Evaluation of the Efficacy and Safety of MV140 (MV140)

February 17, 2021 updated by: Inmunotek S.L.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decrease in the number of RUTI exacerbations.
Time Frame: 1 year
Average reduction of RUTI exacerbations
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of RUTI exacerbations
Time Frame: 1 year
Review of RUTI exacerbations episodes severity per patient
1 year
First RUTI exacerbation
Time Frame: 1 year
When takes place the First RUTI exacerbation for every single patient
1 year
Medication consumption
Time Frame: 1 year
Review of medication consumed from the beginning to the end of the RUTI exacerbation
1 year
Health resource consumption
Time Frame: 1 year
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
Time Frame: 1 year
Counting the number of visits to the emergency service due to RUTI exacerbation
1 year
Number of hospitalizations due to RUTI exacerbations
Time Frame: 1 year
Counting the number of hospitalization days due to RUTI exacerbations
1 year
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
1 year
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.
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inmunotek S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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