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)
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
🩺 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: Review the eligibility criteria below.
Location: GSK Investigational Site — Lenexa, Kansas
Age range: 18 Years to 64 Years
🧪 Interventions in This Study
- Candidate UTI vaccine low dose formulation 1 (COMBINATION_PRODUCT)
- Candidate UTI vaccine low dose formulation 2 (COMBINATION_PRODUCT)
- Candidate UTI vaccine medium dose formulation 1 (COMBINATION_PRODUCT)
- Candidate UTI vaccine medium dose formulation 2 (COMBINATION_PRODUCT)
- Candidate UTI vaccine high dose formulation 1 (COMBINATION_PRODUCT)
- Candidate UTI vaccine high dose formulation 2 (COMBINATION_PRODUCT)
- Candidate UTI vaccine HTD formulation 2 (COMBINATION_PRODUCT)
- Placebo (COMBINATION_PRODUCT)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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,
📞 Contact the Study Coordinator
Phone: (877) 379-3718
Email: GSKClinicalSupportHD@gsk.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Urinary Tract Infections
- To Wipe or Not To Wipe?: That Is The Question — Iowa City, Iowa
- Chlorhexidine Lavage for Recurrent Urinary Tract Infection — Portland, Oregon
- Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery — Boston, Massachusetts
- Prophylactic Antibiotics for Outpatient Urethral Bulking — Miami, Florida
- Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting — Cleveland, Ohio
- A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) — Fresno, California
Explore by condition: All Urinary Tract Infections clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.