Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-07 @ 9:25 PM
Study NCT ID:
NCT02543827
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of MV140
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-25', 'releaseDate': '2022-11-17'}], 'estimatedResultsFirstSubmitDate': '2022-11-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in the number of RUTI exacerbations.', 'timeFrame': '1 year', 'description': 'Average reduction of RUTI exacerbations'}], 'secondaryOutcomes': [{'measure': 'Severity of RUTI exacerbations', 'timeFrame': '1 year', 'description': 'Review of RUTI exacerbations episodes severity per patient'}, {'measure': 'First RUTI exacerbation', 'timeFrame': '1 year', 'description': 'When takes place the First RUTI exacerbation for every single patient'}, {'measure': 'Medication consumption', 'timeFrame': '1 year', 'description': 'Review of medication consumed from the beginning to the end of the RUTI exacerbation'}, {'measure': 'Health resource consumption', 'timeFrame': '1 year', 'description': 'Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures'}, {'measure': 'Number of visits to the emergency service', 'timeFrame': '1 year', 'description': 'Counting the number of visits to the emergency service due to RUTI exacerbation'}, {'measure': 'Number of hospitalizations due to RUTI exacerbations', 'timeFrame': '1 year', 'description': 'Counting the number of hospitalization days due to RUTI exacerbations'}, {'measure': 'Changes from baseline in RUTI Assessment Test', 'timeFrame': '1 year', 'description': 'Compare the RUTI Assessment Test results at the beginning and at the end of the trial'}, {'measure': 'Percentage of difference in immunological parameters from baseline to end of the trial', 'timeFrame': '1 year', 'description': 'Compare the changes from specific cell proliferation baseline against antigens of the vaccine.'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '1 year', 'description': 'Review of the number of adverse event per patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Recurrent Urinary Tract Infections (RUTI)'], 'conditions': ['Urinary Tract Infection Bacterial']}, 'referencesModule': {'references': [{'pmid': '26090341', 'type': 'BACKGROUND', 'citation': 'Lorenzo-Gomez MF, Padilla-Fernandez B, Garcia-Cenador MB, Virseda-Rodriguez AJ, Martin-Garcia I, Sanchez-Escudero A, Vicente-Arroyo MJ, Miron-Canelo JA. Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections. Front Cell Infect Microbiol. 2015 Jun 3;5:50. doi: 10.3389/fcimb.2015.00050. eCollection 2015.'}, {'pmid': '26445597', 'type': 'BACKGROUND', 'citation': 'Lorenzo Gomez MF, Collazos Robles RE, Virseda Rodriguez AJ, Garcia Cenador MB, Miron Canelo JA, Padilla Fernandez B. Urinary tract infections in women with stress urinary incontinence treated with transobturator suburethral tape and benefit gained from the sublingual polibacterial vaccine. Ther Adv Urol. 2015 Aug;7(4):180-5. doi: 10.1177/1756287215576648.'}, {'pmid': '22806485', 'type': 'BACKGROUND', 'citation': 'Lorenzo-Gomez MF, Padilla-Fernandez B, Garcia-Criado FJ, Miron-Canelo JA, Gil-Vicente A, Nieto-Huertos A, Silva-Abuin JM. Evaluation of a therapeutic vaccine for the prevention of recurrent urinary tract infections versus prophylactic treatment with antibiotics. Int Urogynecol J. 2013 Jan;24(1):127-34. doi: 10.1007/s00192-012-1853-5. Epub 2012 Jul 18.'}, {'pmid': '30527360', 'type': 'BACKGROUND', 'citation': 'Sanchez Ramon S, Manzanares M, Candelas G. MUCOSAL anti-infections vaccines: Beyond conventional vaccines. Reumatol Clin (Engl Ed). 2020 Jan-Feb;16(1):49-55. doi: 10.1016/j.reuma.2018.10.012. Epub 2018 Dec 7. English, Spanish.'}, {'pmid': '25330031', 'type': 'BACKGROUND', 'citation': 'Sanchez-Ramon S, Perez de Diego R, Dieli-Crimi R, Subiza JL. Extending the clinical horizons of mucosal bacterial vaccines: current evidence and future prospects. Curr Drug Targets. 2014;15(12):1132-43. doi: 10.2174/1389450115666141020160705.'}, {'pmid': '27966556', 'type': 'BACKGROUND', 'citation': 'Benito-Villalvilla C, Cirauqui C, Diez-Rivero CM, Casanovas M, Subiza JL, Palomares O. MV140, a sublingual polyvalent bacterial preparation to treat recurrent urinary tract infections, licenses human dendritic cells for generating Th1, Th17, and IL-10 responses via Syk and MyD88. Mucosal Immunol. 2017 Jul;10(4):924-935. doi: 10.1038/mi.2016.112. Epub 2016 Dec 14.'}, {'pmid': '33552074', 'type': 'BACKGROUND', 'citation': 'Martin-Cruz L, Sevilla-Ortega C, Benito-Villalvilla C, Diez-Rivero CM, Sanchez-Ramon S, Subiza JL, Palomares O. A Combination of Polybacterial MV140 and Candida albicans V132 as a Potential Novel Trained Immunity-Based Vaccine for Genitourinary Tract Infections. Front Immunol. 2021 Jan 21;11:612269. doi: 10.3389/fimmu.2020.612269. eCollection 2020.'}, {'pmid': '29171130', 'type': 'BACKGROUND', 'citation': 'Yang B, Foley S. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune(R). BJU Int. 2018 Feb;121(2):289-292. doi: 10.1111/bju.14067. Epub 2017 Nov 23.'}, {'pmid': '38319200', 'type': 'DERIVED', 'citation': 'Lorenzo-Gomez MF, Foley S, Nickel JC, Garcia-Cenador MB, Padilla-Fernandez BY, Gonzalez-Casado I, Martinez-Huelamo M, Yang B, Blick C, Ferreira F, Caballero R, Saz-Leal P, Casanovas M. Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections. NEJM Evid. 2022 Apr;1(4):EVIDoa2100018. doi: 10.1056/EVIDoa2100018. Epub 2022 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.', 'detailedDescription': 'Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who gave their informed consent.\n* Age between 18 and 75 years.\n* Must be able to meet the dosage regimen.\n* Subjects who had had at least 5 episodes of cystitis in the last 12 months.\n* Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.\n* Subjects who were free of urinary tract infections at the time of inclusion in the study.\n\nExclusion Criteria:\n\n* Had not given their informed consent.\n* Age was not within the established age range.\n* Could not offer cooperation and/or had severe psychiatric disorders.\n* Presented a pathologic post-micturition residue.\n* Presented moderate to severe incontinence.\n* Presented genital tumours.\n* Presented Urinary tract tumours.\n* Presented lithiasis.\n* Presented alterations in the immune system.\n* Presented complicated UTIs.'}, 'identificationModule': {'nctId': 'NCT02543827', 'acronym': 'MV140', 'briefTitle': 'Evaluation of the Efficacy and Safety of MV140', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inmunotek S.L.'}, 'officialTitle': 'Prospective Randomized, Double-blind, Parallel-controlled Versus Placebo in a Polyvalent Sublingual Bacterial Vaccine to 3 Months and 6 Months in Women With RUTI for the Immunomodulatory Efficacy Evaluation, Safety and Clinical Impact', 'orgStudyIdInfo': {'id': 'MV140-SLG-003'}, 'secondaryIdInfos': [{'id': '2013-001838-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MV140 I', 'description': 'The subjects will receive daily dose of MV140 during 6 months', 'interventionNames': ['Biological: MV140']}, {'type': 'EXPERIMENTAL', 'label': 'MV140 II', 'description': 'The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months', 'interventionNames': ['Biological: MV140', 'Biological: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The subjects will receive daily dose of placebo during 6 month', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'MV140', 'type': 'BIOLOGICAL', 'description': 'The subjects will receive daily dose of MV140 during 3 or 6 months', 'armGroupLabels': ['MV140 I', 'MV140 II']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'The subjects will receive daily dose of placebo during 3 or 6 months', 'armGroupLabels': ['MV140 II', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37001', 'city': 'Salamanca', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Centro de Salud Universidad Centro', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '37006', 'city': 'Salamanca', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Centro de Salud Capuchinos', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '37300', 'city': 'Peñaranda de Bracamonte', 'state': 'Salamanca, Castilla Y LEÓN', 'country': 'Spain', 'facility': 'CENTRO DE SALUD de PEÑARANDA', 'geoPoint': {'lat': 40.90108, 'lon': -5.20026}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Royal Berkshire Hospital Nhs Foundation Trust', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Fernanda Lorenzo, PhD; MD-prof', 'role': 'STUDY_DIRECTOR'}, {'name': 'Isidoro Martín, PhD; MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alfonso Sánchez, PhD; MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manuel José Vicente, PhD; MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stephen Foley, FRCS (Urol)', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inmunotek S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-17', 'type': 'RELEASE'}, {'date': '2023-09-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Inmunotek S.L.'}}}}