For Females Aged 18-64 Years Who Experience UTI Linked to E. coli

The study is investigating a new vaccine designed to prevent urinary tract infections (UTIs) caused by E. coli, a bacteria commonly responsible for these infections. The trial will evaluate the vaccine’s efficacy and safety by comparing the health outcomes (including rates of UTIs and side effects) over one year between participants who receive the new vaccine and those who do not receive any form of vaccination.

Who Can Join The Study?

The study is looking for participants based in the United States, Argentina, and South Africa who match the following criteria:

• Female participants aged 18-64 years, who:
  • Are not pregnant or lactating;
  • Have had at least one diagnosed E. coli urinary tract infection (UTI) confirmed by a urine culture test in the past 12 months;
  • Do not have a history of complicated UTIs or UTIs that have been linked to physiological or anatomical abnormalities within the urinary tract (see more information about this criterion below); 
  • Have not previously been administered a vaccine or immunostimulant targeting recurrent UTIs; and
  • Are not taking preventative medication and treatments for recurrent UTIs (for example antibiotics, methenamine (Hiprex), D-mannose)*

*Those who are willing to stop taking preventative medication and treatments for a period of 4 weeks before enrolling in the study and for the entire duration of the study (i.e., approximately 14 months) may still be eligible for the study. Additional information can be found below.

All volunteers will be screened for eligibility before entering the study. To find out whether you qualify, and how to join the study, read more below.

Learn More About The Study

In order to assess the efficacy of the new UTI vaccine, each study participant will be randomly assigned to a study group and will receive either the study vaccine or a placebo. A placebo is an inactive substance designed to look like the vaccine but that has no therapeutic effect. Neither the participant nor the doctor will know which one is given, to ensure the study results are unbiased and that both groups are handled in the same way.

The new UTI vaccine has already been administered to healthy volunteers and is currently being monitored and evaluated, has passed the first step of clinical development (i.e., phase 1) where it has been assessed as safe to administer to a wider population. However, it has not yet been approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities for use in people with bladder infections. It is considered investigational.

The biopharmaceutical company GlaxoSmithKline (also called “GSK”) is sponsoring this study. GSK discovers and makes vaccines, medicines, and other innovative therapies. As sponsor, GSK also pays the study doctor and study research sites to run this study.

Click the button below to locate a clinical trial site near you, or read more below about How To Join The UTI Vaccine Clinical Trial and review the Frequently Asked Questions.

How To Join The UTI Vaccine Clinical Trial

This study is currently enrolling participants in the United States, Argentina, and South Africa.

To determine if you may qualify for the study, please review the Frequently Asked Questions below.

If you believe you meet the eligibility criteria, visit the Find a Study Site page to locate the nearest clinical trial site and follow the instructions provided on how to proceed with the next steps.

Frequently Asked Questions

How can I join the study?

See the detailed information provided above.

If I’m interested in participating in UTI research but I am not located in a country with a listed study site, what can I do?

This study is specifically looking for participants based in the United States, Argentina, and South Africa. If you’re interested in participating in UTI research but there are no study sites near you, you can sign up to our research participation list to be notified about future opportunities.

What does ‘not having previously received a vaccine or immunostimulant for recurrent UTIs’ mean, with regard to eligibility for this trial? 

To participate in this study, you must not have received any past vaccination (e.g., Uromune and StroVac) or treatment designed to stimulate the immune system to prevent UTIs (e.g., Uro-Vaxom). 

What is the definition of a history of complicated UTIs or UTIs that have been linked to physiological or anatomical abnormality, with regard to eligibility for this trial?  

You will not be able to participate in the study if you have a history of complicated UTIs, which refers to having symptoms that are known or suspected to be related to other underlying conditions such as interstitial cystitis, asymptomatic bacteriuria, overactive bladder, and chronic incontinence. You are also ineligible to join the study if you have an active upper UTI, such as pyelonephritis (a kidney infection) or urosepsis (a severe infection affecting the bloodstream).

Additionally, you are not eligible for the study if you have an anatomical or physiological condition that is thought to increase your risk of getting UTIs or lead to persistent bacterial colonization. This includes conditions such as kidney or bladder stones, urinary tract obstruction or narrowing, primary kidney disease, neurogenic bladder, or any other structural or functional abnormality of the urinary tract. 

If you’re unsure whether any of this applies to you, you will have the opportunity to discuss this with the clinical trials team during the study screening process.

What counts as having had at least one E. coli UTI confirmed by a urine test in the past 12 months, which is a condition to participate in this study?  

To meet this requirement, you do not need to have symptoms at the time of enrollment. You must have had a urine culture test that confirmed E. coli (at least 10⁴ CFU/mL) as the cause of your infection. This means that a lab tested your urine and identified E. coli as the bacteria responsible for your UTI, which will need to be provided as documented proof at recruitment. If you are currently experiencing symptoms of a UTI, you may still be eligible to participate. You can be screened and enrolled if a new urine culture confirms E. coli and you meet all other eligibility criteria.

If I usually take medication and treatments to prevent UTIs (e.g., antibiotics, methenamine (Hiprex), D-mannose), can I still join the study?

You may still be eligible for this study if you are willing to discontinue your preventative treatment for a period of 4 weeks before enrolling and for the entire duration of the study (i.e., approximately 14 months). However, if you are currently taking any medication or supplements to prevent UTIs, we strongly recommend that you consult your clinician before stopping any treatment. If you’re unsure whether this applies to any medication or treatments that you are currently taking, you will have the opportunity to discuss this with the clinical trials team during the study screening process.

What will I be administered during the study?

You will be randomly assigned to a study group and will receive either the study vaccine or a placebo. The placebo is a safe and commonly used saltwater solution that looks like the study vaccine but does not contain any active ingredient. This helps researchers determine whether the vaccine has a real effect compared to no treatment. Neither you nor the doctor will know which group you are in to ensure the study results are unbiased and that both groups are handled in the same way. 

How are the treatment groups assigned?

A computer is used to assign study participants into study treatment groups by chance. This is called randomization. You will have a 1 in 2 (50%) chance of being placed in either treatment group (the study vaccine or placebo). You and the study doctor will not know which group you are in. This is to make sure the results of each group being studied are handled in the same way.

Will I be able to find out which medicine I took?

Only in case of a medical emergency, you, the study staff, and your healthcare provider will be told what study treatment you received during the study. At the end of the study, all the research sites will be provided with a summary of the study results and access to treatment information about all of their participants. Participants can request details on the treatment they received once the study results are available. Please note that study results will take time to become available and will not be accessible immediately after your participation ends.

How long does participation in the study last?

Your involvement in the study would last approximately 14 months in total. This includes a screening period of up to 2 weeks, a treatment phase consisting of two vaccinations administered 2 months apart, and a follow-up period of 12 months after the second vaccination.

How many times will I have to visit the study research site?

You will need to attend one screening visit, two visits to receive the vaccine (spaced two months apart), and four follow-up visits. Additional unscheduled visits may be organized if necessary.

There will also be two telemedicine visits, which are remote consultations conducted via phone or video call and do not require an in-person visit to the study site.

How long will I need to be at the study research site for each visit?

The length of each study visit will vary depending on the type of visit (screening, vaccination, or follow-up), and the research site will provide more details. As a general indication, vaccination visits may last up to four hours, while follow-up visits are typically no longer than two hours.

What kind of tests will I have at study site visits?

At each study visit, you will undergo a medical checkup, during which the study doctor will conduct a general physical examination, including measuring your blood pressure, body temperature, and pulse. Urine and blood tests will be performed. 

During the two vaccination visits, you will receive either the study vaccine or a placebo.

How will I be administered the study vaccine or placebo and what will the process be like?

During the two vaccination visits, trained healthcare staff will administer either the study vaccine or a placebo via injection in your upper arm. You will be monitored for at least one hour after administration to ensure your safety. The study team will provide you with all necessary information about follow-up visits and any additional procedures required as part of the trial.

Has the new investigational medicine already been studied in people?

The study vaccine has already been administered to healthy volunteers and is currently being monitored and evaluated and has passed the first step of clinical development (i.e., phase 1) where it has been assessed as safe to administer to a wider population. It has not yet been approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities for use in people with bladder infections, so it is considered investigational.

Could there be any side effects from the study vaccine?

Although the safety of the study vaccine has already been thoroughly reviewed in earlier phases of the study, like with all medicines there is a chance of side effects. It is very important to tell the study team about any changes in your health or if you are not feeling well. If you are interested in joining the study, the study doctor will explain more about any potential side effects and how to report them throughout the duration of the study. 

What happens if I get a UTI during the study? 

If you develop signs or symptoms of a UTI during the study, you will contact the study team and attend an unscheduled visit to assess your condition, conduct a urine test, and determine if the criteria for a UTI diagnosis have been met. Treatment will be provided based on the study doctor’s recommendations.

What are the benefits of being in the study?

While you may or may not directly benefit from being in the clinical study, the research could help develop new preventative options for UTIs, potentially reducing the need for frequent antibiotic treatments. The information collected in this study may help doctors learn more about effective ways to prevent UTIs, ultimately contributing to better options and health outcomes for patients in the future.

Are there any costs to participate, and will I receive compensation?

Taking part in this study will not incur any costs for you. You will receive the study substance, attend study visits, and undergo all necessary tests at no charge. However, if you develop a UTI during the course of the study, you will have to cover the treatment costs yourself.

You will be compensated for your participation, and travel expenses to and from the study site may be reimbursed. The study site will provide more information on compensation and eligibility for travel reimbursement.

Do I have to stay in the study if I decide to join?

No, participating in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.

Has the study already begun?

Yes, the study has already begun and is currently accepting new participants. The study research sites are available to be contacted by potential participants who are interested in joining.

Do I need health insurance or a doctor’s referral to participate?

Health insurance and doctor’s referrals are not required in order to participate. Potential participants can find a study site and instructions on how to reach out by clicking the button below.