<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/NCT02261480</url>
  </required_header>
  <id_info>
    <org_study_id>iSCREEN</org_study_id>
    <nct_id>NCT02261480</nct_id>
  </id_info>
  <brief_title>A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease</brief_title>
  <official_title>Investigation in Sickle Cell Disease of a New Reagent Assay Examining Natural Parvovirus B19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parvovirus B19 is a small virus that is the cause of &quot;fifth&quot; disease, a common infection in&#xD;
      childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the bone&#xD;
      marrow to stop producing red blood cells temporarily, which can be life-threatening. A novel&#xD;
      vaccine is currently in development for children with SCD. This study is the first step&#xD;
      within a larger parvovirus B19 multi-institutional project that will help develop this new&#xD;
      vaccine, as it will define the value and utility of using a novel assay for measurement of&#xD;
      parvovirus-specific antibodies. The main objective is to investigate the relationship between&#xD;
      the newly developed VP1u ELISA assay and the gold standard neutralization assay for&#xD;
      parvovirus B19 infection.&#xD;
&#xD;
      The most accurate test, called a neutralizing antibody assay, to see if a person has had or&#xD;
      currently has the infection is very complex and expensive and would be very difficult to use&#xD;
      in a large research study to test the new vaccine. A new and simpler test has developed. The&#xD;
      main goal of this study, iSCREEN, is to find out if this new test works.&#xD;
&#xD;
      There will be distinct labs performing the VP1u ELISA and the neutralization assays and the&#xD;
      respective laboratories will not have access to each other's results for individual subjects.&#xD;
      The VP1u ELISA will be performed at St. Jude Children's Research Hospital. Neutralization&#xD;
      assays will be conducted at the National Heart, Lung and Blood Institute.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants with sickle cell disease (SCD) will be divided into three study groups depending&#xD;
      on their history of parvovirus B19 infection. Each will have blood drawn and/or&#xD;
      nasopharyngeal wash which will provide the biological material for evaluation by assay.&#xD;
&#xD;
        -  Group A participants will have a documented prior history of parvovirus B19 infection&#xD;
           (aplastic crisis).&#xD;
&#xD;
        -  Group B participants will have no documented history of parvovirus B19 infection&#xD;
           (aplastic crisis) and will serve as the negative controls for the investigation of the&#xD;
           relationship between the VP1u ELISA and the gold standard neutralization assay for&#xD;
           parvovirus B19 infection.&#xD;
&#xD;
        -  Group C participants will have suspected and/or confirmed acute parvovirus B19 infection&#xD;
           (febrile illness with anemia without adequate compensatory reticulocytosis).&#xD;
&#xD;
      PRIMARY OBJECTIVES&#xD;
&#xD;
        -  To estimate the correlation between the VP1u enzyme-linked immunosorbent assay (ELISA)&#xD;
           and the gold standard neutralization assay for parvovirus B19 infection in subjects with&#xD;
           SCD who have had a documented infection from parvovirus B19 causing aplastic crisis.&#xD;
&#xD;
        -  To identify a cut-off for negativity in the VP1u ELISA and in the neutralization assay&#xD;
           in subjects with SCD.&#xD;
&#xD;
      SECONDARY OBJECTIVES&#xD;
&#xD;
        -  To characterize the performance characteristics of the VP1u ELISA, including sensitivity&#xD;
           and specificity.&#xD;
&#xD;
        -  To describe the kinetics of antibody responses generated following an acute parvovirus&#xD;
           B19 infection in the serum and in the nasal mucosa of patients with SCD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">March 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>Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean assay value using new VP1u ELISA and neutralization assays between Group B and Group A participants</measure>
    <time_frame>Baseline</time_frame>
    <description>To identify the cut-off for negativity for this patient population in the VP1u ELISA and in the neutralization assays, an ROC analysis will be conducted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the sensitivity and specificity of the VP1u ELISA with the neutralization assay</measure>
    <time_frame>Baseline</time_frame>
    <description>Sensitivity and specificity of VP1u ELISA will be assessed by using the neutralization assay as the gold standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody response following acute parvovirus B19 infection</measure>
    <time_frame>Baseline, and Days 7, 30 and 120</time_frame>
    <description>Descriptive statistics, such as mean, standard deviation, median and range, will be developed and plotted.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Group A: Documented Prior History</arm_group_label>
    <description>Pediatric and adult participants with sickle cell disease (SCD) with a documented prior history of parvovirus B19 infection (aplastic crisis).&#xD;
Group A participants will have blood draw and nasopharyngeal wash on day 1 only. Nasopharyngeal wash will be optional for Group A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: No Prior History</arm_group_label>
    <description>Pediatric and adult participants with SCD who have never had a documented parvovirus B19 infection (aplastic crisis).&#xD;
Group B participants will have blood draw and nasopharyngeal wash on day 1 only. Nasopharyngeal wash will be optional for Group B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C: Suspected and/or Confirmed</arm_group_label>
    <description>Sickle cell disease patients with suspected and/or confirmed acute parvovirus B19 infection, the latter defined as febrile illness with anemia without adequate compensatory reticulocytosis.&#xD;
Group C participants will have blood draw and nasopharyngeal wash on day 1, day 7±4 days, day 30±7 days, and day 120±14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>When possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care.</description>
    <arm_group_label>Group A: Documented Prior History</arm_group_label>
    <arm_group_label>Group B: No Prior History</arm_group_label>
    <arm_group_label>Group C: Suspected and/or Confirmed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nasopharyngeal wash</intervention_name>
    <description>Nasopharyngeal washes are optional for Group A and Group B participants. Nasopharyngeal washes will be performed on all subjects in Group C. The technique used will be the same as used for regular standard of care per St. Jude guidelines.</description>
    <arm_group_label>Group A: Documented Prior History</arm_group_label>
    <arm_group_label>Group B: No Prior History</arm_group_label>
    <arm_group_label>Group C: Suspected and/or Confirmed</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and/or nasopharyngeal wash samples will be taken and retained. If participants agree,&#xD;
      leftover samples will be saved for potential health research in the future.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sickle cell disease patients being seen at St. Jude Children's Research Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria - Individuals not experiencing an acute illness (Group A):&#xD;
&#xD;
          -  Males and females with a diagnosis of SCD of any genotype&#xD;
&#xD;
          -  Ages &gt; 1 year.&#xD;
&#xD;
          -  Medical records available for verification of prior parvovirus B19 infection status.&#xD;
&#xD;
        Exclusion Criteria - Individuals not experiencing an acute illness (Group A):&#xD;
&#xD;
          -  Patients on chronic transfusion therapy.&#xD;
&#xD;
          -  Patients experiencing an acute febrile illness.&#xD;
&#xD;
          -  Any medical or social reason, which in the opinion of the principal investigators&#xD;
             (PIs) would make the participation of the subject ill-advised.&#xD;
&#xD;
        Inclusion Criteria - Individuals with confirmed (Group B) or suspected (Group C) acute&#xD;
        parvovirus B19 infection:&#xD;
&#xD;
          -  Males and females with a diagnosis of SCD of any genotype.&#xD;
&#xD;
          -  Ages &gt; 1 year.&#xD;
&#xD;
          -  Symptoms of acute parvovirus infection (defined as worsened anemia with insufficient&#xD;
             compensatory reticulocytosis in the setting of a febrile illness).&#xD;
&#xD;
        Exclusion Criteria - Individuals with confirmed (Group B) or suspected (Group C) acute&#xD;
        parvovirus B19 infection:&#xD;
&#xD;
          -  Patients on chronic transfusion therapy.&#xD;
&#xD;
          -  Current epistaxis&#xD;
&#xD;
          -  Any medical or social reason, which in the opinion of the principal investigators&#xD;
             (PIs) would make the participation of the subject ill-advised.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Hankins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 16, 2016</last_update_submitted>
  <last_update_submitted_qc>September 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parvovirus B19 Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Parvoviridae Infections</mesh_term>
    <mesh_term>Erythema Infectiosum</mesh_term>
    <mesh_term>Anemia, Sickle Cell</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/NCT02261480
org study id: iSCREEN
nct id: NCT02261480
lead sponsor: 
collaborator: 
has dmc: No
Parvovirus B19 is a small virus that is the cause of "fifth" disease, a common infection in
      childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the bone
      marrow to stop producing red blood cells temporarily, which can be life-threatening. A novel
      vaccine is currently in development for children with SCD. This study is the first step
      within a larger parvovirus B19 multi-institutional project that will help develop this new
      vaccine, as it will define the value and utility of using a novel assay for measurement of
      parvovirus-specific antibodies. The main objective is to investigate the relationship between
      the newly developed VP1u ELISA assay and the gold standard neutralization assay for
      parvovirus B19 infection.

      The most accurate test, called a neutralizing antibody assay, to see if a person has had or
      currently has the infection is very complex and expensive and would be very difficult to use
      in a large research study to test the new vaccine. A new and simpler test has developed. The
      main goal of this study, iSCREEN, is to find out if this new test works.

      There will be distinct labs performing the VP1u ELISA and the neutralization assays and the
      respective laboratories will not have access to each other's results for individual subjects.
      The VP1u ELISA will be performed at St. Jude Children's Research Hospital. Neutralization
      assays will be conducted at the National Heart, Lung and Blood Institute.
Participants with sickle cell disease (SCD) will be divided into three study groups depending
      on their history of parvovirus B19 infection. Each will have blood drawn and/or
      nasopharyngeal wash which will provide the biological material for evaluation by assay.

        -  Group A participants will have a documented prior history of parvovirus B19 infection
           (aplastic crisis).

        -  Group B participants will have no documented history of parvovirus B19 infection
           (aplastic crisis) and will serve as the negative controls for the investigation of the
           relationship between the VP1u ELISA and the gold standard neutralization assay for
           parvovirus B19 infection.

        -  Group C participants will have suspected and/or confirmed acute parvovirus B19 infection
           (febrile illness with anemia without adequate compensatory reticulocytosis).

      PRIMARY OBJECTIVES

        -  To estimate the correlation between the VP1u enzyme-linked immunosorbent assay (ELISA)
           and the gold standard neutralization assay for parvovirus B19 infection in subjects with
           SCD who have had a documented infection from parvovirus B19 causing aplastic crisis.

        -  To identify a cut-off for negativity in the VP1u ELISA and in the neutralization assay
           in subjects with SCD.

      SECONDARY OBJECTIVES

        -  To characterize the performance characteristics of the VP1u ELISA, including sensitivity
           and specificity.

        -  To describe the kinetics of antibody responses generated following an acute parvovirus
           B19 infection in the serum and in the nasal mucosa of patients with SCD.
observational model: Case-Control
time perspective: Prospective
measure: Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection
time frame: Baseline
measure: Mean assay value using new VP1u ELISA and neutralization assays between Group B and Group A participants
time frame: Baseline
description: To identify the cut-off for negativity for this patient population in the VP1u ELISA and in the neutralization assays, an ROC analysis will be conducted.
measure: Compare the sensitivity and specificity of the VP1u ELISA with the neutralization assay
time frame: Baseline
description: Sensitivity and specificity of VP1u ELISA will be assessed by using the neutralization assay as the gold standard.
measure: Antibody response following acute parvovirus B19 infection
time frame: Baseline, and Days 7, 30 and 120
description: Descriptive statistics, such as mean, standard deviation, median and range, will be developed and plotted.
arm group label: Group A: Documented Prior History
description: Pediatric and adult participants with sickle cell disease (SCD) with a documented prior history of parvovirus B19 infection (aplastic crisis).
Group A participants will have blood draw and nasopharyngeal wash on day 1 only. Nasopharyngeal wash will be optional for Group A.
arm group label: Group B: No Prior History
description: Pediatric and adult participants with SCD who have never had a documented parvovirus B19 infection (aplastic crisis).
Group B participants will have blood draw and nasopharyngeal wash on day 1 only. Nasopharyngeal wash will be optional for Group B.
arm group label: Group C: Suspected and/or Confirmed
description: Sickle cell disease patients with suspected and/or confirmed acute parvovirus B19 infection, the latter defined as febrile illness with anemia without adequate compensatory reticulocytosis.
Group C participants will have blood draw and nasopharyngeal wash on day 1, day 7±4 days, day 30±7 days, and day 120±14 days.
intervention type: Other
intervention name: Blood draw
description: When possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care.
arm group label: Group A: Documented Prior History
arm group label: Group B: No Prior History
arm group label: Group C: Suspected and/or Confirmed
intervention type: Other
intervention name: Nasopharyngeal wash
description: Nasopharyngeal washes are optional for Group A and Group B participants. Nasopharyngeal washes will be performed on all subjects in Group C. The technique used will be the same as used for regular standard of care per St. Jude guidelines.
arm group label: Group A: Documented Prior History
arm group label: Group B: No Prior History
arm group label: Group C: Suspected and/or Confirmed
Blood and/or nasopharyngeal wash samples will be taken and retained. If participants agree,
      leftover samples will be saved for potential health research in the future.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Jane Hankins, MD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor
mesh term: Infections
mesh term: Parvoviridae Infections
mesh term: Erythema Infectiosum
mesh term: Anemia, Sickle Cell