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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
Led by GlaxoSmithKline · Updated on 2026-04-21
448
Participants Needed
8
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, immune response, and preliminary clinical efficacy of a candidate vaccine for urinary tract infections (UTIs) in adults aged 18 to 64 years. This trial focuses on adults generally for safety and immune response, and specifically on females with a history of at least one confirmed E. coli UTI within the past year for clinical efficacy. The study includes two parts: an initial dose-escalation safety phase and a proof-of-principle efficacy phase, designed to establish the highest tolerated dose and evaluate the vaccine's impact on UTI occurrence. Participants receive one of several vaccine dose formulations or placebo administered by injection on Day 1 and Day 61. Part 1 involves healthy male and female adults and tests increasing antigen doses for safety. After safety review, Part 2 enrolls females with previous E. coli UTIs to assess vaccine efficacy compared to placebo over a 12-month period. The vaccine is given intramuscularly following a 0 and 2 months schedule. Throughout the study, participants are monitored for side effects at the injection site and systemic reactions during the first week after each dose, as well as for any adverse events up to 426 days from the first dose. Blood tests, pregnancy monitoring, and clinical exams are conducted. The main outcome measures include the frequency of adverse events and the rate of urine culture confirmed UTIs in females during the follow-up period. Participants are followed closely for safety and immune response, with the trial lasting over a year from initial vaccination.
CONDITIONS
Brief 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
- Written informed consent given before any study procedures
- Female participants of non-childbearing potential allowed
- Female participants of childbearing potential must use adequate contraception for 1 month before and 1 month after vaccination, have a negative pregnancy test on vaccination day, and agree to continue contraception during treatment
- Blood sample may be collected for hormone levels
- For Part 1 (Safety Lead-In): males and females aged 18-64 years, healthy by medical history, lab tests, and exam
- For Part 2 (Proof of Principle): females aged 18-64 years with documented history of at least one urine culture confirmed E. coli UTI in the past 12 months
You will not qualify if you...
- History of allergic reaction or hypersensitivity to vaccine components
- Immunosuppressive or immunodeficient conditions
- Hypersensitivity to latex
- History of potential immune-mediated diseases
- Significant lung, heart, liver, or kidney problems
- Certain endocrine, blood, metabolic, urinary, skin, or digestive conditions posing risk or interfering with study
- Neurological disorders including seizures or neuroinflammatory diseases
- Cognitive or psychiatric conditions interfering with participation
- Unsafe for intramuscular injection
- Other clinical conditions posing additional risk
- For Part 1: Significant blood or biochemical abnormalities at screening
- For Part 2: UTIs caused by non-E. coli pathogens or complicated UTI conditions
- Urinary tract abnormalities or foreign devices
- Use of investigational or non-registered products within 30 days before study
- Previous vaccines targeting recurrent UTIs
- Current prophylactic treatments for recurrent UTIs
- Planned vaccines outside protocol 15 days before and after study doses
- Recent or planned immunoglobulin or blood product treatments
- Use of immune-modifying drugs recently or planned
- Participation in other clinical studies with investigational interventions during this study
- Pregnant or breastfeeding women
- Planning pregnancy during study or contraception period
- History of chronic alcohol or drug abuse
- Persons under guardianship, trusteeship, or deprived of liberty
- Study personnel or their immediate family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 2 months
Participants receive two intramuscular doses of the candidate UTI vaccine or placebo following a 0 and 2 months schedule.
2 vaccination visits on Day 1 and Day 61 with multiple follow-up visits for safety monitoring in the week after each dose
Duration - Approximately 10 months post-treatment
Participants are monitored for safety and immune response, including adverse events and vaccine efficacy, for up to 12 months after the second dose.
Ongoing safety and efficacy visits up to Day 426 (12 months post-Dose 2)
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
E
EU GSK Clinical Trials Call Center
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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