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    Summary
    EudraCT Number:2020-005888-31
    Sponsor's Protocol Code Number:EHVA_P01/ANRS_VRI08
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-03-07
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-005888-31
    A.3Full title of the trial
    A phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    EHVA_P01/ANRS_VRI08
    A.4.1Sponsor's protocol code numberEHVA_P01/ANRS_VRI08
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT08844775
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInserm-ANRS
    B.1.3.4CountryFrance
    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 supportANRS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportHorizon 2020
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Henri Mondor
    B.5.2Functional name of contact pointPr Yves Lévy
    B.5.3 Address:
    B.5.3.1Street Address51 avenue du marechal de lattre de tassigny
    B.5.3.2Town/ cityCRETEIL
    B.5.3.3Post code94010
    B.5.3.4CountryFrance
    B.5.4Telephone number33149814442
    B.5.5Fax number33149812469
    B.5.6E-mailyves.levy@aphp.fr
    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 nameDREP-HIV-PT1
    D.3.2Product code SUB259135
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameDNA-HIV-PT123
    D.3.2Product code SUB217960/SUB217962/SUB217961
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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.IMP: 3
    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 nameCN54gp140
    D.3.2Product code SUB259133
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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.IMP: 4
    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 nameMPLA-L
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    it's a Phase 1-2 preventive , prophilactic HIV vaccine trial.
    Vaccine target are healthy subjects aged from 18 to 55 years old. Safety and the immunogenicity of DREP-HIV-PT1 vaccine will be evaluated at first alone then in comparaison to the DNA-HIV-PT123 vacccine with CN54gp140 adjuvanted by MPLA-L coinjection. DREP-HIV-PT1 will be injected intramuscularly via the Stratis device (needle free seringue) manufactured by PharmaJet, the other products will be injected with a seringue with needle.
    E.1.1.1Medical condition in easily understood language
    It's a FIH trial and will be performed on healthy subjects with a prophylactic HIV vaccine.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10054925
    E.1.2Term Prophylaxis against HIV infection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1 Dose escalation (Phase I)
    To evaluate the safety of 0.2 and 1mg of DREP-HIV-PT1 administered IM by Stratis® at weeks 0 and 4
    Part 2 Randomised comparison (Phase II)
    To compare the safety of 0.2 and 1mg of DREP-HIV-PT1 combined with CN54gp140/MPLA-L with the safety of DNA-HIV-PT123 combined with CN54gp140/MPLA-L
    To compare the immunogenicity of 0.2 and 1mg of DREP-HIV-PT123 combined with CN54gp140/MPLA-L with the immunogenicity of DNA-HIV-PT123 combined with CN54gp140/MPLA-L
    E.2.2Secondary objectives of the trial
    To characterise the humoral and cellular immune responses to the high and low dose DREP combination regimens in the context of the DNA combination regimen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy adults aged 18- 55 years on the day of screening
    2. BMI between 18-30 kg/m2 (inclusive)
    3. Unlikely to acquire HIV during follow-up
    4. Willing and able to provide written informed consent
    5. If female and of childbearingi potential and not sterilised, willing to use a highly effective method of contraceptionii from screening until 12 weeks after last injection
    6. If male and not sterilised, willing to avoid impregnating female partnersiii from screening until 12 weeks after last injection
    7. Willing to avoid all other vaccines from at least 28 days before and after each study injectioniv
    8. Willing and able to comply with visit schedule and provide blood samples
    9. Being covered by medical insurance or in National Healthcare System
    E.4Principal exclusion criteria
    1. Pregnant or lactating
    2. Has a significant clinical history or physical finding on clinical examination during screening that is not compatible with healthy status, may compromise the volunteer’s safety, preclude vaccination or compromise interpretation of the immune response to vaccine. For clarity, this could be the presence of active disease that is evolving and or likely to require escalation in treatment to control it. Individuals with mild/moderate, well-controlled comorbidities are allowed.
    3. HIV 1 or 2 infection or indeterminate test at screening
    4. History of anaphylaxis or angioedema
    5. History of severe or multiple allergies to drugs or pharmaceutical agents
    6. Known hypersensitivity to any component of the vaccine formulation used in this trial
    7. History of severe local or general reaction to vaccination defined as
    a. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
    b. general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
    8. Receipt of any experimental vaccine within 5 years before screening.
    9. Receipt of blood products or immunoglobulins within 18 weeks before screening.
    10. Receipt of any immunosuppressive agents within 18 weeks before screening by any route other than skin and intranasal.
    11. Detection of antibodies to hepatitis C
    12. Participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days before screening
    13. Any of the values indicated in the table 7 of the protocol confirmed on repeat testing
    E.5 End points
    E.5.1Primary end point(s)
    Part One (Phase I)
    Primary Outcome Measure
    -Any adverse reaction that results in a clinical decision that no further immunisations can be given
    Part Two (Phase II)
    Primary Outcome Measures- Immunogenicity
    -Env-specific total IgG binding antibody response rates assessed by binding antibody multiplex assay (BAMA) (week 26)
    -Magnitude of Env-specific total IgG binding antibody responses to HIV-1 Env proteins assessed by binding antibody multiplex assay (BAMA) (week 26)
    Primary Outcome Measure- Safety
    -Any adverse reaction that results in a clinical decision that no further immunisations can be given.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1 (Phase I)
    From Week 0 to Week 4 for the safety outcome
    Part 2 (Phase II)
    -From Week 0 to Week 24 for the safety outcome
    -Week 26 for the immunogenicity
    E.5.2Secondary end point(s)
    For the part 1 (Phase I)
    Secondary Outcome Measures- Safety
    -Grade 3 or worse local or systemic solicited adverse events
    -Grade 1 or 2 local or systemic solicited adverse events
    -Non-solicited adverse events
    -Serious adverse events
    Secondary Outcome Measures – Immunological
    -Binding antibodies to ZM96gp140 measured by ELISA
    For the part 2 (Phase II)
    Secondary Outcome Measures- Immunogenicity
    -Env-specific total IgG binding antibody response rates assessed by
    binding antibody multiplex assay (BAMA) (week 6)
    -Magnitude of Env-specific total IgG binding antibody responses to HIV-1
    Env proteins assessed by binding antibody multiplex assay (BAMA)
    (week 6)
    -Breadth of Env-specific total IgG binding antibody responses to HIV-1
    Env proteins assessed by binding antibody multiplex assay (BAMA)
    (week 26)
    -Durability of Env-specific total IgG binding antibody responses to HIV-1
    Env proteins assessed by binding antibody multiplex assay (BAMA)
    (week 36). This is defined as response rates and magnitudes at week 36
    -Response rate and magnitude of Env-specific CD4+ and CD8+ T-cell
    responses measured by intracellular cytokine staining (ICS) (week 26)
    -Durability of Env-specific CD4+ and CD8+ T-cell responses measured by
    intracellular cytokine staining (ICS) (week 36). This is defined as
    response rates and magnitudes at week 36
    Secondary Outcome Measures- Safety
    -Grade 3 or worse local or systemic solicited adverse events
    -Grade 1 or 2 local or systemic solicited adverse events
    -Non-solicited adverse events
    -Serious adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the part 1 (Phase I)
    From Week 0 to Week 16 for the safety
    Week 0 and Week 6 for the immunogenicity
    For the part 2 (Phase II)
    From Week 0 to Week 48 for the safety
    Weeks 6,26 and 36 for the immunogenicity
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open for part 1, signle blind for part 2 for patients and lab analysers
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    DNA-HIV-PT123 vaccine as comparator and the CN54gp140/MPLA-L vaccine as booster
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Switzerland
    United Kingdom
    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
    The trial will be closed when all participants have made their final follow-up visit and assessments completed, the data entered into the database, checked and locked.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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.4.1In the member state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 70
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
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