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 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 219685
• Study Type: interventional
• Target: 448
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Urinary Tract Infections

Keywords

Urinary Tract infection (UTI); UTI vaccine; E. coli; Safety; Immunogenicity; Efficacy

Outcome Measures

Primary Outcomes (15)

• Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)

  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

  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

  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

  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

  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

  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 any immediate unsolicited AEs

  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

  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 serious adverse events (SAEs)

  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

  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 medically-attended adverse events (MAAEs) leading to study withdrawal

  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)

• Part 1 and 2: Number of participants reporting AEs leading to study withdrawal

  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

  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

  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

  From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2

Secondary Outcomes (3)

• 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

  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

  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

  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)

Study Arms (8)

Part 1 Group A1/A2

EXPERIMENTAL

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; Combination Product: Placebo

Part 1 Group B1/B2

EXPERIMENTAL

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

Combination Product: Candidate UTI vaccine low dose formulation 2; Combination Product: Placebo

Part 1 Group C1/C2

EXPERIMENTAL

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

Combination Product: Candidate UTI vaccine medium dose formulation 1; Combination Product: Placebo

Part 1 Group D1/D2

EXPERIMENTAL

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

Combination Product: Candidate UTI vaccine medium dose formulation 2; Combination Product: Placebo

Part 1 Group E1/E2

EXPERIMENTAL

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

Combination Product: Candidate UTI vaccine high dose formulation 1; Combination Product: Placebo

Part 1 Group F1/F2

EXPERIMENTAL

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

Combination Product: Candidate UTI vaccine high dose formulation 2; Combination Product: Placebo

Part 2 Group 1

EXPERIMENTAL

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

Part 2 Group 2

PLACEBO COMPARATOR

Participants receive placebo on Day 1 and Day 61.

Combination Product: Placebo

Interventions

Candidate UTI vaccine low dose formulation 1 COMBINATION_PRODUCT

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

Part 1 Group A1/A2

Candidate UTI vaccine low dose formulation 2 COMBINATION_PRODUCT

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

Part 1 Group B1/B2

Candidate UTI vaccine medium dose formulation 1 COMBINATION_PRODUCT

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

Part 1 Group C1/C2

Placebo COMBINATION_PRODUCT

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

Part 1 Group A1/A2; Part 1 Group B1/B2; Part 1 Group C1/C2; Part 1 Group D1/D2; Part 1 Group E1/E2; Part 1 Group F1/F2; Part 2 Group 2

Candidate UTI vaccine medium dose formulation 2 COMBINATION_PRODUCT

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

Part 1 Group D1/D2

Candidate UTI vaccine high dose formulation 1 COMBINATION_PRODUCT

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

Part 1 Group E1/E2

Candidate UTI vaccine high dose formulation 2 COMBINATION_PRODUCT

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

Part 1 Group F1/F2

Candidate UTI vaccine HTD formulation 2 COMBINATION_PRODUCT

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

Part 2 Group 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Any clinically significant hematologic and/or biochemical laboratory abnormality at Screening Visit.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Lenexa, Kansas, 66219, United States

RECRUITING

GSK Investigational Site

Secaucus, New Jersey, 07094, United States

RECRUITING

GSK Investigational Site

Rochester, New York, 14609, United States

RECRUITING

GSK Investigational Site

Weatherford, Texas, 76086, United States

RECRUITING

GSK Investigational Site

Seattle, Washington, 98104, United States

RECRUITING

GSK Investigational Site

Wenatchee, Washington, 98801, United States

RECRUITING

GSK Investigational Site

Johannesburg, 2113, South Africa

RECRUITING

GSK Investigational Site

Soshanguve, 0152, South Africa

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected in an observer-blind manner
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

ZA (2); US (6)