UTI Vaccine for Urinary Tract Infections

Recruiting at 22 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: GlaxoSmithKline

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

Disqualifiers: Immunodeficient, Neurological disorders, others

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.

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.

What data supports the effectiveness of the treatment Uromune (MV-140) for preventing urinary tract infections?

Research shows that the MV140 vaccine, also known as Uromune, is effective in preventing recurrent urinary tract infections (UTIs) in women. Studies have demonstrated that it reduces the risk of UTIs, decreases the need for antibiotics, and improves the quality of life for women with recurrent UTIs. ^{1 2 3 4 5}

Is the UTI vaccine safe for humans?

The MV140 vaccine, also known as Uromune, has been shown to be safe in humans, with studies indicating it safely reduces the risk of recurrent urinary tract infections without significant side effects. ^{1 2 3 4 5}

How is the UTI vaccine different from other treatments for urinary tract infections?

The UTI vaccine, known as MV140 or Uromune, is unique because it is a sublingual (under the tongue) bacterial vaccine that helps prevent recurrent urinary tract infections by boosting the body's immune response, unlike traditional treatments that often rely on antibiotics. ^{1 2 3 5 6}

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Candidate UTI vaccine (Cancer 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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Spain 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. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

MV140 sublingual vaccine reduces recurrent urinary tract infection in women: Results from the first North American clinical experience study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. Canada 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

MV140 mucosal bacterial vaccine improves uropathogenic E. coli clearance in an experimental model of urinary tract infection. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of MV140 in preventing recurrent UTIs - a multi-centre double-blinded RCT protocol. [2023]