NCT06702449

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 448 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial consists of 2 parts. Part 1 will consist of antigen dose-escalation (start with least dose with gradual increase in dose) Safety Lead-In (SLI) in healthy participants. Part 2 (Proof of Principle \[PoP\]) will start after the safety review of all safety data in Part 1 and will consist of participants with history of at least 1 episode of urine culture confirmed E. coli UTI in the last 12 months prior to the study intervention administration.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Candidate UTI vaccine low dose formulation 1	Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Candidate UTI vaccine low dose formulation 2	Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Candidate UTI vaccine medium dose formulation 1	Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Candidate UTI vaccine medium dose formulation 2	Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Candidate UTI vaccine high dose formulation 1	Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Candidate UTI vaccine high dose formulation 2	Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Candidate UTI vaccine HTD formulation 2	Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
COMBINATION_PRODUCT	Placebo	Placebo administered intramuscularly according to a 0, 2 months administration schedule.

Timeline

• Start date: 2024-11-19
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-11-25
• Last updated: 2025-08-07

Locations

8 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study