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Completed

NCT Number: NCT02543827

Evaluation of the Efficacy and Safety of MV140

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.

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Key information

Conditions

Urinary Tract Infection Bacterial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Salud Capuchinos, Salamanca, Castille and León, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MV140

Biological

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

Placebo

Biological

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

Primary outcomes

  1. Decrease in the number of RUTI exacerbations.

    Time frame: 1 year

    Average reduction of RUTI exacerbations

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Inmunotek S.L.

Industry

Registry information

Official study 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

Acronym: MV140

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2015
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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