<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/NCT02991599</url>
  </required_header>
  <id_info>
    <org_study_id>2012ZX10002001003004003</org_study_id>
    <nct_id>NCT02991599</nct_id>
  </id_info>
  <brief_title>Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients</brief_title>
  <official_title>Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanxi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanxi Medical University</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>
      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune&#xD;
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three&#xD;
      injections at months 0, 1, and 6 in methadone maintenance treatment patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone&#xD;
      Maintenance Treatment&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;&#xD;
&#xD;
      Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and Rate of Participants With Anti-HBs Seroconversion at Month 7</measure>
    <time_frame>Month 7</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-HBs Concentration at Month 7</measure>
    <time_frame>Month 7</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-HBs Concentration at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Rate of Participants With Anti-HBs Seroconversion at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events After Vaccination</measure>
    <time_frame>Within 7 days after the vaccination, at Month 0, 1, and 6</time_frame>
    <description>Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events After Vaccination</measure>
    <time_frame>Within 28 days after the vaccination, at Month 0, 1, and 6</time_frame>
    <description>Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-HBs Concentration at Month 18</measure>
    <time_frame>Month 18</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Rate of Participants With Anti-HBs Seroconversion at Month 18</measure>
    <time_frame>Month 18</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-HBs Concentration at Month 30</measure>
    <time_frame>Month 30</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Rate of Participants With Anti-HBs Seroconversion at Month 30</measure>
    <time_frame>Month 30</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-HBs Concentration at Month 42</measure>
    <time_frame>Month 42</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Rate of Participants With Anti-HBs Seroconversion at Month 42</measure>
    <time_frame>Month 42</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number and Rate of Participants With Anti-HBs High-level Response at Month 7</measure>
    <time_frame>Month 7</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number and Rate of Participants With Anti-HBs High-level Response at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number and Rate of Participants With Anti-HBs High-level Response at Month 18</measure>
    <time_frame>Month 18</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number and Rate of Participants With Anti-HBs High-level Response at Month 30</measure>
    <time_frame>Month 30</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number and Rate of Participants With Anti-HBs High-level Response at Month 42</measure>
    <time_frame>Month 42</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Hepatitis B Vaccine</condition>
  <arm_group>
    <arm_group_label>60 µg dose hepatitis B vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 µg dose hepatitis B vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>60 µg dose hepatitis B vaccine</intervention_name>
    <description>three-dose, 60 µg per dose</description>
    <arm_group_label>60 µg dose hepatitis B vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>20 µg dose hepatitis B vaccine</intervention_name>
    <description>three-dose, 20 µg per dose</description>
    <arm_group_label>20 µg dose hepatitis B vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 70 years at the enrolment&#xD;
&#xD;
          -  Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface&#xD;
             antibody (anti-HBs) at enrollment&#xD;
&#xD;
          -  Willing to adhere to the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being pregnant&#xD;
&#xD;
          -  Intolerance or allergy to any component of the vaccine&#xD;
&#xD;
          -  Any vaccination during the month preceding enrollment&#xD;
&#xD;
          -  Ongoing opportunistic infection&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Hematological disorder&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Unexplained fever the week before enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suping Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanxi Medical University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.</citation>
    <PMID>28343774</PMID>
  </results_reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>May 23, 2019</results_first_submitted>
  <results_first_submitted_qc>May 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 30, 2019</results_first_posted>
  <last_update_submitted>November 26, 2021</last_update_submitted>
  <last_update_submitted_qc>November 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanxi Medical University</investigator_affiliation>
    <investigator_full_name>Suping Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hepatitis B, Vaccine</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>methadone maintenance treatment</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IM 20μg Group</title>
          <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
        </group>
        <group group_id="P2">
          <title>IM 60μg Group</title>
          <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IM 20μg Group</title>
          <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
        </group>
        <group group_id="B2">
          <title>IM 60μg Group</title>
          <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
        </group>
        <group group_id="B3">
          <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="98"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="196"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="42.5" spread="7.5"/>
                    <measurement group_id="B2" value="44.0" spread="7.5"/>
                    <measurement group_id="B3" value="43.2" spread="7.5"/>
                  </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="23"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Han ethnicity</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
                <category>
                  <title>minority ethnicity</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <title>Urban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rural</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 7</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml.</description>
        <time_frame>Month 7</time_frame>
        <population>73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 7</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml.</description>
          <population>73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-HBs Concentration at Month 7</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
        <time_frame>Month 7</time_frame>
        <population>73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 .</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-HBs Concentration at Month 7</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
          <population>73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 .</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="630.4" lower_limit="157.7" upper_limit="1103.0"/>
                    <measurement group_id="O2" value="742.9" lower_limit="187.0" upper_limit="1298.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-HBs Concentration at Month 12</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
        <time_frame>Month 12</time_frame>
        <population>60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-HBs Concentration at Month 12</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
          <population>60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.9" lower_limit="49.9" upper_limit="202.0"/>
                    <measurement group_id="O2" value="182.2" lower_limit="97.7" upper_limit="266.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 12</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
        <time_frame>Month 12</time_frame>
        <population>60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 12</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
          <population>60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Adverse Events After Vaccination</title>
        <description>Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine</description>
        <time_frame>Within 7 days after the vaccination, at Month 0, 1, and 6</time_frame>
        <population>196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Adverse Events After Vaccination</title>
          <description>Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine</description>
          <population>196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Adverse Events After Vaccination</title>
        <description>Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine</description>
        <time_frame>Within 28 days after the vaccination, at Month 0, 1, and 6</time_frame>
        <population>196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Adverse Events After Vaccination</title>
          <description>Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine</description>
          <population>196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 7</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.</description>
        <time_frame>Month 7</time_frame>
        <population>73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 7</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.</description>
          <population>73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 12</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
        <time_frame>Month 12</time_frame>
        <population>60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 12</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
          <population>60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-HBs Concentration at Month 18</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
        <time_frame>Month 18</time_frame>
        <population>47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-HBs Concentration at Month 18</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
          <population>47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382.2" lower_limit="196.3" upper_limit="960.7"/>
                    <measurement group_id="O2" value="490.5" lower_limit="72.4" upper_limit="1053.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 18</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
        <time_frame>Month 18</time_frame>
        <population>47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 18</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
          <population>47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 18</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
        <time_frame>Month 18</time_frame>
        <population>47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 18</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
          <population>47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-HBs Concentration at Month 30</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
        <time_frame>Month 30</time_frame>
        <population>46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-HBs Concentration at Month 30</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
          <population>46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239.9" lower_limit="119.3" upper_limit="599.1"/>
                    <measurement group_id="O2" value="306.4" lower_limit="60.2" upper_limit="579.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 30</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
        <time_frame>Month 30</time_frame>
        <population>46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 30</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
          <population>46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-HBs Concentration at Month 42</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
        <time_frame>Month 42</time_frame>
        <population>45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-HBs Concentration at Month 42</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）</description>
          <population>45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>mIU/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.6" lower_limit="12.4" upper_limit="170"/>
                    <measurement group_id="O2" value="97.7" lower_limit="17.5" upper_limit="186.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 42</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
        <time_frame>Month 42</time_frame>
        <population>45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs Seroconversion at Month 42</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）&#xD;
. The accepted protective serum anti-HBs level was ≥10 mIU/ml</description>
          <population>45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 30</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
        <time_frame>Month 30</time_frame>
        <population>46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 30</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
          <population>46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 42</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
        <time_frame>Month 42</time_frame>
        <population>45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
        <group_list>
          <group group_id="O1">
            <title>IM 20μg Group</title>
            <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
          <group group_id="O2">
            <title>IM 60μg Group</title>
            <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Rate of Participants With Anti-HBs High-level Response at Month 42</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.</description>
          <population>45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>IM 20μg Group</title>
          <description>Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
        </group>
        <group group_id="E2">
          <title>IM 60μg Group</title>
          <description>Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="97"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="97"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Suping Wang, PhD</name_or_title>
      <organization>Shanxi Medical University</organization>
      <phone>#86-351-4135103</phone>
      <email>spwang88@163.com</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/NCT02991599
org study id: 2012ZX10002001003004003
nct id: NCT02991599
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three
      injections at months 0, 1, and 6 in methadone maintenance treatment patients.
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone
      Maintenance Treatment

      Intervention:

      Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;

      Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
time frame: Month 7
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
measure: Anti-HBs Concentration at Month 7
time frame: Month 7
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
measure: Anti-HBs Concentration at Month 12
time frame: Month 12
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
time frame: Month 12
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
measure: Occurrence of Adverse Events After Vaccination
time frame: Within 7 days after the vaccination, at Month 0, 1, and 6
description: Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
measure: Occurrence of Adverse Events After Vaccination
time frame: Within 28 days after the vaccination, at Month 0, 1, and 6
description: Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
measure: Anti-HBs Concentration at Month 18
time frame: Month 18
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
time frame: Month 18
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
measure: Anti-HBs Concentration at Month 30
time frame: Month 30
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
time frame: Month 30
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
measure: Anti-HBs Concentration at Month 42
time frame: Month 42
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
time frame: Month 42
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
. The accepted protective serum anti-HBs level was ≥10 mIU/ml
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 7
time frame: Month 7
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 12
time frame: Month 12
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 18
time frame: Month 18
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 30
time frame: Month 30
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 42
time frame: Month 42
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
arm group label: 60 µg dose hepatitis B vaccine
arm group type: Experimental
description: 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
arm group label: 20 µg dose hepatitis B vaccine
arm group type: Experimental
description: 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
intervention type: Biological
intervention name: 60 µg dose hepatitis B vaccine
description: three-dose, 60 µg per dose
arm group label: 60 µg dose hepatitis B vaccine
intervention type: Biological
intervention name: 20 µg dose hepatitis B vaccine
description: three-dose, 20 µg per dose
arm group label: 20 µg dose hepatitis B vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Suping Wang
role: Principal Investigator
affiliation: Shanxi Medical University
citation: Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.
PMID: 28343774
responsible party type: Principal Investigator
investigator affiliation: Shanxi Medical University
investigator full name: Suping Wang
investigator title: Professor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Vaccines
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 