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Uromune, a promising new vaccine aimed at preventing recurrent urinary
tract infections (UTIs), specifically cystitis, has gained attention in
the medical community. This detailed post addresses all your queries
about Uromune, from how it stimulates the immune system to fight off
infections to clinical trial results demonstrating its efficacy and
safety. Discover who can benefit most from Uromune, how to get
vaccinated, and what to expect in terms of results and potential side

What is Uromune?

Uromune, also known as MV140, is a sublingual polyvalent bacterial vaccine designed for the prevention of recurrent urinary tract infections (RUTIs). It contains a suspension of inactivated bacterial cells from selected strains of Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis.

The vaccine is administered sublingually (under the tongue) every 24 hours for a duration of three months.

Clinical studies have suggested that Uromune may be an effective alternative to antibiotics for the prophylaxis of rUTIs.

In a retrospective cohort study, patients treated with Uromune daily for three months had significantly higher UTI-free rates compared to those treated with six months of antibiotic prophylaxis over 15 months.

It has been shown to be particularly effective in women over 50 years old.

Additionally, Uromune has been compared favourably to prophylactic treatment with antibiotics, showing a significant reduction in the number of infections and potentially offering an alternative strategy that could reduce antibiotic consumption and address concerns related to antimicrobial resistance.

The vaccine’s impact on the management of recurrent urinary tract infections in the frail elderly has also been highlighted, with studies showing a significant decrease in the number of UTIs and an improvement in patients’ quality of life.

Patient taking sublingual Uromune vaccine

What is the mechanism of action of Uromune?

The immunological mechanisms underlying the efficacy of Uromune involve licensing human dendritic cells to generate Th1, Th17, and IL-10 responses, which are crucial for an effective immune response against urinary pathogens.

The vaccine works by activating spleen tyrosine kinase (Syk)- and myeloid differentiation primary response gene 88 (MyD88)-mediated pathways in dendritic cells, which in turn activate nuclear factor κB (NF-κB) and p38.

These pathways are essential for the generation of Th1/Th17 and IL-10 immune responses. Additionally, the c-Jun N-terminal Kinase (JNK) and extracellular-signal-regulated kinase (ERK) pathways contribute to Th1 and IL-10 responses, respectively.

What are the primary indications for Uromune?

The indications for Uromune, are for the prevention of recurrent urinary tract infections (RUTIs) in patients with a history of three or more uncomplicated UTIs in the 12 months prior to the first visit. It is used as a prophylactic treatment in patients with a history of frequent rUTIs.

The vaccine is administered sublingually every 24 hours over a course of three months.

Clinical studies have shown that Uromune can significantly reduce the number of UTI episodes in patients following treatment, with some studies indicating a higher UTI-free rate in patients treated with Uromune compared to those treated with antibiotic prophylaxis.

The vaccine is particularly noted for its effectiveness in reducing UTI recurrence in women, including menopausal women, and has been observed to have minimal side effects.

What is the dosage and administration method for Uromune?

The typical dosage and administration method for Uromune, is sublingual (under the tongue) administration daily for a period of three months.

What are the side effects associated with Uromune?

The potential side effects associated with Uromune, when administered sublingually every 24 hours for a period of three months, are reported to be minimal. In a prospective analysis, Uromune was found to decrease the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects.

Another study reported that one patient had to discontinue treatment due to an adverse event, which was a rash over the face and neck.

No major safety issues were identified in the trials included in a systematic review, which supports the safety profile of Uromune.

While these studies suggest that Uromune is generally well-tolerated, it is important to monitor patients for any adverse reactions, especially considering the individual variability in immune responses to sublingual vaccines.

What are the contraindications for Uromune?

The medical literature does not explicitly detail contraindications for Uromune. However, one patient in a study had to discontinue treatment due to an adverse event presenting as a rash over the face and neck, which suggests that hypersensitivity or allergic reactions to the vaccine components may be a contraindication.

It is important to consider the individual patient history and potential allergies to the bacterial strains included in the vaccine when considering Uromune for RUTI prevention. Additionally, as with any medical intervention, the risk-benefit profile should be evaluated on a case-by-case basis.


In summary, Uromune is a sublingual vaccine that has shown promise in the prevention of recurrent urinary tract infections, offering a potential alternative to long-term antibiotic prophylaxis.

If you would like to speak to a specialist about Uromune please contact The Pelvic Specialists.


Mr Neil Haldar MD MBBS FRCS

Mr Ian Currie MB ChB FRCOG


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.

Nickel JC, Saz-Leal P, Doiron RC.

Canadian Urological Association Journal = Journal De l’Association Des Urologues Du Canada.

Evaluation of a Therapeutic Vaccine for the Prevention of Recurrent Urinary Tract Infections Versus Prophylactic Treatment With Antibiotics.

Lorenzo-Gómez MF, Padilla-Fernández B, García-Criado FJ, et al.

International Urogynecology Journal. 2013;24(1):127-34.

Impact of Whole-Cell Bacterial Immunoprophylaxis in the Management of Recurrent Urinary Tract Infections in the Frail Elderly.

Lorenzo-Gómez MF, Padilla-Fernández B, Flores-Fraile J, et al.

Vaccine. 2021;39(42):6308-6314.

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.

Benito-Villalvilla C, Cirauqui C, Diez-Rivero CM, et al.

Mucosal Immunology. 2017;10(4):924-935.

Active Immunoprophyilaxis With Uromune® Decreases the Recurrence of Urinary Tract Infections at Three and Six Months After Treatment Without Relevant Secondary Effects.

Ramírez Sevilla C, Gómez Lanza E, Manzanera JL, Martín JAR, Sanz MÁB.

BMC Infectious Diseases. 2019;19(1):901.

First Experience in the UK of Treating Women With Recurrent Urinary Tract Infections With the Bacterial Vaccine Uromune.

Yang B, Foley S.

BJU International. 2018;121(2):289-292.