Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Proof-of-Concept Study of Immune Tests After StroVac (drug combination) Vaccination in Adults with Urinary Tract Infections

Registered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on people who have experienced a Urinary Tract Infection. The investigation uses a vaccine called StroVac, which contains harmless (inactivated) versions of several bacteria that can cause these infections: Escherichia coli, Morganella morganii, Proteus mirabilis, Klebsiella pneumoniae, and Enterococcus faecalis. By exposing the immune system to these dead bacteria, the vaccine aims to help the body recognize and fight real infections more effectively.

The purpose of the study is to find out whether certain laboratory tests can reliably measure the body’s response to the vaccine. Researchers will use a test called ELISA to look for specific proteins called IgG in the blood and IgA in the urine, which show how the immune system is reacting. Additional methods include an opsonophagocytosis assay, an agglutination test, and a neutralisation test, all of which help determine whether the antibodies can effectively target the bacteria.

Participants will receive the vaccine and then provide blood and urine samples at several scheduled visits, starting before the injection and continuing after the vaccination. The samples are examined to see if antibody levels rise compared with the initial baseline. Throughout the study, any side effects or health changes are recorded to ensure safety, and the overall process lasts only a few months.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    After agreeing to take part, you are assigned a participant number and receive a copy of the study information.

    Your consent is recorded and you are scheduled for the first study visit.

  2. Step 2

    Baseline assessment (pre‑vaccination)

    At the first visit, a health questionnaire is completed and a physical check is performed to confirm eligibility for the study on urinary tract infection.

    A blood sample and a urine sample are taken to establish your initial levels of igg (a type of antibody in the blood) and iga (an antibody found in urine).

    The results are used as the reference point for later comparisons.

  3. Step 3

    Vaccination with <b>strovac</b>

    You receive a single injection of strovac suspension for injection.

    The dose is 501 milligrams of inactivated bacterial strains (escherichia coli, morganella morganii, proteus mirabilis, klebsiella pneumoniae, enterococcus faecalis).

    The injection is given intramuscularly according to the study protocol.

  4. Step 4

    Short observation after injection

    You remain in the clinic for about 30 minutes so that staff can watch for any immediate reactions such as redness, swelling, or feeling unwell.

    Any symptoms that appear are recorded as adverse events.

  5. Step 5

    Scheduled follow‑up visits

    You return for several follow‑up visits that are spaced over the trial period; the exact dates are set by the study schedule.

    At each visit, additional blood and urine samples are collected to measure changes in igg and iga levels.

    The laboratory will use tests such as elisa (a method to detect antibodies) and other functional assays to evaluate the immune response.

    You are asked about any side effects or health changes since the previous visit, and all information is recorded.

  6. Step 6

    Final assessment (visit 4)

    During the last scheduled visit, a final set of blood and urine samples is taken.

    These samples are compared with the baseline results to determine whether your antibody levels have increased.

    All adverse events that occurred during the trial are reviewed and documented.

  7. Step 7

    Completion of trial participation

    After the final visit, no further study procedures are required from you.

    The study team will continue to analyze the collected data, and you will be informed that your participation in the trial is concluded.

Who can join the trial?

4 criteria

  • The patient must sign and date a written Informed Consent Form, which shows they understand the study and agree to take part.
  • They must be an adult (age 18 or older) who has had repeated urinary tract infections and is eligible to receive the vaccine called StroVac according to its official prescribing information (SmPC).
  • The decision to receive the StroVac treatment must be made before deciding to join the study, and the treatment choice must be independent of the study.
  • Women who are sexually active and could become pregnant must use a highly effective method of birth control throughout the study period, from the first visit to the last visit.

Who cannot join the trial?

21 criteria

  • If you have any reason listed in the official StroVac medication guide that says you should not receive the vaccine, known as a contraindication.
  • If you have taken antibiotics by mouth or injection (called parenteral antibiotics) within the 7 days before the first study visit.
  • If you received any vaccine, whether a live vaccine (contains weakened germs) or an inactivated vaccine (contains killed germs), in the 28 days before the first visit, or plan to get a vaccine during the study.
  • If you are a woman who is currently breastfeeding.
  • If you are a woman who could become pregnant (woman of childbearing potential) and a pregnancy test shows you are pregnant, or you plan to become pregnant during the study.
  • If you have a serious medical illness such as cancer (also called carcinoma) or any other condition that the doctor believes would make participation unsafe or interfere with the study results.
  • If you have a psychiatric condition (mental health problem) that might prevent you from understanding the study or following the instructions.
  • If the doctor thinks you are unlikely to follow the study procedures as required.
  • If you are currently taking part in another clinical trial or have used another experimental drug (investigational medicinal product (IMP)) within the last 30 days, or for a longer time if the drug stays in your body for many days (five half‑lives).
  • If you have already taken part in the treatment phase of this same study.
  • If you have a problem with drug or alcohol abuse.
  • If you have an acute urinary tract infection (a recent bladder or kidney infection) that started within the past 7 days.
  • If you are closely related to, financially dependent on, or work for the study investigators or the company sponsoring the trial.
  • If you are living in a facility because a court or government order requires it (institutionalized).
  • If you have a known infectious disease such as HIV (human immunodeficiency virus), HBV (hepatitis B), or HCV (hepatitis C).
  • If you donated blood or plasma within the 7 days before the first visit, or plan to donate blood while you are in the study.
  • If you have any major surgery planned during the time you would be in the study.
  • If you have taken medicines that can change the results of immune system tests (immunological assays) in the 3 months before the first visit.
  • If you took any NSAIDs (non‑steroidal anti‑inflammatory drugs such as ibuprofen or aspirin) within 24 hours before the first visit.
  • If you are on anticoagulation treatment (blood‑thinning medication) within the 7 days before the first visit.
  • If you received cancer treatments such as chemotherapy, radiation therapy, or other cytotoxic drugs in the 6 months before the first visit.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

StroVac® is a vaccine given by injection. It contains five types of bacteria that have been killed so they cannot cause infection: Escherichia coli, Morganella morganii, Proteus mirabilis, Klebsiella pneumoniae, and Enterococcus faecalis. By exposing the body to these inactivated germs, the vaccine is meant to teach the immune system to recognize and fight the real bacteria if a person later comes into contact with them. In this trial the vaccine is used to see whether blood and urine tests can detect the antibodies that the body makes after receiving StroVac.

What is already known about the treatment

StroVac - StroVac is a suspension for injection that is given as a single intramuscular dose of 501 mg. It is a vaccine containing killed strains of common urinary‑tract bacteria and is already marketed in several European countries to help prevent recurrent urinary tract infections. The vaccine works by showing these dead bacteria to the immune system, which then makes antibodies that can recognize and fight the same bacteria if they cause an infection later. It belongs to the class of bacterial vaccines, acting as an immune‑boosting preparation.

Investigated diseases

Urinary Tract Infection - A urinary tract infection is an infection that affects any part of the urinary system, most often the bladder. It usually starts with irritation of the bladder lining, causing symptoms such as a frequent urge to urinate and a burning sensation. If the infection spreads upward, it can involve the ureters and kidneys, leading to more generalized discomfort and fever. The condition may recur when bacteria remain in the urinary tract after the initial episode.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-527508-25-00Protocol codeSU 5.10Estimated enrolment20 patients

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.