<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/NCT02242968</url>
  </required_header>
  <id_info>
    <org_study_id>140194</org_study_id>
    <secondary_id>14-I-0194</secondary_id>
    <nct_id>NCT02242968</nct_id>
  </id_info>
  <brief_title>Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products</brief_title>
  <official_title>Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      - Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group&#xD;
      of healthy volunteers for clinical trials. Clinical trials are studies that test these&#xD;
      vaccines and therapies in people.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To screen volunteers for clinical trials for investigational or licensed vaccines or drugs&#xD;
      to treat or prevent virus infections.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Healthy adults age 18 or older.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be asked questions about their health history, including sexual&#xD;
           activity and drug use. They will give blood samples. They may have a physical exam. They&#xD;
           may give a urine sample.&#xD;
&#xD;
        -  Participants may have the inside of their nose either swabbed or washed with some fluid.&#xD;
           The fluid will be collected. They may give a stool sample.&#xD;
&#xD;
        -  Participants may have an electrocardiogram. Soft, sticky patches will be attached to&#xD;
           participants chest, arms, and legs. They will lie still on a table while the patches&#xD;
           detect the heart s electrical signals. A machine will record these signals.&#xD;
&#xD;
        -  Participants may have lung function tests. These tests measure the volume of air moving&#xD;
           in and out of the lungs. Participants will forcibly blow air into a machine.&#xD;
&#xD;
        -  Participants will be told if any tests show a medical problem.&#xD;
&#xD;
        -  If a participant is eligible and decides to join an investigational clinical trial,&#xD;
           researchers will explain the study and the risks involved. Participants will sign a&#xD;
           separate consent for that clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases.&#xD;
      Among other things, testing of vaccines or antiviral medications requires knowing whether the&#xD;
      prospective subject has been previously infected by the virus to be studied. We will recruit&#xD;
      healthy persons for this study and screen them for their eligibility to potentially&#xD;
      participate in clinical trials of investigational or licensed vaccines or antiviral products.&#xD;
      In most cases this will involve a medical history, physical examination, and obtaining blood&#xD;
      to test for past exposure to one or more viruses being studied in ongoing and upcoming&#xD;
      vaccine or antiviral therapy trials. In some cases, blood may be tested for viral DNA or RNA&#xD;
      and urine, stool, nasal swab, or nasal wash may be tested for viruses. Additional testing,&#xD;
      such as an electrocardiogram (EKG) and pulmonary function tests (PFTs) may also be done. In a&#xD;
      subset of volunteers not screening for enrollment in a clinical trial but willing to donate a&#xD;
      small volume of blood, nasal swab, throat swab, and/or urine in support of research assay&#xD;
      development, no additional testing is anticipated. Overall, this study should 1) help us to&#xD;
      identify a group of healthy volunteers who will be eligible, based on testing for their prior&#xD;
      exposure to viruses, to participate in vaccine or antiviral therapy trials, and 2) allow for&#xD;
      ready procurement of biological specimens from healthy volunteers to facilitate rapid&#xD;
      research assay development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 24, 2023</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products.</measure>
    <time_frame>Within one year from enrollment of each individual.</time_frame>
    <description>A pool of subjects qualified to participate in clinical trials.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Vaccines</condition>
  <condition>Antiviral Agents</condition>
  <condition>Immunologic Factors</condition>
  <condition>Physiological Effects of Drugs</condition>
  <condition>Anti-Infective Agents</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Male and Female healthy volunteers between aged 18 and 65 years.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers, male or female ages 18-65.@@@&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Age: 18 or older&#xD;
&#xD;
          -  Available to participate for the planned duration of at least one clinical trial for&#xD;
             which screening is being done or to donate blood, nasal swab, throat swab, and/or&#xD;
             urine in support of assay development&#xD;
&#xD;
          -  Able and willing to complete the informed consent process&#xD;
&#xD;
          -  Agree to have blood and/or urine, stool, nasal swab, or wash samples collected as&#xD;
             needed for the clinical trial screening or sample donation process&#xD;
&#xD;
          -  Agree to participate in procedures, such as electrocardiogram or pulmonary function&#xD;
             tests, as may be needed for the clinical trial screening process&#xD;
&#xD;
          -  Do not have plans to become pregnant while on this study&#xD;
&#xD;
          -  Able to provide a medical history and other relevant personal information as&#xD;
             appropriate&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  A condition that requires active medical intervention or monitoring to avert serious&#xD;
             danger to the participant s health or well-being&#xD;
&#xD;
          -  Known to be pregnant or breast-feeding&#xD;
&#xD;
          -  If planning to enroll in a clinical trial, the receipt of immunoglobulin within the&#xD;
             past 6 months or anticipated within the next year&#xD;
&#xD;
          -  Any other condition that in the opinion of the investigator would make the subject&#xD;
             unsuitable for enrollment or could interfere with the subject participating in and&#xD;
             completing the study or a specimen donation.&#xD;
&#xD;
          -  Use of recreational drugs or alcohol dependency or abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard T Davey, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jocelyn Voell, R.N.</last_name>
    <phone>(301) 435-7913</phone>
    <email>jvoell@niaid.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Richard T Davey, M.D.</last_name>
    <phone>(301) 496-8029</phone>
    <email>rdavey@niaid.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY dial 711</phone_ext>
      <email>ccopr@nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-I-0194.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>May 9, 2023</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Licensed Vaccines</keyword>
  <keyword>Blood Draw</keyword>
  <keyword>Investigational Vaccines</keyword>
  <keyword>Healthy Volunteers</keyword>
  <keyword>Eligibility Screening</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/NCT02242968
org study id: 140194
secondary id: 14-I-0194
nct id: NCT02242968
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      - Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group
      of healthy volunteers for clinical trials. Clinical trials are studies that test these
      vaccines and therapies in people.

      Objective:

      - To screen volunteers for clinical trials for investigational or licensed vaccines or drugs
      to treat or prevent virus infections.

      Eligibility:

      - Healthy adults age 18 or older.

      Design:

        -  Participants will be asked questions about their health history, including sexual
           activity and drug use. They will give blood samples. They may have a physical exam. They
           may give a urine sample.

        -  Participants may have the inside of their nose either swabbed or washed with some fluid.
           The fluid will be collected. They may give a stool sample.

        -  Participants may have an electrocardiogram. Soft, sticky patches will be attached to
           participants chest, arms, and legs. They will lie still on a table while the patches
           detect the heart s electrical signals. A machine will record these signals.

        -  Participants may have lung function tests. These tests measure the volume of air moving
           in and out of the lungs. Participants will forcibly blow air into a machine.

        -  Participants will be told if any tests show a medical problem.

        -  If a participant is eligible and decides to join an investigational clinical trial,
           researchers will explain the study and the risks involved. Participants will sign a
           separate consent for that clinical trial.
Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases.
      Among other things, testing of vaccines or antiviral medications requires knowing whether the
      prospective subject has been previously infected by the virus to be studied. We will recruit
      healthy persons for this study and screen them for their eligibility to potentially
      participate in clinical trials of investigational or licensed vaccines or antiviral products.
      In most cases this will involve a medical history, physical examination, and obtaining blood
      to test for past exposure to one or more viruses being studied in ongoing and upcoming
      vaccine or antiviral therapy trials. In some cases, blood may be tested for viral DNA or RNA
      and urine, stool, nasal swab, or nasal wash may be tested for viruses. Additional testing,
      such as an electrocardiogram (EKG) and pulmonary function tests (PFTs) may also be done. In a
      subset of volunteers not screening for enrollment in a clinical trial but willing to donate a
      small volume of blood, nasal swab, throat swab, and/or urine in support of research assay
      development, no additional testing is anticipated. Overall, this study should 1) help us to
      identify a group of healthy volunteers who will be eligible, based on testing for their prior
      exposure to viruses, to participate in vaccine or antiviral therapy trials, and 2) allow for
      ready procurement of biological specimens from healthy volunteers to facilitate rapid
      research assay development.
observational model: Cohort
time perspective: Prospective
measure: To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products.
time frame: Within one year from enrollment of each individual.
description: A pool of subjects qualified to participate in clinical trials.
arm group label: Healthy Volunteers
description: Male and Female healthy volunteers between aged 18 and 65 years.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard T Davey, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
last name: Jocelyn Voell, R.N.
phone: (301) 435-7913
email: jvoell@niaid.nih.gov
last name: Richard T Davey, M.D.
phone: (301) 496-8029
email: rdavey@niaid.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-I-0194.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor