<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/NCT02203357</url>
  </required_header>
  <id_info>
    <org_study_id>HepB-2014</org_study_id>
    <nct_id>NCT02203357</nct_id>
  </id_info>
  <brief_title>A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults</brief_title>
  <official_title>A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangxi Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liuzhou City Center for disease control and prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Kangtai Biological Products Co., LTD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody&#xD;
      persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine&#xD;
      with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young&#xD;
      adults, and the comparative immunogenicity among the three groups will be measured at 1 mon&#xD;
      post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,&#xD;
      the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</measure>
    <time_frame>one month after a series vaccination of the regimen</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs antibody will be compared among the three vaccine groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</measure>
    <time_frame>1-year after the first dose of the regimens</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs will be compared among the three vaccine groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</measure>
    <time_frame>2-year after the first dose of the regimens</time_frame>
    <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety of HBV Vaccine Determined by Number of Participants With Adverse Events</measure>
    <time_frame>0-3 day after the first dose of immunization</time_frame>
    <description>Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">353</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>20μg, 0-1-6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>60μg, 0-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>60μg, 0-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hepatitis B vaccine</intervention_name>
    <description>Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
    <arm_group_label>20μg, 0-1-6</arm_group_label>
    <arm_group_label>60μg, 0-1</arm_group_label>
    <arm_group_label>60μg, 0-2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects aged between 16 and 25 as established by medical history and clinical&#xD;
             examination&#xD;
&#xD;
          -  Written informed consent will be obtained from each subject before the serum screening&#xD;
             of HBV markers&#xD;
&#xD;
          -  Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody&#xD;
&#xD;
          -  Have never been immunized with HBV vaccine before&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a medical history of allergic to any ingredient of vaccine&#xD;
&#xD;
          -  Family history of seizures or progressive neurological disease&#xD;
&#xD;
          -  Autoimmune disease or immunodeficiency&#xD;
&#xD;
          -  Women with pregnant&#xD;
&#xD;
          -  Bleeding disorder diagnosed by a doctor&#xD;
&#xD;
          -  Chronic diseases: hepatitis, tumor, tuberculosis,et.al&#xD;
&#xD;
          -  Any prior administration of immunoglobulins or blood products in the last 3 mon before&#xD;
             recruitment&#xD;
&#xD;
          -  Subjects had a medical history of serious adverse reactions to vaccines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhongliao Fang, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Guangxi provincial center for desease control and prevention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hui Zhuang, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Health Science Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>March 20, 2019</results_first_submitted>
  <results_first_submitted_qc>September 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 3, 2019</results_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Xueen Liu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>hepatitis B</keyword>
  <keyword>hepatitis B vaccine</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>adults</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>20μg, 0-1-6</title>
          <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.</description>
        </group>
        <group group_id="P2">
          <title>60μg, 0-1</title>
          <description>111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.</description>
        </group>
        <group group_id="P3">
          <title>60μg, 0-2</title>
          <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>mon7/2/3</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="110"/>
                <participants group_id="P3" count="124"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>mon12</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>mon24</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="70"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="70"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>20μg, 0-1-6</title>
          <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.</description>
        </group>
        <group group_id="B2">
          <title>60μg, 0-1</title>
          <description>111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.</description>
        </group>
        <group group_id="B3">
          <title>60μg, 0-2</title>
          <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.</description>
        </group>
        <group group_id="B4">
          <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="117"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="125"/>
            <count group_id="B4" value="353"/>
          </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="20.32" spread="1.13"/>
                    <measurement group_id="B2" value="20.11" spread="0.94"/>
                    <measurement group_id="B3" value="20.18" spread="1.07"/>
                    <measurement group_id="B4" value="20.20" spread="1.05"/>
                  </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="40"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="83"/>
                    <measurement group_id="B4" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="125"/>
                    <measurement group_id="B4" value="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs antibody will be compared among the three vaccine groups.</description>
        <time_frame>one month after a series vaccination of the regimen</time_frame>
        <group_list>
          <group group_id="O1">
            <title>20μg, 0-1-6</title>
            <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.</description>
          </group>
          <group group_id="O2">
            <title>60μg, 0-1</title>
            <description>111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.</description>
          </group>
          <group group_id="O3">
            <title>60μg, 0-2</title>
            <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs antibody will be compared among the three vaccine groups.</description>
          <units>mIU/ml</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1847.99" lower_limit="1417.75" upper_limit="2408.8"/>
                    <measurement group_id="O2" value="839.27" lower_limit="507.34" upper_limit="1388.35"/>
                    <measurement group_id="O3" value="1244.8" lower_limit="889.61" upper_limit="1742.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs will be compared among the three vaccine groups.</description>
        <time_frame>1-year after the first dose of the regimens</time_frame>
        <group_list>
          <group group_id="O1">
            <title>20μg, 0-1-6</title>
            <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
          <group group_id="O2">
            <title>60μg, 0-1</title>
            <description>111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
          <group group_id="O3">
            <title>60μg, 0-2</title>
            <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs will be compared among the three vaccine groups.</description>
          <units>mIU/ml</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1456.63" lower_limit="1102.78" upper_limit="1924.00"/>
                    <measurement group_id="O2" value="256.30" lower_limit="175.70" upper_limit="373.85"/>
                    <measurement group_id="O3" value="235.15" lower_limit="172.81" upper_limit="319.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</title>
        <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.</description>
        <time_frame>2-year after the first dose of the regimens</time_frame>
        <group_list>
          <group group_id="O1">
            <title>20μg, 0-1-6</title>
            <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
          <group group_id="O2">
            <title>60μg, 0-1</title>
            <description>111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
          <group group_id="O3">
            <title>60μg, 0-2</title>
            <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults</title>
          <description>The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and &lt; 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but &lt; 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.&#xD;
The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.</description>
          <units>mIU/ml</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="427.46" lower_limit="274.92" upper_limit="664.51"/>
                    <measurement group_id="O2" value="89.74" lower_limit="50.43" upper_limit="159.70"/>
                    <measurement group_id="O3" value="89.80" lower_limit="56.96" upper_limit="141.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety of HBV Vaccine Determined by Number of Participants With Adverse Events</title>
        <description>Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.</description>
        <time_frame>0-3 day after the first dose of immunization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>20μg, 0-1-6</title>
            <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
          <group group_id="O2">
            <title>60μg, 0-1</title>
            <description>111young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
          <group group_id="O3">
            <title>60μg, 0-2</title>
            <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.&#xD;
Hepatitis B vaccine: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of HBV Vaccine Determined by Number of Participants With Adverse Events</title>
          <description>Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.</description>
          <units>number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>20μg, 0-1-6</title>
          <description>117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.</description>
        </group>
        <group group_id="E2">
          <title>60μg, 0-1</title>
          <description>111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.</description>
        </group>
        <group group_id="E3">
          <title>60μg, 0-2</title>
          <description>125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="2" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>injection site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Hui Zhuang</name_or_title>
      <organization>Peking University Health Science Center</organization>
      <phone>86-10-82801617</phone>
      <email>zhuangbmu@126.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/NCT02203357
org study id: HepB-2014
nct id: NCT02203357
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody
      persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine
      with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young
      adults, and the comparative immunogenicity among the three groups will be measured at 1 mon
      post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,
      the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
time frame: one month after a series vaccination of the regimen
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.
The GMCs of anti-HBs antibody will be compared among the three vaccine groups.
measure: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
time frame: 1-year after the first dose of the regimens
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.
The GMCs of anti-HBs will be compared among the three vaccine groups.
measure: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
time frame: 2-year after the first dose of the regimens
description: The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.
The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.
measure: Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
time frame: 0-3 day after the first dose of immunization
description: Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.
arm group label: 20μg, 0-1-6
arm group type: Active Comparator
description: 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
arm group label: 60μg, 0-1
arm group type: Experimental
description: 112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
arm group label: 60μg, 0-2
arm group type: Experimental
description: 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
intervention type: Biological
intervention name: Hepatitis B vaccine
description: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
arm group label: 20μg, 0-1-6
arm group label: 60μg, 0-1
arm group label: 60μg, 0-2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Zhongliao Fang, Dr.
role: Study Director
affiliation: Guangxi provincial center for desease control and prevention
last name: Hui Zhuang, Dr.
role: Study Director
affiliation: Peking University Health Science Center
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Xueen Liu
investigator title: Dr.
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 