Uromune MV140 Recurrent Urinary Tract Infection (rUTI) Vaccine Clinical Trials, Dosage, Indication, Side Effects
Immunotek S.L. Uromune™ MV140 is an inactivated, oral spray, novel sublingual mucosal-based bacterial vaccine that reduces recurrent Urinary Tract Infections (rUTI). In clinical research, MV140 has been found to induce immune responses both systemically and in the genitourinary tract, especially the bladder's innate immune system. MV140 contains four whole-cell inactivated bacteria, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis, in a suspension with water. Uropathogenic Escherichia coli (UPEC) accounts for the majority of community-acquired UTIs.
Uromune became available for clinical evaluation in 2010. In August 2020, CAUJ published a systematic review (VOL. 14 NO. 8) of the current literature and plans for the future regarding the use of MV140. Five studies met the inclusion criteria for primary review. In two retrospective comparative studies, subjects treated with Uromune daily for three months (519 women in total) had significantly higher UTI-free rates (35–90%) than subjects treated with six months of antibiotic prophylaxis (0% in 499 women in total) over 15 months (p<0.001 for both studies). In three prospective, uncontrolled studies, UTI-free rates for subjects treated with Uromune ranged from 33–78% over 9–24 months.
Uromune is approved for adults in various countries and through Expanded Access programs in 2024. However, It is not U.S. FDA-approved. Since 2017 (NCT04173013), about 21,000 patients, representing 1.5 million doses of Uromune, have been administered in special access programs.
Immunotek S.L. is at 5 Punto Mobi Street, 28805 Alcalá de Henares, Madrid, Spain. Immunotek launched an Expanded Access Program for UROMUNE in 2019 for individuals who failed antibiotic therapy.
Uromune MV140 rUTI Vaccine Availability
Uromune MV140 is commercially unavailable in the U.S., Australia, Canada, and Spain. This UTI vaccine is available in countries such as England, Mexico, the Dominican Republic, and Singapore. Uromune is available off-license in about 20 countries through Expanded Access Programs.
In Australia, Uromune is available from the Therapeutic Goods Administration Special Access Scheme or the Authorised Prescriber pathway. As of October 2024, Uromune vaccine appointment requests can be submitted at this Vax-Before-Travel link.
Uromune MV140 rUTI Vaccine Efficacy
Various clinical studies have evaluated the beneficial role of MV140 in preventing rUTIs. In 2012, an Original Article concluded the results obtained in a study favor the use of this bacterial-based therapeutic vaccine to reduce the frequency, duration, severity, and costs of rUTIs. In 2017, a prospective study suggested that Uromune was safe and effective at preventing UTIs in women. The journal Vaccine published a prospective analysis in 2021 of MV140 in the frail elderly from nursing homes, 200 subjects (160 females, mean age 82.67 years; 40 males, mean age 80.23 years) had a median of 4 UTI (or asymptomatic bacteriuria) episodes per month treated with antibiotics. The UTI rate decreased following MV140 treatment in females to a median of 0.1 UTI/month. U I-free rates for the 12 months following initiation of the vaccine were observed in 18% of women, while 81.7% were treated for <3 UTIs/year.
The NEJM Evidence published an Orginal Article on January 21, 2022: Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections. In this Phase 3 controlled clinical trial of modest size and duration, MV140 showed promising clinical efficacy in reducing recurrent UTI in women.
Ontario, Canada-based Dr. Curtis Nickel presented the pivotal, randomized, placebo-controlled trial in 2021. In women with rUTI, MV140 significantly reduced the risk of UTI, from a median UTI rate in the placebo group of three over the nine months to zero, a median in both the three- and six-month groups. The vaccine decreased the overall need for antibiotics, healthcare resources, and costs associated with rUTI management.
A study published in 2023 reported 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.
A prospective, descriptive, and multicenter research study published in February 2024 found that 1,104 women with three or more uncomplicated UTIs following immunoprophylaxis with Uromune® concluded patients at baseline with less than five UTIs will have better results and would benefit from a prophylaxis protocol with Uromune®. Uromine vaccination reduced the number of UTIs by about 70% and Increased the time to the next UTI from 48 days to 275 days.
On March 29, 2024, a Secondary Analysis of a Randomized Placebo-controlled Efficacy Phase 3 Study found three months of MV140 use is associated with a reduction of the personal burden of UTI by reducing overall UTI symptoms and antibiotic use, improving the qualify of life in women with rUTI.
Initial results from a long-term follow-up study of the safety and effectiveness of the MV140 vaccine for recurrent UTIs were announced at the European Association of Urology Congress on April 6, 2024. These results show that 54% of study participants, both men and women with recurrent UTIs, remained UTI-free for nine years following vaccination.
Uromune MV140 rUTI Vaccine Administration
In phase 3 clinical research, MV-140 was administered sublingually, which is known to bypass degradation by gastric fluids and gastrointestinal enzymes. A pineapple-flavored suspension spray was administered under the tongue daily for three months. Self-administered oral administration is a potential alternative to antibiotic treatments.
Uromune MV140 rUTI Vaccine Mechanism of Action
MV140 mechanism of action induces antibody production and activation of human dendritic cells to generate T helper (Th) 1, Th17, and interleukin-10. This results in anti-inflammatory T-cell responses in secondary lymphoid organs and locally in the bladder.
rUTI Prevention
Royal Berkshire Foundation Trust research shows that over 50% of people given the Uromune MV140 vaccine can prevent recurrent urinary tract infections for up to 9 years. A systematic review analysis reported UTI-free rates among MV140 vaccinated women of 32–90%.
Uromune MV140 rUTI Vaccine Indication
Uropathogenic Escherichia coli (UPEC) bacteria cause 80% of urinary tract infections, mainly cystitis. MV140 has demonstrated clinical efficacy in preventing recurrent cystitis. 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. Early clinical data present a compelling case for MV140 vaccination, which appears more effective than antibiotic prophylaxis at preventing rUTIs. Current rUTI infections, consisting of three or more episodes in one year or two or more infections in six months, affect about 10% of women. The risk rate of UTIs in older men is lower than in women.
Uromune MV140 rUTI Vaccine Side Effects
As of July 2024, no notable side effects were reported. Studies evaluating MV140 use in women with rUTIs have not reported any major safety concerns. The American Urological Association Education and Research, Inc. stated in May 2024 that a long-term study on Uromune® revealed an excellent safety record with minimal long-term adverse events. In February 2024, a review found no adverse reactions were reported in the two major comparative studies comparing MV140 to antibiotics. Only 15 reports of ARs have been filed for over 1.5 million doses (data on file, Pharmacovigilance Department, Inmunotek, Spain).
Uromune MV140 rUTI Vaccine Cost
The cost of Uromune vaccination varies by country. In Australia, a three-month treatment of the Uromune MV140 Vaccine costs about $320. In Mexico, the Benavides website lists the Uromune vaccine 6ml spray for $3,882 (pesos). In most UTI vaccine clinics, additional service fees apply.
Uromune MV140 rUTI Vaccine Price Benefit
Clinical studies confirm that MV140 significantly reduces the number of UTIs when compared to prevaccination UTI rates, antibiotic prophylaxis, and placebo. Results from this observational, prospective study, including women with rUTI, demonstrated a significant clinical, healthcare, and economic impact due to their associated direct costs, primarily from medical consultations. The decreased frequency of urinary infections following vaccination with Uromune resulted in a significantly reduced need for healthcare resources. L likewise, a marked drop in healthcare-associated expenses was found, including those driven by antibiotic use, PCP consultations, specialized care, and complementary tests, leading to a significant global reduction in expenditures associated with rUTI.
Uromune MV140 Vaccine European Guidelines
The European Association of Urology published rUTI guidelines that include a systematic review of two retrospective and three prospective cohort studies concluded that MV140 might decrease the number of rUTI episodes and/or increase the probability of patients being UTI-free.
Recurrent Uncomplicated UTI in Women: AUA/CUA/SUFU Guideline
Published by the American Urology Association, this document seeks to establish guidance for the evaluation and management of women with rUTI to prevent inappropriate antibiotic use, decrease the risk of antibiotic resistance, reduce adverse antibiotic use effects, provide guidance on anti-nonantibiotic-antibiotic strategies for prevention, and improve clinical outcomes and quality of life by reducing the recurrence of UTI events.
Uromune MV140 UTI Vaccine News
June 1, 2024 - Journal of Urology article: It’s Time to Embrace Vaccination as We Enter the Postantibiotic Era of Recurrent Urinary Tract Infection Management.
May 2, 2024 - The journal Nature published: UTIs make life miserable — scientists are finding new ways to tackle them.
April 22, 2024 - University of Oxford News: Recurrent Urinary Tract Infections can be prevented for up to nine years longer than with standard antibiotic treatments in over half of people treated, a new study has found.
April 6, 2024 - Gernot Bonkat, the EAU Chairman of Guidelines on Urological Infections, said: "These findings are promising. R current UTIs are a substantial economic burden, and the overuse of antibiotic treatments can lead to antibiotic-resistant infections. A follow-up study revealed encouraging data about the long-term safety and effectiveness of the MV140 vaccine. Further research into more complex UTIs and looking at different patient groups are needed to optimize how to use this vaccine better."
December 7, 2023 - An Original Article: Evaluation of MV140 in preventing recurrent urinary tract infections: a multicentre double-blind randomized controlled trial protocol.
February 21, 2023 - MDPI published a study titled "An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection 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.
January 23, 2023—The Mexican Journal of Urology published results from a clinical study on the behavior of the MV140 vaccine to prevent recurrent urinary tract infections in patients with metabolic syndrome and smoking.
January 21, 2022 - The NEJM published an ORIGINAL ARTICLE: Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections. M 140 showed promising clinical efficacy in reducing recurrent UTIs in women suffering from this condition.
September 1, 2021 - Clinical studies confirm the theoretical benefits of the MV140 vaccine as a safe and effective strategy to reduce the incidence and/or prevent rUTI in women. Physicians who treat rUTI and women who suffer from rUTI will soon have an evidence-based alternative to antibiotic management.
October 25, 2018 - This Review describes the pathogenesis of uncomplicated UTI nonantibiotic nonantibiotic treatments.nonantibiotic nonantibiotic management options for the prevention and management of rUTI in patients with a history of uncomplicated rUTI.
November 23, 2017 - Treating women with recurrent urinary tract infections with the bacterial vaccine Uromune® in the U.K. Of the 75 women who completed treatment, 59 (78%) had no subsequent UTIs in the follow-up period.
Uromune MV-140 Vaccine Clinical Trials
As of May 2024, at least eight clinical studies of Uromune, including one phase 3 randomized controlled trial, have been conducted. Four European clinical studies investigated Uromune for the prevention of rUTIs. Over 1,400 women experienced UTI-free rates ranging from 33% to 90%.
Phase 3 study (NCT02543827) - The median (interquartile range) of UTI episodes was 3 (0.5 to 6.0) for placebo compared with 0.0 (0.0 to 1.0) in both groups receiving MV140. Among women treated with placebo, 25% (95% confidence interval [CI], 15% to 35%) were free of UTIs compared with 56% (95% CI, 44% to 67%) and 58% (95% CI, 44% to 67%) of women who received 3 and 6 months of MV140 treatment, respectively. A total of 205 AEs in 101 participants were registered (81, 76, and 48 in the placebo, 3-month MV140, and 6-month MV140 groups, respectively). In this controlled trial of modest size and duration, MV140 showed promising clinical efficacy in reducing recurrent UTI in women suffering from this condition.
Cochrane Central Register of Controlled Trials—First experience in the United Kingdom with the novel sublingual vaccine uromune®in the treatment of women with recurrent urinary tract infections, Yang B, Foley S, International Journal of Surgery (London, England), 2017, 47, S3‐S4 | added to CENTRAL: 31 January 2018 | 2018 Issue 1.
BJUI published an Original Article in 2017 - The first experience treating women with recurrent urinary tract infections in the UK with the bacterial vaccine Uromune®. Study Results: Of the 75 women who completed treatment, 78% had no subsequent UTIs in the follow-up period. Before treatment, all women had experienced a minimum of three or more episodes of rUTI during the preceding 12 months. In proportion, the majority of recurrences occurred in postmenopausal women. O The patient had to stop treatment because of an adverse event (rash over the face and neck).
In 2015, a retrospective cohort study evaluated the medical records of 669 women with rUTIs in Spain; 339 had a 6-month prophylaxis with antibiotics and 360 a 3-month prophylaxis with a sublingual bacterial preparation (MV 140-Uromune®). The time frame after the prophylaxis period until the appearance of a new infection (assessed by uroculture) was scored and followed over one year. The absolute risk reduction (ARR) and number needed to treat (NNT) were also calculated. R results: All patients treated with antibiotics experienced a new UTI during the scoring period of 12 months, with 19 days being the median number of days free of UTIs (range 5–300). In the group treated with the bacterial preparation, 35 (9.7%) patients experienced a UTI in the same period. K plan-Meier curves comparing the accumulated survival (disease-free time) between both groups were significantly different (P < 0.0001). The absolute risk reduction (ARR) was 90.28% (87.18–93.38), and the number needed to treat (NNT) was 1.1 (1.1–1.1). These results suggest that the treatment with this bacterial preparation significantly reduces the incidence of rUTIs, arising as an effective strategy to reduce the frequency of rUTIs. I reduce antibiotic consumption, matching the current recommendations due to increased antimicrobial resistance.
