Evaluation of the Efficacy and Safety of MV140 (MV140)

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection Bacterial
• Intervention / Treatment: Biological: MV140; Biological: Placebo

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
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Castilla Y LEÓN
    • Salamanca, Castilla Y LEÓN, Spain, 37001
      • Centro de Salud Universidad Centro
    • Salamanca, Castilla Y LEÓN, Spain, 37006
      • Centro de Salud Capuchinos
    • Salamanca, Castilla Y LEÓN, Spain, 37007
      • Hospital Universitario de Salamanca
  • Salamanca, Castilla Y LEÓN
    • Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, Spain, 37300
      • CENTRO DE SALUD de PEÑARANDA
• United Kingdom
  • London
    • Reading, London, United Kingdom, RG1 5AN
      • Royal Berkshire Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MV140 I; The subjects will receive daily dose of MV140 during 6 months	Biological: MV140; The subjects will receive daily dose of MV140 during 3 or 6 months
Experimental: MV140 II; The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months	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
Placebo Comparator: Placebo; The subjects will receive daily dose of placebo during 6 month	Biological: Placebo; The subjects will receive daily dose of placebo during 3 or 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in the number of RUTI exacerbations.	Average reduction of RUTI exacerbations	1 year

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Inmunotek S.L.
• 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)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Vaccine; Recurrent Urinary Tract Infections (RUTI)
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Bacterial Infections and Mycoses; Urinary Tract Infections; Bacterial Infections
• Other Study ID Numbers: MV140-SLG-003; 2013-001838-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No