Evaluation of the Efficacy and Safety of MV140

Urinary Tract Infection Bacterial Clinical Trial

— MV140  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543827
• Other study ID #: MV140-SLG-003
• Secondary ID: 2013-001838-17
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Urinary Tract Infection Bacterial
• Urinary Tract Infections

Intervention

Biological:
• MV140
The subjects will receive daily dose of MV140 during 3 or 6 months
• Placebo
The subjects will receive daily dose of placebo during 3 or 6 months

Locations

Country	Name	City	State
Spain	CENTRO DE SALUD de PEÑARANDA	Peñaranda de Bracamonte	Salamanca, Castilla Y LEÓN
Spain	Centro de Salud Capuchinos	Salamanca	Castilla Y LEÓN
Spain	Centro de Salud Universidad Centro	Salamanca	Castilla Y LEÓN
Spain	Hospital Universitario de Salamanca	Salamanca	Castilla Y LEÓN
United Kingdom	Royal Berkshire Hospital Nhs Foundation Trust	Reading	London

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Countries where clinical trial is conducted

Spain,  United Kingdom, 

References & Publications (8)

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. — View Citation

Lorenzo Gómez MF, Collazos Robles RE, Virseda Rodríguez ÁJ, García Cenador MB, Mirón Canelo JA, Padilla Fernández 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. — View Citation

Lorenzo-Gómez MF, Padilla-Fernández B, García-Cenador MB, Virseda-Rodríguez ÁJ, Martín-García I, Sánchez-Escudero A, Vicente-Arroyo MJ, Mirón-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. — View Citation

Lorenzo-Gómez MF, Padilla-Fernández B, García-Criado FJ, Mirón-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. — View Citation

Martin-Cruz L, Sevilla-Ortega C, Benito-Villalvilla C, Diez-Rivero CM, Sanchez-Ramón 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. — View Citation

Sánchez Ramón S, Manzanares M, Candelas G. MUCOSAL anti-infections vaccines: Beyond conventional vaccines. Reumatol Clin. 2020 Jan - Feb;16(1):49-55. doi: 10.1016/j.reuma.2018.10.012. Epub 2018 Dec 7. Review. English, Spanish. — View Citation

Sánchez-Ramón S, Pérez 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. Review. — View Citation

Yang B, Foley S. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune(®). BJU Int. 2018 Feb;121(2):289-292. doi: 10.1111/bju.14067. Epub 2017 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in the number of RUTI exacerbations.	Average reduction of RUTI exacerbations	1 year
Secondary	Severity of RUTI exacerbations	Review of RUTI exacerbations episodes severity per patient	1 year
Secondary	First RUTI exacerbation	When takes place the First RUTI exacerbation for every single patient	1 year
Secondary	Medication consumption	Review of medication consumed from the beginning to the end of the RUTI exacerbation	1 year
Secondary	Health resource consumption	Counting the Health resource consumption due to RUTI exacerbation: visits to specialists, telephone calls, analyzes and urocultures	1 year
Secondary	Number of visits to the emergency service	Counting the number of visits to the emergency service due to RUTI exacerbation	1 year
Secondary	Number of hospitalizations due to RUTI exacerbations	Counting the number of hospitalization days due to RUTI exacerbations	1 year
Secondary	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
Secondary	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
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Review of the number of adverse event per patient	1 year