NCT02543827

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_3

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

August 17, 2015

Last Update Submit

February 17, 2021

Conditions

Urinary Tract Infection Bacterial

Keywords

VaccineRecurrent Urinary Tract Infections (RUTI)

Outcome Measures

Primary Outcomes (1)

  • Decrease in the number of RUTI exacerbations.

    Average reduction of RUTI exacerbations

    1 year

Secondary Outcomes (9)

  • Severity of RUTI exacerbations

    1 year

  • First RUTI exacerbation

    1 year

  • Medication consumption

    1 year

  • Health resource consumption

    1 year

  • Number of visits to the emergency service

    1 year

  • +4 more secondary outcomes

Study Arms (3)

MV140 I

EXPERIMENTAL

The subjects will receive daily dose of MV140 during 6 months

Biological: MV140

MV140 II

EXPERIMENTAL

The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months

Biological: MV140Biological: Placebo

Placebo

PLACEBO COMPARATOR

The subjects will receive daily dose of placebo during 6 month

Biological: Placebo

Interventions

MV140BIOLOGICAL

The subjects will receive daily dose of MV140 during 3 or 6 months

MV140 IMV140 II
PlaceboBIOLOGICAL

The subjects will receive daily dose of placebo during 3 or 6 months

MV140 IIPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centro de Salud Universidad Centro

Salamanca, Castille and León, 37001, Spain

Location

Centro de Salud Capuchinos

Salamanca, Castille and León, 37006, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

CENTRO DE SALUD de PEÑARANDA

Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, 37300, Spain

Location

Royal Berkshire Hospital Nhs Foundation Trust

Reading, London, RG1 5AN, United Kingdom

Location

Related Publications (9)

  • 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: 26090341BACKGROUND

  • 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: 26445597BACKGROUND

  • 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: 22806485BACKGROUND

  • 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: 30527360BACKGROUND

  • 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: 25330031BACKGROUND

  • 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: 27966556BACKGROUND

  • 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: 33552074BACKGROUND

  • 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: 29171130BACKGROUND

  • 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.

    PMID: 38319200DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

September 7, 2015

Study Start

November 1, 2015

Primary Completion

November 4, 2020

Study Completion

December 1, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)ES(4)