Trial to confirm efficacy, safety, and clinical impact between the bacterial mucosal immunotherapy compared with placebo in women with localized recurrent cystitis without risk factors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmunotek S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-05-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Inmunotek S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of the mucosal bacterial therapeutic vaccine MV140 in the reduction in the number of episodes of rUTI, by comparing the number of new UTIs between patients who receive MV140 compared to placebo during 15 months after the beginning of the trial intervention.

Secondary objectives 10

1. To compare the proportion of patients with less than 3 new episodes of UTI during 15 months after the beginning of the trial intervention between patients who received MV140 compared to placebo.
2. To compare the time to first new UTI after the beginning of the trial intervention between patients who received MV140 compared to placebo.
3. To assess the duration of each new UTI episode (if any) between patients who received MV140 compared to placebo. An episode of UTI is considered to have ended 14 days after completion of antibiotic treatment for this indication, if symptomatology has ended.
4. To assess severity of each new UTI episode (if any) between patients who received MV140 compared to placebo.
5. To compare the proportion of patients who have not shown a new episode of UTI during 15 months after the beginning of the trial intervention .
6. To compare the number of cycles of systemic antibiotic treatments used in the trial for new UTI episodes between patients who received MV140 compared to placebo.
7. To assess the reduction in the use of health resources (hospital admissions, emergency hospital visits and outpatient services) due to a UTI.
8. To assess the impact of the study treatment on the subjective experience of participants compared to placebo.
9. To assess the impact of the study treatment on the Quality of Life (QoL) compared to placebo.
10. To assess the safety of the mucosal bacterial therapeutic vaccine MV140 throughout the clinical trial.

Conditions and MedDRA coding

Recurrent Non-Complicated Urinary Tract Infections (rUTIs).

Regulatory references

Scientific advice from competent authorities

Swedish Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Able to understand and willing to comply with study requirements, to follow investigator´s instructions, and to provide written informed consent.
2. Women with a diagnosis of uncomplicated UTI at the time of signing the informed consent form. This UTI episode must be confirmed both by the presence of symptoms (dysuria, overactive bladder (frequent and sudden urge to urinate), pelvic pain (pressure pain), pollakiuria, turbid white urine, hematuria, foul-smelling urine, polyuria, urinary itching, urgency of urination, etc) and a positive urine culture (defined as ≥103 colony forming unit (CFU)/ml). In addition, patients must meet at least one of the following criteria: a) Have not started systemic antibiotic treatment for the current episode of UTI at the time of signing the informed consent form; Or b) Be receiving antibiotic treatment for the current UTI episode with fosfomycin trometamol, nitrofurantoin monohydrate, nitrofurantoin macrocrystal, pivmecillinam and have not completed the dosing regimen.
3. Participants experiencing at least 2 episodes of non-complicated urinary tract infection in the last 6 months, or 3 episodes of non-complicated urinary tract infection in the last 12 months. UTI episodes must have been diagnosed following the criteria indicated in inclusion criterion 2.
4. Participants must have not responded to previous hygienic-sanitary measures and/or suppressive treatment and/or postcoital prophylaxis against UTI.
5. Participants who have resolved the episode of UTI (the one which was diagnosed at the time of signing the informed consent form following the criteria indicated in inclusion criterion 2) at visit 1. An episode of UTI is considered to have ended 14 days after completion of antibiotic treatment for this indication, if symptomatology has ended.
6. Women aged ≥ 18 and ≤65 years.
7. Agree not to participate in another interventional clinical study during her participation in this trial.
8. In the case of women of childbearing potential, those who agree to follow the required contraceptive measures from the time of signing the informed consent until Visit 4 (at least).

Exclusion criteria 19

1. Participant who are in another clinical trial or planning to receive any investigational trial intervention, investigational mucosal bacterial therapeutic vaccine, or investigational device for rUTI, or those who had participated in another trial within 4 weeks prior to screening.
2. Hypersensitivity to any ingredients of the active treatment (MV140) or the placebo regarding bacteria products or any of the excipients.
3. Participating reporting history of significant allergies to auxiliary medication allergies, anaphylaxis, or other serious reactions to vaccines or immunotherapies. If the participant is allergic or intolerant to fosfomycin, she cannot be allergic or intolerant to nitrofurantoin or to pivmecillinam.
4. Pregnant or breast-feeding participant or suspected or intention of being pregnant during the trial.
5. Diabetic women (controlled or not).
6. Participant who has severe immune system deficiencies.
7. Participant having serious underlying disease that could be life-threatening, or the participant is unlikely to survive for the duration of this clinical trial.
8. Participant who, in the opinion of the investigator, has experienced a complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), flank pain, chills, or any other manifestations suggestive of upper UTI within the last 5 days before the study entry.
9. Participant with a pre-baseline impairment in general health condition which requires assistance daily.
10. Underlying factors accepted to result in a complicated UTI: a. Obstruction at any site in the urinary tract b. Primary renal disease (polycystic renal disease) c. Neurogenic bladder d. Foreign material in the urinary tract e. Incomplete voiding f. Vesicoureteral reflux g. Immunosuppression h. Recent history of instrumentation
11. Women receiving systemic or topical corticosteroid treatment within 4 weeks prior to screening
12. Women reporting the use or planned use of any medications that may alter immune responses to the study immunotherapies within 3 weeks prior to screening.
13. Patients who have undergone bone marrow or solid organ transplantation.
14. Patients with diagnosis or suspicion of renal cancer.
15. Patients with history of cone or acute renal failure within the 5 years prior to the participation in the study.
16. Patients with presence of hereditary or acquired immunodeficiency.
17. Patients with presence of chronic infectious diseases, such as hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
18. Patients with any type of indwelling urinary catheter or ureteral stent, ostomy, or intermittent urinary catheterization since the last recurrence of urinary tract infection.
19. Any other clinically significant medical condition, not related to UTI, or laboratory abnormality that, based upon investigator’s opinion, would jeopardize the safety of the patient or impact patient compliance.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of new episodes of UTIs (confirmed both by the presence of symptoms (dysuria, overactive bladder, frequent and sudden urge to urinate), pelvic pain (pressure pain), pollakiuria, turbid white urine, haematuria, foul-smelling urine, polyuria, urinary itching, urgency of urination, etc) and a positive urine culture during 15 months after the beginning of the trial intervention in both arms, and percentage of patients who show new UTI episodes in this period.

Secondary endpoints 11

1. Proportion of participants with less than 3 new UTIs during 15 months after the beginning of the trial intervention in both arms.
2. Time in days from the resolution of the UTI episode present at the time of participant recruitment to a new UTI episode after first IMP administration in both arms.
3. Time in days from the resolution of the UTI episode present at the time of participant recruitment to a new UTI episode after last IMP administration in both arms.
4. Duration of each new UTI episode in days after the beginning of the trial intervention in both arms.
5. Assessment of the severity score of the UTI episode, as determined by the Visual Analogue Score (VAS) score of each new UTI episode, as determined by the Visual Analogue Score (VAS) score, after beginning of the trial intervention in both arms. This assessment will be performed during unscheduled visits in case a new episode of rUTIs is suspected.
6. Number (and percentage of patients in each arm) of subjects who have not shown a new episode of UTI during 15 months after the beginning of the trial intervention in both arms.
7. Number of cycles of systemic antibiotic treatments used for UTI episodes during 15 months after the beginning of the trial intervention in both arms.
8. Descriptive analysis of use of health resources: o To compare number of hospital admissions between two arms o To compare number of emergency hospital visits between two arms o To compare number of outpatients services or visits due to a rUTI between two arms.
9. Descriptive analysis of assessment of the pain by the visual analogue scale (VAS) throughout the entire study in both arms.
10. Quality of life assessment according to the SF-36 questionnaire in both arms.
11. Adverse events (AEs), serious adverse events (SAEs), AR, SAR and SUSAR (number of events and number of participants) occurring during the entire clinical trial, with their severity and relationship to the trial intervention, and also changes in vital signs and laboratory values during the clinical trial in both arms.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmunotek S.L.

Sponsor organisation

Inmunotek S.L.

Address

Calle Punto Mobi 5

City

Alcala De Henares

Postcode

28805

Country

Spain

Scientific contact point

Organisation

Inmunotek S.L.

Contact name

Patricia Giron de Velasco

Public contact point

Organisation

Inmunotek S.L.

Contact name

Patricia Giron de Velasco

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications