xml: <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/NCT05992480</url>
    </required_header>
    <id_info>
      <org_study_id>2023-970</org_study_id>
      <nct_id>NCT05992480</nct_id>
    </id_info>
    <brief_title>REVIVE (Response to the Ebola Virus Vaccine)</brief_title>
    <official_title>An Open-Label, Case-Control Study to Compare the Anamnestic Response to the Recombinant Vesicular Stomatitis Delta Glycoprotein Zaire Ebola Virus (ZEBOV) Glycoprotein (rVSVDG-ZEBOV-GP) Ebola Virus Vaccine Among Ebola Virus Disease Survivors to the Primary Immune Response Among Naïve Age and Sex-Matched Controls</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tulane University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kenema Government Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Merck Sharp &amp; Dohme LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Tulane University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a vaccine-related clinical trial which will be conducted by our study team at&#xD;
        Kenema Government Hospital (KGH)'s Viral Hemorrhagic Fever Program in collaboration with&#xD;
        Tulane University School of Medicine. This study is funded by Merck &amp; Co., the developers of&#xD;
        ERVEBO®. This investigational medicinal product (IMP) was successful in Sierra Leone through&#xD;
        the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) working with the College&#xD;
        of Medical and Allied Health Services (COMAHS) at the University of Sierra Leone. ERVEBO® was&#xD;
        also successfully tested in Liberia and the Republic of Guinea. These successful trials led&#xD;
        to the United States Food and Drug Administration (USFDA) approval of ERVEBO®, as well as&#xD;
        approval for therapeutic use in the Democratic Republic of the Congo, Burundi, Ghana, and&#xD;
        Zambia.&#xD;
  &#xD;
        This particular vaccination study will focus on the anamnestic response to the ERVEBO®&#xD;
        vaccine, (full name - rVSVDG-ZEBOV-GP Ebola Virus Vaccine). The original clinical trials&#xD;
        conducted excluded Ebola Virus Disease (EVD) survivors from participating. However, with&#xD;
        ongoing research, there is evidence of waning immune response and even recurrent infections&#xD;
        in EVD survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ebola virus (EBOV; also known as Zaire ebolavirus, family Filoviridae) is among the most&#xD;
        virulent infectious agents known, producing sporadic outbreaks of severe and highly lethal&#xD;
        hemorrhagic fever in humans and nonhuman primates (NHPs). The West African Ebola Virus&#xD;
        Disease (EVD) Outbreak of 2013 to 2016, which predominantly affected Sierra Leone, Liberia,&#xD;
        and Guinea, resulted in 28,601 confirmed cases and 11,308 fatalities.&#xD;
  &#xD;
        Multiple reports in the literature of recurrent infections among EVD survivors now exist.&#xD;
        Some of these recurrent infections have also resulted in transmission to close contacts of&#xD;
        these survivors. In December 2019, the U.S. Food and Drug Administration approved the&#xD;
        recombinant Vasicular Stomatitis Virus delta-G (rVSVDG) Zaire Ebolavirus (ZEBOV) Glycoprotein&#xD;
        (GP) (rVSVDG-ZEBOV-GP) Ebola vaccine (ERVEBO®; Merck) for use in people 18 years and older.&#xD;
        The current literature and data on EBOV antibody levels in survivors suggest that while the&#xD;
        humoral immune response to EBOV after natural infections wanes over weeks to months, the&#xD;
        response to a single dose of rVSVDG-ZEBOV-GP vaccine is stable over at least two years.&#xD;
  &#xD;
        In this pilot study, the investigators hypothesize that vaccination of EVD survivors with&#xD;
        rVSVDG-ZEBOV-GP will result in a non-inferior immune response compared to vaccination of&#xD;
        non-exposed age- and sex-matched individuals. This study will be an open-label, case-control&#xD;
        study of the safety and immunogenicity of the rVSVDG-ZEBOV-GP vaccine comparing EVD survivors&#xD;
        and EBOV-naïve community members in Sierra Leone. A total of 40 participants will be&#xD;
        recruited and divided 1:1 into EVD survivors (cases) and EBOV-naïve age- and sex-matched&#xD;
        community members (controls). Following a two week screening period, participants will be&#xD;
        followed for six months post-vaccination.&#xD;
  &#xD;
        Subject Population&#xD;
  &#xD;
        Twenty EVD survivors and twenty age and sex-matched controls with no clinical history or&#xD;
        immunologic evidence of prior EBOV infection will be enrolled. All participants will be&#xD;
        citizens of Sierra Leone. In accordance with the currently approved use of the&#xD;
        rVSVDG-ZEBOV-GP vaccine in Sierra Leone, all participants will be 18 years or older and&#xD;
        pregnant and lactating females will be excluded.&#xD;
  &#xD;
        While there is currently an effort to vaccinate all healthcare workers in Sierra Leone, EVD&#xD;
        survivors are excluded in the current vaccine roll-out. The investigators plan to recruit EVD&#xD;
        survivors including healthcare workers thus enhancing access to the vaccine for this&#xD;
        population. All participants will be of African descent. The investigators plan to enroll an&#xD;
        equal number of males and females.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 15, 2024</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>1:1 survivor to control</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assess the immunogenicity and durability of rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination</measure>
      <time_frame>6 months</time_frame>
      <description>Serum samples will be tested for the presence of anti-EBOV GP immunoglobulin G (IgG) and anti-EBOV Viral Protein 40 (VP40) IgG using ELISA plates produced by Zalgen Labs, LLC and run according to the manufacturer's instructions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assess the incidence of adverse events after vaccination with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls</measure>
      <time_frame>6 months</time_frame>
      <description>The investigators will assess the following adverse events at all post-vaccination follow-up time points: arthralgia, diarrhea, fatigue, fever, headache, induration, injection site pain, muscle pain, myalgia, and vomiting. Follow up visits will occur on days 1, 3, 7, 14, 28, 90 and 180 post vaccination.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess the durability of neutralizing antibody titers after immunization with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination</measure>
      <time_frame>6 months</time_frame>
      <description>The investigators will use Pseudovirus Neutralization Assay that has been adapted from a previously described Lassa pseudovirus to produce Ebola pseudoviruses (EBOVpp). EBOVpp are capable of a single round of replication, when used to infect a human embryonic kidney cell line which is capable of fluorescence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine Fc-mediated innate effector function profiles in EVD survivors compared to both naïve vaccinees and EVD survivors vaccinated with rVSVDG-ZEBOV-GP.</measure>
      <time_frame>6 months</time_frame>
      <description>The investigators will use a bead-based multiplexed platform to measure Fc-mediated effector functional profiles and virus specific antibodies using an established EBOV systems serology platform including: (A) monocyte/macrophage phagocytosis and activation, (B) neutrophil phagocytosis and maturation, (C) Natural Killer (NK) cell activation, and (D) complement deposition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess the phenotype, function, and durability of EBOV specific T-cell responses in natural immunity (EVD survivors) and response to vaccination with rVSVDG-ZEBOV-GP in EVD survivors and naïve vaccinees</measure>
      <time_frame>6 months</time_frame>
      <description>EBOV specific T-cells will be characterized by: (A) EBOV protein stimulation and intracellular cytokine staining, (B) magnetic bead-based assays to assess function in supernatants from stimulated cells, and (C) Two-color Interferon-Gamma and Tumor Necrosis Factor-Alpha (TNFa) Enzyme Linked Immunosorbent Spot (ELISPOT).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Ebola Virus Disease</condition>
    <arm_group>
      <arm_group_label>Ebola Virus Disease (EVD) survivors</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with a history of admission and discharge from an Ebola Treatment Unit as registered by the Sierra Leone Association of Ebola Survivors (SLAES), and Anti-EBOV GP IgG positive by ELISA at the time of screening.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Community control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Age- and sex-matched controls who are Anti-EBOV GP IgG negative by ELISA at the time of screening.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>rVSVDG-ZEBOV-GP Ebola Virus Vaccine (ERVEBO)</intervention_name>
      <description>It is an Ebola virus vaccine</description>
      <arm_group_label>Community control</arm_group_label>
      <arm_group_label>Ebola Virus Disease (EVD) survivors</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  EVD survivors&#xD;
  &#xD;
                 -  History of admission and discharge from an Ebola Treatment Unit as registered by&#xD;
                    the Sierra Leone Association of Ebola Survivors (SLAES).&#xD;
  &#xD;
                 -  Anti-EBOV GP IgG positive by ELISA at the time of screening.&#xD;
  &#xD;
                 -  ≥18 years of age.&#xD;
  &#xD;
                 -  &gt;45.5 kg (100lbs).&#xD;
  &#xD;
                 -  Willingness to provide informed, written consent.&#xD;
  &#xD;
                 -  Willingness to undergo all study procedures including rVSVDG-ZEBOV-GP vaccination&#xD;
                    and multiple blood collections over a period of six months.&#xD;
  &#xD;
            -  Age- and sex-matched controls&#xD;
  &#xD;
                 -  Anti-EBOV GP IgG negative by ELISA at the time of screening.&#xD;
  &#xD;
                 -  ≥18 years of age.&#xD;
  &#xD;
                 -  Willingness to provide informed consent.&#xD;
  &#xD;
                 -  Willingness to undergo all study procedures including rVSVDG-ZEBOV-GP vaccination&#xD;
                    and multiple blood collections over a period of six months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have received the rVSVDG-ZEBOV-GP vaccine.&#xD;
  &#xD;
            -  Currently participating in another clinical trial involving a vaccine.&#xD;
  &#xD;
            -  Received a live vaccine within four weeks of screening.&#xD;
  &#xD;
            -  &lt;18 years of age.&#xD;
  &#xD;
            -  Weight &lt;45.5kg (or 100 lbs).&#xD;
  &#xD;
            -  Refusal to provide informed, written consent.&#xD;
  &#xD;
            -  Prisoners of other institutionalized individuals.&#xD;
  &#xD;
            -  Research study staff and their immediate family members.&#xD;
  &#xD;
            -  Inability to participate in research activities.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Known immunocompromised status.&#xD;
  &#xD;
            -  Known allergy to vaccine components.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John Schieffelin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tulane University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>John Schieffelin, MD</last_name>
      <phone>504-988-5117</phone>
      <email>jschieff@tulane.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nell Bond, PhD</last_name>
      <phone>504-988-3818</phone>
      <email>nbond@tulane.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kenema Government Hospital</name>
        <address>
          <city>Kenema</city>
          <state>Eastern</state>
          <country>Sierra Leone</country>
        </address>
      </facility>
      <contact>
        <last_name>Robert Samuels, MBChB</last_name>
        <phone>(232) 78 291 893</phone>
        <email>robjsam190@yahoo.co.uk</email>
      </contact>
      <contact_backup>
        <last_name>Alhaji Turay, BPharm</last_name>
        <phone>(+232) 78 30 19 62</phone>
        <email>turayalhaji84@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Robert Samuels, MDMBChB</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Sierra Leone</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vaccine</keyword>
    <keyword>Ebola</keyword>
    <keyword>Sierra Leone</keyword>
    <keyword>Ebola survivor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Virus Diseases</mesh_term>
      <mesh_term>Hemorrhagic Fever, Ebola</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Principal Investigator or their designee will be the data manager with responsibility for delegating the receiving, entering, cleaning, querying, analyzing, and storing all data accrued from the study. All data will be entered in paper case record forms and transcribed by double entry into an electronic database. This includes safety data, laboratory data (both clinical and immunological) and outcome data.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>From preliminary interim analysis until the final report of the study, the site owns the data and it is agreed that publication will occur in a timely manner.</ipd_time_frame>
      <ipd_access_criteria>All files and source documents will be kept confidentially in locked, fireproof safety cabinets with limited access. The Principal Investigator, co-investigators, and clinical research staff will have access to records. The investigators will permit authorized representatives of the sponsor, regulatory agencies, and monitors to examine (and when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety and progress.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992480
  org study id: 2023-970
  nct id: NCT05992480
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This study is a vaccine-related clinical trial which will be conducted by our study team at
        Kenema Government Hospital (KGH)'s Viral Hemorrhagic Fever Program in collaboration with
        Tulane University School of Medicine. This study is funded by Merck & Co., the developers of
        ERVEBO®. This investigational medicinal product (IMP) was successful in Sierra Leone through
        the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) working with the College
        of Medical and Allied Health Services (COMAHS) at the University of Sierra Leone. ERVEBO® was
        also successfully tested in Liberia and the Republic of Guinea. These successful trials led
        to the United States Food and Drug Administration (USFDA) approval of ERVEBO®, as well as
        approval for therapeutic use in the Democratic Republic of the Congo, Burundi, Ghana, and
        Zambia.
  
        This particular vaccination study will focus on the anamnestic response to the ERVEBO®
        vaccine, (full name - rVSVDG-ZEBOV-GP Ebola Virus Vaccine). The original clinical trials
        conducted excluded Ebola Virus Disease (EVD) survivors from participating. However, with
        ongoing research, there is evidence of waning immune response and even recurrent infections
        in EVD survivors.
  Ebola virus (EBOV; also known as Zaire ebolavirus, family Filoviridae) is among the most
        virulent infectious agents known, producing sporadic outbreaks of severe and highly lethal
        hemorrhagic fever in humans and nonhuman primates (NHPs). The West African Ebola Virus
        Disease (EVD) Outbreak of 2013 to 2016, which predominantly affected Sierra Leone, Liberia,
        and Guinea, resulted in 28,601 confirmed cases and 11,308 fatalities.
  
        Multiple reports in the literature of recurrent infections among EVD survivors now exist.
        Some of these recurrent infections have also resulted in transmission to close contacts of
        these survivors. In December 2019, the U.S. Food and Drug Administration approved the
        recombinant Vasicular Stomatitis Virus delta-G (rVSVDG) Zaire Ebolavirus (ZEBOV) Glycoprotein
        (GP) (rVSVDG-ZEBOV-GP) Ebola vaccine (ERVEBO®; Merck) for use in people 18 years and older.
        The current literature and data on EBOV antibody levels in survivors suggest that while the
        humoral immune response to EBOV after natural infections wanes over weeks to months, the
        response to a single dose of rVSVDG-ZEBOV-GP vaccine is stable over at least two years.
  
        In this pilot study, the investigators hypothesize that vaccination of EVD survivors with
        rVSVDG-ZEBOV-GP will result in a non-inferior immune response compared to vaccination of
        non-exposed age- and sex-matched individuals. This study will be an open-label, case-control
        study of the safety and immunogenicity of the rVSVDG-ZEBOV-GP vaccine comparing EVD survivors
        and EBOV-naïve community members in Sierra Leone. A total of 40 participants will be
        recruited and divided 1:1 into EVD survivors (cases) and EBOV-naïve age- and sex-matched
        community members (controls). Following a two week screening period, participants will be
        followed for six months post-vaccination.
  
        Subject Population
  
        Twenty EVD survivors and twenty age and sex-matched controls with no clinical history or
        immunologic evidence of prior EBOV infection will be enrolled. All participants will be
        citizens of Sierra Leone. In accordance with the currently approved use of the
        rVSVDG-ZEBOV-GP vaccine in Sierra Leone, all participants will be 18 years or older and
        pregnant and lactating females will be excluded.
  
        While there is currently an effort to vaccinate all healthcare workers in Sierra Leone, EVD
        survivors are excluded in the current vaccine roll-out. The investigators plan to recruit EVD
        survivors including healthcare workers thus enhancing access to the vaccine for this
        population. All participants will be of African descent. The investigators plan to enroll an
        equal number of males and females.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 survivor to control
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Assess the immunogenicity and durability of rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination
  time frame: 6 months
  description: Serum samples will be tested for the presence of anti-EBOV GP immunoglobulin G (IgG) and anti-EBOV Viral Protein 40 (VP40) IgG using ELISA plates produced by Zalgen Labs, LLC and run according to the manufacturer's instructions.
  measure: Assess the incidence of adverse events after vaccination with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls
  time frame: 6 months
  description: The investigators will assess the following adverse events at all post-vaccination follow-up time points: arthralgia, diarrhea, fatigue, fever, headache, induration, injection site pain, muscle pain, myalgia, and vomiting. Follow up visits will occur on days 1, 3, 7, 14, 28, 90 and 180 post vaccination.
  measure: Assess the durability of neutralizing antibody titers after immunization with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination
  time frame: 6 months
  description: The investigators will use Pseudovirus Neutralization Assay that has been adapted from a previously described Lassa pseudovirus to produce Ebola pseudoviruses (EBOVpp). EBOVpp are capable of a single round of replication, when used to infect a human embryonic kidney cell line which is capable of fluorescence.
  measure: Determine Fc-mediated innate effector function profiles in EVD survivors compared to both naïve vaccinees and EVD survivors vaccinated with rVSVDG-ZEBOV-GP.
  time frame: 6 months
  description: The investigators will use a bead-based multiplexed platform to measure Fc-mediated effector functional profiles and virus specific antibodies using an established EBOV systems serology platform including: (A) monocyte/macrophage phagocytosis and activation, (B) neutrophil phagocytosis and maturation, (C) Natural Killer (NK) cell activation, and (D) complement deposition.
  measure: Assess the phenotype, function, and durability of EBOV specific T-cell responses in natural immunity (EVD survivors) and response to vaccination with rVSVDG-ZEBOV-GP in EVD survivors and naïve vaccinees
  time frame: 6 months
  description: EBOV specific T-cells will be characterized by: (A) EBOV protein stimulation and intracellular cytokine staining, (B) magnetic bead-based assays to assess function in supernatants from stimulated cells, and (C) Two-color Interferon-Gamma and Tumor Necrosis Factor-Alpha (TNFa) Enzyme Linked Immunosorbent Spot (ELISPOT).
  arm group label: Ebola Virus Disease (EVD) survivors
  arm group type: Experimental
  description: Participants with a history of admission and discharge from an Ebola Treatment Unit as registered by the Sierra Leone Association of Ebola Survivors (SLAES), and Anti-EBOV GP IgG positive by ELISA at the time of screening.
  arm group label: Community control
  arm group type: Active Comparator
  description: Age- and sex-matched controls who are Anti-EBOV GP IgG negative by ELISA at the time of screening.
  intervention type: Biological
  intervention name: rVSVDG-ZEBOV-GP Ebola Virus Vaccine (ERVEBO)
  description: It is an Ebola virus vaccine
  arm group label: Community control
  arm group label: Ebola Virus Disease (EVD) survivors
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: John Schieffelin, MD
  role: Principal Investigator
  affiliation: Tulane University
  last name: John Schieffelin, MD
  phone: 504-988-5117
  email: jschieff@tulane.edu
  last name: Nell Bond, PhD
  phone: 504-988-3818
  email: nbond@tulane.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Sierra Leone
  responsible party type: Sponsor
  mesh term: Virus Diseases
  mesh term: Hemorrhagic Fever, Ebola
  sharing ipd: Yes
  ipd description: The Principal Investigator or their designee will be the data manager with responsibility for delegating the receiving, entering, cleaning, querying, analyzing, and storing all data accrued from the study. All data will be entered in paper case record forms and transcribed by double entry into an electronic database. This includes safety data, laboratory data (both clinical and immunological) and outcome data.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: From preliminary interim analysis until the final report of the study, the site owns the data and it is agreed that publication will occur in a timely manner.
  ipd access criteria: All files and source documents will be kept confidentially in locked, fireproof safety cabinets with limited access. The Principal Investigator, co-investigators, and clinical research staff will have access to records. The investigators will permit authorized representatives of the sponsor, regulatory agencies, and monitors to examine (and when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety and progress.