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    Summary
    EudraCT Number:2014-005093-11
    Sponsor's Protocol Code Number:IVVAC-3S/P2
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-23
    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 number2014-005093-11
    A.3Full title of the trial
    Multicentre, open-label, phase I/IIa clinical study of an immunoprotective therapeutic vaccine candidate (VAC-3S) in Human Immunodeficiency Virus type 1 (HIV-1) chronically infected patients virologically controlled on antiretroviral therapy (ART) who rose an immune response to VAC-3S during IVVAC-3S/P1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    VAC-3S study in patients infected by HIV and controlled with an antiretroviral treatment who rose their immune response in study study IVVAC-3S/P1
    Etude de VAC-3S chez les patients infectés par le VIH et contrôlés par un traitement antirétroviral et ayant montré une réponse immunitaire dans l'étude IVVAC-3S/P1.
    A.4.1Sponsor's protocol code numberIVVAC-3S/P2
    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 SponsorInnaVirVax
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnaVirVax
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnaVirVax
    B.5.2Functional name of contact pointRaphaël Ho Tsong Fang, DVM, PhD
    B.5.3 Address:
    B.5.3.1Street AddressGenopole Entrepris - 4 rue Pierre Fontaine
    B.5.3.2Town/ cityEvry Cedex
    B.5.3.4CountryFrance
    B.5.4Telephone number330160878940
    B.5.5Fax number330180856087
    B.5.6E-mailraphaelfang@innavirvax.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.3.2Product code VAC-3S
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronically infected HIV-1 patients under viral control on Anti-Retroviral therapy.
    E.1.1.1Medical condition in easily understood language
    HIV
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety and tolerability of three intramuscular injections of VAC-3S at 16 µg of peptide equivalent/vaccination administered in 4-weeks intervals from D0 to the interim analysis time point (V5M4).
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of a fourth injection of VAC-3S 20 weeks after the first injection, in the patients who did not reach total anti-3S antibody titers above 500 Arbitrary Units (A.U.).
    • To assess the immunogenicity of three intramuscular injections of VAC-3S at 16 µg of peptide equivalent/vaccination administered at 4-week intervals from D0 till the interim analysis time point (V5M4).
    • To assess the immunogenicity of a fourth injection of VAC-3S 20 weeks after the first injection, in the patients who did not rise total anti-3S antibody titers above 500 Arbitrary Units (A.U.)
    • To assess the time course of markers of progression to AIDS. Markers include CD4/CD8 ratio, CD4+ and CD8+ cell counts and percentages, viral load, phenotypic markers lymphocyte cell differentiation and activation, serum activation markers and HIV DNA bulk from D0 to the final analysis time point.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - HIV-1 infected patient
    - Age between 18 and 60 years
    - ART (AntiRetroviral Therapy) initiation  1 year ago
    - Plasma HIV RNA < 100 copies/ml in the past 12 months
    - CD4+ T cell count ≥ 200 cells/mm3,
    - Nadir CD4+ T cell count ≥ 100 cells/mm3,
    - Female patient of childbearing potential with a negative urine pregnancy test (UPT). Females of non-childbearing potential, i.e., post-menopausal (absence of menstrual bleeding for 1 year, or 6 months with laboratory confirmation of hormonal status), hysterectomy or bilateral oophorectomy, are not required a UPT,
    - Female patient of childbearing potential under highly effective contraception defined as two of the following methods of contraception and willing to have two of them for the entire study duration: masculine or feminine condom use, bilateral tubal ligation, intra-uterine device (IUD), oral, transdermal, systemic or implant contraception on a stable dose for at least 3 months,
    - A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial.
    - Per protocol subject having completed the IVVAC-3S/P1 study.
    - Patient affiliated to a social security system,
    - Patient who has understood the protocol design and provided a signed written informed consent form,
    - Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
    - Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.
    E.4Principal exclusion criteria
    1. Chronic active liver disease,
    2. History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
    3. Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
    4. Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
    5. Ongoing pregnancy,
    6. Breastfeeding women,
    7. Patient with known sensitivities to investigational drug (see please the CIB),
    8. History of allergy to any vaccine,
    9. Any severe chronic condition that would interfere with the study,
    10. History of auto-immune disease,
    11. Organ transplant,
    12. Splenectomy,
    13. Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
    14. Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
    15. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
    16. Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
    E.5 End points
    E.5.1Primary end point(s)
    Occurence of any local or systemic adverse event from baseline to the interim analysis time point based on clinical and laboratory monitoring.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    E.5.2Secondary end point(s)
    - HIV plasma viral load (number of HIV RNA copies/mL) measured by quantitative RT-PCR from baseline to the final analysis time point.
    - The occurrence of any AE between the interim analysis time point and the final analysis time point.
    - Anti-3S Ab titers (IgM, IgA or IgG) using ELISA from baseline to the final analysis time point.
    - CD4+/CD8+ ratio from baseline to the final analysis time point.
    - CD4+ and CD8+ T cell counts and percentages, and T lymphocyte markers of differentiation and activation using immunophenotyping from D0 to the final analysis time point.
    - Serum inflammation nmarkers,
    - HIV DNA bulk
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 51
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    safety and tolerability of VAC-3S
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days21
    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: 15
    F.1.3Elderly (>=65 years) No
    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.4.1In the member state15
    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 Decision2015-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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