Evaluation of the Efficacy and Safety of MV140 (MV140)

• ClinicalTrials.gov Identifier: NCT02543827
• Recruitment Status: Completed
• First Posted: September 7, 2015
• Last Update Posted: February 18, 2021
• Sponsor: Inmunotek S.L.
• Information provided by (Responsible Party): Inmunotek S.L.

Tracking Information

• First Submitted Date: August 17, 2015
• First Posted Date: September 7, 2015
• Last Update Posted Date: February 18, 2021
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: November 4, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 21, 2018)

Decrease in the number of RUTI exacerbations. [ Time Frame: 1 year ]

Average reduction of RUTI exacerbations

• Original Primary Outcome Measures (submitted: September 4, 2015): Decrease in the number of RUTI exacerbations. [ Time Frame: 1 year ]

Current Secondary Outcome Measures (submitted: March 21, 2018)

• Severity of RUTI exacerbations [ Time Frame: 1 year ]
  Review of RUTI exacerbations episodes severity per patient
• First RUTI exacerbation [ Time Frame: 1 year ]
  When takes place the First RUTI exacerbation for every single patient
• Medication consumption [ Time Frame: 1 year ]
  Review of medication consumed from the beginning to the end of the RUTI exacerbation
• Health resource consumption [ Time Frame: 1 year ]
  Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures
• Number of visits to the emergency service [ Time Frame: 1 year ]
  Counting the number of visits to the emergency service due to RUTI exacerbation
• Number of hospitalizations due to RUTI exacerbations [ Time Frame: 1 year ]
  Counting the number of hospitalization days due to RUTI exacerbations
• Changes from baseline in RUTI Assessment Test [ Time Frame: 1 year ]
  Compare the RUTI Assessment Test results at the beginning and at the end of the trial
• Percentage of difference in immunological parameters from baseline to end of the trial [ Time Frame: 1 year ]
  Compare the changes from specific cell proliferation baseline against antigens of the vaccine.
• Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ]
  Review of the number of adverse event per patient

Original Secondary Outcome Measures (submitted: September 4, 2015)

• Severity of RUTI exacerbations [ Time Frame: 1 year ]
• First RUTI exacerbation [ Time Frame: 1 year ]
• Percentage of days without symptoms [ Time Frame: 1 year ]
• Use of antibiotics as a prophylaxis and treatment of infection [ Time Frame: 1 year ]
• Percentage of days without medication [ Time Frame: 1 year ]
• Number of visit to the doctor due to RUTI exacerbations [ Time Frame: 1 year ]
• Number of visits to the emergency service [ Time Frame: 1 year ]
• Number of hospitalizations due to RUTI exacerbations [ Time Frame: 1 year ]
• Days of hospitalization due to RUTI exacerbations [ Time Frame: 1 year ]
• Changes from baseline in RUTI Assessment Test (CAT) [ Time Frame: 1 year ]
• Health costs during RUTI exacerbations [ Time Frame: 1 year ]
• Percentage of difference in immunological parameters from baseline to end of the trial [ Time Frame: 1 year ]
• Number of subjects with Adverse Events [ Time Frame: 1 year ]
• Number of subjects with local reactions [ Time Frame: 1 year ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Efficacy and Safety of MV140
• Official Title: 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
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Urinary Tract Infection Bacterial

Intervention

• Biological: MV140
  The subjects will receive daily dose of MV140 during 3 or 6 months
• Biological: Placebo
  The subjects will receive daily dose of placebo during 3 or 6 months

Study Arms

• Experimental: MV140 I
  The subjects will receive daily dose of MV140 during 6 months
  Intervention: Biological: MV140
• Experimental: MV140 II
  The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months
  Interventions:

  • Biological: MV140
  • Biological: Placebo
• Placebo Comparator: Placebo
  The subjects will receive daily dose of placebo during 6 month
  Intervention: Biological: Placebo

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 4, 2015): 240
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2020
• Actual Primary Completion Date: November 4, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women who gave their informed consent.
• 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:

• Had not given their informed consent.
• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain, United Kingdom

Administrative Information

• NCT Number: NCT02543827
• Other Study ID Numbers: MV140-SLG-003; 2013-001838-17 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Inmunotek S.L.
• Original Responsible Party: Same as current
• Current Study Sponsor: Inmunotek S.L.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Fernanda Lorenzo, PhD; MD-prof
• Principal Investigator: Isidoro Martín, PhD; MD
• Principal Investigator: Alfonso Sánchez, PhD; MD
• Principal Investigator: Manuel José Vicente, PhD; MD
• Principal Investigator: Stephen Foley, FRCS (Urol)

• PRS Account: Inmunotek S.L.
• Verification Date: February 2021