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    Summary
    EudraCT Number:2014-004721-40
    Sponsor's Protocol Code Number:HPV-EU-001
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-06
    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 ConcernedEstonia - SAM
    A.2EudraCT number2014-004721-40
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-controlled, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in HPV type 16 and/or 18 Positive Patients with Biopsy-proven Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), Grade 2/3 (CIN 2/3) or Grade 3 (CIN3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-controlled, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in HPV type 16 and/or 18 Positive Patients with Biopsy-proven Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), Grade 2/3 (CIN 2/3) or Grade 3 (CIN3)3)
    A.4.1Sponsor's protocol code numberHPV-EU-001
    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 SponsorGenexine, Inc
    B.1.3.4CountryKorea, Republic of
    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 supportGenexine, Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAS EGeen
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street AddressSõbra 54
    B.5.3.2Town/ cityTartu
    B.5.3.3Post code50106
    B.5.3.4CountryEstonia
    B.5.4Telephone number+3727309 537
    B.5.5Fax number+3727309 534
    B.5.6E-mailrauno.oja@egeeninc.com
    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 GX-188E
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot answered
    D.3.9.2Current sponsor codepGX27-E6E7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    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 placeboSolution 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
    Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), Grade 2/3 (CIN 2/3) or Grade 3 (CIN3)
    E.1.1.1Medical condition in easily understood language
    Pre-cancerous cells on the cervix
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10008263
    E.1.2Term Cervical dysplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the histopathologic response to three 1 mg doses of GX-188E administered by IM injection in combination with EP delivered by TriGrid® in adult females with biopsy-proven HPV16 or 18-associated CIN 2, CIN 2/3 or CIN 3.
    E.2.2Secondary objectives of the trial
    To evaluate the virologic response to three 1 mg doses of GX-188E administered by IM injection in combination with EP delivered by TriGrid® in adult females with biopsy-proven HPV 16 or 18-associated CIN 2, CIN 2/3 or CIN 3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Female subjects age 18-60 years; (only, of Korea age 19-60 years);
    b. Histologically confirmed HPV-16 or HPV-18-associated CIN 2, CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with overall lesion sizes less than 50% of the cervix area and no evidence of invasive cancer in any specimen;
    c. Colposcopy is satisfactory based on visualization of the entire
    squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
    d. Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrolment;
    e. For women who are not postmenopausal (at least 12 months of nontherapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use a highly effective method of contraception during the treatment period and throughout Week 36 response evaluation visit.
    Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation,symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    Examples of highly effective contraception include the following:
    • Combined oral contraceptive pill
    • Contraceptive transdermal patch
    • Intrauterine device
    • Implants for contraception
    • Injections for contraception (with prolonged release)
    • Hormonal vaginal device
    • Sterilization, surgical tubal ligation
    • Sole sexual partner consisting of surgically sterilized male partner
    with appropriate post-surgical verification of the absence of
    spermatozoa in the ejaculate
    • Double barrier methods: condom and occlusive cap (diaphragm or
    cervical/vault caps) with spermicidal foam/gel/film/cream/
    suppository (Note: a female condom and male condom should not
    be used together as friction between the two can result in either
    product failing)
    f. Able and willing to comply with all study procedures and voluntarily signs informed consent form.
    E.4Principal exclusion criteria
    a. Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
    b. Pregnancy or breastfeeding;
    c. Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;
    d. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
    e. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);
    f. Administration of any blood product within 3 months of enrollment;
    g. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);
    h. Participation in a study with an investigational compound or device within 30 days prior to signing informed consent;
    i. Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
    j. History of seizures (unless seizure free for 5 years);
    k. Tattoos, scars, active lesions/rashes or any implantable leads within 3 cm of the intended site of vaccination/EP;
    l. Any electronic medical implants (such as cardiac pacemaker);
    m. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
    n. A tendency for severe haemorrhage following acute trauma;
    o. Prisoners or subjects who are compulsorily detained (involuntarily
    incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
    p. Any other conditions judged by the investigator that would limit the evaluation of a subject;
    q. Previous randomization into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Histopathological regression of cervical lesions to CIN 1 or less.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 weeks
    E.5.2Secondary end point(s)
    Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN 1 or less.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 weeks
    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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Georgia
    Korea, Republic of
    Ukraine
    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
    Last visit of the last subject enrolled
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 120
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 120
    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 Decision2015-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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