search
Back to results

Evaluation of the Efficacy and Safety of MV140 (MV140)

Primary Purpose

Urinary Tract Infection Bacterial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MV140
Placebo
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection Bacterial focused on measuring Vaccine, Recurrent Urinary Tract Infections (RUTI)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Salud Universidad Centro
  • Centro de Salud Capuchinos
  • Hospital Universitario de Salamanca
  • CENTRO DE SALUD de PEÑARANDA
  • Royal Berkshire Hospital Nhs Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MV140 I

MV140 II

Placebo

Arm Description

The subjects will receive daily dose of MV140 during 6 months

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

The subjects will receive daily dose of placebo during 6 month

Outcomes

Primary Outcome Measures

Decrease in the number of RUTI exacerbations.
Average reduction of RUTI exacerbations

Secondary Outcome Measures

Severity of RUTI exacerbations
Review of RUTI exacerbations episodes severity per patient
First RUTI exacerbation
When takes place the First RUTI exacerbation for every single patient
Medication consumption
Review of medication consumed from the beginning to the end of the RUTI exacerbation
Health resource consumption
Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures
Number of visits to the emergency service
Counting the number of visits to the emergency service due to RUTI exacerbation
Number of hospitalizations due to RUTI exacerbations
Counting the number of hospitalization days due to RUTI exacerbations
Changes from baseline in RUTI Assessment Test
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
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
Review of the number of adverse event per patient

Full Information

First Posted
August 17, 2015
Last Updated
February 17, 2021
Sponsor
Inmunotek S.L.
search

1. Study Identification

Unique Protocol Identification Number
NCT02543827
Brief Title
Evaluation of the Efficacy and Safety of MV140
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 4, 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection Bacterial
Keywords
Vaccine, Recurrent Urinary Tract Infections (RUTI)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MV140 I
Arm Type
Experimental
Arm Description
The subjects will receive daily dose of MV140 during 6 months
Arm Title
MV140 II
Arm Type
Experimental
Arm Description
The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The subjects will receive daily dose of placebo during 6 month
Intervention Type
Biological
Intervention Name(s)
MV140
Intervention Description
The subjects will receive daily dose of MV140 during 3 or 6 months
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
The subjects will receive daily dose of placebo during 3 or 6 months
Primary Outcome Measure Information:
Title
Decrease in the number of RUTI exacerbations.
Description
Average reduction of RUTI exacerbations
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Severity of RUTI exacerbations
Description
Review of RUTI exacerbations episodes severity per patient
Time Frame
1 year
Title
First RUTI exacerbation
Description
When takes place the First RUTI exacerbation for every single patient
Time Frame
1 year
Title
Medication consumption
Description
Review of medication consumed from the beginning to the end of the RUTI exacerbation
Time Frame
1 year
Title
Health resource consumption
Description
Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures
Time Frame
1 year
Title
Number of visits to the emergency service
Description
Counting the number of visits to the emergency service due to RUTI exacerbation
Time Frame
1 year
Title
Number of hospitalizations due to RUTI exacerbations
Description
Counting the number of hospitalization days due to RUTI exacerbations
Time Frame
1 year
Title
Changes from baseline in RUTI Assessment Test
Description
Compare the RUTI Assessment Test results at the beginning and at the end of the trial
Time Frame
1 year
Title
Percentage of difference in immunological parameters from baseline to end of the trial
Description
Compare the changes from specific cell proliferation baseline against antigens of the vaccine.
Time Frame
1 year
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Review of the number of adverse event per patient
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Lorenzo, PhD; MD-prof
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isidoro Martín, PhD; MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfonso Sánchez, PhD; MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel José Vicente, PhD; MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Foley, FRCS (Urol)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud Universidad Centro
City
Salamanca
State/Province
Castilla Y LEÓN
ZIP/Postal Code
37001
Country
Spain
Facility Name
Centro de Salud Capuchinos
City
Salamanca
State/Province
Castilla Y LEÓN
ZIP/Postal Code
37006
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
State/Province
Castilla Y LEÓN
ZIP/Postal Code
37007
Country
Spain
Facility Name
CENTRO DE SALUD de PEÑARANDA
City
Peñaranda de Bracamonte
State/Province
Salamanca, Castilla Y LEÓN
ZIP/Postal Code
37300
Country
Spain
Facility Name
Royal Berkshire Hospital Nhs Foundation Trust
City
Reading
State/Province
London
ZIP/Postal Code
RG1 5AN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26090341
Citation
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.
Results Reference
background
PubMed Identifier
26445597
Citation
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.
Results Reference
background
PubMed Identifier
22806485
Citation
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.
Results Reference
background
PubMed Identifier
30527360
Citation
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.
Results Reference
background
PubMed Identifier
25330031
Citation
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.
Results Reference
background
PubMed Identifier
27966556
Citation
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.
Results Reference
background
PubMed Identifier
33552074
Citation
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.
Results Reference
background
PubMed Identifier
29171130
Citation
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.
Results Reference
background

Learn more about this trial

Evaluation of the Efficacy and Safety of MV140

We'll reach out to this number within 24 hrs