<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/NCT03031912</url>
  </required_header>
  <id_info>
    <org_study_id>CT1401-B</org_study_id>
    <nct_id>NCT03031912</nct_id>
  </id_info>
  <brief_title>African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola</brief_title>
  <official_title>A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cecile Tremblay</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Development Research Centre, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Coalition for Epidemic Preparedness Innovations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Immunization Research Network</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized, placebo-controlled, multi-site, double-blind trial of V920&#xD;
      (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be&#xD;
      conducted in conformance with Good Clinical Practices. The study will take place at 2&#xD;
      Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital)&#xD;
      and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le&#xD;
      Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including&#xD;
      screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will enroll approximately 250 participants, ~100 at 2 sites in Canada and ~100 at 2&#xD;
      sites in Africa. Overall ~200 participants will receive the study vaccine and 50 will receive&#xD;
      a placebo . Sequential enrollment of five study cohorts will occur over time at each study&#xD;
      site according to CD4 T-cell counts: Group 1 will include adult subjects with CD4 ≥ 500&#xD;
      cells/mm3, Group 2 CD4 &gt; 350 and &lt; 500 cells/mm3, Group 3 CD4 ≥ 200 and ≤ 350 cells/mm3,&#xD;
      Group 4 adolescents CD4 ≥ 200 cells/mm3, and Group 5 adults and adolescents CD4 ≥ 200&#xD;
      cells/mm3. Enrolment and vaccine administration will begin with the group with the highest&#xD;
      CD4 count. When the D42 post-vaccination period is completed for all subjects in Group 1, and&#xD;
      the Data Safety Monitoring Board (DSMB) has reviewed the safety data and determined that&#xD;
      there are no concerns, enrolment and vaccination of the next CD4 cohort may begin. Similarly,&#xD;
      when the D42 safety data for Group 2 has been reviewed/approved by the DSMB, enrolment and&#xD;
      vaccination of participants in Group 3 may begin. Adolescents 13-17 years of age (inclusive)&#xD;
      with CD4 ≥ 200 will be enrolled after D42 safety is reviewed in adults with CD4 ≥ 200.&#xD;
      Adolescents 13-17 years of age (inclusive) and adults with CD4 ≥ 200 will be enrolled after&#xD;
      D42 safety is reviewed in adolescents with CD4 ≥ 200.Within each group, participants will be&#xD;
      randomly assigned to receive one dose of ≥2 x 107 pfu of the study vaccine or the placebo in&#xD;
      a ratio of 4 to 1 (160:40). Participants will complete memory aids for 42 days following&#xD;
      vaccination.&#xD;
&#xD;
      Specific procedures to be performed during the trial, as well as their prescribed times and&#xD;
      associated visit windows, are outlined in the Trial Flow Chart - Section 6.0. Details of each&#xD;
      procedure are provided in Section 7.0 - Trial Procedures.&#xD;
&#xD;
      This trial will use an adaptive design based on pre-specified criteria, using an independent,&#xD;
      external DSMB to monitor safety and immunogenicity. There will be 3 formal safety analyses&#xD;
      performed by the DSMB. Data for at least 75% of participants must be available for each&#xD;
      analysis. The first safety analysis will be conducted when the first group (CD4 ≥ 500&#xD;
      cells/mm3) will have completed 42 days of follow-up post vaccination. The second safety&#xD;
      analysis will be conducted when the second group (CD4 &gt; 350 and &lt; 500 cells/mm3) will have&#xD;
      completed 42 days of follow-up post vaccination. The third safety analysis will be conducted&#xD;
      when the third group (Adults CD4 ≥ 200 and ≤ 350 cells/mm3) will have completed 42 days of&#xD;
      follow-up post vaccination. The fourth safety analysis will be conducted when the fourth&#xD;
      group (Adolescents CD4 ≥ 200) will have completed 42 days of follow-up post vaccination.&#xD;
&#xD;
      Results of the safety analysis will be reviewed by the DSMB, which will make recommendations&#xD;
      to the Sponsor to continue, modify or end the trial according to the plan described briefly&#xD;
      in Section 2.2 - Trial Diagram and in detail in Section 8.0 - Statistical Analysis Plan. In&#xD;
      case of an outbreak of Ebola Zaire the DSMB may recommend to vaccinate subjects randomized to&#xD;
      receive placebo with V920 provided at least 84 days of SAE follow-up is conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure number of adverse events following V920 vaccination in HIV-infected adults and adolescents</measure>
    <time_frame>The number of vaccine related SAE's from signing the consent form to day 365 will be recorded and summarized.</time_frame>
    <description>The number of general solicited local (at the injection site) and systemic adverse events during a 14-day follow-up period following vaccination will be summarized. Each participant will record if they had any symptoms and the severity (mild, moderate, or severe).&#xD;
The following local AES will be solicited:&#xD;
i. Pain at injection site ii. Redness at injection site iii. Swelling at injection site&#xD;
The number of AEs of fever, arthritis, arthralgia, rash and blisters/vesicular lesions during a 42-day follow -up period following vaccination will be collected and summarized. Each participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe)&#xD;
This data will be collected on participants memory aids and then entered into an electronic case report form for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 at D28</measure>
    <time_frame>ZEBOV-specific antibody responses measured by ELISA and neutralization on Day 28</time_frame>
    <description>Measure the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 at D28 in HIV-infected adults and adolescents.&#xD;
The V920 vaccine candidate is a live recombinant vesicular stomatitis virus (VSV) expressing the glycoprotein (GP) of Zaire Ebola virus (ZEBOV). Two independent assays are currently being utilized in the clinical development program to clinically evaluate the immunogenicity of V920:&#xD;
GP-ELISA measures the total IgG antibody response and can also be correlated to the plaque reduction neutralization assay (PRNT) titer result.&#xD;
Plaque reduction neutralization assay (PRNT) is a functional assay and a gold standard platform in the field for quantitating the neutralizing antibody response elicited by the vaccine.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Ebola</condition>
  <arm_group>
    <arm_group_label>Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: 50 HIV-infected adults CD4 &gt; 350 and &lt; 500 cells/mm^3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of theV920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive two dosse of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine</intervention_name>
    <description>The rVSVΔG-ZEBOV-GP vaccine is a live attenuated recombinant virus consisting of a single recombinant VSV isolate (11481 nt, strain Indiana) with the gene for the Zaire ebolavirus GP (ZEBOV GP), Kikwit strain replacing the gene for the VSV GP, which has been deleted. This results in a VSV backbone with the ZEBOV GP constituting the envelope of the virus.</description>
    <arm_group_label>Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3</arm_group_label>
    <arm_group_label>Group 2: 50 HIV-infected adults CD4 &gt; 350 and &lt; 500 cells/mm^3</arm_group_label>
    <arm_group_label>Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3</arm_group_label>
    <arm_group_label>Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3</arm_group_label>
    <arm_group_label>Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Normal saline (0.9%) has been chosen as an inert substance to serve as placebo control.</description>
    <arm_group_label>Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3</arm_group_label>
    <arm_group_label>Group 2: 50 HIV-infected adults CD4 &gt; 350 and &lt; 500 cells/mm^3</arm_group_label>
    <arm_group_label>Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3</arm_group_label>
    <arm_group_label>Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3</arm_group_label>
    <arm_group_label>Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages&#xD;
             13 to 65 (inclusive) at the time of screening;&#xD;
&#xD;
          -  On antiretroviral therapy with an undetectable viral load (&lt; 40 c/ml);&#xD;
&#xD;
          -  CD4 T cell counts ≥ 200 cells/mm3;&#xD;
&#xD;
          -  Written informed consent (subject or parent) and assent (adolescent), after reading&#xD;
             the consent form and having adequate opportunity to discuss the study with an&#xD;
             investigator or a qualified designee&#xD;
&#xD;
          -  Free of clinically significant health problems that could affect the safety of the&#xD;
             participant, as determined by the Investigator by pertinent medical history and&#xD;
             clinical examination prior to entry into the study;&#xD;
&#xD;
          -  Available, able, and willing to participate for all study visits and procedures;&#xD;
&#xD;
          -  Males and females who are willing to practice abstinence from sexual intercourse, or&#xD;
             are willing to use effective methods of contraception, from at least 30 days prior to&#xD;
             vaccination until 2 months after vaccination.&#xD;
&#xD;
               1. If the female partner is NOT of childbearing potential, the couple will only be&#xD;
                  required to use condoms, without other adjunctive contraception.&#xD;
&#xD;
               2. For this study, a woman is considered of childbearing potential unless&#xD;
                  postmenopausal (≥ 1 year without menses) or surgically sterilized (tubal&#xD;
                  ligation, bilateral oophorectomy, or hysterectomy)&#xD;
&#xD;
               3. Effective contraception is defined as a contraceptive method with failure rate of&#xD;
                  less than 1% per year when used consistently and correctly and when applicable,&#xD;
                  in accordance with the product label for example:&#xD;
&#xD;
             i. Male condoms PLUS: ii. Oral contraceptives, either combined or progestogen alone&#xD;
             iii. injectable progestogen iv. implants of etenogestrel or levonorgestrel v.&#xD;
             oestrogenic vaginal ring vi. percutaneous contraceptive patches vii. intrauterine&#xD;
             device or intrauterine system&#xD;
&#xD;
          -  Be willing to minimize blood and body fluid exposure of others for 6 weeks after&#xD;
             vaccination&#xD;
&#xD;
               1. Use of effective barrier prophylaxis, such as latex condoms, during penetrative&#xD;
                  sexual intercourse&#xD;
&#xD;
               2. Avoiding the sharing of needles, razors, or toothbrushes&#xD;
&#xD;
               3. Avoiding open-mouth kissing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior infection with a filovirus or prior participation in a filovirus&#xD;
             vaccine trial;&#xD;
&#xD;
          -  History of prior infection with VSV or receipt of a VSV-vectored vaccine;&#xD;
&#xD;
          -  Is a healthcare worker who has direct contact with patients&#xD;
&#xD;
          -  Presence of any febrile illness or any known or suspected acute illness on the day of&#xD;
             any first immunization (subject may be rescheduled);&#xD;
&#xD;
          -  Clinical manifestations of systemic diseases considered by the investigator to impact&#xD;
             safety or immunogenicity&#xD;
&#xD;
          -  Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent)&#xD;
             within one month, or any other cytotoxic or immunosuppressive drug within six months;&#xD;
&#xD;
          -  Receipt of any investigational drug within 12 months of vaccination;&#xD;
&#xD;
          -  Receipt of any live virus vaccine within 42 days prior to study entry or any other&#xD;
             (non-live virus) vaccine within 14 days prior to study entry.&#xD;
&#xD;
          -  History of sensitivity to any component of study vaccines per investigator brochure or&#xD;
             package insert;&#xD;
&#xD;
          -  Any baseline laboratory screening tests which is outside of acceptable range as&#xD;
             defined in the protocol: ALT, AST, creatinine, hemoglobin, platelet count, total white&#xD;
             blood cell count, urine protein, urine occult blood, urine glucose (Appendix 2). To&#xD;
             exclude transient abnormalities, the investigator may repeat a test up to twice, and&#xD;
             if the repeat test is normal, subject may be enrolled;&#xD;
&#xD;
          -  Have an active malignancy or history of metastatic or hematologic malignancy except&#xD;
             non-melanoma skin cancers;&#xD;
&#xD;
          -  Suspected or known alcohol and/or illicit drug abuse within the past 5 years;&#xD;
&#xD;
          -  Moderate or severe illness and/or fever &gt;101°F (38.3ºC) within one week prior to&#xD;
             vaccination;&#xD;
&#xD;
          -  Pregnant or breastfeeding female, or female who intends to become pregnant during the&#xD;
             study period;&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the 120 days&#xD;
             preceding study entry or planned administration during the study period;&#xD;
&#xD;
          -  Any other significant finding that in the opinion of the investigator would increase&#xD;
             the risk of the individual having an adverse outcome from participating in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecile Tremblay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUM</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Canadian Immunization Research Network</investigator_affiliation>
    <investigator_full_name>Cecile Tremblay</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhagic Fever, Ebola</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031912
org study id: CT1401-B
nct id: NCT03031912
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, placebo-controlled, multi-site, double-blind trial of V920
      (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be
      conducted in conformance with Good Clinical Practices. The study will take place at 2
      Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital)
      and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le
      Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including
      screening.
The study will enroll approximately 250 participants, ~100 at 2 sites in Canada and ~100 at 2
      sites in Africa. Overall ~200 participants will receive the study vaccine and 50 will receive
      a placebo . Sequential enrollment of five study cohorts will occur over time at each study
      site according to CD4 T-cell counts: Group 1 will include adult subjects with CD4 ≥ 500
      cells/mm3, Group 2 CD4 > 350 and < 500 cells/mm3, Group 3 CD4 ≥ 200 and ≤ 350 cells/mm3,
      Group 4 adolescents CD4 ≥ 200 cells/mm3, and Group 5 adults and adolescents CD4 ≥ 200
      cells/mm3. Enrolment and vaccine administration will begin with the group with the highest
      CD4 count. When the D42 post-vaccination period is completed for all subjects in Group 1, and
      the Data Safety Monitoring Board (DSMB) has reviewed the safety data and determined that
      there are no concerns, enrolment and vaccination of the next CD4 cohort may begin. Similarly,
      when the D42 safety data for Group 2 has been reviewed/approved by the DSMB, enrolment and
      vaccination of participants in Group 3 may begin. Adolescents 13-17 years of age (inclusive)
      with CD4 ≥ 200 will be enrolled after D42 safety is reviewed in adults with CD4 ≥ 200.
      Adolescents 13-17 years of age (inclusive) and adults with CD4 ≥ 200 will be enrolled after
      D42 safety is reviewed in adolescents with CD4 ≥ 200.Within each group, participants will be
      randomly assigned to receive one dose of ≥2 x 107 pfu of the study vaccine or the placebo in
      a ratio of 4 to 1 (160:40). Participants will complete memory aids for 42 days following
      vaccination.

      Specific procedures to be performed during the trial, as well as their prescribed times and
      associated visit windows, are outlined in the Trial Flow Chart - Section 6.0. Details of each
      procedure are provided in Section 7.0 - Trial Procedures.

      This trial will use an adaptive design based on pre-specified criteria, using an independent,
      external DSMB to monitor safety and immunogenicity. There will be 3 formal safety analyses
      performed by the DSMB. Data for at least 75% of participants must be available for each
      analysis. The first safety analysis will be conducted when the first group (CD4 ≥ 500
      cells/mm3) will have completed 42 days of follow-up post vaccination. The second safety
      analysis will be conducted when the second group (CD4 > 350 and < 500 cells/mm3) will have
      completed 42 days of follow-up post vaccination. The third safety analysis will be conducted
      when the third group (Adults CD4 ≥ 200 and ≤ 350 cells/mm3) will have completed 42 days of
      follow-up post vaccination. The fourth safety analysis will be conducted when the fourth
      group (Adolescents CD4 ≥ 200) will have completed 42 days of follow-up post vaccination.

      Results of the safety analysis will be reviewed by the DSMB, which will make recommendations
      to the Sponsor to continue, modify or end the trial according to the plan described briefly
      in Section 2.2 - Trial Diagram and in detail in Section 8.0 - Statistical Analysis Plan. In
      case of an outbreak of Ebola Zaire the DSMB may recommend to vaccinate subjects randomized to
      receive placebo with V920 provided at least 84 days of SAE follow-up is conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Measure number of adverse events following V920 vaccination in HIV-infected adults and adolescents
time frame: The number of vaccine related SAE's from signing the consent form to day 365 will be recorded and summarized.
description: The number of general solicited local (at the injection site) and systemic adverse events during a 14-day follow-up period following vaccination will be summarized. Each participant will record if they had any symptoms and the severity (mild, moderate, or severe).
The following local AES will be solicited:
i. Pain at injection site ii. Redness at injection site iii. Swelling at injection site
The number of AEs of fever, arthritis, arthralgia, rash and blisters/vesicular lesions during a 42-day follow -up period following vaccination will be collected and summarized. Each participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe)
This data will be collected on participants memory aids and then entered into an electronic case report form for analysis.
measure: Measure the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 at D28
time frame: ZEBOV-specific antibody responses measured by ELISA and neutralization on Day 28
description: Measure the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 at D28 in HIV-infected adults and adolescents.
The V920 vaccine candidate is a live recombinant vesicular stomatitis virus (VSV) expressing the glycoprotein (GP) of Zaire Ebola virus (ZEBOV). Two independent assays are currently being utilized in the clinical development program to clinically evaluate the immunogenicity of V920:
GP-ELISA measures the total IgG antibody response and can also be correlated to the plaque reduction neutralization assay (PRNT) titer result.
Plaque reduction neutralization assay (PRNT) is a functional assay and a gold standard platform in the field for quantitating the neutralizing antibody response elicited by the vaccine.
arm group label: Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3
arm group type: Active Comparator
description: Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo
arm group label: Group 2: 50 HIV-infected adults CD4 > 350 and < 500 cells/mm^3
arm group type: Active Comparator
description: Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo
arm group label: Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3
arm group type: Active Comparator
description: Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of theV920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo
arm group label: Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3
arm group type: Active Comparator
description: Participants will be randomly assigned to receive one dose of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo
arm group label: Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses
arm group type: Active Comparator
description: Participants will be randomly assigned to receive two dosse of ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine or the placebo
intervention type: Biological
intervention name: V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
description: The rVSVΔG-ZEBOV-GP vaccine is a live attenuated recombinant virus consisting of a single recombinant VSV isolate (11481 nt, strain Indiana) with the gene for the Zaire ebolavirus GP (ZEBOV GP), Kikwit strain replacing the gene for the VSV GP, which has been deleted. This results in a VSV backbone with the ZEBOV GP constituting the envelope of the virus.
arm group label: Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3
arm group label: Group 2: 50 HIV-infected adults CD4 > 350 and < 500 cells/mm^3
arm group label: Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3
arm group label: Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3
arm group label: Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses
intervention type: Other
intervention name: Saline
description: Normal saline (0.9%) has been chosen as an inert substance to serve as placebo control.
arm group label: Group 1: 50 HIV-infected adults CD4 ≥ 500 cells/mm^3
arm group label: Group 2: 50 HIV-infected adults CD4 > 350 and < 500 cells/mm^3
arm group label: Group 3: 50 HIV-infected adults CD4 ≥ 200 and ≤ 350 cells/mm^3
arm group label: Group 4: HIV infected adolescents CD4 ≥ 200 cells/mm^3
arm group label: Group 5: HIV infected adults and adolescents CD4 ≥ 200 cells/mm^3 with 2 doses
criteria: 
gender: All
minimum age: 13 Years
maximum age: 65 Years
healthy volunteers: No
last name: Cecile Tremblay, MD
role: Principal Investigator
affiliation: CHUM
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Canadian Immunization Research Network
investigator full name: Cecile Tremblay
investigator title: Principal Investigator
mesh term: Hemorrhagic Fever, Ebola
sharing ipd: No