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Trial to confirm efficacy, safety, and clinical impact between the bacterial mucosal immunotherapy compared with placebo in women with localized recurrent cystitis without risk factors
EU CTIS ID: 2025-524377-16-00
What this study is testing
To evaluate the efficacy of the mucosal bacterial therapeutic vaccine MV140 in the reduction in the number of episodes of rUTI, by comparing the number of new UTIs between patients who receive MV140 compared to placebo during 15 months after the beginning of the trial intervention.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand and willing to comply with study requirements, to follow investigator´s instructions, and to provide written informed consent.
- Women with a diagnosis of uncomplicated UTI at the time of signing the informed consent form. This UTI episode must be confirmed both by the presence of symptoms (dysuria, overactive bladder (frequent and sudden urge to urinate), pelvic pain (pressure pain), pollakiuria, turbid white urine, hematuria, foul-smelling urine, polyuria, urinary itching, urgency of urination, etc) and a positive urine culture (defined as ≥103 colony forming unit (CFU)/ml). In addition, patients must meet at least one of the following criteria: a) Have not started systemic antibiotic treatment for the current episode of UTI at the time of signing the informed consent form; Or b) Be receiving antibiotic treatment for the current UTI episode with fosfomycin trometamol, nitrofurantoin monohydrate, nitrofurantoin macrocrystal, pivmecillinam and have not completed the dosing regimen.
- Participants experiencing at least 2 episodes of non-complicated urinary tract infection in the last 6 months, or 3 episodes of non-complicated urinary tract infection in the last 12 months. UTI episodes must have been diagnosed following the criteria indicated in inclusion criterion 2.
- Participants must have not responded to previous hygienic-sanitary measures and/or suppressive treatment and/or postcoital prophylaxis against UTI.
- Participants who have resolved the episode of UTI (the one which was diagnosed at the time of signing the informed consent form following the criteria indicated in inclusion criterion 2) at visit 1. An episode of UTI is considered to have ended 14 days after completion of antibiotic treatment for this indication, if symptomatology has ended.
- Women aged ≥ 18 and ≤65 years.
You likely can't join if
- Participant who are in another clinical trial or planning to receive any investigational trial intervention, investigational mucosal bacterial therapeutic vaccine, or investigational device for rUTI, or those who had participated in another trial within 4 weeks prior to screening.
- Underlying factors accepted to result in a complicated UTI: a. Obstruction at any site in the urinary tract b. Primary renal disease (polycystic renal disease) c. Neurogenic bladder d. Foreign material in the urinary tract e. Incomplete voiding f. Vesicoureteral reflux g. Immunosuppression h. Recent history of instrumentation
- Women receiving systemic or topical corticosteroid treatment within 4 weeks prior to screening
- Women reporting the use or planned use of any medications that may alter immune responses to the study immunotherapies within 3 weeks prior to screening.
- Patients who have undergone bone marrow or solid organ transplantation.
- Patients with diagnosis or suspicion of renal cancer.
See the full eligibility criteria
Who can join
- Able to understand and willing to comply with study requirements, to follow investigator´s instructions, and to provide written informed consent.
- Women with a diagnosis of uncomplicated UTI at the time of signing the informed consent form. This UTI episode must be confirmed both by the presence of symptoms (dysuria, overactive bladder (frequent and sudden urge to urinate), pelvic pain (pressure pain), pollakiuria, turbid white urine, hematuria, foul-smelling urine, polyuria, urinary itching, urgency of urination, etc) and a positive urine culture (defined as ≥103 colony forming unit (CFU)/ml). In addition, patients must meet at least one of the following criteria: a) Have not started systemic antibiotic treatment for the current episode of UTI at the time of signing the informed consent form; Or b) Be receiving antibiotic treatment for the current UTI episode with fosfomycin trometamol, nitrofurantoin monohydrate, nitrofurantoin macrocrystal, pivmecillinam and have not completed the dosing regimen.
- Participants experiencing at least 2 episodes of non-complicated urinary tract infection in the last 6 months, or 3 episodes of non-complicated urinary tract infection in the last 12 months. UTI episodes must have been diagnosed following the criteria indicated in inclusion criterion 2.
- Participants must have not responded to previous hygienic-sanitary measures and/or suppressive treatment and/or postcoital prophylaxis against UTI.
- Participants who have resolved the episode of UTI (the one which was diagnosed at the time of signing the informed consent form following the criteria indicated in inclusion criterion 2) at visit 1. An episode of UTI is considered to have ended 14 days after completion of antibiotic treatment for this indication, if symptomatology has ended.
- Women aged ≥ 18 and ≤65 years.
- Agree not to participate in another interventional clinical study during her participation in this trial.
- In the case of women of childbearing potential, those who agree to follow the required contraceptive measures from the time of signing the informed consent until Visit 4 (at least).
What rules you out
- Participant who are in another clinical trial or planning to receive any investigational trial intervention, investigational mucosal bacterial therapeutic vaccine, or investigational device for rUTI, or those who had participated in another trial within 4 weeks prior to screening.
- Underlying factors accepted to result in a complicated UTI: a. Obstruction at any site in the urinary tract b. Primary renal disease (polycystic renal disease) c. Neurogenic bladder d. Foreign material in the urinary tract e. Incomplete voiding f. Vesicoureteral reflux g. Immunosuppression h. Recent history of instrumentation
- Women receiving systemic or topical corticosteroid treatment within 4 weeks prior to screening
- Women reporting the use or planned use of any medications that may alter immune responses to the study immunotherapies within 3 weeks prior to screening.
- Patients who have undergone bone marrow or solid organ transplantation.
- Patients with diagnosis or suspicion of renal cancer.
- Patients with history of cone or acute renal failure within the 5 years prior to the participation in the study.
- Patients with presence of hereditary or acquired immunodeficiency.
- Patients with presence of chronic infectious diseases, such as hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
- Patients with any type of indwelling urinary catheter or ureteral stent, ostomy, or intermittent urinary catheterization since the last recurrence of urinary tract infection.
- Any other clinically significant medical condition, not related to UTI, or laboratory abnormality that, based upon investigator’s opinion, would jeopardize the safety of the patient or impact patient compliance.
- Hypersensitivity to any ingredients of the active treatment (MV140) or the placebo regarding bacteria products or any of the excipients.
- Participating reporting history of significant allergies to auxiliary medication allergies, anaphylaxis, or other serious reactions to vaccines or immunotherapies. If the participant is allergic or intolerant to fosfomycin, she cannot be allergic or intolerant to nitrofurantoin or to pivmecillinam.
- Pregnant or breast-feeding participant or suspected or intention of being pregnant during the trial.
- Diabetic women (controlled or not).
- Participant who has severe immune system deficiencies.
- Participant having serious underlying disease that could be life-threatening, or the participant is unlikely to survive for the duration of this clinical trial.
- Participant who, in the opinion of the investigator, has experienced a complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), flank pain, chills, or any other manifestations suggestive of upper UTI within the last 5 days before the study entry.
- Participant with a pre-baseline impairment in general health condition which requires assistance daily.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.