nonresponders with each risk factor. Potential risk factors include including age, smoking status, sex, diabetes, immunosuppression.
arm group label: Healthcare worker
arm group type: Experimental
description: Healthcare worker who has previously received at least 5 doses of hepatitis B vaccine with aluminum adjuvant (Recombivax B or Engerix B) and has an antibody to the hepatitis B surface antigen (antiHBs) that is less than 10 mIU/ml.
intervention type: Biological
intervention name: Recombinant hepatitis B vaccine with CpG adjuvant
description: Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
arm group label: Healthcare worker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary S Hayney, PharmD, MPH
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Mary S Hayney, PharmD, MPH
phone: 6082654666
email: mary.hayney@wisc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
sharing ipd: No