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Urinary Tract Infection BacterialPhase 3MV140NCT02543827

Evaluation of the Efficacy and Safety of MV140

A Phase 3 study testing MV140 in people with Urinary Tract Infection Bacterial, run by Inmunotek S.L. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Urinary Tract Infection Bacterial
What is being tested?
MV140
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
5 sitesin 2 countries
Study dates
Nov 2015to Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • Presented Urinary tract tumours.
  • Presented lithiasis.
  • Presented alterations in the immune system.
  • Presented complicated UTIs.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Spain4 sites

  • CENTRO DE SALUD de PEÑARANDA

    Peñaranda de Bracamonte, Salamanca, Castilla Y LEÓN, 37300

  • Centro de Salud Universidad Centro

    Salamanca, Castille and León, 37001

  • Centro de Salud Capuchinos

    Salamanca, Castille and León, 37006

  • Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007

Other trials in Spain

United Kingdom1 site

  • Royal Berkshire Hospital Nhs Foundation Trust

    Reading, London, RG1 5AN

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
MV140, Placebo
Keywords
Vaccine, Recurrent Urinary Tract Infections (RUTI)
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MV140Biological

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

  • PlaceboBiological

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

Study groups in NCT02543827
Study groupRoleWhat they receive
MV140 IExperimentalThe subjects will receive daily dose of MV140 during 6 months
Receives: Biological: MV140
MV140 IIExperimentalThe subjects will receive daily dose of MV140 during 3 months and placebo during 3 months
Receives: Biological: MV140; Biological: Placebo
PlaceboPlacebo comparatorThe subjects will receive daily dose of placebo during 6 month
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in the number of RUTI exacerbations.

    Average reduction of RUTI exacerbations

    Measured: 1 year

Secondary outcomes (9)

  1. Severity of RUTI exacerbations

    Review of RUTI exacerbations episodes severity per patient

    Measured: 1 year

  2. First RUTI exacerbation

    When takes place the First RUTI exacerbation for every single patient

    Measured: 1 year

  3. Medication consumption

    Review of medication consumed from the beginning to the end of the RUTI exacerbation

    Measured: 1 year

  4. Health resource consumption

    Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures

    Measured: 1 year

  5. Number of visits to the emergency service

    Counting the number of visits to the emergency service due to RUTI exacerbation

    Measured: 1 year

  6. Number of hospitalizations due to RUTI exacerbations

    Counting the number of hospitalization days due to RUTI exacerbations

    Measured: 1 year

  7. Changes from baseline in RUTI Assessment Test

    Compare the RUTI Assessment Test results at the beginning and at the end of the trial

    Measured: 1 year

  8. 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.

    Measured: 1 year

  9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Review of the number of adverse event per patient

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion4 Nov 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543827
Sponsor's protocol ID
MV140-SLG-003
Other IDs
2013-001838-17
Acronym
MV140
Status last verified
Feb 2021
First submitted
17 Aug 2015
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26090341

  • 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.

    PubMed 26445597

  • 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.

    PubMed 22806485

  • 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.

    PubMed 30527360

  • 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.

    PubMed 25330031

  • 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.

    PubMed 27966556

  • 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.

    PubMed 33552074

  • 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.

    PubMed 29171130

  • Lorenzo-Gomez MF, Foley S, Nickel JC, Garcia-Cenador MB, Padilla-Fernandez BY, Gonzalez-Casado I, Martinez-Huelamo M, Yang B, Blick C, Ferreira F, Caballero R, Saz-Leal P, Casanovas M. Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections. NEJM Evid. 2022 Apr;1(4):EVIDoa2100018. doi: 10.1056/EVIDoa2100018. Epub 2022 Jan 21.

    PubMed 38319200

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MV140 in people with Urinary Tract Infection Bacterial, run by Inmunotek S.L. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in the number of RUTI exacerbations. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543827, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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