<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/NCT03774628</url>
  </required_header>
  <id_info>
    <org_study_id>JSVCT061</org_study_id>
    <nct_id>NCT03774628</nct_id>
  </id_info>
  <brief_title>Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination</brief_title>
  <official_title>Long-term Immunity of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried and Booster Dose Effects at 10 Years Post-primary Vaccination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Province Centers for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Province Centers for Disease Control and Prevention</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua&#xD;
      Biological Products Co.,Ltd is used to prevent human rabies. The vaccine was completed in the&#xD;
      Phase III clinical trial from August 2008 to February 2009 in Lianshui County, Jiangsu&#xD;
      Province (Approval of Drug Clinical Trial No. 2008L03156). A total of 1200 subjects aged&#xD;
      10-60 years were randomly assigned trial group (Kanghua vaccine group, 600 participants) and&#xD;
      control groups (Pasteur vaccine group, 600 participants). The result showed that this vaccine&#xD;
      could provide good immunogenicity and mild adverse reactions. On April 28, 2012, the drug&#xD;
      registration approval was obtained (Approval No. 2012S00222).&#xD;
&#xD;
      To disclose the effects of booster immunization of human diploid cell rabies vaccine (HDCV)&#xD;
      after eight years of primary vaccination. Sixty subjects who had participated the phase Ⅲ&#xD;
      clinical trial of freeze-dried HDCV were selected and given booster immunization after eight&#xD;
      years of primary vaccination. The result showed that the freeze-dried HDCV has good immune&#xD;
      effects with one-dose of booster immunization after eight years of primary vaccination． In&#xD;
      order to find a ten years of immunization persistence and booster dose immune effect, the&#xD;
      investigators decided to perform this immunization persistence and booster immunity trial&#xD;
      among these subjects who had received five doses of rabies vaccine vaccines (around ten years&#xD;
      after the fundamental immunity). The investigators do the recruitment among these subjects&#xD;
      who had participated in the previous phase Ⅲ trail and the subjects were divided into two&#xD;
      layers, such as trial group (Kanghua vaccine group) and the control group (Paste vaccine&#xD;
      group). Each layer of the subjects randomly received one booster dose (Day 0) and two booster&#xD;
      doses (Day 0, 3) the freeze-dried HDCV in a ratio of 1:1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">February 19, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2019</primary_completion_date>
  <phase>N/A</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>Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination</measure>
    <time_frame>10 years after primary vaccination</time_frame>
    <description>calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination</measure>
    <time_frame>10 years after primary vaccination</time_frame>
    <description>calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of serum rabies virus neutralizing antibodies to protective levels</measure>
    <time_frame>6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</time_frame>
    <description>calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive seroconversion rate of serum rabies virus neutralizing antibody</measure>
    <time_frame>6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</time_frame>
    <description>calculate the positive seroconversion rate of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody</measure>
    <time_frame>6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</time_frame>
    <description>calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean geometric increases (GMIs) of serum rabies virus neutralizing antibody</measure>
    <time_frame>6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</time_frame>
    <description>calculate the mean geometric increases (GMIs) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">342</enrollment>
  <condition>Rabies</condition>
  <arm_group>
    <arm_group_label>Chengdu Kanghua (one booster shot)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chengdu Kanghua (two booster shots)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>two doses at 0 and 3 days, on A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Chengdu Kanghua (one booster shot)</intervention_name>
    <description>A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0</description>
    <arm_group_label>Chengdu Kanghua (one booster shot)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Chengdu Kanghua (two booster shots)</intervention_name>
    <description>A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0 and 3</description>
    <arm_group_label>Chengdu Kanghua (two booster shots)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who participated in the Phase III clinical study of the vaccine and&#xD;
             completed the full immunization&#xD;
&#xD;
          -  Subjects or legal guardians can and will comply with the requirements of the protocol&#xD;
&#xD;
          -  Subjects are able to understand and sign the informed consent&#xD;
&#xD;
          -  Subjects with temperature &lt;=37.0°C on axillary setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female in pregnancy&#xD;
&#xD;
          -  Subjects who have been vaccinated other rabies vaccines after participating in the&#xD;
             phase III clinical study of the vaccine (excluding those who participated in the&#xD;
             8-year booster immunization)&#xD;
&#xD;
          -  Subject who has serious adverse reaction history after vaccination such as allergies,&#xD;
             hives, difficulty in breathing, angioedema or abdominal pain or allergic to any&#xD;
             ingredient of the this rabies vaccine, including excipient&#xD;
&#xD;
          -  Any acute disease, serious chronic disease, fever，and chronic disease at acute stage&#xD;
&#xD;
          -  Subject with autoimmune diseases or immunodeficiency&#xD;
&#xD;
          -  Subject with asthma, unstable over the past two years requiring emergency treatment,&#xD;
             hospitalization, intubation, oral or intravenous corticosteroids&#xD;
&#xD;
          -  Subject with diabetes (Type I or II) excluding gestational diabetes&#xD;
&#xD;
          -  Subject with thyroidectomy history, or require treatment in the past 12 months due to&#xD;
             thyroid disease&#xD;
&#xD;
          -  Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor&#xD;
             deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood&#xD;
             clotting disorder&#xD;
&#xD;
          -  Subject with cancer, or has been treated in active cancer period or not clearly cured,&#xD;
             or may recur during the study period&#xD;
&#xD;
          -  Subject with uncontrolled epilepsy or other progressive neurological disease&#xD;
&#xD;
          -  Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any&#xD;
             situation&#xD;
&#xD;
          -  Any prior administration of immunodepressant, cytotoxic treatment or inhaled&#xD;
             corticosteroids in last 6 months, excluding those corticosteroid spray therapy for&#xD;
             allergic rhinitis, topical corticosteroid treatment for acute non-concurrent&#xD;
             dermatitis)&#xD;
&#xD;
          -  Ongoing anti-tuberculosis prevention or treatment&#xD;
&#xD;
          -  Subject who cannot comply with the trial requirements, or with mental&#xD;
             illness/dual-stage affective psychosis in the past or at present&#xD;
&#xD;
          -  Any medical, psychological, social or other condition judged by investigator, that may&#xD;
             interfere subject's compliance with the protocol or signature on informed consent&#xD;
&#xD;
          -  Untolerable adverse reactions occurred after booster dose injection within 10 years&#xD;
             later;&#xD;
&#xD;
          -  Any condition that in the opinion of the investigators may be not suitable for&#xD;
             continued participation after booster dose injection within 10 years later&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lianshui Xinyi Center for Disease Control and Prevention</name>
      <address>
        <city>Huai'an</city>
        <state>Jiangsu</state>
        <zip>223400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>November 28, 2020</last_update_submitted>
  <last_update_submitted_qc>November 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</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/NCT03774628
org study id: JSVCT061
nct id: NCT03774628
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua
      Biological Products Co.,Ltd is used to prevent human rabies. The vaccine was completed in the
      Phase III clinical trial from August 2008 to February 2009 in Lianshui County, Jiangsu
      Province (Approval of Drug Clinical Trial No. 2008L03156). A total of 1200 subjects aged
      10-60 years were randomly assigned trial group (Kanghua vaccine group, 600 participants) and
      control groups (Pasteur vaccine group, 600 participants). The result showed that this vaccine
      could provide good immunogenicity and mild adverse reactions. On April 28, 2012, the drug
      registration approval was obtained (Approval No. 2012S00222).

      To disclose the effects of booster immunization of human diploid cell rabies vaccine (HDCV)
      after eight years of primary vaccination. Sixty subjects who had participated the phase Ⅲ
      clinical trial of freeze-dried HDCV were selected and given booster immunization after eight
      years of primary vaccination. The result showed that the freeze-dried HDCV has good immune
      effects with one-dose of booster immunization after eight years of primary vaccination． In
      order to find a ten years of immunization persistence and booster dose immune effect, the
      investigators decided to perform this immunization persistence and booster immunity trial
      among these subjects who had received five doses of rabies vaccine vaccines (around ten years
      after the fundamental immunity). The investigators do the recruitment among these subjects
      who had participated in the previous phase Ⅲ trail and the subjects were divided into two
      layers, such as trial group (Kanghua vaccine group) and the control group (Paste vaccine
      group). Each layer of the subjects randomly received one booster dose (Day 0) and two booster
      doses (Day 0, 3) the freeze-dried HDCV in a ratio of 1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination
time frame: 10 years after primary vaccination
description: calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination
measure: Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination
time frame: 10 years after primary vaccination
description: calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination
measure: Proportion of serum rabies virus neutralizing antibodies to protective levels
time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
description: calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
measure: Positive seroconversion rate of serum rabies virus neutralizing antibody
time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
description: calculate the positive seroconversion rate of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
measure: Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody
time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
description: calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
measure: Mean geometric increases (GMIs) of serum rabies virus neutralizing antibody
time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
description: calculate the mean geometric increases (GMIs) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
arm group label: Chengdu Kanghua (one booster shot)
arm group type: Experimental
description: one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.
arm group label: Chengdu Kanghua (two booster shots)
arm group type: Experimental
description: two doses at 0 and 3 days, on A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.
intervention type: Biological
intervention name: Chengdu Kanghua (one booster shot)
description: A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0
arm group label: Chengdu Kanghua (one booster shot)
intervention type: Biological
intervention name: Chengdu Kanghua (two booster shots)
description: A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0 and 3
arm group label: Chengdu Kanghua (two booster shots)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Rabies