Uromune MV140 Urinary Tract Infection (UTI) Vaccine Clinical Trials, Dosage, Indication, News
Immunotek S.L. Uromune™ MV140 Urinary Tract Infection (UTI) inactivated, oral spray vaccine is approved for use by adults in various countries. MV140 contains four whole-cell inactivated bacteria, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis, in a suspension with water. This 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.
In clinical research, MV140 has been found to induce immune responses both systemically and in the genitourinary tract. The beneficial role of bacterial preparations for the prevention of rUTIs has been evaluated.
In 2017, a prospective study suggested that Uromune was safe and effective at preventing UTIs in women. 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. The full study results are expected by late 2024. In a previous clinical trial, patients were initially followed up for 12 months, and data from the women in the cohort was published in BJU International in 2017. Immunotek launched an Expanded Access Program for UROMUNE in 2019 for individuals for whom antibiotic therapy has failed, but of consideration in all cases, considering antibiotic-induced adverse reactions and increasing antibiotic resistance.
Immunotek S.L. is located at 5 Punto Mobi Street, 28805 Alcalá de Henares, Madrid, Spain.
Uromune MV140 Vaccine Administration
In phase 3 clinical research, MV-140 has been administered sublingually, which is known to bypass degradation by gastric fluids and gastrointestinal enzymes. Two sprays of a pineapple-flavored suspension are administered under the tongue daily for three months. Self-administered oral administration is a potential alternative to antibiotic treatments.
Uromune MV140 Vaccine Availability
MV140 first became available in Spain. It is now licensed in Mexico and available off-license in 26 countries through special access programs. MV140 is no longer available in the U.S. Uromune vaccine appointment requests in 2024 can be scheduled at this PVax link.
Uromune MV140 Vaccine Efficacy
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. UTI-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.
Uromune MV140 Vaccine Indication
Early clinical data presents a compelling case for vaccination, which appears to be more effective than antibiotic prophylaxis. The MV140 vaccine is a potential alternative to antibiotic treatments, which can lead to antibiotic-resistant infections. Recurrent (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.
Ontario, Canada-based Dr. Curtis Nickel presented in 2021 the pivotal, randomized, placebo-controlled trial. 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 the use of antibiotics, healthcare resources, and costs associated with rUTI management.
Uromune MV140 Vaccine Side Effects
No notable side effects were reported in April 2024.
Uromune MV140 Vaccine Cost
The cost of Uromune vaccination varies by country. In Australia, a three-month treatment of the Uromune MV140 Vaccine costs about $320.
Uromune MV140 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 decrease in the frequency of urinary infections following vaccination with Uromune resulted in a significantly reduced need for healthcare resources. 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 News
April 6, 2024 - Gernot Bonkat, the EAU Chairman of Guidelines on Urological Infections, said: "These findings are promising. Recurrent UTIs are a substantial economic burden, and the overuse of antibiotic treatments can lead to antibiotic-resistant infections. This follow-up study reveals 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 better how to use this vaccine."
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 - 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 - Behavior of 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. MV140 showed promising clinical efficacy in reducing recurrent UTIs in women suffering from this condition. Adverse effects were not clinically limiting.
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 and the need for nonantibiotic treatments and explores the nonantibiotic management options for the prevention and management of rUTI in patients with a history of uncomplicated rUTI.
Uromune MV-140 Vaccine Clinical Trials
As of 2024, at least eight clinical studies of Uromune, including one phase 3 randomized controlled trial, have been conducted. Several 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. Adverse effects were not clinically limiting. The Last Update was posted on September 29, 2023.
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 - First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune®. Study Results: Of the 75 women who completed treatment, 78% had no subsequent UTIs in the follow-up period. Prior to treatment, all women had experienced a minimum of three or more episodes of rUTI during the preceding 12 months. Proportionally, the majority of recurrences occurred in postmenopausal women. One 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 during 1 year. The absolute risk reduction (ARR) and number needed to treat (NNT) were also calculated. Results: All patients treated with antibiotics experienced a new UTI during the scoring period of 12 months, being 19 days 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. Kaplan-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) 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. It reduces antibiotic consumption, matching the current recommendations due to the raise of antimicrobial resistance.
