<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/NCT03031743</url>
  </required_header>
  <id_info>
    <org_study_id>AIGHD-CSP2013-001</org_study_id>
    <nct_id>NCT03031743</nct_id>
  </id_info>
  <brief_title>The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan</brief_title>
  <official_title>Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial&#xD;
      in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition&#xD;
      and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion&#xD;
      to rotavirus vaccination. The infants will be matched for vaccination dose, age and&#xD;
      breast-feeding practices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>differences in fecal microbiota composition</measure>
    <time_frame>2 years</time_frame>
    <description>The primary study objective is to see if there are significant differences in the fecal microbiota composition between rotavirus vaccine (Rotarix TM) immune responders (defined as anti-RV IgA antibodies at a concentration of &gt; or = to 20 U/ml in a previously seronegative individual 4 weeks after the last Rotarix dose) and rotavirus vaccine immune non-responders (defined as anti-RV IgA antibodies at a concentration of &lt;20 U/mL 4 weeks after the last Rotarix dose)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Rotavirus</condition>
  <arm_group>
    <arm_group_label>rotavirus (Rotarix TM) vaccination</arm_group_label>
    <description>Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Infants living in a peri-urban slum outside of Karachi, Pakistan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants already consented and enrolled in the overarching study: Immunogenicity of&#xD;
             Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast&#xD;
             Feeding around the Time of Vaccination on the Immunogenicity or Rotarix Vaccine trial&#xD;
             (NCT01199874)&#xD;
&#xD;
        Overarching study (NCT01199874)inclusion criteria:&#xD;
&#xD;
          -  6 weeks 0 days to 7 weeks 6 days age at the time of enrollment&#xD;
&#xD;
          -  Healthy infant free of chronic or serious medical condition as determined by history&#xD;
             and physical exam at time of enrollment&#xD;
&#xD;
          -  written informed consent obtained from parents or guardians for overarching study&#xD;
             Nested study additional inclusion criteria&#xD;
&#xD;
          -  written informed consent obtained from parents or legal guardians for this nested&#xD;
             study&#xD;
&#xD;
          -  availability of a baseline, pre-vaccination fecal sample&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Overarching study (NCT01199874)exclusion criteria&#xD;
&#xD;
          -  hypersensitivity to any of the vaccine components&#xD;
&#xD;
          -  Use of any investigational drug or vaccine other than the study vaccine within 30 days&#xD;
             of first dose of study vaccine or during the study&#xD;
&#xD;
          -  use of any immunosuppressive drugs&#xD;
&#xD;
          -  previous intussusceptions or abdominal surgery&#xD;
&#xD;
          -  enrollment in any other trials&#xD;
&#xD;
          -  birth weight less than 1500 grams; or if birthweight is unknown, weight less than 2000&#xD;
             grams on or before 28 days&#xD;
&#xD;
          -  immunoglobulin and/or blood products use since birth or during the study period Nested&#xD;
             study additional exclusion criteria&#xD;
&#xD;
          -  positive serum anti-rotavirus IgA (&gt; or= 20U/mL) at 6 weeks of age, indicative of&#xD;
             rotavirus infection prior to vaccination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa C Harris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Vanessa Harris</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>rotavirus vaccine</keyword>
  <keyword>human microbiome</keyword>
  <keyword>fecal microbiome</keyword>
  <keyword>vaccine immunogenicity</keyword>
  <keyword>Rotarix</keyword>
  <keyword>immune response, mucosal</keyword>
  <!-- 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/NCT03031743
org study id: AIGHD-CSP2013-001
nct id: NCT03031743
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial
      in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition
      and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion
      to rotavirus vaccination. The infants will be matched for vaccination dose, age and
      breast-feeding practices.
observational model: Case-Control
time perspective: Prospective
measure: differences in fecal microbiota composition
time frame: 2 years
description: The primary study objective is to see if there are significant differences in the fecal microbiota composition between rotavirus vaccine (Rotarix TM) immune responders (defined as anti-RV IgA antibodies at a concentration of > or = to 20 U/ml in a previously seronegative individual 4 weeks after the last Rotarix dose) and rotavirus vaccine immune non-responders (defined as anti-RV IgA antibodies at a concentration of <20 U/mL 4 weeks after the last Rotarix dose)
arm group label: rotavirus (Rotarix TM) vaccination
description: Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vanessa C Harris, MD
role: Principal Investigator
affiliation: Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Vanessa Harris
investigator title: Principal Investigator