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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
Led by GlaxoSmithKline · Updated on 2026-04-21
448
Participants Needed
8
Research Sites
131 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants able and willing to follow the study protocol.
- Signed written informed consent before any study procedures.
- Female participants of non-childbearing potential may participate.
- Female participants of childbearing potential must use effective contraception for 1 month before and during the study and have a negative pregnancy test at vaccination.
- Blood samples may be taken for hormone level testing.
- Part 1 (Safety Lead-In): Healthy males and females aged 18 to 64 years.
- Part 2 (Proof of Principle): Females aged 18 to 64 years with at least one urine culture confirmed E. coli uncomplicated UTI in the past 12 months.
You will not qualify if you...
- History of allergic reaction to vaccine components or latex.
- Confirmed or suspected immunosuppressive or immunodeficient conditions.
- History of potential immune-mediated diseases (pIMD).
- Significant lung, heart, liver, or kidney problems.
- History of certain endocrine, blood, metabolic, urinary, skin, or digestive diseases posing risk or study difficulties.
- Neurological disorders including seizures or neuroinflammatory diseases.
- Behavioral or psychiatric conditions affecting study participation.
- Unsafe to receive intramuscular injections.
- Other conditions posing risk per investigator judgment.
- Part 1: Significant abnormal blood or lab tests at screening.
- Part 2: UTIs caused by fungal, parasitic, viral pathogens, Pseudomonas aeruginosa, or Enterobacter species.
- Symptoms from other urinary diseases interfering with assessments.
- Anatomical or physiological urinary tract anomalies or devices increasing infection risk.
- Use of investigational or non-registered products within 30 days before study start.
- Previous vaccination or immunostimulant targeting recurrent UTI.
- Current use of preventive agents for recurrent UTI.
- Planned vaccinations outside protocol timing.
- Recent or planned immunoglobulin or blood product use.
- Prolonged immune-modifying drug use or planned long-acting immune therapies.
- Participation in another clinical trial with investigational interventions.
- Pregnant or lactating women.
- Planning pregnancy or stopping contraception before 1 month after study.
- History of chronic alcohol or drug abuse.
- Persons under guardianship, trusteeship, or deprived of liberty.
- Study staff or immediate family members involved in this study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
GSK Investigational Site
Lenexa, Kansas, United States, 66219
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2
GSK Investigational Site
Secaucus, New Jersey, United States, 07094
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3
GSK Investigational Site
Rochester, New York, United States, 14609
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4
GSK Investigational Site
Weatherford, Texas, United States, 76086
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5
GSK Investigational Site
Seattle, Washington, United States, 98104
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6
GSK Investigational Site
Wenatchee, Washington, United States, 98801
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7
GSK Investigational Site
Johannesburg, South Africa, 2113
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8
GSK Investigational Site
Soshanguve, South Africa, 0152
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Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
8
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