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

April 16, 2026 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial consists of 2 parts. Part 1 will consist of antigen dose-escalation (start with least dose with gradual increase in dose) Safety Lead-In (SLI) in healthy participants. Part 2 (Proof of Principle [PoP]) will start after the safety review of all safety data in Part 1 and will consist of participants with history of at least 1 episode of urine culture confirmed E. coli UTI in the last 12 months prior to the study intervention administration.

Study Type

Interventional

Enrollment (Estimated)

448

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Africa
      • Johannesburg, South Africa, 2113
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Essack Aziz Mitha
        • Contact:
        • Contact:
      • Soshanguve, South Africa, 0152
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zinhle Ayanda Zwane
  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carlos A Fierro
        • Contact:
        • Contact:
    • New Jersey
      • Secaucus, New Jersey, United States, 07094
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guarang Brahmbhatt
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Matthew G Davis
        • Contact:
        • Contact:
    • Texas
      • Weatherford, Texas, United States, 76086
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Stamatis
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ashley Fuller
        • Contact:
        • Contact:
      • Wenatchee, Washington, United States, 98801
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anton Grasch
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Group A1/A2
Participants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61.
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: Placebo
Placebo administered intramuscularly according to a 0, 2 months administration schedule.
Experimental: Part 1 Group B1/B2
Participants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61.
Combination product: Placebo
Placebo 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.
Experimental: Part 1 Group C1/C2
Participants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61.
Combination product: Placebo
Placebo 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.
Experimental: Part 1 Group D1/D2
Participants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61.
Combination product: Placebo
Placebo 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.
Experimental: Part 1 Group E1/E2
Participants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61.
Combination product: Placebo
Placebo 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.
Experimental: Part 1 Group F1/F2
Participants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61.
Combination product: Placebo
Placebo 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.
Experimental: Part 2 Group 1
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.
Combination product: Candidate UTI vaccine HTD formulation 2
Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Placebo Comparator: Part 2 Group 2
Participants receive placebo on Day 1 and Day 61.
Combination product: Placebo
Placebo administered intramuscularly according to a 0, 2 months administration schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)
Time Frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Solicited administration site events include pain, redness and swelling at administration site.
During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting solicited administration site AEs
Time Frame: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Solicited administration site events include pain, redness and swelling at administration site.
During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting solicited systemic AEs
Time Frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature greater than or equal to (>=) 38.0°C and preferred location for measuring temperature is the axilla.
During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting solicited systemic AEs
Time Frame: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature >=38.0°C and preferred location for measuring temperature is the axilla.
During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting unsolicited AEs
Time Frame: During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting unsolicited AEs
Time Frame: During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting serious adverse events (SAEs)
Time Frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting potential immune-mediated diseases (pIMDs) leading to study withdrawal
Time Frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
pIMDs are a subset of Adverse Events of Special Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting AEs leading to study withdrawal
Time Frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value
Time Frame: At 7 days post-Dose 1 (Day 8) compared with baseline (pre-Dose 1, Day 1)
At 7 days post-Dose 1 (Day 8) compared with baseline (pre-Dose 1, Day 1)
Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value
Time Frame: At 7 days post-Dose 2 (Day 68) compared with Day 61 (pre-Dose 2)
At 7 days post-Dose 2 (Day 68) compared with Day 61 (pre-Dose 2)
Part 2: Incidence rate (IR) of the first occurrence of a urine culture confirmed UTI due to E. coli in the investigational group compared to the IR in placebo group
Time Frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Part 1 and 2: Number of participants reporting any immediate unsolicited AEs
Time Frame: During the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
During the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting any immediate unsolicited AEs
Time Frame: During the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
During the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting medically-attended adverse events (MAAEs) leading to study withdrawal
Time Frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
An MAAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider.
From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Time Frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Part 2: IR of the first occurrence of a urine culture confirmed UTI due to E. coli in the investigational group compared to the IR in placebo group
Time Frame: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Time Frame: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219685

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on Candidate UTI vaccine low dose formulation 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe