<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/NCT01679665</url>
  </required_header>
  <id_info>
    <org_study_id>JSVCT012</org_study_id>
    <nct_id>NCT01679665</nct_id>
  </id_info>
  <brief_title>Systems Biology of Vaccination for EV71 Vaccine in Humans</brief_title>
  <official_title>Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Province Centers for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bejing Vigoo Biological Co., LTD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jiangsu Province Centers for Disease Control and Prevention</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1&#xD;
      and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good&#xD;
      safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the&#xD;
      candidate vaccine for the phase 3 clinical trial.&#xD;
&#xD;
      This clinical trial is a supplementary phase 2 trial, which is designed to study the gene&#xD;
      expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5&#xD;
      years old use a systems biology approach combined with microarray analysis，RT-PCR and&#xD;
      neutralizing antibody testing for PBMC and serum collected form the studied children&#xD;
      population, to predict immunogenicity, and explore mechanistic insights about the EV71&#xD;
      vaccine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine</measure>
    <time_frame>Frame: 3 days after first dose</time_frame>
    <description>Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine</measure>
    <time_frame>7 days after first dose</time_frame>
    <description>Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine</measure>
    <time_frame>28 days after first dose</time_frame>
    <description>Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine</measure>
    <time_frame>28 days after second dose</time_frame>
    <description>Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine</measure>
    <time_frame>6 months after first dose</time_frame>
    <description>Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination</measure>
    <time_frame>28 days after the first vaccination</time_frame>
    <description>GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination</measure>
    <time_frame>28 days after second vaccination</time_frame>
    <description>GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the safety of EV71 vaccine in healthy children aged 2-5 years</measure>
    <time_frame>28 days after the first dose</time_frame>
    <description>Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the safety of EV71 vaccine in healthy children aged 2-5 years</measure>
    <time_frame>28 days after the second dose</time_frame>
    <description>Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Systems Biology</condition>
  <condition>Early Gene</condition>
  <condition>EV71 Vaccine</condition>
  <arm_group>
    <arm_group_label>320U /0.5ml in children (from 2 to 5 years old)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 48 children aged 2-5 years old on day 0,28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0/0.5ml placebo in children (from 2 to 5 years old)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>320U /0.5ml</intervention_name>
    <description>inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval</description>
    <arm_group_label>320U /0.5ml in children (from 2 to 5 years old)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>0/0.5ml placebo</intervention_name>
    <description>0/0.5ml placebo, two doses, 4 weeks interval</description>
    <arm_group_label>0/0.5ml placebo in children (from 2 to 5 years old)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects aged from 2 to 5 years old as established by medical history and&#xD;
             clinical examination&#xD;
&#xD;
          -  The pre-vaccination neutralizing antibody against EV71 &lt;1:8 which is determined by&#xD;
             ELISA&#xD;
&#xD;
          -  The subjects' guardians are able to understand and sign the informed consent&#xD;
&#xD;
          -  Had never received the vaccine against EV71&#xD;
&#xD;
          -  Subjects who can and will comply with the requirements of the protocol&#xD;
&#xD;
          -  Subjects with temperature &lt;37.1°C on axillary setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who has a medical history of HFMD&#xD;
&#xD;
          -  &lt;= 37 weeks gestation&#xD;
&#xD;
          -  Subjects with a birth weight &lt;2.5 kg&#xD;
&#xD;
          -  Subject that has a medical history of any of the following: allergic history, or&#xD;
             allergic to any ingredient of vaccine&#xD;
&#xD;
          -  Family history of seizures or progressive neurological disease&#xD;
&#xD;
          -  Family history of congenital or hereditary immunodeficiency&#xD;
&#xD;
          -  Severe malnutrition or dysgenopathy&#xD;
&#xD;
          -  Major congenital defects or serious chronic illness, including perinatal brain damage&#xD;
&#xD;
          -  Autoimmune disease&#xD;
&#xD;
          -  Bleeding disorder diagnosed by a doctor or significant bruising or bleeding&#xD;
             difficulties with IM injections or blood draws&#xD;
&#xD;
          -  Any acute infections in last 7 days&#xD;
&#xD;
          -  Any prior administration of immunodepressant or corticosteroids in last 6month&#xD;
&#xD;
          -  Any prior administration of blood products in last 3 month&#xD;
&#xD;
          -  Any prior administration of other research medicines in last 1month&#xD;
&#xD;
          -  Any prior administration of attenuated live vaccine in last 28 days&#xD;
&#xD;
          -  Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal&#xD;
             vaccine&#xD;
&#xD;
          -  Under the anti - TB prevention or therapy&#xD;
&#xD;
          -  Any condition that in the opinion of the investigator, may interfere with the&#xD;
             evaluation of study objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jiangsu Provincial Center for Diseases Control and Prevention</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 7, 2013</last_update_submitted>
  <last_update_submitted_qc>May 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01679665
org study id: JSVCT012
nct id: NCT01679665
lead sponsor: 
collaborator: 
has dmc: No
Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1
      and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good
      safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the
      candidate vaccine for the phase 3 clinical trial.

      This clinical trial is a supplementary phase 2 trial, which is designed to study the gene
      expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5
      years old use a systems biology approach combined with microarray analysis，RT-PCR and
      neutralizing antibody testing for PBMC and serum collected form the studied children
      population, to predict immunogenicity, and explore mechanistic insights about the EV71
      vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
time frame: Frame: 3 days after first dose
description: Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
time frame: 7 days after first dose
description: Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
time frame: 28 days after first dose
description: Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
time frame: 28 days after second dose
description: Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
time frame: 6 months after first dose
description: Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years
measure: GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination
time frame: 28 days after the first vaccination
description: GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
measure: GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination
time frame: 28 days after second vaccination
description: GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
measure: the safety of EV71 vaccine in healthy children aged 2-5 years
time frame: 28 days after the first dose
description: Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years
measure: the safety of EV71 vaccine in healthy children aged 2-5 years
time frame: 28 days after the second dose
description: Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years
arm group label: 320U /0.5ml in children (from 2 to 5 years old)
arm group type: Experimental
description: inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 48 children aged 2-5 years old on day 0,28
arm group label: 0/0.5ml placebo in children (from 2 to 5 years old)
arm group type: Placebo Comparator
description: 0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28
intervention type: Biological
intervention name: 320U /0.5ml
description: inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
arm group label: 320U /0.5ml in children (from 2 to 5 years old)
intervention type: Biological
intervention name: 0/0.5ml placebo
description: 0/0.5ml placebo, two doses, 4 weeks interval
arm group label: 0/0.5ml placebo in children (from 2 to 5 years old)
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor