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MV140 for Women with Recurrent Uncomplicated Urinary Tract Infections

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in women with recurrent urinary tract infections, which means repeated infections of the bladder or other parts of the urinary system. The study is testing a mucosal bacterial vaccine called MV140 to see whether it can lower the number of new infections. Some participants will receive MV140 as a spray under the tongue, while others will receive a placebo. During the study, some participants may also use standard infection medicines such as fosfomycin, pivmecillinam, or nitrofurantoin if needed for treatment of an infection episode.

The purpose of the study is to confirm whether MV140 is safe and helpful in reducing repeated urinary tract infections. The trial lasts about 15 months after treatment begins. Over this time, participants are followed for new infection episodes, and study visits are used to check symptoms and general health. The study also looks at side effects and how the treatment affects daily life.

The vaccine used in the study contains inactive forms of common bacteria that can cause urinary tract infections: Klebsiella pneumoniae, Escherichia coli, Enterococcus faecalis, and Proteus vulgaris. These bacteria are not alive in the vaccine. The treatment is given as a small spray under the tongue.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Trial start and treatment assignment
After joining the trial, you are assigned to one of two treatment groups in a random way. The trial is double-blind, which means that neither you nor the study team knows whether you receive the study vaccine or the placebo. A placebo is a product with no active medicine.
The study compares MV140, a sublingual spray given under the tongue, with a placebo for MV140. The spray dose is 0.2 ml each time it is given. The trial also allows background treatment with one of the following oral medicines: fosfomycin calcium 3 g, pivmecillinam hydrochloride 1200 mg, or nitrofurantoin 100 mg with ascorbic acid. These medicines are taken by mouth.
The main purpose of the trial is to see whether MV140 lowers the number of new urinary tract infections during 15 months after the trial treatment begins.
Step 2
Trial treatment period
You receive the assigned trial product during the study period. If you are in the active group, you receive MV140 as a 0.2 ml sublingual spray. If you are in the comparison group, you receive the placebo for MV140 instead.
The trial also includes the oral background medicines listed in the study information: fosfomycin calcium 3 g, pivmecillinam hydrochloride 1200 mg, or nitrofurantoin 100 mg with ascorbic acid. The study information does not provide a more exact schedule, so only the dose and route can be stated.
The trial follows you for 15 months after the beginning of the trial treatment to count any new urinary tract infections and to compare the two groups.
Step 3
Monitoring for new urinary tract infections
During the 15-month study period, you are monitored for new urinary tract infections. A new infection must be confirmed by both symptoms and a positive urine culture. A urine culture is a laboratory test that checks whether bacteria are present in the urine.
The symptoms that may be checked include pain or burning when passing urine, a strong or sudden need to urinate, frequent urination, pelvic pain or pressure, cloudy white urine, blood in the urine, bad-smelling urine, increased urine amount, itching when urinating, and urgency to urinate.
The study measures how many new infections happen, how many people have new infections, and whether some people have fewer than 3 new infections during the 15 months.
Step 4
Unscheduled visits for suspected infection
If a new urinary tract infection is suspected, an unscheduled visit may take place. An unscheduled visit means a visit that is not part of the regular study schedule and happens because of symptoms.
During these visits, the study assesses the infection, including how severe it feels. The severity may be recorded using a VAS, which means visual analogue score. This is a simple scale used to show how strong pain or discomfort is.
The study also measures how long each infection lasts, how long it takes for a new infection to appear after the first trial product dose, and how long it takes after the last trial product dose.
Step 5
Additional study assessments
During the trial, your pain may be assessed with a visual analogue score throughout the study.
Your quality of life may be assessed using the SF-36 questionnaire. This is a set of questions about general health and daily well-being.
The trial also records the use of health care services related to urinary tract infections, including hospital admissions, emergency hospital visits, and outpatient visits.
The study monitors adverse events, which means unwanted medical problems, including serious ones. It also checks changes in vital signs and laboratory test results during the trial.
Step 6
End of follow-up
Your participation continues until the end of the 15-month follow-up period after the trial treatment begins.
At the end of the study period, the trial compares the two groups based on the number of new urinary tract infections, infection severity, duration of infections, pain scores, quality of life results, health care use, and safety findings.

Who can join the trial?

10 criteria

Be able to understand the study rules, be willing to follow the study instructions, and sign a written informed consent form. Informed consent means the person agrees to join the study after being told what it involves.
Be a woman with a current uncomplicated urinary tract infection when signing the informed consent. Uncomplicated means it is not made more serious by other major medical problems.
Have the current urinary tract infection confirmed by both symptoms and a positive urine culture. A urine culture is a laboratory test that grows bacteria from urine to show infection. The test must show at least 10³ colony forming units per milliliter, which means a small amount of bacteria that meets the study’s infection rule.
Have at least one of these for the current infection: have not started systemic antibiotic treatment yet, or be taking one of the allowed antibiotics for this infection and not have finished the full treatment course. Systemic antibiotics are medicines that work through the whole body.
Have had at least 2 episodes of uncomplicated urinary tract infection in the last 6 months, or 3 episodes in the last 12 months. Each episode must have met the study’s infection rules.
Have not improved with previous hygiene measures, suppressive treatment, or postcoital prophylaxis. Prophylaxis means medicine taken to help prevent infection, and postcoital means after sexual intercourse.
Have the current urinary tract infection resolved by Visit 1. Resolved means the infection has ended, and symptoms are gone. For this study, an infection is considered ended 14 days after finishing antibiotic treatment, if symptoms have stopped.
Be between 18 and 65 years old.
Agree not to take part in another interventional clinical study while in this trial. An interventional study is a study where a treatment or procedure is given to see its effect.
If able to become pregnant, agree to use the required contraception methods from the time of signing consent until at least Visit 4. Contraception means methods used to prevent pregnancy.

Who cannot join the trial?

19 criteria

Being in another clinical trial now, planning to receive another investigational treatment or device for recurrent urinary tract infections, or having taken part in another trial within the last 4 weeks.
Having any condition that can cause a complicated urinary tract infection, such as blockage anywhere in the urinary tract, polycystic kidney disease (a kidney disease with many fluid-filled sacs), neurogenic bladder (bladder problems caused by nerve damage), foreign material in the urinary tract, incomplete bladder emptying, vesicoureteral reflux (urine flowing backward toward the kidneys), immunosuppression (a weakened immune system), or recent urinary tract procedures or instruments.
Using systemic or topical corticosteroids within the last 4 weeks; corticosteroids are medicines that reduce inflammation and can affect the immune system.
Using, or planning to use, medicines that may change how the immune system responds within the last 3 weeks.
Having had a bone marrow transplant or a solid organ transplant such as a kidney, liver, or heart transplant.
Having renal cancer or a suspicion of renal cancer; renal means related to the kidneys.
Having had kidney failure in the past 5 years, including cone or acute renal failure as listed in the study record.
Having a hereditary or acquired immunodeficiency, which means the immune system is weak because of a condition present from birth or developed later.
Having a chronic infectious disease such as hepatitis B, hepatitis C, or HIV.
Having a urinary catheter left in place, a ureteral stent (a small tube placed in the tube from kidney to bladder), an ostomy (a surgically created opening for body waste), or using intermittent catheterization since the last UTI recurrence.
Having any other serious medical condition not related to UTI, or an important abnormal lab result, if the study doctor thinks it could make participation unsafe or make it hard to follow the study.
Having an allergy or strong sensitivity to any part of MV140 or the placebo, including bacterial products or other ingredients.
Having a history of major allergies to helper medicines, anaphylaxis (a severe, life-threatening allergic reaction), or serious reactions to vaccines or immunotherapies; also, if allergic or intolerant to fosfomycin, the person cannot be allergic or intolerant to nitrofurantoin or pivmecillinam.
Being pregnant, breast-feeding, suspected of being pregnant, or planning to become pregnant during the trial.
Having diabetes, whether it is well controlled or not.
Having severe immune system deficiency, meaning the body’s defense system is very weak.
Having a serious illness that could be life-threatening, or being unlikely to survive for the length of the study.
Having had a complicated UTI, an active infection of the upper urinary tract such as pyelonephritis (kidney infection) or urosepsis (infection spreading into the blood), or having flank pain, chills, or other signs of an upper UTI within the last 5 days before study entry.
Having poor general health before the study that requires help with daily activities.

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Unidade Local De Saude De Amadora Sintra E.P.E.
Amadora, Portugal
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Unidade Local De Saúde De Santa Maria, E.P.E.
Lisbon, Portugal

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Investigated drugs

Fosfomycin
is an oral antibiotic used as background treatment in the trial. It is a standard medicine for urinary tract infections and is given by mouth to help treat or prevent infection during the study.
MV140
is the main study treatment. It is a mucosal bacterial vaccine given as a spray under the tongue. It contains inactivated bacteria linked to urinary tract infections, and it is being tested to see if it can help the body reduce future urinary infections in women who have repeated UTIs.
Pivmecillinam
is an oral antibiotic used as background treatment in the trial. It is used to treat urinary tract infections and is included to provide standard infection treatment while the study checks the effect of the vaccine.
Nitrofurantoin
is an oral antibiotic used as background treatment in the trial. It is commonly used for urinary tract infections and is given to help manage or prevent infection during the study period.

What is already known about the treatment

Fosfomycin
Fosfomycin calcium is an oral antibiotic taken by mouth, usually as a single-dose granule or powder that is mixed with water. It is still widely used in medicine and is well described in medical literature, especially for urinary tract infections. It is mainly used to treat uncomplicated bladder infections, and it works by blocking an early step in bacterial cell wall building, which weakens and kills the bacteria. It belongs to the class of antibiotics called phosphonic acid derivatives, and in this trial it is used as background treatment for recurrent urinary tract infections.
MV140
MV140 is a sublingual spray suspension placed under the tongue, where it is absorbed through the lining of the mouth. It is an experimental bacterial vaccine made from inactivated strains of common urinary bacteria, and it is being studied in medical literature for preventing repeated urinary tract infections rather than treating an active infection. Its main use in research is to help reduce the number of new infections in women with recurrent urinary tract infections, and it is thought to work by training the immune system to recognize these bacteria more effectively. It belongs to the group of other bacterial vaccines.
Pivmecillinam
Pivmecillinam hydrochloride is an oral antibiotic taken by mouth, usually as tablets. It is an established medicine in clinical practice and is well known in medical literature, especially for urinary tract infections. It is mainly used to treat uncomplicated urinary tract infections, and it works by interfering with bacterial cell wall formation, which stops the bacteria from growing and surviving. It belongs to the penicillin group of antibiotics, more specifically to the class of amidinopenicillins, and in this trial it is used as background treatment.
Nitrofurantoin
Nitrofurantoin is an oral medicine taken by mouth, often as capsules or tablets, and some products also include ascorbic acid. It is an established and commonly used antibiotic with a long history in medical practice and medical literature, especially for urinary tract infections. It is mainly used to treat and help prevent bladder infections, and it works inside bacteria by damaging important cell parts and blocking vital processes they need to live. It belongs to the class of nitrofuran antibiotics, and in this trial it is used as background treatment for recurrent urinary tract infections.

Investigated diseases

Recurrent urinary tract infection - This is a condition in which urinary tract infections happen again and again over time. Each episode usually starts with symptoms such as burning or pain when urinating, a frequent need to urinate, urgency, lower pelvic discomfort, cloudy or foul-smelling urine, or blood in the urine. The infection may clear and then return after a symptom-free period. Over time, the pattern is marked by repeated separate episodes rather than one continuous illness.