Multicentre, randomised, double-blind, placebo-controlled clinical trial to confirm the efficacy, safety, and clinical impact of the mucosal bacterial therapeutic vaccine MV140 in women with non-complicated recurrent urinary tract infections (rUTIs).
This research study is looking into a new treatment called MV140, described as a 'bacterial therapeutic vaccine,' for women who suffer from recurrent urinary tract infections (rUTIs). A recurrent UTI means getting UTIs often. The study wants to find out if MV140 is effective at reducing the number of new UTIs and if it's safe to use, compared to a placebo (a dummy treatment). Participants will be randomly assigned to receive either MV140 or the placebo, alongside standard UTI treatments like antibiotics, over 15 months. The main goal is to measure how many new UTI episodes people experience and how many participants avoid new UTIs during this time.
At a glance
What is this study about?
This study is a clinical trial exploring a new approach to help women who frequently get urinary tract infections, often called UTIs. If you've had two or more UTIs in six months, or three or more in a year, you know how uncomfortable and disruptive they can be. This new treatment, named MV140, is described as a 'bacterial therapeutic vaccine'. It's designed to help your body fight off the bacteria that cause these infections, rather than just treating them with antibiotics each time an infection happens.
The study aims to answer two main questions: does MV140 actually work to reduce the number of new UTIs, and is it a safe treatment to use? To do this, some women in the study will receive MV140, while others will get a placebo, which looks just like MV140 but contains no active medicine. This comparison helps researchers understand the true effects of MV140. Some well-known antibiotics for UTIs, like Fosfomycin, Pivmecillinam, and Nitrofurantoin, may also be part of the care you receive if you get a UTI during the study.
This is a 'Phase III' study, which means it's a very important stage where doctors want to confirm previous findings and gather a lot of information before a new treatment might become widely available. The study will look at how many new UTIs women experience over 15 months, the severity of any new infections, and how often antibiotics are needed. They will also look at whether the treatment means fewer hospital visits for UTIs.
Key takeaways
- Exploring a new treatment (MV140) for frequent UTIs in women.
- Compares MV140 to a dummy treatment (placebo).
- Aims to see if MV140 reduces new UTI episodes and is safe.
- Study duration is 15 months.
- Open to women aged 18 and over who get recurrent UTIs.
- Standard UTI antibiotics are still available if needed during the study.
Who may be eligible?
This study is looking for women aged 18 and older who frequently get urinary tract infections (rUTIs). There isn't an upper age limit, so women of any adult age can potentially take part if they meet other criteria.
To be considered for the study, you would typically need to have a history of recurrent UTIs. This means you've likely had several UTIs within a specific timeframe, making you a suitable candidate to assess whether the new treatment can help reduce these infections.
As with all clinical trials, there will be other medical checks and criteria to ensure the study is safe for you and that the results are clear. Your doctor or the study team will discuss these details with you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you a woman?
- Do you experience recurrent (frequent) urinary tract infections?
- Are you able to attend regular study visits over 15 months?
What does participation involve?
If you decide to take part in this study, you would be involved for 15 months. During this time, you would be randomly assigned to receive either the new MV140 treatment or a placebo (a dummy treatment). Neither you nor your study doctor would know which one you are receiving – this is to ensure the results are fair.
You would have regular check-ups and visits with the study team. If you suspect you have a new UTI during the study, you would have an unscheduled visit for assessment. This would include checking for typical UTI symptoms like painful urination, needing to go to the toilet often, or cloudy urine, and also providing a urine sample for testing. The team would monitor how long any new UTIs last, how severe they are, and how often you need to take antibiotics for them. They would also keep track of any hospital visits or emergency care you might need related to UTIs.
Potential risks and benefits
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Common questions
What is a 'recurrent UTI'?
A recurrent UTI means you get urinary tract infections often, usually defined as two or more in six months or three or more in a year.
What is MV140?
MV140 is a new treatment being tested in this study. It's described as a 'bacterial therapeutic vaccine' designed to help your body fight off UTI-causing bacteria.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used to compare against the new treatment fairly.
Will I still get antibiotics if I get a UTI during the study?
Yes, if you get a UTI during the study, you will still receive standard antibiotic treatments like Fosfomycin, Pivmecillinam, or Nitrofurantoin, as decided by your doctor.
How long will I be in the study?
Your involvement in this study, including follow-up, would last for 15 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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