Evaluation of the Efficacy and Safety of MV140

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Urinary Tract Infection Bacterial

Intervention / Treatment
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* Biological: MV140
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MV140 I<br>The subjects will receive daily dose of MV140 during 6 months | Biological: MV140<br>* The subjects will receive daily dose of MV140 during 3 or 6 months<br>|
| Experimental: MV140 II<br>The subjects will receive daily dose of MV140 during 3 months and placebo during 3 months | Biological: MV140<br>* The subjects will receive daily dose of MV140 during 3 or 6 months<br>Biological: Placebo<br>* The subjects will receive daily dose of placebo during 3 or 6 months<br>|
| Placebo Comparator: Placebo<br>The subjects will receive daily dose of placebo during 6 month | Biological: Placebo<br>* The subjects will receive daily dose of placebo during 3 or 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the number of RUTI exacerbations. | Average reduction of RUTI exacerbations | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of RUTI exacerbations | Review of RUTI exacerbations episodes severity per patient | 1 year | 
| First RUTI exacerbation | When takes place the First RUTI exacerbation for every single patient | 1 year | 
| Medication consumption | Review of medication consumed from the beginning to the end of the RUTI exacerbation | 1 year | 
| Health resource consumption | 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 | Counting the number of visits to the emergency service due to RUTI exacerbation | 1 year | 
| Number of hospitalizations due to RUTI exacerbations | Counting the number of hospitalization days due to RUTI exacerbations | 1 year | 
| Changes from baseline in RUTI Assessment Test | 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 | 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 | Review of the number of adverse event per patient | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Recurrent Urinary Tract Infections (RUTI)