Could sublingual vaccination be a viable option for the prevention of recurrent urinary tract infection in Canada? A systematic review of the current literature and plans for the future

Abstract

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 Introduction: We conducted a systematic review to examine the role of a novel sublingual vaccine – Uromune – for prevention of recurrent urinary tract infection (rUTI) to understand its potential role for Canadian women suffering from rUTI.
 Methods: Databases were searched for studies published from 2010-2020 that investigated use of Uromune in management of rUTI. Only original clinical studies which included use of Uromune as prophylaxis for uncomplicated rUTI in women that included UTI-free rate following initiation of vaccine as an outcome were included.
 Results: Of 73 publications related to Uromune and UTIs, 19 unique clinical studies were identified evaluating Uromune for prevention of rUTI. Five studies met our inclusion criteria for primary review. These included 1,408 women treated with Uromune. In 2 retrospective comparative studies, subjects treated with Uromune daily for 3 months had significantly higher UTI-free rates (35 to 90%) than subjects treated with 6 months of antibiotic prophylaxis (0% in 499 women in total) over 15 months (p<0.001 for both studies). In 3 prospective uncontrolled studies, UTI-free rates for subjects treated with Uromune ranged from 33 to 78% over 9-24 months. No major safety issues were identified in these trials. Additional unique studies evaluating Uromune for rUTI that did not meet our criteria added consistent confirmation of the potential efficacy and safety of Uromune to prevent rUTI.
 Conclusions: Although these findings require confirmation in currently active prospective clinical studies, including a randomized placebo-controlled trial, Uromune may be an alternative to antibiotics to prevent rUTI in Canadian women.

Sublingual Bacterial Vaccination Reduces Recurrent Infections in Patients With Autoimmune Diseases Under Immunosuppressant Treatment

“…Furthermore, our results are further supported by recently published data in common variable immunodeficiency subjects suffering from RRTIs, where MV130 treatment significantly reduced the number of episodes of respiratory infection, antibiotic uptake, and unscheduled medical visits (11). On the other hand, different retrospective and prospective studies indicate that MV140 protect women suffering from uncomplicated RUTI, increasing the probability of UTI-free status and/or reducing the frequency of UTIs (16)(17)(18)(19)(20)(21).…”

“…The rationale for using MV130 and MV140 daily for 3 months was supported by previous publications with both formulations (11,13,(16)(17)(18)(19)(20)(21)(22). We sought to determine the clinical benefit of MV130 in a cohort of patients with SAD and recurrent infections who underwent immunization with MV130 for 3 months.…”

“…These formulations have shown to confer a non-specific broadspectrum protection against recurrent respiratory tract infections (RRTI) from bacterial and viral origin (MV130) (11,(13)(14)(15) or recurrent urinary tract infections (RUTI) (MV140) (16)(17)(18)(19)(20)(21). Both MV130 and MV140 have been described as putative TIbVs (10).…”

A Combination of Polybacterial MV140 and Candida albicans V132 as a Potential Novel Trained Immunity-Based Vaccine for Genitourinary Tract Infections

“…MV140 (Uromune) is a polyvalent bacterial preparation based on whole heat-inactivated components used to prevent RUTIs ( 38 ). This sublingual vaccine is composed of bacteria causing the majority of RUTIs in Europe: 75% Gram-negative bacteria (25% Escherichia coli , 25% Proteus vulgaris and 25% Klebsiella pneumoniae ) and 25% Gram-positive bacteria ( Enterococcus faecalis ) ( 26 ).…”

Strategies to Tackle Antimicrobial Resistance: The Example of Escherichia coli and Pseudomonas aeruginosa

“…MV140, also known as Uromune, is a sublingual vaccine composed of a mixture of inactivated Escherichia coli , Klebsiella pneumoniae , Proteus vulgaris and Enterococcus faecalis currently pre-licensed in phase 3 stage. Although randomized placebo-controlled clinical trials are still underway, preliminary data from retrospective and prospective uncontrolled studies reported a significant efficacy of the vaccine to prevent recurrent UTIs in women between 16 and 97 years old [ 109 , 110 ]. However, the compliance of this treatment could be questioned considering the 3-month daily administration period.…”