<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/NCT02220439</url>
  </required_header>
  <id_info>
    <org_study_id>AIGHD-CSP2013-001a</org_study_id>
    <nct_id>NCT02220439</nct_id>
  </id_info>
  <brief_title>Does the Fecal Microbiome Influence Rotarix Immunogenicity</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>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wageningen University and Research</agency>
      <agency_class>Other</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 proposal for a nested case-control study within an ongoing rotavirus vaccine&#xD;
      immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the&#xD;
      fecal microbiota composition and diversity of infants who do (control) and do not (case)&#xD;
      demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for&#xD;
      vaccination dose, age and breast-feeding practices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>microbiome diversity (Shannon's index) and composition (relative abundance)</measure>
    <time_frame>at 6 weeks of age, pre-rotavirus vaccination</time_frame>
    <description>Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups&#xD;
Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups&#xD;
The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>microbiome diversity (Shannon's index) and composition (relative abundance)</measure>
    <time_frame>at 1 to 3 years of age post-rotavirus vaccination</time_frame>
    <description>Microbiota composition post vaccination will be measured by calculating and comparing a % of the phylogenetic groups present in both groups&#xD;
Diversity post vaccination will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups&#xD;
The relative abundance of microbial groups post vaccination will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">76</enrollment>
  <condition>Rotavirus Infections</condition>
  <condition>Reaction - Vaccine Nos</condition>
  <condition>Intestinal Bacteria Flora Disturbance</condition>
  <arm_group>
    <arm_group_label>Case: non-rotavirus seroconverters</arm_group_label>
    <description>Infants not demonstrating seroconversion to rotavirus vaccination, as measured anti-RV Immunoglobulin A &lt; 20 U/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: rotavirus seroconverters</arm_group_label>
    <description>Infants demonstrating seroconversion to rotavirus vaccination, as measured by anti-rotavirus Immunoglobulin A &gt; 20 U/ml</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      fecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be nested within an existing rotavirus immunogenicity study being conducted&#xD;
        in Karachi, Pakistan (clinicaltrials.gov: NCT01199874) . The physical setting is a&#xD;
        peri-urban slum outside of Karachi, primarily populated by fishermen. Parents and legal&#xD;
        guardians of infants participating in NCT01199874 will provide new informed consent for&#xD;
        inclusion in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        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 into in the study.&#xD;
&#xD;
          -  Written informed consent obtained from the parents or guardians.&#xD;
&#xD;
          -  Availability of baseline fecal sample collected before Rotarix vaccination&#xD;
&#xD;
          -  Written informed consent obtained from the parents or guardians for nested study&#xD;
&#xD;
        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 trial (besides NCT01199874).&#xD;
&#xD;
          -  Birth weight less than 1500 grams; or if birth weight is unknown, weight less than&#xD;
             2000 grams on or before 28 days.&#xD;
&#xD;
          -  Immunoglobulin and/or blood products use since birth or during the study period.&#xD;
             Nested study additional exclusion criteria:&#xD;
&#xD;
          -  Positive serum anti-rotavirus Immunoglobulin A (&gt; 20 U/ml) at 6 weeks of age,&#xD;
             indicative of prior rotavirus infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Weeks</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa C Harris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>June 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</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>V.C. Harris, M.D.</investigator_title>
  </responsible_party>
  <keyword>rotavirus</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>enteric vaccine</keyword>
  <keyword>vaccine immunogenicity</keyword>
  <keyword>rotavirus vaccine</keyword>
  <keyword>gut microbiome</keyword>
  <keyword>microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotavirus Infections</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/NCT02220439
org study id: AIGHD-CSP2013-001a
nct id: NCT02220439
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine
      immunogenicity clinical trial 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: microbiome diversity (Shannon's index) and composition (relative abundance)
time frame: at 6 weeks of age, pre-rotavirus vaccination
description: Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups
Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups
The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
measure: microbiome diversity (Shannon's index) and composition (relative abundance)
time frame: at 1 to 3 years of age post-rotavirus vaccination
description: Microbiota composition post vaccination will be measured by calculating and comparing a % of the phylogenetic groups present in both groups
Diversity post vaccination will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups
The relative abundance of microbial groups post vaccination will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
arm group label: Case: non-rotavirus seroconverters
description: Infants not demonstrating seroconversion to rotavirus vaccination, as measured anti-RV Immunoglobulin A < 20 U/ml
arm group label: Control: rotavirus seroconverters
description: Infants demonstrating seroconversion to rotavirus vaccination, as measured by anti-rotavirus Immunoglobulin A > 20 U/ml
fecal samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Weeks
maximum age: N/A
healthy volunteers: No
last name: Vanessa C Harris, MD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Vanessa Harris
investigator title: V.C. Harris, M.D.
mesh term: Rotavirus Infections