Uromune (MV140) UTI Vaccine Research in the UK

Clinical Evidence, Trials and Long-Term Outcomes

Introduction

The Urology Partnership has led clinical research into the Uromune (MV140) UTI vaccine in the United Kingdom since its introduction in 2014.

Consultant urologists Mr Bob Yang and Mr Steve Foley were the first clinicians to introduce Uromune in the UK and have played a central role in international clinical trials, long-term outcome studies, and ongoing immunological research into recurrent urinary tract infections (UTIs).

Their work represents one of the longest-running real-world datasets on Uromune globally, with over nine years of patient follow-up data.

Key Clinical Findings

  • Median UTI episodes reduced from 3 to 0 in randomised controlled trials
  • 56–58% of patients remained infection-free, compared to 25% with placebo
  • Up to 67–75% reduction in UTI frequency observed in real-world studies
  • Effective in women, men and children
  • Effective in complex UTIs – for example chronic embedded infections, catheter infections and neurogenic bladders
  • Demonstrated safety and tolerability across multiple clinical settings

Clinical Leadership and Research Expertise

Mr Bob Yang and Mr Steve Foley are consultant urological surgeons with extensive experience in the management of recurrent and complex urinary tract infections.

They have contributed to the field through:

  • Leading the first UK cohort of patients treated with Uromune (2014)
  • Acting as Principal Investigators for the UK arm of an international randomised controlled trial (RCT)
  • Publishing clinical findings in peer-reviewed journals, including the New England Journal of Medicine and the British Journal of Urology International
  • Presenting research at international urology conferences
  • Developing treatment protocols for complex UTI patient groups

Their combined clinical and research experience positions them as experts in treating UTIs and two of the most experienced clinicians using Uromune in the UK.

What is Uromune (MV140)?

Uromune (MV140) is an immunomodulatory treatment designed to reduce recurrent urinary tract infections. It is commonly referred to as a “UTI vaccine“, although it differs from traditional vaccines in its mechanism and application.

Unlike antibiotics, which aim to eliminate bacteria directly, Uromune works by stimulating the body’s immune system to recognise and respond more effectively to the pathogens that commonly cause UTIs.

The formulation contains inactivated whole bacteria from four of the most common UTI-causing organisms:

  • Escherichia coli (E. coli)
  • Enterococcus species
  • Klebsiella species
  • Proteus species

Mechanism of Action

Research into Uromune suggests that recurrent UTIs are often linked to a failure of the local immune response within the urinary tract, rather than repeated external infection alone.

Uromune is designed to:

  • Stimulate mucosal immunity within the urinary tract
  • Enhance recognition of uropathogenic bacteria
  • Target embedded or persistent infections
  • Reduce bacterial colonisation over time

Emerging research, including work by Mr Bob Yang, highlights the role of biofilms and intracellular bacterial reservoirs in chronic urinary tract infections. These findings provide a potential explanation for infection persistence despite repeated antibiotic treatment (Yang et al., 2025).

Administration and Prescribing Status in the UK

Uromune is administered as a daily sublingual spray, typically over a three-month course.

It is currently an unlicensed medication in the UK and can only be prescribed on a named-patient basis by a specialist consultant following a full clinical assessment.


Clinical Research and Effectiveness of Uromune (MV140)

Patient Cohorts Studied

Uromune has been evaluated across a wide range of complex and high-risk patient groups, many of whom are underrepresented in traditional clinical trials. A lot of this work in the UK has been led by Mr Bob Yang and Mr Steve Foley.

These include:

  • Older (geriatric) patients
  • Patients with long-term urinary catheters
  • Immunocompromised individuals
  • Transplant recipients
  • Patients undergoing chemotherapy
  • Patients with neurogenic bladder dysfunction
  • Paediatric patients

This breadth of data provides valuable real-world insight into treatment performance.


Clinical Research Timeline

2014 – Introduction in the UK

Mr Yang and Mr Foley established the first UK cohort of patients treated with Uromune, focusing on safety, tolerability and patient selection.

Early Outcomes

In the first UK cohort study, treatment with Uromune was associated with a substantial reduction in the frequency of recurrent urinary tract infections. The majority of patients experienced a marked reduction in infection episodes, with a significant proportion remaining infection-free during follow-up. (Yang, 2017)


2017 – First UK Publication

Findings from the initial cohort were published in the British Journal of Urology, contributing to early clinical understanding in a UK population.


International Randomised Controlled Trial (RCT)

Mr Yang and Mr Foley served as Principal Investigators for the UK arm of a multi-centre RCT comparing MV140 to placebo.

Results were published in NEJM Evidence, demonstrating significant clinical efficacy.

RCT Outcomes

In this trial involving 240 women with recurrent UTIs, MV140 significantly reduced infection rates compared to placebo.

Patients treated with MV140 had a median of 0 – 1 UTIs during the study period, compared to 3 UTIs in the placebo group (p<0.001).

Additionally, 56–58% of patients receiving MV140 remained UTI-free, compared to 25% in the placebo group (Lorenzo-Gómez et al., 2022).

Most importantly, the side-effect data when compared to placebo showed an excellent safety profile for Uromune.


Long-Term Follow-Up (9 Years)

Following a mandatory pause in clinical trials during the Covid-19 pandemic, Mr Yang and Mr Foley conducted post-pandemic analysis of long-term outcomes. This provided insights into sustained effectiveness and informed best-practice protocols.

Long-Term Real-World Outcomes

Long-term follow-up data from UK patients suggests that the clinical benefits of Uromune may be sustained over multiple years.

Supporting observational and real-world studies have shown:

  • Overall Efficacy: 54% of participants (48 out of 89) remained completely UTI-free over the 9-year follow-up period (range 58–107 months). This included 39 women (54%) and 9 men (53%).
  • Infection-Free Duration: The average infection-free period across the cohort was 54.7 months (approximately 4.5 years). Women had a slightly longer average infection-free duration of 56.7 months, whilst men averaged 44.3 months.
  • Symptom Severity: Patients who did experience recurrent UTIs reported that their infections were less frequent and considerably less severe. Many noted that simply increasing fluid intake was sufficient to manage the symptoms, significantly reducing the need for antibiotic therapy.
  • Safety Profile: The long-term safety record was excellent. Out of the remaining 84 patients (5 passed away from unrelated causes), no long-term adverse events were reported.
  • Repeat Dosing: 40% of the participants opted to have repeat doses of the vaccine after one or two years to help maintain their immunity.

Key observations from long-term datasets also include:

  • Continued reduction in infection frequency
  • Reduced dependence on long-term antibiotics
  • Durable immune response over extended follow-up

This dataset led by Mr Bob Yang and Mr Steve Foley represents one of the longest real-world follow-ups for patients treated with Uromune globally.


Ongoing Immunological Research

Research led by Mr Yang and Mr Foley continues to explore the underlying immunology of recurrent UTIs.

Current focus areas include:

  • Bacterial biofilms and persistent infection
  • Intracellular bacterial reservoirs
  • Immune dysfunction in chronic UTIs
  • Mechanisms of action of immunomodulatory therapies

This work contributes to a broader shift in understanding UTIs as complex, immune-mediated conditions.

Furthermore, Mr Bob Yang’s research into embedded and chronic UTIs has significantly advanced our understanding of why standard urine tests often fail to detect bacteria in symptomatic patients, especially those with chronic or embedded UTIs. Because these patients frequently see their symptoms resolve with antibiotics, an underlying bacterial cause is highly likely.

His work has been instrumental in driving the development of novel molecular diagnostics, such as the Lodestar Dx. By identifying bacterial DNA—even when concurrent antibiotic use renders traditional urine cultures ineffective—these advanced tests provide a far more accurate and reliable diagnosis.


Media Coverage and Recognition

Research into Uromune (MV140) and UTI vaccines has received increasing attention from both scientific journals and international media including The BBC and ABC News. This reflects growing interest in non-antibiotic approaches to recurrent urinary tract infections.

Frequently Asked Questions

What is the Uromune (MV140) vaccine?

Uromune is an immunotherapy designed to reduce recurrent UTIs by enhancing the body’s immune response to common urinary pathogens.

Is Uromune available in the UK?

Yes, but it is unlicensed and must be prescribed by a specialist on a named-patient basis.

How effective is Uromune?

Clinical studies, including a randomised controlled trial, show a significant reduction in UTI recurrence and higher infection-free rates compared to placebo.

How is Uromune different from antibiotics?

Antibiotics treat active infections, whereas Uromune aims to prevent recurrence by improving immune function.

Who is suitable for the Uromune UTI vaccine?

Patients with recurrent or complex UTIs, particularly when the condition first starts, but also in patients where conventional treatments have failed, Uromune may also be considered.

References

  • Yang, B. (2017). Using Uromune as a novel treatment in women with recurrent urinary tract infections. BAUS Annual Meeting Poster.
  • Yang, B. & Foley, S. (2018). First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune®. BJU International.
  • Lorenzo-Gómez, M.-F. et al. (2022). Sublingual MV140 for prevention of recurrent urinary tract infections. NEJM Evidence.
  • European Association of Urology (2024). Press release on clinical research developments.
  • Yang, B. et al. (2025). Understanding recurrent urinary tract infections: the role of biofilms and intracellular bacterial reservoirs. Available at: https://pubmed.ncbi.nlm.nih.gov/40357538/

Page reviewed by: Mr Bob Yang, Consultant Urological Surgeon 

Date published: 25 March 2026

Date modified: 25 March 2026

Last reviewed: 25 March 2026