<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/NCT04403880</url>
  </required_header>
  <id_info>
    <org_study_id>HVTN 405/HPTN 1901</org_study_id>
    <secondary_id>5UM1AI068614-14</secondary_id>
    <nct_id>NCT04403880</nct_id>
  </id_info>
  <brief_title>Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19</brief_title>
  <official_title>Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HIV Vaccine Trials Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>HIV Prevention Trials Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HIV Vaccine Trials Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn more about infection with and recovery from the virus&#xD;
      called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this&#xD;
      virus by the name &quot;coronavirus.&quot; It can cause the disease called COVID-19.&#xD;
&#xD;
      The information gained from the study will be used to help develop better tests for&#xD;
      SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and&#xD;
      treatments by allowing researchers to determine the difference between the body's immune&#xD;
      response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to characterize the SARS-CoV-2-specific immunity in convalescent individuals.&#xD;
&#xD;
      The observational cohort study will include 3 groups, as described in the table below.&#xD;
&#xD;
      Participants will complete a minimum of one visit (1-8 weeks post resolution of COVID-19 OR&#xD;
      2-10 weeks post most recent positive SARS-CoV-2 test, if asymptomatic) and optional visits&#xD;
      approximately 2 months, 4 months, and 1 year later. Participants diagnosed with SARS-CoV-2&#xD;
      infection at an optional follow-up visit may be contacted more frequently. Additional follow&#xD;
      up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2&#xD;
      infection and COVID-19.&#xD;
&#xD;
      Study visits may include physical examinations, medical history, questionnaires, pregnancy&#xD;
      tests (for participants assigned female at birth), blood draws, optional nasal samples, and&#xD;
      optional HIV testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2020</start_date>
  <completion_date type="Actual">April 21, 2022</completion_date>
  <primary_completion_date type="Actual">April 21, 2022</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by peptide microarray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific antibody binding response rate</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific antibody binding response magnitude</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific antibody binding response epitope specificity</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific antibody neutralization response rate</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by neutralizing antibody assay (NAb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific antibody neutralization response magnitude</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by neutralizing antibody assay (NAb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific antibody neutralization response epitope specificity</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by neutralizing antibody assay (NAb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by antibody-dependent cellular cytotoxicity assay (ADCC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by antibody-dependent cellular cytotoxicity assay (ADCC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by antibody-dependent cellular cytotoxicity assay (ADCC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific CD4+ and CD8+ T cell responses</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific CD4+ and CD8+ T cell response rate</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific memory B cell characterization</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by phenotyping and monoclonal antibody isolation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Tabulated overall and by group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection of viral RNA in nasopharyngeal or nasal swab samples</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by real-time reverse transcription polymerase chain reaction (RT-PCR) assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate of SARS-CoV-2-specific binding antibodies in nasal samples</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples</measure>
    <time_frame>Measured through participant's last visit at Month 0, 2, 4, or 12</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">759</enrollment>
  <condition>SARS-CoV-2</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3&#xD;
1A: Persons with asymptomatic infection, ages 18 through 55, inclusive&#xD;
1B: Persons with asymptomatic infection, age &gt; 55&#xD;
1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55&#xD;
1D: Persons with symptomatic infection (ie, COVID-19), age &gt; 55</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3&#xD;
2A: Persons 18 through 55 years of age&#xD;
2B: Persons &gt; 55 years of age</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sample collection</intervention_name>
    <description>Optional nasal specimen(s)&#xD;
Blood collection</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Persons reporting a positive test for SARS-CoV-2 and resolution of COVID-19 within 1-8&#xD;
        weeks of enrollment OR, if asymptomatic infection, reporting positive SARS-CoV-2 test&#xD;
        within 2-10 weeks of enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older.&#xD;
&#xD;
          -  Reports having had a positive test for SARS-CoV-2.&#xD;
&#xD;
          -  Reports resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic&#xD;
             infection, reports positive SARS-CoV-2 test within 2-10 weeks of enrollment. Not&#xD;
             excluded: individuals with symptoms consistent with residual sequelae of resolved&#xD;
             COVID-19, in the clinical judgement of the investigator.&#xD;
&#xD;
          -  Access to a participating HVTN or HPTN CRS and willingness to be followed for the&#xD;
             planned duration of the study.&#xD;
&#xD;
          -  Ability and willingness to provide informed consent.&#xD;
&#xD;
          -  Assessment of understanding: volunteer demonstrates understanding of this study.&#xD;
&#xD;
          -  Volunteers who were assigned female sex at birth: negative urine or serum beta human&#xD;
             chorionic gonadotropin (β-HCG) pregnancy test within 4 days of enrollment visit (ie,&#xD;
             prior to enrollment blood draw or nasal collections). Persons who are NOT of&#xD;
             reproductive potential due to having undergone hysterectomy or bilateral oophorectomy&#xD;
             (verified by medical records) or having reached menopause (no menses for ≥ 1 year ),&#xD;
             are not required to undergo pregnancy testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reports current COVID-19.&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Receipt of SARS-CoV-2 specific antibodies (eg, convalescent plasma or sera, monoclonal&#xD;
             antibodies, hyperimmune globulin). Not excluded: antibody therapy without SARS-CoV-2&#xD;
             specificity (eg, IL-6 pathway inhibitors for COVID-19).&#xD;
&#xD;
          -  SARS-CoV-2 vaccine(s) received in a prior vaccine trial.&#xD;
&#xD;
          -  Any medical, psychiatric, occupational, or other condition that, in the judgment of&#xD;
             the investigator, would interfere with, or serve as a contraindication to, protocol&#xD;
             adherence or a volunteer's ability to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry Corey</last_name>
    <role>Study Chair</role>
    <affiliation>HIV Vaccine Trials Network, Fred Hutch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shelly Karuna</last_name>
    <role>Study Chair</role>
    <affiliation>HIV Vaccine Trials Network, Fred Hutch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Vaccine CRS</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA CARE Center CRS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridge HIV CRS</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University CRS</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037-1894</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ponce de Leon Center CRS</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308-2012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hope Clinic of the Emory Vaccine Center CRS</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adolescent &amp; Young Adult Research at The CORE Center (AYAR at CORE)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Adolescent Trials Unit CRS</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University CRS</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital Vaccine CRS (BWH VCRS)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115-6110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fenway Health Clinical Research Site CRS</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215-4302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Medical School Clinical Research Center CRS</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronx Prevention Research Center CRS</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harlem Prevention Center CRS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia P&amp;S CRS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Blood Center CRS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Vaccines to Prevent HIV Infection CRS</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chapel Hill CRS</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Prevention CRS</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Vaccine CRS</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-2582</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Vaccine and Prevention CRS</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109-1024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malawi CRS</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS</name>
      <address>
        <city>Bellavista</city>
        <state>Callao</state>
        <zip>15081</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Miguel CRS</name>
      <address>
        <city>San Miguel</city>
        <state>Lima</state>
        <zip>32-15088</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion Civil Selva Amazonica (ACSA) CRS</name>
      <address>
        <city>Iquitos</city>
        <state>Maynas</state>
        <zip>1</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Via Libra CRS</name>
      <address>
        <city>Lima</city>
        <zip>15001</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barranco CRS</name>
      <address>
        <city>Lima</city>
        <zip>15063</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Josha Research CRS</name>
      <address>
        <city>Bloemfontein</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emavundleni CRS</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groote Schuur HIV CRS</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khayelitsha CRS / (CIDRI UCT)</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masiphumelele Clinical Research Site (MASI) CRS</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatsworth CRS</name>
      <address>
        <city>Chatsworth</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Botha's Hill CRS</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAPRISA eThekwini CRS</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vulindlela CRS</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isipingo CRS</name>
      <address>
        <city>Isipingo</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliptown Soweto CRS</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soweto HVTN CRS</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurum Institute Klerksdorp CRS</name>
      <address>
        <city>Klerksdorp</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qhakaza Mbokodo Research Clinic CRS</name>
      <address>
        <city>Ladysmith</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nelson Mandela Academic Research Unit CRS</name>
      <address>
        <city>Mthatha</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Stanza Clinical Research Centre CRS</name>
      <address>
        <city>Pretoria</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rustenburg CRS</name>
      <address>
        <city>Rustenburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Setshaba Research Centre CRS</name>
      <address>
        <city>Soshanguve</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tembisa Clinic 4 CRS</name>
      <address>
        <city>Tembisa</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Aurum Institute Tembisa Clinical Research Centre CRS</name>
      <address>
        <city>Tembisa</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongaat CRS</name>
      <address>
        <city>Tongaat</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verulam CRS</name>
      <address>
        <city>Verulam</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matero Reference Clinic CRS</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's CRS</name>
      <address>
        <city>Chitungwiza</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zengeza CRS</name>
      <address>
        <city>Chitungwiza</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seke South CRS</name>
      <address>
        <city>Harare</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
    <country>Peru</country>
    <country>South Africa</country>
    <country>United States</country>
    <country>Zambia</country>
    <country>Zimbabwe</country>
  </location_countries>
  <removed_countries>
    <country>Mozambique</country>
    <country>Tanzania</country>
  </removed_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 17, 2023</submitted>
    <returned>June 13, 2023</returned>
    <submitted>July 18, 2023</submitted>
    <returned>August 15, 2023</returned>
  </pending_results>
  <!-- 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/NCT04403880
org study id: HVTN 405/HPTN 1901
secondary id: 5UM1AI068614-14
nct id: NCT04403880
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn more about infection with and recovery from the virus
      called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this
      virus by the name "coronavirus." It can cause the disease called COVID-19.

      The information gained from the study will be used to help develop better tests for
      SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and
      treatments by allowing researchers to determine the difference between the body's immune
      response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.
This study aims to characterize the SARS-CoV-2-specific immunity in convalescent individuals.

      The observational cohort study will include 3 groups, as described in the table below.

      Participants will complete a minimum of one visit (1-8 weeks post resolution of COVID-19 OR
      2-10 weeks post most recent positive SARS-CoV-2 test, if asymptomatic) and optional visits
      approximately 2 months, 4 months, and 1 year later. Participants diagnosed with SARS-CoV-2
      infection at an optional follow-up visit may be contacted more frequently. Additional follow
      up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2
      infection and COVID-19.

      Study visits may include physical examinations, medical history, questionnaires, pregnancy
      tests (for participants assigned female at birth), blood draws, optional nasal samples, and
      optional HIV testing.
observational model: Cohort
time perspective: Other
measure: Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by peptide microarray
measure: SARS-CoV-2-specific antibody binding response rate
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by binding antibody multiplex assay (BAMA)
measure: SARS-CoV-2-specific antibody binding response magnitude
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by binding antibody multiplex assay (BAMA)
measure: SARS-CoV-2-specific antibody binding response epitope specificity
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by binding antibody multiplex assay (BAMA)
measure: SARS-CoV-2-specific antibody neutralization response rate
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by neutralizing antibody assay (NAb)
measure: SARS-CoV-2-specific antibody neutralization response magnitude
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by neutralizing antibody assay (NAb)
measure: SARS-CoV-2-specific antibody neutralization response epitope specificity
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by neutralizing antibody assay (NAb)
measure: SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by antibody-dependent cellular cytotoxicity assay (ADCC)
measure: SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by antibody-dependent cellular cytotoxicity assay (ADCC)
measure: SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by antibody-dependent cellular cytotoxicity assay (ADCC)
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell responses
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by flow cytometry
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell response rate
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by flow cytometry
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by flow cytometry
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by flow cytometry
measure: SARS-CoV-2-specific memory B cell characterization
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by phenotyping and monoclonal antibody isolation
measure: SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Tabulated overall and by group
measure: Detection of viral RNA in nasopharyngeal or nasal swab samples
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by real-time reverse transcription polymerase chain reaction (RT-PCR) assay
measure: Response rate of SARS-CoV-2-specific binding antibodies in nasal samples
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by binding antibody multiplex assay (BAMA)
measure: Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples
time frame: Measured through participant's last visit at Month 0, 2, 4, or 12
description: Measured by binding antibody multiplex assay (BAMA)
arm group label: Group 1
description: Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3
1A: Persons with asymptomatic infection, ages 18 through 55, inclusive
1B: Persons with asymptomatic infection, age > 55
1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55
1D: Persons with symptomatic infection (ie, COVID-19), age > 55
arm group label: Group 2
description: Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3
2A: Persons 18 through 55 years of age
2B: Persons > 55 years of age
arm group label: Group 3
description: Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)
intervention type: Other
intervention name: Sample collection
description: Optional nasal specimen(s)
Blood collection
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Larry Corey
role: Study Chair
affiliation: HIV Vaccine Trials Network, Fred Hutch
last name: Shelly Karuna
role: Study Chair
affiliation: HIV Vaccine Trials Network, Fred Hutch
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country: Malawi
country: Peru
country: South Africa
country: United States
country: Zambia
country: Zimbabwe
country: Mozambique
country: Tanzania
responsible party type: Sponsor
mesh term: COVID-19
submitted: May 17, 2023
returned: June 13, 2023
submitted: July 18, 2023
returned: August 15, 2023