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    Summary
    EudraCT Number:2013-002735-23
    Sponsor's Protocol Code Number:IPROTECT1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-08
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-002735-23
    A.3Full title of the trial
    Assessment of the therapeutic properties of the VAC-3S immunoprotective vaccine when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection. A European multicenter, randomized, double-blind, placebo-controlled, phase II study
    Evaluación de las propiedades terapéuticas de la vacuna inmunoprotectora VAC-3S asociada a los tratamientos antirretrovirales (ART) estándares en el curso de la infección por VIH-1. Un ensayo de fase II multicéntrico europeo, aleatorizado, doble ciego, controlado con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the therapeutic properties of the VAC-3S immunoprotective vaccine when combined with standard therapy in the course of HIV infection.
    Evaluación de las propiedades terapéuticas de la vacuna inmunoprotectora VAC-3S asociada a los tratamientos estándares en el curso de la infección por VIH.
    A.4.1Sponsor's protocol code numberIPROTECT1
    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 Entreprises ? Campus 3. 4, rue Pierre Fontaine
    B.5.3.2Town/ cityEvry
    B.5.3.3Post code91058
    B.5.3.4CountryFrance
    B.5.4Telephone number+330160 878 940
    B.5.5Fax number+330180 856 087
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVAC-3S
    D.3.9.2Current sponsor codeIVV-3S
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number16 to 64
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    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
    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 14.1
    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
    The primary objective of the current Phase 2 study is to evaluate the immunogenicity of VAC-3S at doses of 16 ?g, 32 ?g and 64 ?g at 4 weeks after 3 vaccinations q4weeks in virologically controlled HIV-1 infected patients with CD4+ T cell counts between 200 and 500 cells/mm3 who are receiving standard-of-care antiretroviral treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    ? to evaluate the safety, tolerability and virological impact of anti-3S antibody titers following vaccination with VAC-3S 3 times every 4 weeks, and maintenance vaccinations 3 times every 12 weeks after the initial vaccination schedule;
    ? to evaluate the overall immunogenicity of VAC-3S at doses of 16 ?g and 32 ?g after 3 maintenance vaccinations at the end of the full immunization scheme;
    ? to evaluate anti-3S antibody decay rates over time;
    ? to assess the impact of VAC-3S immunotherapy on CD4 cell counts and percentages in a cohort of virologically controlled HIV-1 infected patients with stable CD4 cell counts;
    ? to assess the impact of VAC-3S on immunologic markers panels including NKp44L expression on the surface of CD4 T lymphocytes and phenotypic markers of lymphocyte activation and differentiation.
    ? to evaluate the impact of VAC-3S on inflammatory biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Documented HIV-1 infection,
    2. Adults > 18 and < 60 years of age,
    3. Able and willing to comply with the protocol, including availability for all scheduled study visits,
    4. Provided a signed written informed consent,
    5. Meets study screening physical, medical history and laboratory assessments (defined below),
    6. On stable antiretroviral therapy that is consistent with the current standard of care for at least 12 months prior to study screening,
    7. Plasma HIV RNA < 50 cps/mL during the previous 12 months,
    8. CD4+ T cell count at screening > 200 and < 500 cells/mm3,
    9. Adequate hematology, biochemistry, and metabolic blood tests
    defined as being less than grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1), except for the
    numeration of CD4 and for the numeration of lymphocytes,
    10. Adequate hepatic and renal function defined as being less than Grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1),
    11. Female patients of childbearing age with one documented negative blood pregnancy tests between Screening and Visit 1/Month 0; Female patient of childbearing potential must be receiving two forms of effective contraception and must be willing to use them throughout the study duration. These include oral, transdermal, systemic or implant contraception birth control, intra-uterine devices (IUD), abstinence and double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam),
    12. Affiliated with the National Medical Insurance System,
    13.Believed by investigator to be able and willing to comply with the requirements of the study protocol and will be available for all scheduled visits at the study site.
    E.4Principal exclusion criteria
    1. Not meeting all of the inclusion criteria listed above,
    2. Administration of any investigational drug or device within 28 days prior to screening,
    3. Prior history of an AIDS-defining event,
    4. Active co-infection with either HCV or HBV or any other active viral hepatitis co-infection,
    5. Any acute or clinically significant infections within the past month,
    6. Known allergy or intolerance to components of VAC-3S as documented through medical records or via patient interview,
    7. Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non-invasive methods,
    8. Receipt of any known vaccinations within the past 1 month prior to screening,
    9. Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL-2, IL-7, growth hormone?),
    10. Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti-diabetic treatment, anticoagulants (excluding daily ?baby-dose? aspirin) or daily NSAIDs within one week of study enrollment,
    11. Receipt of any contraindicated medications listed in Appendix 23.2,
    12. History of or active auto-immune disease,
    13. Acute or chronic psychiatric conditions which in the opinion of the investigator would need continual psychological support and/or medications incompatible with study participation,
    14. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
    15. Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise safety of the patient or the ability to properly administer the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in anti-3S antibody titers after 3 vaccinations q4weeks measured 4 weeks after the third vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between week 0 and week 12
    E.5.2Secondary end point(s)
    1. Assessment of safety & tolerability
    ? Overall general clinical tolerance,
    ? Local tolerance,
    ? Laboratory monitoring of clinical safety,
    ? HIV RNA monitoring of viral blips.
    2. Evaluation of the inflammatory/immunological interface
    ? Impact on chronic inflammatory biomarkers.
    3. Assessment of immunogenic characteristics of VAC-3S
    ? Evaluation of the effect of the base immunization schedule of 3 vaccinations at 4-week intervals (total of 3 vaccinations),
    ? Evaluation of the effect of 1, 2 and 3 maintenance vaccinations (a total of 6 vaccinations).
    4. Assessment of immunological effects
    ? NKP44L expression,
    ? Immune activation,
    ? Immune differentiation.
    5. Evaluation of secondary virological effects
    ? Impact on markers of HIV reservoir.
    6. Specific secondary assessments not covered under secondary objectives number 1 to 5:
    ? Characterization of anti-3S antibodies,
    ? Identification of composite endpoints,
    ? Identification of factors predictive of response,
    ? Specific statistical analysis to identify patient subgroups,
    ? Response in subgroups of patients as a function of ongoing treatments [type of ART, statins],
    ? Estimation of the optimal time to re-vaccinate subjects after the last dose of VAC-3S (defined as the median/mean time to an anti-3S antibody titer <50 AU),
    ? Evaluation of increasing doses of VAC-3S on:
    - Safety/Tolerability of VAC-3S,
    - Maximum anti-3S antibody titers,
    - Time to reach the maximum anti-3S antibody titer,
    - Decay of anti-3S antibody titers over time after the last vaccination with VAC-3S,
    ? Evaluation of the impact of different levels of CD4+ T cell count on the:
    - Safety/Tolerability of VAC-3S,
    - Maximum anti-3S antibody titer,
    - Time to reach the maximum anti-3S antibody titer,
    - Decay of anti-3S antibody titers over time after the last dose of VAC-3S.
    ? Evaluation of the effect of the maximum anti-3S antibody titer on:
    - Safety/tolerability,
    - Time to decay based upon an initially maximum anti-3S antibody titer, including subgroup evaluation by CD4 strata.
    ? Evaluation of anti-carrier antibody titers or surrogate markers thereof.
    ? Impact on metabolic endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between week 0 and week 72
    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 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 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 concerned7
    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 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
    End of trial is defined as last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 90
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
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