Study Results
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Basic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2015-11-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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MV140 I
The subjects will receive daily dose of MV140 during 6 months
MV140
The subjects will receive daily dose of MV140 during 3 or 6 months
MV140 II
The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months
MV140
The subjects will receive daily dose of MV140 during 3 or 6 months
Placebo
The subjects will receive daily dose of placebo during 3 or 6 months
Placebo
The subjects will receive daily dose of placebo during 6 month
Placebo
The subjects will receive daily dose of placebo during 3 or 6 months
Interventions
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MV140
The subjects will receive daily dose of MV140 during 3 or 6 months
Placebo
The subjects will receive daily dose of placebo during 3 or 6 months
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 75 years.
* Must be able to meet the dosage regimen.
* Subjects who had had at least 5 episodes of cystitis in the last 12 months.
* Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
* Subjects who were free of urinary tract infections at the time of inclusion in the study.
Exclusion Criteria
* Age was not within the established age range.
* Could not offer cooperation and/or had severe psychiatric disorders.
* Presented a pathologic post-micturition residue.
* Presented moderate to severe incontinence.
* Presented genital tumours.
* Presented Urinary tract tumours.
* Presented lithiasis.
* Presented alterations in the immune system.
* Presented complicated UTIs.
18 Years
75 Years
FEMALE
No
Sponsors
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Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Fernanda Lorenzo, PhD; MD-prof
Role: STUDY_DIRECTOR
Isidoro Martín, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Alfonso Sánchez, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Manuel José Vicente, PhD; MD
Role: PRINCIPAL_INVESTIGATOR
Stephen Foley, FRCS (Urol)
Role: PRINCIPAL_INVESTIGATOR
Locations
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Centro de Salud Universidad Centro
Salamanca, Castille and León, Spain
Centro de Salud Capuchinos
Salamanca, Castille and León, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
CENTRO DE SALUD de PEÑARANDA
Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, Spain
Royal Berkshire Hospital Nhs Foundation Trust
Reading, London, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2013-001838-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MV140-SLG-003
Identifier Type: -
Identifier Source: org_study_id
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