Impact of whole-cell bacterial immunoprophylaxis in the management of recurrent urinary tract infections in the frail elderly

Lorenzo-Gómez, María Fernanda; Padilla‐Fernández, Bárbara; Flores-Fraile, Javier; Valverde-Martínez, Sebastián; González-Casado, Ignacio; Hernández, José-María De Dios; Sánchez-Escudero, Alfonso; Arroyo, Manuel-José Vicente; Martínez-Huélamo, Misericordia; Criado, Filomena Herrera; Blanco-Tarrío, Emilio; Márquez-Sánchez, Magaly Teresa; Flores-Fraile, María-Carmen; Saz-Leal, Paula; Mirón-Canelo, José Antonio; García-Perdomo, H.A.; García-Cenador, M.B.

doi:10.1016/j.vaccine.2021.08.093

Cited by 11 publications

(11 citation statements)

References 17 publications

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“…Globally, there is strong evidence to suggest that MV140 may be effective in preventing rUTI. Several non‐randomized studies conducted to date demonstrate promise regarding the efficacy of MV140 [11,14–17]. For example, a prospective study of 784 women by Ramirez Sevilla et al.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of MV140 in preventing recurrent urinary tract infections: a multicentre double‐blind randomized controlled trial protocol

Kovacic,

Canagasingham,

Zhong

et al. 2023

BJU International

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ObjectivesTo determine, firstly, whether MV140 reduces rates of recurrent urinary tract infections (rUTIs) in patients older than 65 years, measured as the number of urinary tract infections (UTIs) detected over 12 months following the completion of a 3‐month treatment course and, additionally, to assess the number of re‐admissions to the emergency department, the rate of antibiotic use for UTIs, the safety profile of MV140, and quality of life.Materials and MethodsThis is a multicentre, double‐blind, randomized controlled trial with two arms. Patients will be randomized and allocated to receive either a 3‐month course of MV140 or placebo (two sublingual sprays daily). Participants will have 3‐monthly consultations with the investigator for 12 months to assess differences in rates of rUTIs between the two groups. Study candidates will be identified and recruited from inpatient and outpatient clinics across Sydney via referral to the investigation team. After obtaining consent, participants will undergo initial study consultations including urine microscopy and culture, uroflowmetry, and bladder scan to assess postvoid residual urine volume. Participants will be randomized and provided with a unique trial number. Electronic medical records will be reviewed to collect relevant information. Participants will be provided with a study diary to record relevant data.ResultsFollow‐up consultations will be conducted every 3 months for a 12‐month duration, during which the study diary will be reviewed. These follow‐up consultations will primarily occur via telephone review, however, there will be flexibility for in‐person reviews for participants who find telephone consultation prohibitively difficult.ConclusionThis is a multicentre, double‐blinded, randomised control trial, the first in Australia to assess the safety and efficacy of MV140 Uromune vaccine in prevention of recurrent UTIs. Results have been promissing in the global literatures.

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Section: Discussionmentioning

confidence: 99%

Evaluation of MV140 in preventing recurrent urinary tract infections: a multicentre double‐blind randomized controlled trial protocol

Kovacic,

Canagasingham,

Zhong

et al. 2023

BJU International

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“…Future studies should target specific genetic characteristics (for, e.g., virulence factors) which may help in predicting recurrence and helps to target preventive strategies. Preventive intervention strategies such as immunoprophylaxis could be informed by the genetic information of recurrent strains, and may reduce the burden of disease caused by pathogenic and resistant E. coli strains [ 40 ].…”

Section: Discussionmentioning

confidence: 99%

Recurrent E. coli Urinary Tract Infections in Nursing Homes: Insight in Sequence Types and Antibiotic Resistance Patterns

et al. 2022

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Introduction: Recurrent urinary tract infections (rUTI) largely contribute to antibiotic use in older adults. Understanding the genetic characteristics of Escherichia coli (E.coli) is needed to identify patients at risk for recurrence. The aim of this study was to obtain a greater understanding of the genetics of E. coli rUTI in nursing home residents. Methods: This is a secondary analysis of a multicenter Dutch nursing home study (PROGRESS). E. coli strains from residents with a suspected UTI and positive urine culture were analyzed using antimicrobial susceptibility testing and whole-genome sequencing (WGS). Same-strain recurrences were identified by single-nucleotide polymorphism (SNP) analysis. Result: In total, 121 E. coli strains were analyzed using WGS, of which 54 belonged to a rUTI episode. One third of E. coli rUTI episodes were caused by the same strain (n = 18, 33.3%). Same-strain recurrence occurred anywhere between 30 and 434 days after the index UTI, caused by sequence types (ST): ST12, ST23, ST73, ST131, ST453, ST538 and ST2522, in seven nursing home residents. In both single UTI and rUTI, antimicrobial resistance rates were low. Conclusion: Recurrent UTI in nursing home residents are caused by same-strain E. coli as well as due to different E. coli strains or other uropathogens. Same-strain recurrence can occur over 400 days after the index UTI, suggesting that some strains have the ability to colonize the bladder or gut for longer periods.

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“…In studies examining the impact of MV140 on men with rUTIs, one [ 30 ] enrolled 136 men who experienced a 30% UTI-free rate at a 6-month follow-up, while another smaller study [ 34 ] described 14 men with rUTIs who reported a UTI-free rate of 71% at 12 months (10/14). Other studies evaluating subjects (men and/or women) with complicated UTIs including men with prostatitis [ 35 ], neurogenic bladder [ 36 ], autoimmune disease and treatment-mediated immunosuppressed patients [ 37 ], chronic renal disease and kidney transplant [ 38 , 39 , 40 , 41 ], lymphoproliferative disorders [ 42 ], frail elderly [ 43 , 44 ], children [ 45 ] and postsurgery [ 46 ] consistently reported favorable UTI-free rates ranging from 30–50% and significant UTI reduction rates and/or improved quality of life after MV140 treatment.…”

Section: Effectiveness Of Mv140 In Other Populations Of Patients With...mentioning

confidence: 99%

“…Strong evidence examining the use of MV140 in one particularly vulnerable population, the frail elderly, where the clinical impact would be enormous, is limited but certainly suggestive of effectiveness. In one prospective analysis of MV140 in the frail elderly [ 43 ] from nursing homes, 200 subjects (160 females, mean age 82.67 years; 40 males, mean age 80.23 years) had a median of 4.0 UTI (or asymptomatic bacteriuria) episodes per month treated with antibiotics. The UTI rate decreased significantly following MV140 treatment in females to a median of 0.1 UTI/month (range 0.0–0.4 UTIs/month).…”

Section: Effectiveness Of Mv140 In Other Populations Of Patients With...mentioning

confidence: 99%

An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women

Nickel

d’Oiron

2023

Pathogens

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Uncomplicated recurrent urinary tract infections (rUTIs) in women are associated with episodic bothersome symptoms and have a significant impact on the mental and physical quality of life. Treatment with antibiotics (short- and long-term dosing) results in acute and chronic side effects and costs and promotes general antibiotic resistance. Improved nonantibiotic management of rUTI in women represents a true, unmet medical need. MV140 is a novel sublingual mucosal-based bacterial vaccine developed for the prevention of rUTI in women. Based on observational, prospective, and randomized placebo-controlled studies, MV140 has been shown to safely prevent (or reduce the risk of) UTIs, reduce antibiotic use, overall management costs, and patient burden while improving the overall quality of life in women suffering from rUTIs.

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Impact of whole-cell bacterial immunoprophylaxis in the management of recurrent urinary tract infections in the frail elderly

Cited by 11 publications

References 17 publications

Evaluation of MV140 in preventing recurrent urinary tract infections: a multicentre double‐blind randomized controlled trial protocol

Evaluation of MV140 in preventing recurrent urinary tract infections: a multicentre double‐blind randomized controlled trial protocol

Recurrent E. coli Urinary Tract Infections in Nursing Homes: Insight in Sequence Types and Antibiotic Resistance Patterns

An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women

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