Uromune MV140 Urinary Tract Infection (UTI) Vaccine

UTIs Return Following Antimicrobial Resistance

Karen McClorey Hackett — Mon, 28 Apr 2025 09:18:54 +0000

Reviewer:

The global resistance to antibiotics is complicating the treatment of approximately 150 million urinary tract infections (UTIs) that occur annually.

According to new research, nearly half of the women presenting with symptoms at a major referral hospital have infections resistant to multiple drugs.

The study, conducted by researchers at Mzuzu University and published in the National Library of Medicine, found that the prevalence of UTIs among women assessed at Zomba Central Hospital in Malawi is 48.5%.

The most frequently isolated bacteria were Escherichia coli (27.2%), Staphylococcus species (26.5%), Enterobacter species (19.2%), Citrobacter freundii (11.9%), Proteus species (6%), Enterococcus species, and Serratia marcescens (4.6%).

Compared to other antibiotics, meropenem and amikacin were effective against most pathogens, with average sensitivity rates of 51% and 56%, respectively.

Nevertheless, high levels of resistance to ampicillin (87%), ceftriaxone (77%), ciprofloxacin (70%), gentamicin (77%), and cefoxitin (64%) were observed in this study.

"The data indicates a public health concern that extends beyond the expected physiological susceptibility during pregnancy," said Pizga Kumwenda, the study's lead investigator and a senior lecturer in microbiology and immunology at Mzuzu University.

From a UTI prevention perspective, several studies have evaluated the beneficial role of the Immunotek S.L. oral spray Uromune™ (MV140) vaccine in preventing recurrent urinary tract infections (rUTIs) caused by various pathogens.

For example, results from a long-term follow-up study on the safety and effectiveness of the MV140 vaccine for rUTIs were announced at the European Association of Urology Congress on April 6, 2024. The results show that 54% of study participants, both men and women, remained UTI-free for nine years following vaccination.

As of April 28, 2025, Uromune is unavailable in the U.S., Canada, and Spain.

However, this rUTI vaccine is commercially available and through Expanded Access Programs in approximately 20 countries, including England, Mexico, and Australia.

Information regarding Uromune vaccination services in these countries is available at this Vax-Before-Travel link.

Sub Title:

Uromune MV140 is an inactivated, oral spray, mucosal-based bacterial vaccine that reduces recurrent Urinary Tract Infections

Reference:

Characterization of urinary tract infections among females at a tertiary hospital in Malawi: a retrospective study

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Novel Urinary Tract Infection Diagnosis Coming Soon

Karen McClorey Hackett — Mon, 03 Mar 2025 20:36:56 +0000

Reviewer:

Robert Carlson, MD

With millions of women and men impacted by Urinary tract infections (UTIs) yearly, healthcare providers are embracing innovations to avoid misdiagnosis and overtreatment for this common bacterial disease.

Most UTIs are caused by uropathogenic E. coli (E. coli), but less common pathogens also cause infections.

About 400 million UTI cases and 236,000 related fatalities were estimated globally in 2019.

UTIs are characterized according to several schema and terminologies. The traditional UTI diagnosis endorsed by the U.S. CDC relies on symptoms, urinalysis, and culture, which are interpreted according to historical guidelines.

While foundational, this approach presents limitations, particularly in complex cases.

Furthermore, low-level bacteriuria and the presence of fastidious organisms are often overlooked in standard urine culture.

According to a mini-review published in January 2025, new technologies, including rapid molecular-based pathogen identification, next-generation sequencing, and advanced antimicrobial susceptibility testing, are advanced diagnostic methods representing unique challenges and advantages.

These researchers wrote, 'Given the challenges associated with traditional methods, it is unsurprising that the diagnostic field is pursuing solutions through novel technology. Market analysis demonstrates that over 30 direct-from-specimen products are developing for rapid detection, ID, phenotypic AST, and/or resistance gene detection for urinary microbes.'

'The methods can be categorized into methods that screen for bacteriuria, multiplex nucleic acid amplification tests, next-generation sequencing tests, and novel phenotypic AST approaches. Selected tests in development are described herein.'

These researchers added, 'In general, there is a tremendous need for outcomes research that defines the proper utilization of new assays amid the increasing complexity of clinical urology. Ideally, to leverage advanced diagnostics in real-world practice, the field must define the indication for such methods in the context of existing framework and definitions.'

'Only in this way can powerful analytic technologies be utilized for maximum diagnostic value.'

As of March 2025, the U.S. Centers for Disease Control and Prevention says most UTIs can be treated with antibiotics prescribed by a healthcare professional.

Uncomplicated and Recurring UTI patients require prophylactic antibiotic regimens, as vaccines are unavailable in the U.S.

As of 2025, international travelers seeking UTI vaccine appointments in about 20 countries can send requests at this Vax-Before-Travel link.

Researchers recently confirmed that the increasing burden of UTIs implies that proper prevention and treatment efforts should be strengthened, especially in high-income regions and aging societies.

Sub Title:

Oral UTI vaccine available in twenty countries in 2025

References:

Novel technologies for the diagnosis of urinary tract infections

US CDC - UTI

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UTI Vaccine Reported Very Effective in Portugal

Karen McClorey Hackett — Sun, 29 Dec 2024 10:49:29 +0000

Reviewer:

Robert Carlson, MD

A recent study found that 73% of adult Portuguese patients with urinary tract infections (UTIs) reported a reduction in symptom severity or duration of illness after treatment with Uromune™ (MV140). This inactivated oral spray serves as a novel sublingual mucosal-based bacterial vaccine.

This prospective observational study, which involved 125 patients with complicated and uncomplicated recurrent UTIs, was published in the journal MDPI Vaccines (12(12), 1426) on December 18, 2024. In addition to the primary outcome of symptom reduction, the study assessed overall patient satisfaction, adverse events, and the effectiveness of Uromune in subgroups with specific UTI risk factors.

During the 12 months following the start of treatment, 38% of patients were free of UTIs. Meanwhile, 34% reported experiencing one or two episodes, while the remaining 28% had three or more recurrent UTIs.

This data indicates a mean reduction of 3.20 UTI episodes per year per patient (with a confidence interval of 2.87 to 3.53; p < 0.001).

Based in Lisbon, Portugal, the researchers found that Uromune was more effective in post-menopausal women than in pre-menopausal women (74.7% vs. 59.4%, respectively; p = 0.029). Additionally, the vaccine was noted to be less effective in men.

Since 2017, various studies have evaluated the beneficial role of MV140 in preventing UTIs, which are among the most common bacterial infections, affecting millions of women and men annually. Uropathogenic E. coli causes most UTIs.

On November 4, 2024, the JAMA Network published a Consensus Statement for UTO clinical guideline development. However, most topics relating to the prevention, diagnosis, and treatment of UTIs lack high-quality prospective data. Clear recommendations cannot be made, and further research is of utmost importance to inform true evidence-based rather than eminence-based practice.

These researchers wrote, 'Sublingual vaccines, such as Uromune, may, in the future, be the cornerstone for prevention, even in patients with complicated UTIs, if future placebo-controlled research is able to reproduce the results of this study.'

While approved in various countries such as Mexico and the United Kingdom, Uromune™ (MV140) is not offered in Canada or the United States. International travelers can request a vaccine appointment abroad at Vax-Before-Travel.

Sub Title:

MV140 Is Effective in the Reduction of Urinary Tract Infections in Prospective Real-Life Study

Reference:

Immunoprophylaxis with MV140 Is Effective in the Reduction of Urinary Tract Infections—A Prospective Real-Life Study

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UTI Treatment Options Now Include Antibiotics, Cranberries, Vaccines

Karen McClorey Hackett — Tue, 20 Aug 2024 18:55:24 +0000

Reviewer:

Robert Carlson, MD

With over 50% of women reporting at least one urinary tract infection (UTI) in their lives, it has become a challenge for many women to identify the best interventions.

Most UTIs are bacterial bladder infections in females with no structural abnormalities of their urinary tract.

Based on recent announcements in 2024, efforts are being made to review science-based evidence supporting potential UTI interventions.

For example, a meta-analysis and systematic review of six studies published on July 18, 2024, offered evidence supporting possible nondrug preventions. This study found that antibiotic use was 49% lower with the consumption of cranberry juice than with placebo liquid and 59% lower with no treatment.

This study also found cranberry compounds were associated with a decrease in the prevalence of UTI symptoms.

Regarding new, innovative antibiotics, the U.S. Food and Drug Administration approved Pivya™ (pivmecillinam) tablets on April 24, 2024, for the treatment of female adults with uncomplicated UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

The FDA says Pivua is a unique class of antibiotics with potent in vitro and in vivo activity against the most common bacteria in UTI, including resistant strains such as ESBL-producing E coli.

"Uncomplicated UTIs are a prevalent condition impacting women and one of the most frequent reasons for antibiotic use," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, in a press release.

Over the past decade, limited studies in Europe and other countries have tested UTI vaccines, revealing positive results.

Uro-Vaxom® (OM-89) is an immunostimulant vaccine consisting of an oral tablet with 18 heat-killed strains of E coli bacteria. A review found that the risk ratio for developing at least one UTI in the female population was significantly lower in the OM-89 group (RR 0.61, 95% CI 0.48–0.78), and the mean number of UTIs was about half compared to placebo.

Uro-Vaxom has been used in Europe with minimal documented adverse events and is recommended by the European Association of Urology.

Separately, Uromune™ (MV140) is an inactivated, oral spray, mucosal-based bacterial vaccine that reduces recurrent UTIs. In clinical research over the past few years, Uromune induced immune responses systemically and in the genitourinary tract, especially the bladder's innate immune system.

Since 2017, about 21,000 patients, representing 1.5 million doses of Uromune, have been administered in special access programs in various countries.

When selecting the best UTI therapy in 2024, availability becomes essential.

According to recent announcements, UTI vaccines and Pivya may become available in the United States in 2025, which leaves cranberry UTI therapy available today.

As with all clinical sessions, the U.S. CDC says speaking with a healthcare provider is the best option.

Sub Title:

Pivya pivmecillinam tablets granted US FDA approval in 2024

References:

Cranberry Juice, Cranberry Tablets, or Liquid Therapies for Urinary Tract Infection

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

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Medical Tourism Services Include UTI Vaccines

Donald Hackett — Wed, 03 Jul 2024 09:52:23 +0000

Reviewer:

Robert Carlson, MD

An in-depth analysis of medical tourism reveals that companies are focusing on the needs of international patients, including access to advanced treatments, says the Company Filing Analytics Database of GlobalData, a leading data and analytics company.

On July 1, 2024, GlobalData reported medical tourism now provides an additional revenue stream for companies.

For instance, Max Healthcare Institute Ltd recently revealed that its international patient yearly revenue grew by 14%. And Fortis Healthcare Ltd.'s medical travel revenue grew 12%.

In a press release, Misa Singh, a Business Fundamentals Analyst at GlobalData, commented, "Vying for a piece of this big opportunity."

"....some (companies) are focused on positioning themselves as a key destination for international patients in certain areas of medical care."

"Other prominent discussion agendas include compliance with regulatory requirements, a focus on building reputation and brand in different countries, and the rollout of an international patient support program."

Regarding vaccine services, Vax-Before-Travel recently referred over 1,000 people to international destinations that offer access to urinary tract infection (UTI) vaccines and treatments, which are unavailable in the United States in 2024.

Sub Title:

GlobalData finds medical tourism gains prominence in 2024

References:

Medical tourism gains prominence in filing documents of companies, finds GlobalData

GlobalData Company Filings Database

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