Clinical trial NCT02543827: Evaluation of the Efficacy and Safety of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infection Bacterial
Keywords: Vaccine
Recurrent Urinary Tract Infections (RUTI)
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Decrease in the number of RUTI exacerbations.
timeFrame: 1 year
Secondary outcomes:
measure: Severity of RUTI exacerbations
timeFrame: 1 year
measure: First RUTI exacerbation
timeFrame: 1 year
measure: Medication consumption
timeFrame: 1 year
measure: Health resource consumption
timeFrame: 1 year
measure: Number of visits to the emergency service
timeFrame: 1 year
measure: Number of hospitalizations due to RUTI exacerbations
timeFrame: 1 year
measure: Changes from baseline in RUTI Assessment Test
timeFrame: 1 year
measure: Percentage of difference in immunological parameters from baseline to end of the trial
timeFrame: 1 year
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 year
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Centro de Salud Universidad Centro
state: Castilla Y LEÓN
city: Salamanca
country: Spain
facility: Centro de Salud Capuchinos
state: Castilla Y LEÓN
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla Y LEÓN
city: Peñaranda de Bracamonte
country: Spain
facility: CENTRO DE SALUD de PEÑARANDA
state: Salamanca, Castilla Y LEÓN
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital Nhs Foundation Trust
state: London
Study officials:
name: Fernanda Lorenzo, PhD; MD-prof
role: STUDY_DIRECTOR
name: Isidoro Martín, PhD; MD
role: PRINCIPAL_INVESTIGATOR
name: Alfonso Sánchez, PhD; MD
role: PRINCIPAL_INVESTIGATOR
name: Manuel José Vicente, PhD; MD
role: PRINCIPAL_INVESTIGATOR
name: Stephen Foley, FRCS (Urol)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.