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    Summary
    EudraCT Number:2013-001838-17
    Sponsor's Protocol Code Number:MV140-SLG-003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-08-03
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2013-001838-17
    A.3Full title of the trial
    A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP PLACEBO-CONTROLLED CLINICAL STUDY FOR THE ASSESSMENT OF THE IMMUNOMODULATORY EFFICACY, SAFETY AND CLINICAL IMPACT AFTER THREE AND SIX MONTHS TREATMENT WITH A SUBLINGUAL POLYVALENT BACTERIAL VACCINE (IN ORAL MUCOSA) IN WOMEN WITH RECURRENT URINARY TRACT INFECTIONS (rUTIs).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Efficacy and Safety of MV140
    A.3.2Name or abbreviated title of the trial where available
    Evaluation of the Efficacy and Safety of MV140
    A.4.1Sponsor's protocol code numberMV140-SLG-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02543827
    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 SponsorSyner-Med (PP) Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportSyner-Med (PP) Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyner-Med (PP) Ltd
    B.5.2Functional name of contact pointKhalil Ahmed, Head of Medical Aff
    B.5.3 Address:
    B.5.3.1Street AddressSyner-Med House, 120 High Street
    B.5.3.2Town/ cityPurley
    B.5.3.3Post codeCR8 2AD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02086556388
    B.5.6E-mailkhalila@syner-med.com
    B.Sponsor: 2
    B.1.1Name of SponsorInmunoteK S.L.
    B.1.3.4CountrySpain
    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 supportInmunotek S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInmunoteK S.L.
    B.5.2Functional name of contact pointMiguel Casanovas, Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressPunto Mobi, 5-28805 Alcalá de Henares
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code5-28805
    B.5.3.4CountrySpain
    B.5.4Telephone number0091 290 89 42
    B.5.6E-mailmcasanovas@inmunotek.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.3.1Product nameUromune
    D.3.2Product code MV140
    D.3.4Pharmaceutical form Sublingual spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    Sublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMV140
    D.3.9.1CAS number 8000045-24-1
    D.3.9.2Current sponsor codeMV140
    D.3.9.3Other descriptive nameBACTERIA
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1,000,000,000
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual spray
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Urinary Tract infection
    E.1.1.1Medical condition in easily understood language
    Urinary Tract infection
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038140
    E.1.2Term Recurrent urinary tract 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 main objective of this study is to obtain the prevention of recurrent Urinary Tract Infections in women immunized with multivalent bacterial vaccine, MV140 after treatment for three or six months, compared with placebo group.

    Primary efficacy variable is reduction in the average number of episodes of UTIs in immunized women, after active treatment of 3 to 6 months, at 12 months follow up. For this, the number of episodes of UTIs will be assessed during follow-up period.
    - Reduction in the average number of episodes of UTIs in women treated with MV140 for 3 months compared to placebo.
    - Reduction in the average number of episodes of UTIs in women treated with MV140 for 6 months compared to placebo.
    - Reduction in the average number of episodes of UTIs in women treated with MV140 for 6 months compared to women treated with MV140 for 3 months.

    E.2.2Secondary objectives of the trial
    • To compare the event rate, during the time of the study, between the treatment groups against placebo.
    • To compare by a cost-benefit ratio the three treatment groups.
    • Time elapsed from start of treatment until the appearance of the first UTI
    • Use of antibiotics for treatment of infections
    Treatments to be permitted will be graded on a scale of 1-3 points according to the need of treatment required, according to the established medical history.
     Point 1: Use of one of these two treatment options, considering the possibility of allergies, when only lower urinary tract infection without fever is suspected:
     Rule A: Septrim forte® (Trimetoprim 160mg+sulfamethoxazol 800mg) 1 tablet orally every 12 hours for 6 days.
    Rule A in the UK: Trimetoprim 200mg twice daily for 7 days.
     Rule B: Fosfomycin 1 gram orally every 8 hours for 6 days.
     Rule B in the UK: Nitrofurontoin 100mg twice daily for 7 days
     Point 2: Use of one of these two patterns, considering the possibility of allergies,
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The individuals to be included in the study will meet the following criteria:
     Women who have given their informed consent. Age between 18 and 75 years.
     Must be able to meet the dosage regimen
     Individuals who have had at least 5 episodes of cystitis in the last 12 months.
     Individuals who have not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
     Individuals who are free of urinary tract infections at the time of inclusion in the study.
    E.4Principal exclusion criteria
    Non- included individuals will be those who/whose:
     Have not given their informed consent.
     Age is not within the established age range.
     Cannot offer cooperation and/or have severe psychiatric disorders
     Present a pathologic post-micturition residue.
     Present moderate to severe incontinence
     Present genital tumors.
     Presents Urinary tract tumors.
     Present lithiasis
     Present alterations in the immune system
     Present complicated UTIs
    E.5 End points
    E.5.1Primary end point(s)
    The main objective of this study is to achieve the prevention of Recurrent Urinary Tract Infections in women immunized with multivalent bacterial vaccine after treatment for three or six months, compared with placebo group.

    - Primary variable: mean number of episodes of urinary tract infections.
    - Primary efficacy variable is reduction in the average number of episodes of UTIs in immunized women, after active treatment of 3 to 6 months, at 12 months follow up. For this, the number of episodes of UTIs will be assessed during follow-up period.
     Reduction in the average number of episodes of UTIs in women treated with MV140 for 3 months compared to placebo.
     Reduction in the average number of episodes of UTIs in women treated with MV140 for 6 months compared to placebo.
     Reduction in the average number of episodes of UTIs in women treated with MV140 for 6 months compared to women treated with MV140 for 3 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary and secondary variables including adverse events will be evaluated at baseline, 3 months, 6 months, 9 months and 12 months follow up time points in Phase I of the study.

    In phase II Primary and secondary variables including adverse events will be evaluated at 15 months, 18 months, 21 months and 24 months follow up time points.
    E.5.2Secondary end point(s)
    • To compare the event rate, during the time of the study, between the treatment groups against placebo.
    • To compare by a cost-benefit ratio the three treatment groups.
    • Time elapsed from start of treatment until the appearance of the first UTI
    • Use of antibiotics for treatment of infections
    Treatments to be permitted will be graded on a scale of 1-3 points according to the need of treatment required, according to the established medical history.
     Point 1: Use of one of these two treatment options, considering the possibility of allergies, when only lower urinary tract infection without fever is suspected:
     Rule A: Septrim forte® (Trimetoprim 160mg+sulfamethoxazol 800mg) 1 tablet orally every 12 hours for 6 days.
    Rule A in the UK: Trimetoprim 200mg twice daily for 7 days.
     Rule B: Fosfomycin 1 gram orally every 8 hours for 6 days.
     Rule B in the UK: Nitrofurontoin 100mg twice daily for 7 days
     Point 2: Use of one of these two patterns, considering the possibility of allergies, one or another treatment modality for intercurrent ITU when renal parenchymal damage is suspected by the presence of fever, but with uncomplicated pyelonephritis criteria, which can be treated on an out-patient basis:
     Rule A: Septrim forte® (Trimetoprim 160mg+sulfamethoxazol 800mg) 1 tablet orally every 12 hours for 14 days plus intramuscular injection of gentamicin 2 mg / kg / day in a single daily dose for 4 days.
     Rule A in the UK: Ciprofloxacin 500mg for 14 days
     Rule B: Levofloxacin 500mg every 24 hours orally for 14 days.
     Point 3: Need for hospital admission for intravenous treatment when an UTI is suspected with risk of sepsis or complicated pyelonephritis: intravenous treatment will be carried out at least 3 days until the event is controlled, fever has decreased and complicated infection blood parameters evolve favourably (leukocytosis):
     Rule A: Third-generation cephalosporin: Cefotaxime 1 g intravenously every 8 hours at least for 3 days, then switch to oral administration according to dosing described in “2 points” section.
     Rule A in the UK: Gentamicin dose determined by weight as per local treatment guidelines
     Rule B: Amoxicillin (1000 mg) / clavulanate (200 mg) endovenously every 8 hours plus 100 mg of tobramycin intravenously every 12 hours at least for 3 days, then switch to oral administration according to dosing described in “2 points” section.
     Rule B in the UK: Targeted treatments as recommended by microbiologist.
    • Use of health resources: Emergency Hospital visits/consultations as follows:
     Hospitalization: 3 points
     Emergency Hospital visit: 2 points
     Unscheduled medical consultation due to a UTI: 1 point.
    • Health expenditure: expenses derived from consumption of health resources will be accounted according to the rates of that hospital.
    • Quality of life through the questionnaire SF36
    • Satisfaction questionnaire with investigational medicinal product.
    • Family Resources (absenteeism)
    • Change from specific cell proliferation baseline against antigens of the vaccine.
    • Safety Variables
     Overall rate, severity and relationship of any adverse event (AE) per administration and per patient.
     Evaluation of local tolerance - reactions at the site of administration (and due to any medication administered for the treatment of AE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary variables will be evaluated at baseline, 3 months, 6 months, 9 months, 12 months, 15th months, 18 months, 21 months and 24 months follow up time points.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA0
    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 No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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)
    Standard treatment duration of MV140 is 3 months and in the Phase I of the study under consideration participants in active arms will be treated with MV140 for either 3 month or 6 months. Participants who suffer from 2 or more episodes of UTI in Phase I will be given vaccine MV140 for 3 months in the Phase II of the study. There is no plan to provide MV140 beyond the study duration.
    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 Thames Valley and South Midlands Clinical Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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