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Study on the Safety and Effectiveness of a UTI Vaccine (GSKVX000000046019) for Adults Aged 18-64 and Women Aged 18-64 with 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 focused on studying a vaccine for Urinary Tract Infections (UTIs), which are infections that affect parts of the urinary system, such as the bladder and urethra. The vaccine being tested is designed to prevent UTIs caused by a type of bacteria called E. coli. The vaccine is given as a suspension for injection, which means it is a liquid form that is injected into the muscle. The study will compare the effects of the vaccine to a placebo, which is a substance with no active ingredients.

The purpose of the study is to assess the safety and effectiveness of the vaccine in adults aged 18 to 64. Participants will receive two doses of the vaccine or placebo. The study will monitor participants for any side effects or reactions to the vaccine, as well as its ability to prevent new cases of UTIs. The study will also look at how the body responds to the vaccine, which is known as immunogenicity. This means checking if the vaccine helps the body to build protection against the infection.

The study will take place over a period of time, with follow-up visits to check on participants' health and any occurrences of UTIs. The goal is to see if the vaccine can effectively reduce the number of UTIs caused by E. coli in the participants. This research is important for developing new ways to prevent UTIs and improve the health of those who are prone to these infections.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the study criteria.
A blood sample may be collected to check hormone levels if applicable. You will also be asked to provide written informed consent, confirming your understanding and agreement to participate in the study.
Step 2
First dose administration
You will receive the first dose of the study vaccine or a placebo. The vaccine is administered as a suspension for injection through intramuscular use.
After receiving the injection, you will be monitored for 60 minutes to observe any immediate reactions.
Step 3
Post-dose 1 monitoring
For the first 7 days after the first dose, you will be asked to report any reactions at the injection site or any general symptoms you may experience.
For 30 days following the first dose, you should report any unexpected symptoms or side effects.
Step 4
Second dose administration
Approximately 60 days after the first dose, you will receive the second dose of the study vaccine or placebo, administered in the same manner as the first.
You will again be monitored for 60 minutes after the injection to observe any immediate reactions.
Step 5
Post-dose 2 monitoring
For the first 7 days after the second dose, you will be asked to report any reactions at the injection site or any general symptoms you may experience.
For 30 days following the second dose, you should report any unexpected symptoms or side effects.
Step 6
Long-term follow-up
You will be monitored for any serious side effects or medical events until the end of the study, which is approximately 12 months after the second dose.
During this period, you will be asked to report any urinary tract infections confirmed by urine culture, particularly those caused by E. coli.

Who can join the trial?

11 criteria

Participants who, in the opinion of the study doctor, can and will follow the study rules.
Participants must provide written consent before any study-specific procedures are done.
Female participants of non-childbearing potential can join the study. This means women who cannot become pregnant.
Female participants of childbearing potential can join the study if they meet these conditions:
- Have used effective birth control for 1 month before receiving the study treatment.
- Have a negative pregnancy test on the day they receive the study treatment.
- Agree to continue using effective birth control during the study and for at least 1 month after the study treatment ends.
- A blood sample may be taken to check hormone levels, specifically follicle stimulating hormone (FSH) and estradiol.
- For Part 1 of the study:
  - Both females and males aged 18 to 64 years can participate.
  - Participants must be healthy based on their medical history, lab tests, and a physical exam.
  - For Part 2 of the study:
    
    Only females aged 18 to 64 years can participate.
    Participants must have had at least one episode of a urinary tract infection (UTI) caused by E. coli confirmed by a urine test in the last 12 months.

Who cannot join the trial?

8 criteria

Patients who are currently experiencing a **Urinary Tract Infection (UTI)** cannot participate. A UTI is an infection in any part of the urinary system, like the bladder or kidneys.
Patients who have had a UTI caused by **E. coli** in the past 3 months are not eligible. **E. coli** is a type of bacteria that can cause infections.
Patients with a known allergy to any component of the vaccine cannot join. An allergy is when your body reacts negatively to something.
Patients who are pregnant or planning to become pregnant during the study cannot participate. Pregnancy is the condition of carrying a developing embryo or fetus within the female body.
Patients who are breastfeeding are not eligible. Breastfeeding is feeding a baby with milk directly from the breast.
Patients with a weakened immune system cannot participate. The immune system is the body's defense against infections.
Patients who have received another vaccine within the last 4 weeks are not eligible. A vaccine is a substance that helps protect against certain diseases.
Patients who are participating in another clinical trial cannot join. A clinical trial is a research study to test new treatments.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

UTI Vaccine The UTI vaccine is a new treatment being tested to see if it can help prevent urinary tract infections (UTIs) caused by a type of bacteria called E. coli. This vaccine is designed to help your body build a defense against these bacteria, which are a common cause of UTIs. The study is looking at how safe the vaccine is and how well it works in stopping new infections. If successful, this vaccine could be a new way to protect people, especially women, from getting UTIs.

What is already known about the treatment

UTI Vaccine – This vaccine is administered through an injection and is currently being studied in clinical trials to determine its safety and effectiveness. It is designed to prevent urinary tract infections (UTIs), specifically those caused by E. coli bacteria, in adults aged 18 to 64. The vaccine works by stimulating the body's immune system to recognize and fight off the bacteria before it can cause an infection. It falls under the pharmacological classification of vaccines, which are substances used to stimulate the production of antibodies and provide immunity against diseases.

Investigated diseases

Urinary Tract Infections – Urinary Tract Infections (UTIs) occur when bacteria, most commonly Escherichia coli, enter the urinary tract and multiply. The infection can affect any part of the urinary system, including the urethra, bladder, ureters, and kidneys. Symptoms often include a strong, persistent urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. As the infection progresses, it may cause pelvic pain in women or rectal pain in men. If the infection reaches the kidneys, it can lead to more severe symptoms such as fever, chills, and back pain. UTIs are more common in women than men and can recur, especially in individuals with certain risk factors.