RecruitingPhase 1/2

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

United States, South Africa448 participantsStarted 2024-11-19

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 study intervention administration, and * has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series. * Blood sample for simultaneous follicle stimulating hormone (FSH) and estradiol levels may be collected. Additional inclusion criterion only for participants in Part 1 of the study (SLI): * Female and male between and including 18 through 64 YOA at the time of ICF signature. * Healthy participants, according to medical history, laboratory assessment and clinical examination at Screening Visit. Additional inclusion criterion only for participants in Part 2 of the study (PoP): * Females between and including 18 through 64 YOA at the time of ICF signature. * Female participants with documented history of at least 1 episode of urine culture confirmed E. coli uncomplicated UTI in …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)

Timeframe: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)

Part 1 and 2: Number of participants reporting solicited administration site AEs

Timeframe: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)

Part 1 and 2: Number of participants reporting solicited systemic AEs

Timeframe: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)

Part 1 and 2: Number of participants reporting solicited systemic AEs

Timeframe: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)

Part 1 and 2: Number of participants reporting unsolicited AEs

Timeframe: During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)

Part 1 and 2: Number of participants reporting unsolicited AEs

Timeframe: During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)

Trial details

NCT IDNCT06702449

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Urinary Tract Infections trials