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Evaluation of the Efficacy and Safety of MV140 (MV140)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02543827
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Inmunotek S.L.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacterial Biological: MV140 Biological: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 4, 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in the number of RUTI exacerbations. [ Time Frame: 1 year ]
    Average reduction of RUTI exacerbations


Secondary Outcome Measures :
  1. Severity of RUTI exacerbations [ Time Frame: 1 year ]
    Review of RUTI exacerbations episodes severity per patient

  2. First RUTI exacerbation [ Time Frame: 1 year ]
    When takes place the First RUTI exacerbation for every single patient

  3. Medication consumption [ Time Frame: 1 year ]
    Review of medication consumed from the beginning to the end of the RUTI exacerbation

  4. Health resource consumption [ Time Frame: 1 year ]
    Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures

  5. Number of visits to the emergency service [ Time Frame: 1 year ]
    Counting the number of visits to the emergency service due to RUTI exacerbation

  6. Number of hospitalizations due to RUTI exacerbations [ Time Frame: 1 year ]
    Counting the number of hospitalization days due to RUTI exacerbations

  7. 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

  8. 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.

  9. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543827


Locations
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Spain
Centro de Salud Universidad Centro
Salamanca, Castilla Y LEÓN, Spain, 37001
Centro de Salud Capuchinos
Salamanca, Castilla Y LEÓN, Spain, 37006
Hospital Universitario de Salamanca
Salamanca, Castilla Y LEÓN, Spain, 37007
CENTRO DE SALUD de PEÑARANDA
Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, Spain, 37300
United Kingdom
Royal Berkshire Hospital Nhs Foundation Trust
Reading, London, United Kingdom, RG1 5AN
Sponsors and Collaborators
Inmunotek S.L.
Investigators
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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)
More Information
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Publications:

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Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT02543827    
Other Study ID Numbers: MV140-SLG-003
2013-001838-17 ( EudraCT Number )
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inmunotek S.L.:
Vaccine
Recurrent Urinary Tract Infections (RUTI)
Additional relevant MeSH terms:
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Urinary Tract Infections
Bacterial Infections
Infections
Urologic Diseases
Bacterial Infections and Mycoses