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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (33 items).
Location: GSK Investigational Site — Lenexa, Kansas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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):
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- GSK Investigational Site — Lenexa, Kansas
- GSK Investigational Site — Secaucus, New Jersey
- GSK Investigational Site — Rochester, New York
- GSK Investigational Site — Weatherford, Texas
- GSK Investigational Site — Seattle, Washington
- GSK Investigational Site — Wenatchee, Washington
- GSK Investigational Site — Johannesburg,
- GSK Investigational Site — Soshanguve,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.