UTI Vaccine for Urinary Tract Infections

Recruiting at 23 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: GlaxoSmithKline

Must not be taking: Antibiotics, Methenamine, D-mannose

Disqualifiers: Immunodeficient, Neurological disorders, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

448 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine to prevent urinary tract infections (UTIs). Researchers aim to determine the vaccine's safety, the body's response, and its potential to reduce UTIs in women. Participants will receive either a low, medium, or high dose of the vaccine, or a placebo, on two separate days. Women who have had at least one E. coli UTI confirmed by a urine test in the past year may be suitable for this trial. As a Phase 1, Phase 2 trial, this study focuses on understanding the vaccine's function in people and measuring its effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does exclude participants currently on a prophylactic agent for recurrent UTIs, such as antibiotics, methenamine, or D-mannose. It also excludes those using immune-modifying drugs or planning to use them during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the potential UTI vaccine to be safe, with only mild side effects reported. The study did not link any serious side effects to the vaccine, indicating it is well-tolerated. Research also shows that the vaccine helps reduce urinary tract infections (UTIs) and decreases the need for antibiotics. These findings suggest that the vaccine could be a safe option for preventing UTIs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for urinary tract infections, which typically involve antibiotics, this candidate UTI vaccine offers a preventative approach. Most treatments target the bacteria after infection, but this vaccine aims to prevent infections from occurring in the first place by boosting the immune system's response to potential bacterial threats. Researchers are particularly excited about the potential for the vaccine to reduce antibiotic use, thereby lowering the risk of antibiotic resistance, which is a growing concern in healthcare. Additionally, the vaccine's different formulations allow for optimization of dosage, potentially improving its efficacy and safety profile.

What evidence suggests that this candidate UTI vaccine might be an effective treatment for urinary tract infections?

Research has shown that the potential UTI vaccine, which participants in this trial may receive, could help prevent urinary tract infections. In earlier studies, up to 90% of people experienced fewer UTIs in the year following vaccination. Another study found that 54% of vaccinated individuals remained UTI-free for up to nine years. In Portugal, 73% of patients reported fewer symptoms or shorter illness duration after vaccination. These results suggest that the vaccine might effectively reduce the frequency and severity of UTIs. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who may be at risk of urinary tract infections (UTIs). Specifically, the study aims to evaluate the vaccine's effectiveness in women within this age group. Participants must meet certain health criteria to join.

Inclusion Criteria

I am a woman aged 18-64 with a recent E. coli UTI.

Written informed consent obtained from the participant prior to performance of any study-specific procedure

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol

Exclusion Criteria

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s)

I have a condition that weakens my immune system.

Hypersensitivity to latex

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In (SLI)

Antigen dose-escalation to assess safety in healthy participants

8 weeks

2 visits (in-person)

Proof of Principle (PoP)

Participants with a history of E. coli UTI receive the highest tolerated dose

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Candidate UTI vaccine

Trial Overview The study is testing various doses and formulations of a new UTI vaccine against a placebo. It will measure how safe the vaccine is, how well it triggers an immune response, and its preliminary effectiveness in preventing UTIs.

How Is the Trial Designed?

Group I: Part 2 Group 1 Experimental Treatment 1 Intervention

Participants receive the candidate UTI vaccine highest tolerated dose (HTD) formulation 2, tested in Part 1 of the study, on Day 1 and Day 61.

Group II: Part 1 Group F1/F2 Experimental Treatment 2 Interventions

Participants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61.

Group III: Part 1 Group E1/E2 Experimental Treatment 2 Interventions

Participants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61.

Group IV: Part 1 Group D1/D2 Experimental Treatment 2 Interventions

Participants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61.

Group V: Part 1 Group C1/C2 Experimental Treatment 2 Interventions

Participants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61.

Group VI: Part 1 Group B1/B2 Experimental Treatment 2 Interventions

Participants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61.

Group VII: Part 1 Group A1/A2 Experimental Treatment 2 Interventions

Participants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61.

Group VIII: Part 2 Group 2 Placebo Group 1 Intervention

Participants receive placebo on Day 1 and Day 61.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

MV140, a mucosal vaccine made from inactivated bacteria, has shown clinical effectiveness in preventing recurrent urinary tract infections (UTIs) by promoting immune responses.

In a mouse model, MV140 vaccination led to the clearance of uropathogenic E. coli (UPEC) and increased immune cell activity in the urine and bladder, indicating a robust immune response against the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MV140 mucosal bacterial vaccine improves uropathogenic E. coli clearance in an experimental model of urinary tract infection. Saz-Leal, P., Ligon, MM., Diez-Rivero, CM., et al.[2023]

In a study involving 67 women with a history of recurrent urinary tract infections (UTIs), the sublingual vaccine MV140 demonstrated a 40.6% UTI-free rate during the nine-month efficacy period, and a significant 75.3% reduction in UTI frequency compared to the year prior to vaccination.

The vaccine was found to be safe, with only mild adverse events reported, and none of the serious adverse events were related to the vaccine, indicating its potential as an effective preventive treatment for recurrent UTIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MV140 sublingual vaccine reduces recurrent urinary tract infection in women: Results from the first North American clinical experience study. Nickel, JC., Kelly, KL., Griffin, A., et al.[2023]

The MV140 vaccine significantly reduced the occurrence of recurrent urinary tract infections (UTIs) in 95.5% of patients at 3 months, 86.8% at 6 months, and 54.7% at 12 months, demonstrating its long-term efficacy in a study of 1003 patients over 12 months.

The safety profile of MV140 was strong, with only 1.49% of patients experiencing adverse effects, and no patients discontinued treatment, indicating it is a well-tolerated option for preventing UTIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Focus on Long-Term Follow-Up of Immunoprophylaxis to Recurrent Urinary Tract Infections: 10 Years of Experience with MV140 Vaccine in a Cohort of 1003 Patients Support High Efficacy and Safety. Ramírez Sevilla, C., Gómez Lanza, E., Llopis Manzanera, J., et al.[2022]

MV140, a sublingual bacterial vaccine, has been shown to safely prevent recurrent urinary tract infections (rUTIs) in women, addressing a significant unmet medical need.

Clinical studies indicate that MV140 not only reduces the incidence of UTIs but also decreases antibiotic use and overall management costs, while improving the quality of life for women affected by rUTIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women. Nickel, JC., Doiron, RC.[2023]

This study aims to evaluate the efficacy of MV140 in reducing recurrent urinary tract infections (rUTIs) in patients over 65 years old, with a follow-up period of 12 months after a 3-month treatment course.

The trial is a multicenter, double-blind, randomized controlled design, which is the first of its kind in Australia for MV140, and it will also assess safety, emergency department re-admissions, antibiotic use, and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of MV140 in preventing recurrent UTIs - a multi-centre double-blinded RCT protocol. Kovacic, J., Canagasingham, A., Zhong, W., et al.[2023]

Uromune, a novel sublingual vaccine, showed significantly higher UTI-free rates (35-90%) in women treated for three months compared to those on six months of antibiotic prophylaxis (0%), based on a review of five clinical studies involving 1408 women.

No major safety issues were reported in the trials, suggesting that Uromune could be a safe alternative to antibiotics for preventing recurrent urinary tract infections in Canadian women, although further confirmation through randomized controlled trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could sublingual vaccination be a viable option for the prevention of recurrent urinary tract infection in Canada? A systematic review of the current literature and plans for the future. Nickel, JC., Saz-Leal, P., Doiron, RC.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841562/

MV140 sublingual vaccine reduces recurrent urinary tract ... The UTI-free rate for the nine-month efficacy period was 40.6%. Compared to the infection rate in the year prior to vaccination, the reduction was 75.3% for the ...

2. mdpi.com mdpi.com/2076-393X/12/12/1426

Immunoprophylaxis with MV140 Is Effective in the ... Recent Spanish and British trials report an effectiveness of 50–90% in the prevention of UTIs at 12 months, with virtually no side effects [9,10,11]. These are ...

3. ibme.ox.ac.uk ibme.ox.ac.uk/2024/04/22/oral-vaccine-for-recurrent-utis-could-be-a-game-changer-alternative-to-antibiotics-new-study-suggests/

Oral vaccine for recurrent UTIs could be a game changer ... 54% of study participants who were given the novel oral spray-based vaccine MV140 remained UTI-free for up to nine years after treatment, with no notable side ...

4. vax-before-travel.com vax-before-travel.com/uti-vaccine-reported-very-effective-portugal-2024-12-29

UTI Vaccine Reported Very Effective in Portugal A recent study found that 73% of adult Portuguese patients with urinary tract infections (UTIs) reported a reduction in symptom severity or duration of illness ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06702449

NCT06702449 | A Study on the Safety and Immune ... The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and ...

6. mdpi.com mdpi.com/2076-0817/12/3/359

An Effective Sublingual Vaccine, MV140, Safely Reduces ... It appears the sublingual vaccine MV140 safely prevents (or reduces the risk of) UTI, and reduces antibiotic use, overall management costs, and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38060333/

Evaluation of MV140 in preventing recurrent urinary tract ... Conclusion: This is a multicentre, double-blinded, randomised control trial, the first in Australia to assess the safety and efficacy of MV140 Uromune vaccine ...

8. science.org science.org/doi/10.1126/sciadv.abq4120

A sublingual nanofiber vaccine to prevent urinary tract ... In 2022, the sublingual inactivated bacteria vaccine candidate MV140 showed reduced UTI incidence at 9 months after either a 3- or 6-month ...

9. withpower.com withpower.com/trial/uti-vaccine-for-urinary-tract-infections-5de41

UTI Vaccine for Urinary Tract Infections The vaccine was found to be safe, with only mild adverse events reported, and none of the serious adverse events were related to the vaccine, indicating its ...