Table of contents
- Trial overview
- Who can participate
- What is being measured
- Study design and phase
- Why this trial matters
Trial overview
The clinical trial NCT06702449 is studying GSKVX000000046019 as a candidate vaccine for urinary tract infections in adults 18 through 64 years of age.[1] The study is authorised and includes 448 participants.[1]
The trial compares GSKVX000000046019 with other study products, including GSKVX000000044501 and sterile saline solution, which is a saltwater solution used as a placebo.[1] The brief summary says the study is designed to assess reactogenicity, safety, and efficacy against new E. coli UTIs.[1]
Who can participate
Adults aged 18 to 64 years can join the study, and the efficacy part is focused on females aged 18 to 64 years.[1] This means the study has one group looking mainly at safety and immune response in adults, and another group looking at how well the vaccine may prevent infection in women.[1]
The trial data do not list more detailed eligibility rules, so the main known target population is adults in this age range, especially females for the prevention part of the study.[1]
What is being measured
Researchers are mainly measuring solicited adverse events, which are expected side effects that are specifically asked about after vaccination.[1] They also track unsolicited adverse events, which are any other health problems reported during the study.[1]
The study also records immediate unsolicited adverse events during the first 60 minutes after each dose, as well as serious adverse events, medically important adverse events, and events that lead to study withdrawal through Day 426.[1] In Part 1, the study looks at hematological and biochemical laboratory abnormalities, meaning changes in blood tests and chemistry tests after vaccination.[1]
In 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 a lab test on urine.[1]
Study design and phase
This is an interventional study, which means participants receive a study product rather than only being observed.[1] The trial is in Phase 1/2, so it combines early safety testing with an early look at whether the vaccine may help prevent disease.[1]
The study includes two parts: Part 1, called SLI, and Part 2, called PoP.[1] Part 1 focuses on safety and immune response, while Part 2 focuses on prevention of E. coli UTIs.[1]
The trial uses intramuscular administration, which means the study product is given as an injection into a muscle.[1]
Why this trial matters
UTIs are common, and this study is looking for a way to help prevent new infections rather than only treating them after they start.[1] By checking both immune response and real infection outcomes, the trial can show whether GSKVX000000046019 deserves further study in larger trials.[1]
The trial is especially important for females aged 18 to 64 years because that is the group used to measure clinical efficacy against new E. coli UTIs.[1] The results will also help researchers understand the short-term safety profile and laboratory changes after vaccination.[1]
