<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/NCT02213341</url>
  </required_header>
  <id_info>
    <org_study_id>DAIT CoFAR9</org_study_id>
    <nct_id>NCT02213341</nct_id>
  </id_info>
  <brief_title>Impact of Vaccination on Th2 Immunity in Infancy</brief_title>
  <official_title>Impact of Vaccination on Th2 Immunity in Infancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Consortium of Food Allergy Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the responses in the immune system of infants after&#xD;
      they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators&#xD;
      will do this by studying the immune cells and allergy responses in the blood prior to and&#xD;
      after receipt of the third DTaP vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-site study of infants who are scheduled to receive their third series (~6&#xD;
      month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and&#xD;
      pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk,&#xD;
      egg, or peanut. Infants will be assigned to one of two groups depending on the infant's&#xD;
      sensitization to milk, egg, and peanut.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">June 14, 2016</completion_date>
  <primary_completion_date type="Actual">June 14, 2016</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>Allergen-specific IgE</measure>
    <time_frame>baseline and day 28</time_frame>
    <description>Magnitude of increase of allergen-specific IgE. For each child, the maximum allergen-specific IgE change to milk, egg, or peanut will be considered as the primary endpoint.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">77</enrollment>
  <condition>Food Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>Positive blood test to milk, egg, and/or peanut</arm_group_label>
    <description>Family history to atopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative blood test to allergy</arm_group_label>
    <description>A negative skin prick test to egg, milk, and peanut and a negative Immunoglobulin E (IgE) to egg, milk, and peanut.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Skin prick allergen test</intervention_name>
    <description>To test for hypersensitivity to milk, egg, or peanut</description>
    <arm_group_label>Negative blood test to allergy</arm_group_label>
    <arm_group_label>Positive blood test to milk, egg, and/or peanut</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <arm_group_label>Negative blood test to allergy</arm_group_label>
    <arm_group_label>Positive blood test to milk, egg, and/or peanut</arm_group_label>
    <other_name>venipuncture</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Infants who are scheduled to receive their ~6 month (third dose of primary series) vaccines&#xD;
        including the DTaP vaccine as part of routine care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent from parent/guardian&#xD;
&#xD;
          -  General good health without other known need for blood draws that would conflict with&#xD;
             the study volume requirements&#xD;
&#xD;
          -  Aged 5 months - 7 months, any race/ethnicity, any gender&#xD;
&#xD;
          -  Subjects must not have yet received their third DTaP vaccination, which typically is&#xD;
             given at 6 months of age. Subjects must have previously received two doses of the DTaP&#xD;
             vaccination, at ages 2 months and 4 months&#xD;
&#xD;
          -  Willingness to return for follow-up testing as defined in the protocol and consent if&#xD;
             screening tests indicate eligibility&#xD;
&#xD;
          -  Group 1 participants must have all of the following:&#xD;
&#xD;
               -  A negative skin prick test to egg, milk, and peanut&#xD;
&#xD;
               -  A negative IgE to egg, milk, and peanut&#xD;
&#xD;
          -  Group 2 participants must have all of the following:&#xD;
&#xD;
               -  A positive family history of allergic disease&#xD;
&#xD;
               -  Atopic Dermatitis not requiring prescription medication&#xD;
&#xD;
               -  A positive IgE to milk, egg, and/or peanut&#xD;
&#xD;
        If Group 1 enrollment is completed first, participants must have all of the following to be&#xD;
        enrolled in Group 2:&#xD;
&#xD;
          -  A family history of atopy&#xD;
&#xD;
          -  Atopic dermatitis not requiring prescription medication&#xD;
&#xD;
        If Group 2 enrollment is completed first, participants must have all of the following to be&#xD;
        enrolled in Group 1:&#xD;
&#xD;
        -No personal or family history of atopic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of anemia requiring any treatment&#xD;
&#xD;
          -  Previous allergic reaction to any food, defined as itching, rash, hives, swelling,&#xD;
             vomiting, diarrhea, sneezing, rhinorrhea, wheezing, breathing difficulty, or passing&#xD;
             out immediately after food ingestion.&#xD;
&#xD;
          -  Evidence of non-IgE-mediated reaction to milk or soy (i.e. milk/soy protein&#xD;
             intolerance) or evidence of food protein induced enterocolitis syndrome (FPIES)&#xD;
&#xD;
          -  Severe atopic dermatitis (liberally defined as requiring prescription medication)&#xD;
&#xD;
          -  Unable to obtain serum sample for determination of egg, milk and peanut IgE levels&#xD;
&#xD;
          -  Use of short-acting anti-histamines (diphenhydramine, etc.) more than one time within&#xD;
             3 days of skin testing or on the day of skin testing&#xD;
&#xD;
          -  Any history of intravenous or oral steroid medication&#xD;
&#xD;
          -  Known underlying immune defect/deficiency or bleeding disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Months</minimum_age>
    <maximum_age>7 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugh A. Sampson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mt. Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Sicherer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.niaid.nih.gov/</url>
    <description>National Institute of Allergy and Infectious Diseases (NIAID)</description>
  </link>
  <link>
    <url>https://www.niaid.nih.gov/about/dait</url>
    <description>Division of Allergy, Immunology, and Transplantation (DAIT)</description>
  </link>
  <link>
    <url>http://www.cofargroup.org/</url>
    <description>Consortium of Food Allergy Research (CoFAR)</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Milk Allergy</keyword>
  <keyword>Egg Allergy</keyword>
  <keyword>Peanut Allergy</keyword>
  <keyword>Infant Vaccination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</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/NCT02213341
org study id: DAIT CoFAR9
nct id: NCT02213341
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the responses in the immune system of infants after
      they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators
      will do this by studying the immune cells and allergy responses in the blood prior to and
      after receipt of the third DTaP vaccine.
This is a single-site study of infants who are scheduled to receive their third series (~6
      month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and
      pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk,
      egg, or peanut. Infants will be assigned to one of two groups depending on the infant's
      sensitization to milk, egg, and peanut.
observational model: Case-Control
time perspective: Prospective
measure: Allergen-specific IgE
time frame: baseline and day 28
description: Magnitude of increase of allergen-specific IgE. For each child, the maximum allergen-specific IgE change to milk, egg, or peanut will be considered as the primary endpoint.
arm group label: Positive blood test to milk, egg, and/or peanut
description: Family history to atopy
arm group label: Negative blood test to allergy
description: A negative skin prick test to egg, milk, and peanut and a negative Immunoglobulin E (IgE) to egg, milk, and peanut.
intervention type: Procedure
intervention name: Skin prick allergen test
description: To test for hypersensitivity to milk, egg, or peanut
arm group label: Negative blood test to allergy
arm group label: Positive blood test to milk, egg, and/or peanut
intervention type: Procedure
intervention name: Blood draw
arm group label: Negative blood test to allergy
arm group label: Positive blood test to milk, egg, and/or peanut
other name: venipuncture
Whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Months
maximum age: 7 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Hugh A. Sampson, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mt. Sinai
last name: Scott Sicherer, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
url: https://www.niaid.nih.gov/
description: National Institute of Allergy and Infectious Diseases (NIAID)
url: https://www.niaid.nih.gov/about/dait
description: Division of Allergy, Immunology, and Transplantation (DAIT)
url: http://www.cofargroup.org/
description: Consortium of Food Allergy Research (CoFAR)
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity