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    Summary
    EudraCT Number:2016-004853-34
    Sponsor's Protocol Code Number:CT14B
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-05-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2016-004853-34
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola – ACHIV-Ebola
    A.3.2Name or abbreviated title of the trial where available
    ACHIV-Ebola
    A.4.1Sponsor's protocol code numberCT14B
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03031912
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/095/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDalhousie University
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMERCK
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDalhousie University
    B.5.2Functional name of contact pointCanadian Center for Vaccinology
    B.5.3 Address:
    B.5.3.1Street AddressBox 9700, 5850/5890 University Avenue
    B.5.3.2Town/ cityHalifax
    B.5.3.3Post codeB3K 6R8
    B.5.3.4CountryCanada
    B.5.4Telephone number1902470-8141
    B.5.5Fax number1902470-7232
    B.5.6E-mailccfv@iwk.nshealth.ca
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namerVSVΔG-ZEBOV-GP Ebola Vaccine
    D.3.2Product code V920
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeV-920, BPSC 1001
    D.3.9.3Other descriptive nameV-920, rVSV ZEBOV GP
    D.3.9.4EV Substance CodeSUB186137
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number20000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ebola is caused by infection with a virus of the family Filoviridae, genus Ebolavirus. There are five identified Ebola virus species, four of which are known to cause disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); Taï Forest virus (Taï Forest ebolavirus, formerly Côte d’Ivoire ebolavirus); and Bundibugyo virus (Bundibugyo ebolavirus). The fifth, Reston virus (Reston ebolavirus), has caused disease in nonhuman primates, but not in humans.
    E.1.1.1Medical condition in easily understood language
    Ebola, previously known as Ebola hemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus species. Ebola can cause disease in humans and nonhuman primates.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10014074
    E.1.2Term Ebola virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and tolerability of V920 in HIV-infected adults and adolescents.

    Evaluate the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 at D28 in HIV-infected adults and adolescents.
    E.2.2Secondary objectives of the trial
    Evaluate VSV viremia and shedding after administration of V920.

    Evaluate ZEBOV-specific antibody responses induced by V920 through D180 and D365.

    Evaluate the impact of V920 on HIV viral load, CD4 counts, and CD4/CD8 ratio.

    Evaluate the safety and tolerability of two doses of V920 in HIV-infected adults and adolescents administered 56 days apart.

    Evaluate the immunogenicity of two doses of V920 administered 56 days apart via ZEBOV-specific antibody responses induced by V920 at D28 post-dose 2 in HIV-infected adults and adolescents.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages 13 to 70 (inclusive) at the time of screening;

    2. On antiretroviral therapy with an undetectable viral load (< 40 c/ml);

    3. CD4 T cell counts ≥ 200 cells/mm3;

    4. Written informed consent (subject or parent) and assent (adolescent), after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee
    5. Free of clinically significant health problems that could affect the safety of the participant, as determined by the Investigator by pertinent medical history and clinical examination prior to entry into the study;

    6. Available, able, and willing to participate for all study visits and procedures;

    7. Males and females who are willing to practice abstinence from sexual intercourse, or are willing to use effective methods of contraception, from at least 30 days prior to vaccination until 2 months after vaccination.
    a. If the partner is NOT of childbearing potential, the couple will only be required to use condoms, without other adjunctive contraception.
    b. For this study, a woman is considered of childbearing potential unless postmenopausal (≥ 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
    c. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label for example:
    i. Male condoms PLUS:
    ii. Oral contraceptives, either combined or progestogen alone
    iii. injectable progestogen
    iv. implants of etenogestrel or levonorgestrel
    v. oestrogenic vaginal ring
    vi. percutaneous contraceptive patches
    vii. intrauterine device or intrauterine system

    8. Be willing to minimize blood and body fluid exposure of others for 8 weeks after vaccination
    a. Avoiding the sharing of needles, razors, or toothbrushes
    b. Avoiding open-mouth kissing
    E.4Principal exclusion criteria
    1. History of prior infection with a filovirus or prior participation in a filovirus vaccine trial;

    2. History of prior infection with VSV or receipt of a VSV-vectored vaccine;

    3. Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization (subject may be rescheduled);

    4. Clinical manifestations of systemic diseases considered by the investigator to impact safety or immunogenicity

    5. Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 12 months;

    6. Receipt of any investigational drug within 12 months of vaccination;

    7. Receipt of any live virus vaccine within 42 days prior to study entry or any other (non-live virus) vaccine within 14 days prior to study entry.

    8. History of sensitivity to any component of study vaccines per investigator brochure or package insert;

    9. Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol: ALT, AST, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose (Appendix 2). To exclude transient abnormalities, the investigator may repeat a test up to twice, and if the repeat test is normal, subject may be enrolled;

    10. Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers;

    11. Suspected or known alcohol and/or illicit drug abuse within the past 5 years;

    12. Moderate or severe illness and/or fever >101°F (38.3ºC) orally or > 100°F (37.8ºC) axillary within one week prior to vaccination;

    13. Pregnant or breastfeeding female, or female who intends to become pregnant during the study period;

    14. Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period;

    15. Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints
    a. ZEBOV-specific antibody responses measured by ELISA and neutralization on Day 28 in Cohorts 1-5 combined.
    b. ZEBOV-specific antibody responses measured by ELISA and neutralization on Day 28 after the last dose of vaccine (equivalent to Day 84 from first dose) in Cohort 5.

    Safety Endpoints
    a. The occurrence of adverse events, in all participants, in all cohorts
    b. The occurrence of vaccine related SAE through to Day 365.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immunogenicity Endpoints
    on Day 28

    Safety Endpoints
    For a:
    i. The occurrence of each solicited local and systemic AE, during a 14-day follow-up period following each vaccination, and fever, arthritis, arthralgia, rash and blisters/vesicular lesions during a 42-day follow –up period following vaccination.
    ii. The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality at days 0, 3, 7, 14, and 28 after each vaccination.
    iii. The occurrence of any unsolicited AE, during a 42-day follow-up period after each vaccination.
    For b:
    through to Day 365
    E.5.2Secondary end point(s)
    Immunogenicity Endpoints
    a. ZEBOV-specific antibody responses measured by ELISA and neutralization on Day 28 in Cohort 5.
    b. ZEBOV-specific antibody responses measured by ELISA and neutralization on Days 180 and 365 after the first dose of vaccine.

    Safety Endpoints
    a. Detection of rVSV by PCR in blood, urine, and saliva in all subjects (D3, 7, 14, 28, 42 following each vaccination)
    b. Detection of rVSV by PCR in through 42 days from skin vesicles, joint fluid, or skin biopsies if specimens are obtained
    c. The occurrence of any SAE through to Day 365
    d. Decrease in CD4 T cell-count ( i.e., CD4< 200 mm3)
    e. Increase in HIV viral load (i.e., VL > 50 c/ml over two consecutive measurements)

    Decrease in CD4 T cell-count

    Increase in HIV viral load
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity Endpoints
    on Days 28, 180 and 365

    Safety Endpoints
    Detection of rVSV by PCR in blood, urine, and saliva in all subjects: Day 3, 7, 14, 28, 42

    Detection of rVSV by PCR in through 42 days from skin vesicles, joint fluid, or skin biopsies if specimens are obtained

    The occurrence of any SAE through to Day 365

    Increase in HIV viral load load (i.e., VL > 50 c/ml over two consecutive measurements)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Burkina Faso
    Canada
    Senegal
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For purposes of analysis and reporting, the overall trial ends when the Sponsor receives the last serology assay result or subject data from the last study-related phone call or visit and the database has been cleaned and locked.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Centre de recherche du Centre hospitalier de l'Universite de Montreal
    G.4.3.4Network Country Canada
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation The Ottawa Hospital - General Campus
    G.4.3.4Network Country Canada
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Centre Muraz
    G.4.3.4Network Country Burkina Faso
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Insitut de Recherche en Santé, de Surveillance Epidémiologique et de Formations
    G.4.3.4Network Country Senegal
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Dalhousie University: Canadian Center for Vaccinology - Halifax
    G.4.3.4Network Country Canada
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Canada
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