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
GlaxoSmithKline
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.
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.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Female participants of non-childbearing potential may be enrolled in the clinical study. * Female participants of childbearing potential may be enrolled in the clinical study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of stud…
Interventions
- Combination ProductCandidate UTI vaccine low dose formulation 1
Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
- Combination ProductCandidate UTI vaccine low dose formulation 2
Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
- Combination ProductCandidate UTI vaccine medium dose formulation 1
Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
- Combination ProductCandidate UTI vaccine medium dose formulation 2
Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
- Combination ProductCandidate UTI vaccine high dose formulation 1
Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Locations (8)
- GSK Investigational SiteLenexa, Kansas
- GSK Investigational SiteSecaucus, New Jersey
- GSK Investigational SiteRochester, New York
- GSK Investigational SiteWeatherford, Texas
- GSK Investigational SiteSeattle, Washington
- GSK Investigational SiteWenatchee, Washington