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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age

A Seamless Phase 1/2, Observer-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Immunogenicity of a UTI Vaccine When Administered to Adults 18 Through 64 Years of Age and Clinical Efficacy When Administered to Females 18 Through 64 Years of Age

A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age (NCT06702449) is a Phase 1 / Phase 2 interventional studying Urinary Tract Infections, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Urinary Tract Infections, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 448 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - Written willing to sign a consent form obtained from the participant prior to performance of any study-specific procedure. - Female participants of non-childbearing potential may be enrolled in the clinical study. - Female participants of childbearing potential may be enrolled in the clinical study, if the participant: - has practiced adequate contraception for 1 month prior to study intervention administration, and - has a negative pregnancy test on the day of study intervention administration, and - has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series. - Blood sample for simultaneous follicle stimulating hormone (FSH) and estradiol levels may be collected. Additional inclusion criterion only for participants in Part 1 of the study (SLI): - Female and male between and including 18 through 64 YOA at the time of ICF signature. - Healthy participants, according to medical history, laboratory assessment and clinical examination at Screening Visit. Additional inclusion criterion only for participants in Part 2 of the study (PoP): - Females between and including 18 through 64 YOA at the time of ICF signature. - Female participants with documented history of at least 1 episode of urine culture confirmed E. coli uncomplicated UTI in the last 12 months prior to study vaccine administration. Who Should NOT Join This Trial: Medical conditions: - History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Hypersensitivity to latex. - History of pIMD. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Female participants of non-childbearing potential may be enrolled in the clinical study. * Female participants of childbearing potential may be enrolled in the clinical study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study intervention administration, and * has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series. * Blood sample for simultaneous follicle stimulating hormone (FSH) and estradiol levels may be collected. Additional inclusion criterion only for participants in Part 1 of the study (SLI): * Female and male between and including 18 through 64 YOA at the time of ICF signature. * Healthy participants, according to medical history, laboratory assessment and clinical examination at Screening Visit. Additional inclusion criterion only for participants in Part 2 of the study (PoP): * Females between and including 18 through 64 YOA at the time of ICF signature. * Female participants with documented history of at least 1 episode of urine culture confirmed E. coli uncomplicated UTI in the last 12 months prior to study vaccine administration. Exclusion Criteria: Medical conditions: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Hypersensitivity to latex. * History of pIMD. * Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * History of endocrinologic, hematologic, metabolic, urologic, dermatologic, or gastrointestinal conditions that, in the opinion of the investigator, places the participant at unacceptable risk or would make adhering to study procedures for the duration of the study difficult. * Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures. * Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study. * Condition that in the judgment of the investigator would make intramuscular injection unsafe. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Additional exclusionary medical conditions only for participants in Part 1 of the study (SLI): • Any clinically significant hematologic and/or biochemical laboratory abnormality at Screening Visit. Additional exclusionary medical conditions only for participants in Part 2 of the study (PoP): * The participant has UTI that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or any Enterobacter species. * The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments. * The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract. * The participant has an indwelling catheter, nephrostomy, ureteral stent, or other foreign material in the urinary tract. * The participant who, in the opinion of the investigator, has an otherwise complicated UTI or has an active upper UTI. * Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period. * Previous administration of a vaccine or immunostimulant targeting rUTI. * Participants currently on a prophylactic agent for rUTI (including antibiotics, methenamine, D-mannose). * Planned administration and/or administration of a vaccine not foreseen by the study protocol in the period starting 15 days before the first dose and ending 15 days after the last dose of study intervention(s) administration. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period. * Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study. * Up to 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone equivalent \>=20 mg/day for adult participants. Inhaled and topical steroids are allowed. * Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug, vaccine or invasive medical device). * Pregnant or lactating female participant. * Female participant planning to become pregnant or planning to discontinue contraceptive precautions before 1 month after completion of the study intervention administration series. * History of chronic alcohol consumption and/or drug abuse, based on investigator judgment. * Persons under guardianship or trusteeship. * Persons deprived of liberty. * Any study personnel or their immediate dependents, family, or household members.

Treatments Being Tested

COMBINATION_PRODUCT

Candidate UTI vaccine low dose formulation 1

Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine low dose formulation 2

Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine medium dose formulation 1

Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine medium dose formulation 2

Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine high dose formulation 1

Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine high dose formulation 2

Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine HTD formulation 2

Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Placebo

Placebo administered intramuscularly according to a 0, 2 months administration schedule.

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Secaucus, New Jersey, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Weatherford, Texas, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Wenatchee, Washington, United States
GSK Investigational Site
Johannesburg, South Africa
GSK Investigational Site
Soshanguve, South Africa

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06702449), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06702449 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06702449?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06702449?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06702449. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06702449. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.