Table of contents
- Trial overview
- Who can participate
- What is being measured
- Study design and phase
- What the trial seeks to learn
Trial overview
The source data lists one interventional study of GSKVX000000044501 for urinary tract infections.[1] The study is titled as a safety, immunogenicity, and clinical efficacy study of a UTI vaccine in adults 18 through 64 years of age, with efficacy assessed in females 18 through 64 years of age.[1]
The study status is Authorised, and the planned enrollment is 448 participants.[1] The phase is Phase 1/2, which means it is early clinical research that looks at both safety and early signs of benefit.[1]
Who can participate
Part 1 of the study includes adults 18 through 64 years of age, and it focuses on safety and immune response.[1] Part 2 focuses on females 18 through 64 years of age and looks at whether the vaccine can help prevent new E. coli UTIs.[1]
This means the study has two target groups: a broader adult group for early safety testing and a female group for the outcome that measures prevention of infection.[1]
What is being measured
The main safety measures include solicited administration site and systemic adverse events during 7 days after each dose.[1] Solicited events are side effects that researchers expect and ask about on purpose, while systemic events are effects that can affect the whole body.[1]
The study also measures any unsolicited adverse events during 30 days after each dose, and any immediate unsolicited adverse events during the 60 minutes after each dose.[1] Unsolicited events are health problems that are reported even if they were not specifically expected or asked about.[1]
More serious outcomes are also tracked, including serious adverse events, pIMDs, MAAEs, and events that lead to study withdrawal until Day 426.[1] In simple terms, the researchers are watching for severe medical problems, immune-related issues, major medical events, and any problem that makes a participant stop the study.[1]
For Part 1, the study measures hematological and biochemical laboratory abnormalities and changes from baseline values after each dose.[1] Baseline means the test result before treatment starts, so researchers can compare later results with the starting point.[1]
For Part 2, the main efficacy endpoint is the first urine culture confirmed UTI caused by E. coli from 14 days after Dose 2 up to 12 months later.[1] A urine culture confirmed infection means the infection is proven by testing a urine sample in the lab.[1]
Study design and phase
The trial is designed to test both reactogenicity and safety, as well as efficacy against new E. coli UTIs.[1] Reactogenicity means common short-term reactions after vaccination, such as local or whole-body symptoms.[1]
The study compares GSKVX000000044501 with sterile saline solution in at least part of the design, showing that a placebo control is used.[1] A placebo is a comparison treatment that does not contain the active study vaccine and helps show whether the study vaccine makes a difference.[1]
The source data also lists GSKVX000000046019 alongside GSKVX000000044501 as an intervention in the study.[1] The trial data do not explain the full role of each product in the study design, so the key point is that GSKVX000000044501 is part of the vaccine research being tested.[1]
What the trial seeks to learn
The brief summary says the study aims to assess the reactogenicity and safety profile of the candidate UTI vaccine.[1] It also aims to assess efficacy in preventing new cases of UTI due to E. coli compared with placebo.[1]
In patient-friendly terms, the trial is asking two main questions: first, does the vaccine look safe enough to continue studying, and second, does it help lower the chance of getting a new E. coli UTI?[1] These are the main goals of early vaccine research in this condition.[1]
