Uromune (MV140) / Inmunotek - LARVOL DELTA

Safety and Efficacy of MV140 Sublingual Vaccine (Uromune) in Preventing Recurrent Urine Infections Post Renal Transplant: A Case Series. (PubMed, Transpl Infect Dis) - No abstract available

Journal • Infectious Disease • Nephrology • Transplantation

Autovaccine immunoprophylaxis in patients with neurogenic bladder experiencing recurrent urinary tract infections. (PubMed, Front Immunol) - "Participants received a sublingual bacterial autovaccine (Uromune®) prepared from uropathogens isolated from their own urine cultures...Autovaccination appears to be a promising strategy for reducing the burden of recurrent UTIs in NB patients, with high patient satisfaction and fewer hospital visits. These findings support the need for larger, multicenter trials to confirm efficacy and define optimal treatment protocols."

Journal • Infectious Disease • Nephrology

To determine the effectiveness of Uromune reducing urinary tract infections in patients with a spinal cord injury who suffer from them recurrently (UAA 2025) - No abstract available

Clinical • CNS Disorders • Infectious Disease • Nephrology • Orthopedics

Efficacy of active immunoprophylaxis with Uromune therapy for the prevention of recurrent urinary tract infections in men: A single centre observational study (UAA 2025) - No abstract available

Clinical • Observational data • Infectious Disease • Nephrology

Bacterial Vaccines for Preventing Recurrent Urinary Tract Infections: A Systematic Review and Meta-Analysis (UAA 2025) - "The highest pooled risk ratio (RR) was found with MV140, 2.1 (95% CI: 1.3–2.5), and the second one was the Uro-Vaxom with RR 1.9, 95% CI: 1.5–2.2, and third one is Uromune with the RR of 1.8, 95% CI: 1.4–2.2...Bacterial vaccines are alternative, safe, and efficient ways to prevent rUTIs, reduce antibiotic use, and decrease the risk of AMR. Although some short-term benefits are shown, more high-quality, long-term trials are warranted to confirm long-term effects and optimize vaccination strategies. These results support the addition of bacterial vaccines to daily clinical practice to tackle these challenges sustainably."

Retrospective data • Review • Infectious Disease • Nephrology

Evaluating the use of Uromune® autovaccine in recurrent urinary tract infections: a pilot unicenter retrospective study in Reus, Spain. (PubMed, BMC Infect Dis) - "Uromune® autovaccine was associated with a significant reduction in the frequency of recurrent UTIs and related hospitalizations, offering substantial relief to patients. These findings suggest that Uromune® may be a promising option for managing recurrent UTIs, though controlled studies are needed to confirm its efficacy compared to standard treatments."

Journal • Retrospective data • Chronic Kidney Disease • Infectious Disease • Nephrology • Renal Disease

To determine the effectiveness of Uromune reducing urinary tract infections in patients with a spinal cord injury who suffer from them recurrently (UAA 2024) - No abstract available

Clinical • CNS Disorders • Infectious Disease • Nephrology • Orthopedics

Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer. (PubMed, J Immunol Res) - "Moreover, OM-89, Uromune, Urovac, Urivac, and ExPEC4V showed therapeutic benefits in controlling urinary tract infections in adults, especially women. Later, several similar bacterial lysate-based therapeutics have been developed to treat cancers, including bladder cancer, non-small cell lung cancer, and myeloma; among them, BCG for in situ bladder cancer is well-known. Proinflammatory cytokines, including IL-1, IL-6, IL-12, and TNF-α, may activate bacterial antigen-specific adaptive responses that could restore tumor antigen recognition and response by tumor-specific type 1 helper cells and cytotoxic T cells; therefore, bacterial lysates are worth investigating as a vaccination adjuvants or add-on therapies for several cancers."

Journal • Review • Bladder Cancer • Chronic Obstructive Pulmonary Disease • Genito-urinary Cancer • Hematological Malignancies • Immunology • Infectious Disease • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Nephrology • Non Small Cell Lung Cancer • Oncology • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sarcoma • Sinusitis • Solid Tumor • IL12A • IL6 • TNFA

Use of Uromune vaccine to prevent recurrent UTIs in kidney transplant recipients (UKKW 2024) - "To date we have 15 patients dosed with vaccine, 3 discontinued it due to adverse symptoms (palpitations, abnormal taste), one died of longstanding metastatic cancer before treatment completion. We report on 11 who have completed 6 months of follow up. Number (median (IQR)) of UTI/month pre-vaccine was 0.42 (0.25-1.1), in the first 3 months post vaccine 0 (0- 0.17), and within 6 months 0 (0-0.33)(p<0.0001, one way ANOVA) (Figure)."

Clinical • Immunology • Infectious Disease • Oncology • Transplant Rejection • Transplantation

Uromune in Treating Recurrent Urinary Tract Infections in Women (clinicaltrials.gov) - P2 | N=67 | Terminated | Sponsor: Queen's University | Active, not recruiting ➔ Terminated; Convenience sample based on available funding. Increased Covid-related costs of clinical research resulted in early termination

Trial termination • Infectious Disease • Nephrology

MV140 Mucosal Vaccine Induces Targeted Immune Response for Enhanced Clearance of Uropathogenic E. coli in Experimental Urinary Tract Infection. (PubMed, Vaccines (Basel)) - "This was accompanied by a highly significant increase in CD4+ T cells in the bladder and an increase in urinary neutrophils. Collectively, our results support that MV140 induces cross-reactive humoral and cellular immune responses and cross-protection against UPEC strains."

Journal • Infectious Disease • Nephrology • CD4

Evaluating the Safety and Effectiveness of Uromune® Bacterial Vaccine over a 9-Year Period in the UK: A Study on Managing Recurrent Urinary Tract Infections in Men and Women in the Initial Cohort (AUA 2024) - "This is the first long-term study on Uromune® and reveals an excellent safety record with minimal long-term adverse events. Furthermore, it underscores Uromune's sustained efficacy, albeit less than the outcomes reported in previous 1 year studies. Uromune® shows great promise as an alternative to conventional treatments for preventing recurrent UTIs."

Clinical • CNS Disorders • Gastrointestinal Cancer • Hepatology • Infectious Disease • Lung Cancer • Movement Disorders • Nephrology • Novel Coronavirus Disease • Oncology • Pancreatic Cancer • Pneumonia • Progressive Supranuclear Palsy • Solid Tumor

Immunoactive Prophylaxis Protocol of Uncomplicated Recurrent Urinary Tract Infections in a Cohort of 1104 Women Treated with Uromune® Vaccine. (PubMed, Life (Basel)) - "Patients at baseline with less than five UTIs will have better result and would benefit from a prophylaxis protocol with Uromune®."

Journal • Infectious Disease • Nephrology

Bacterial Vaccines for the Management of Recurrent Urinary Tract Infections: A Systematic Review and Meta-analysis. (PubMed, Eur Urol Focus) - "There is limited evidence to suggest that vaccinations are effective at reducing UTI recurrence in adult female patients in the short term. Owing to low quality of evidence, the literature requires further long-term RCTs with large sample sizes utilising standardised definitions for conclusive evidence of the long-term efficacy of vaccination in rUTI prevention."

Journal • Retrospective data • Review • Infectious Disease • Nephrology

Reducing Recurrent Urinary Tract Infections in Women with MV140 Impacts Personal Burden of Disease: Secondary Analyses of a Randomized Placebo-controlled Efficacy Study. (PubMed, Eur Urol Open Sci) - P3 | "Three months of MV140 is associated with a reduction of the personal burden of UTI by reducing overall UTI symptoms and antibiotic use, improving QoL in women with rUTI. Three months of MV140 vaccine, which has previously been shown to reduce the risk of urinary tract infection safely, is associated with a reduction in the personal burden of disease."

Clinical • HEOR • Journal • Infectious Disease • Nephrology • Pneumonia

Use of Uromune vaccine to prevent recurrent UTIs in kidney transplant recipients (BTS 2024) - No abstract available

Clinical • Transplantation

Assessing the long-term efficacy and safety of Uromune® bacterial vaccine in the initial cohort: A 9-year study in the uk for treating recurrent urinary tract infections in men and women (EAU 2024) - No abstract available

Clinical • Infectious Disease • Nephrology

Evaluation of MV140 in preventing recurrent UTIs - a multi-centre double-blinded RCT protocol. (PubMed, BJU Int) - "Follow-up consultations will be conducted every three months for a 12 month duration during which the study diary will be reviewed. These follow-up consultations will primarily occur via telephone review, however flexibility for in-person reviews will be for participants whom find telephone consultation prohibitive."

Journal • Infectious Disease • Nephrology

Immunoprophylaxis with autovaccine decreases hospital admissions and emergency room visits in patients with neurogenic bladder (AUA 2023) - "Subjects initiated a 3-month sublingual daily course of Uromune®... Autovaccines are well-tolerated and emerge as an effective treatment to prevent UTIs in patients with neurogenic bladder. They are effective regardless of the number and the type of isolated bacteria. Effectiveness perceived by the patient has shown to be positive."

Clinical • Infectious Disease • Nephrology

MV140 sublingual vaccine reduces risk of recurrent urinary tract infection (rUTI) in North American women: Results from the first North American clinical experience study (AUA 2023) - "This first Health Canada-approved North American experience with the sublingual vaccine, MV140, demonstrates its safety and potential effectiveness in real world clinical practice in reducing UTI risk and rendering a significant number of women suffering from rUTI completely UTI-free."

Clinical • Infectious Disease • Nephrology

Infection phenotype in Interstitial cystitis/bladder pain syndrome : Does bacterial-induced mucosal cellular immune imbalance hypersensitivity explain response to MV140 recurrent UTI vaccine? (AUA 2023) - "Sublingual MV140 vaccine in IC/BPS patients with rUTI not only report UTI-free or reduced UTI incidence status but also after approximately 9 months post vaccination, many have resolution of their-long term treatment refractory IC/BPS symptoms. This suggests some cases of IC/BPS may be etiologically based on a Th2 cell type hypersensitivity to bacteria within or entering the urinary microbiome that responds to a vaccine whose mechanism of action is to normalize or balance the bladder Th1/Th2 mucosal immune system."

Allergy • Immune Modulation • Immunology • Infectious Disease • Interstitial Cystitis • Musculoskeletal Pain • Pain

Candida albicans V132 induces trained immunity and enhances the responses triggered by the polybacterial vaccine MV140 for genitourinary tract infections. (PubMed, Front Immunol) - "Remarkably, splenocytes from sublingually V132-immunized and MV140 in vivo treatment mice show stronger Th17 responses than mice exposed to excipients upon in vitro stimulation with MV140. Overall, we provide novel mechanistic insights into how V132-induced trained immunity enhances both innate and adaptive immune responses triggered by MV140, which might open the door for new interventions for GUTIs with important clinical implications."

Journal • Candidiasis • Infectious Disease • Nephrology • Urology • Vaginitis • IL6 • TNFA

Uromune in Treating Recurrent Urinary Tract Infections in Women (clinicaltrials.gov) - P2 | N=62 | Active, not recruiting | Sponsor: Queen's University | Trial primary completion date: Oct 2021 ➔ Oct 2022

Trial primary completion date • Infectious Disease • Nephrology

Impact of MV140 on patient related burden of disease associated with the management of recurrent urinary tract infections (rUTI) (AUA 2022) - "UTI symptom severity was significantly reduced in the vaccinated groups with a concomitant improvement in quality of life experienced by the vaccinated subjects compared to those receiving placebo (Figure 1). Conclusions : MV140 significantly reduces the personal burden of UTI disease by safely decreasing risk of subsequent UTI, reducing severity of breakthrough UTI, reducing antibiotic use, healthcare resources, costs and ultimately improving the quality of life in women suffering from rUTI."

Clinical • HEOR • Infectious Disease • Nephrology • Pain

Re-imagining urinary tract infection in women: Clues from the urobiome of asymptomatic healthy controls vs vaccinated women with recurrent urinary tract infection (AUA 2022) - "In patients with rUTI those deficient mucosal–based mechanisms may be enhanced by an effective vaccine. This possible concept–shift regarding the cause of rUTI in women would have profound management implications."

Clinical • Immunology • Infectious Disease • Nephrology