<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/NCT04439435</url>
  </required_header>
  <id_info>
    <org_study_id>2020-06</org_study_id>
    <nct_id>NCT04439435</nct_id>
  </id_info>
  <brief_title>Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children</brief_title>
  <official_title>Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Chongqing 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>
      Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis,and chronic&#xD;
      infection with HBV often leads to chronic hepatitis, liver cirrhosis,and hepatocellular&#xD;
      carcinoma. So far, the most effective way to prevent HBV infection in susceptible population&#xD;
      is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus&#xD;
      (HBV) after vaccination remains widely debated. This study aims to evaluate the existence of&#xD;
      immune protection in healthy children with negative hepatitis B surface antibody and find a&#xD;
      method to evaluate the immune protection induced by hepatitis B vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One method to determine the long-term protection provided by hepatitis B vaccine against HBV&#xD;
      infection is to estimate the cumulative incidence of chronic carrier status and breakthrough&#xD;
      infection of previously vaccinated individuals in different periods. Up to now, no&#xD;
      international standard suggests that hepatitis B vaccine should be used as a routine&#xD;
      immunization program. However, it is an important issue to discuss the immune protection of&#xD;
      healthy children with negative hepatitis B surface antibody and the duration of this&#xD;
      protection in the future. Therefore, this study aims to evaluate the existence of immune&#xD;
      protection of healthy children with negative hepatitis B surface antibody, find a method to&#xD;
      evaluate the immune protection induced by hepatitis B vaccine.&#xD;
&#xD;
      The main content of the study: To recruit healthy children. Children lacking HBsAb were&#xD;
      selected for immune memory test and receive a Hep B booster. The results of Antibody positive&#xD;
      group and antibody negative group were compared and analyzed. To find out the most suitable&#xD;
      method for evaluating immune protection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody</measure>
    <time_frame>1-month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of humoral and cellular immune response after hepatitis B vaccine boosters</measure>
    <time_frame>1-month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vaccine Reaction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Children Aged 1-15 in Chongqing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who are 1-15 years old in Chongqing&#xD;
&#xD;
          -  After birth, three injections of Hep B were inoculated in time according to the&#xD;
             procedure of 0, 1 and 6 months(The vaccination certificate record)&#xD;
&#xD;
          -  No HBV booster vaccine given since primary HBV immunization&#xD;
&#xD;
          -  Children or guardian knew and agreed to accept the study&#xD;
&#xD;
          -  Follow - up study and blood collection after vaccination can be accepted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or impossible to participate in this research project;&#xD;
&#xD;
          -  Have a history of allergy or have had a serious vaccine reaction&#xD;
&#xD;
          -  Have immune impairment diseases and appear immune impairment;&#xD;
&#xD;
          -  Immunosuppressive treatment, receive any injection or oral administration of cortisone&#xD;
             or cancer chemotherapy;&#xD;
&#xD;
          -  Any kind of vaccine or any kind of observation drug has been vaccinated in the past&#xD;
             four weeks;&#xD;
&#xD;
          -  Any acute disease or other infection requiring antibiotic or antiviral treatment in&#xD;
             the past four weeks;&#xD;
&#xD;
          -  Fever symptoms occurred in the past week ( axillary temperature ≥ 38 °C)&#xD;
&#xD;
          -  Blood transfusion experience;&#xD;
&#xD;
          -  Has a history of more serious infectious diseases ( five types of hepatitis, AIDS,&#xD;
             syphilis, gonorrhea, etc. );&#xD;
&#xD;
          -  Hepatitis B infection or carriers(lineal relationship);&#xD;
&#xD;
          -  Abnormal physical examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>YAO ZHAO, postdoctor</last_name>
    <role>Study Director</role>
    <affiliation>Chongqing Children's Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>YAO ZHAO, postdoctor</last_name>
    <phone>86-23-6360-3083</phone>
    <email>Zhaoy@cqmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chongqing Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>YAO ZHAO, postdoctor</last_name>
      <phone>86-23-6360-3083</phone>
      <email>Zhaoy@cqmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Qiu Li</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04439435
org study id: 2020-06
nct id: NCT04439435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis,and chronic
      infection with HBV often leads to chronic hepatitis, liver cirrhosis,and hepatocellular
      carcinoma. So far, the most effective way to prevent HBV infection in susceptible population
      is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus
      (HBV) after vaccination remains widely debated. This study aims to evaluate the existence of
      immune protection in healthy children with negative hepatitis B surface antibody and find a
      method to evaluate the immune protection induced by hepatitis B vaccine.
One method to determine the long-term protection provided by hepatitis B vaccine against HBV
      infection is to estimate the cumulative incidence of chronic carrier status and breakthrough
      infection of previously vaccinated individuals in different periods. Up to now, no
      international standard suggests that hepatitis B vaccine should be used as a routine
      immunization program. However, it is an important issue to discuss the immune protection of
      healthy children with negative hepatitis B surface antibody and the duration of this
      protection in the future. Therefore, this study aims to evaluate the existence of immune
      protection of healthy children with negative hepatitis B surface antibody, find a method to
      evaluate the immune protection induced by hepatitis B vaccine.

      The main content of the study: To recruit healthy children. Children lacking HBsAb were
      selected for immune memory test and receive a Hep B booster. The results of Antibody positive
      group and antibody negative group were compared and analyzed. To find out the most suitable
      method for evaluating immune protection.
observational model: Cohort
time perspective: Prospective
measure: Proportion of Cellular Immunity in Children with Negative Hepatitis B Antibody
time frame: 1-month
measure: Changes of humoral and cellular immune response after hepatitis B vaccine boosters
time frame: 1-month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: YAO ZHAO, postdoctor
role: Study Director
affiliation: Chongqing Children's Hospital of Chongqing Medical University
last name: YAO ZHAO, postdoctor
phone: 86-23-6360-3083
email: Zhaoy@cqmu.edu.cn
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Chongqing Medical University
investigator full name: Qiu Li
investigator title: Director
mesh term: Hepatitis B