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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001838-17 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MV140 I | Experimental | The subjects will receive daily dose of MV140 during 6 months |
|
| MV140 II | Experimental | The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months |
|
| Placebo | Placebo Comparator | The subjects will receive daily dose of placebo during 6 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MV140 | Biological | The subjects will receive daily dose of MV140 during 3 or 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in the number of RUTI exacerbations. | Average reduction of RUTI exacerbations | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of RUTI exacerbations | Review of RUTI exacerbations episodes severity per patient | 1 year |
| First RUTI exacerbation | When takes place the First RUTI exacerbation for every single patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda Lorenzo, PhD; MD-prof | Study Director | |
| Isidoro Martín, PhD; MD | Principal Investigator | |
| Alfonso Sánchez, PhD; MD | Principal Investigator | |
| Manuel José Vicente, PhD; MD | Principal Investigator | |
| Stephen Foley, FRCS (Urol) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Universidad Centro | Salamanca | Castille and León | 37001 | Spain | ||
| Centro de Salud Capuchinos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26090341 | Background | 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. | |
| 26445597 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 17, 2022 | |
| Reset | Sep 25, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 17, 2022 | Sep 25, 2023 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo | Biological | The subjects will receive daily dose of placebo during 3 or 6 months |
|
| 1 year |
| Medication consumption | Review of medication consumed from the beginning to the end of the RUTI exacerbation | 1 year |
| Health resource consumption | Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures | 1 year |
| Number of visits to the emergency service | Counting the number of visits to the emergency service due to RUTI exacerbation | 1 year |
| Number of hospitalizations due to RUTI exacerbations | Counting the number of hospitalization days due to RUTI exacerbations | 1 year |
| Changes from baseline in RUTI Assessment Test | Compare the RUTI Assessment Test results at the beginning and at the end of the trial | 1 year |
| Percentage of difference in immunological parameters from baseline to end of the trial | Compare the changes from specific cell proliferation baseline against antigens of the vaccine. | 1 year |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Review of the number of adverse event per patient | 1 year |
| Salamanca |
| Castille and León |
| 37006 |
| Spain |
| Hospital Universitario de Salamanca | Salamanca | Castille and León | 37007 | Spain |
| CENTRO DE SALUD de PEÑARANDA | Peñaranda de Bracamonte | Salamanca, Castilla Y LEÓN | 37300 | Spain |
| Royal Berkshire Hospital Nhs Foundation Trust | Reading | London | RG1 5AN | United Kingdom |
| 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. |
| 22806485 | Background | 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. |
| 30527360 | Background | 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. |
| 25330031 | Background | 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. |
| 27966556 | Background | 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. |
| 33552074 | Background | 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. |
| 29171130 | Background | 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. |
| 38319200 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |