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UTI Vaccine Study for Adults 18-64

This study is testing a new vaccine to prevent urinary tract infections (UTIs). Researchers want to see how safe the Candidate UTI vaccine is and how well your body's immune system responds to it. They are also looking at how effective the vaccine is in preventing UTIs in women. The study is open to adults aged 18 to 64. Participants will receive one of several doses of the Candidate UTI vaccine. Success will be measured by tracking any side effects you might experience after vaccination. The study is currently unclear on its recruitment status and aims to enroll 448 participants.

Study design
This interventional study plans to enroll 448 participants. It has two parts: an initial safety lead-in with healthy participants, followed by a second part for women with a history of UTIs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for 7 days after the first vaccine dose and for 7 days after the second vaccine dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18–64InterventionalPrevention
GlaxoSmithKline
~448 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Candidate UTI vaccine low dose formulation 1Candidate UTI vaccine low dose formulation 2Candidate UTI vaccine medium dose formulation 1Candidate UTI vaccine medium dose formulation 2Candidate UTI vaccine high dose formulation 1Candidate UTI vaccine high dose formulation 2

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)
Measured over During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
+14 more outcomes measured

Conditions

Urinary Tract Infections

Explore related trials

Urinary Tract Infection

Where it's being run

8 sites across 6 states
Washington2
South Africa2
Kansas1
New Jersey1
New York1
Texas1

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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 the last 12 months prior to study vaccine administration.

Exclusion

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Hypersensitivity to latex.
History of pIMD.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
History of endocrinologic, hematologic, metabolic, urologic, dermatologic, or gastrointestinal conditions that, in the opinion of the investigator, places the participant at unacceptable risk or would make adhering to study procedures for the duration of the study difficult.
Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures.
Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
Condition that in the judgment of the investigator would make intramuscular injection unsafe.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
The participant has UTI that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or any Enterobacter species.
The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments.
The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract.
The participant has an indwelling catheter, nephrostomy, ureteral stent, or other foreign material in the urinary tract.
The participant who, in the opinion of the investigator, has an otherwise complicated UTI or has an active upper UTI.
Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
Previous administration of a vaccine or immunostimulant targeting rUTI.
Participants currently on a prophylactic agent for rUTI (including antibiotics, methenamine, D-mannose).
Planned administration and/or administration of a vaccine not foreseen by the study protocol in the period starting 15 days before the first dose and ending 15 days after the last dose of study intervention(s) administration.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
Up to 3 months prior to the study intervention administration:
For corticosteroids, this will mean prednisone equivalent \>=20 mg/day for adult participants. Inhaled and topical steroids are allowed.
Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug, vaccine or invasive medical device).
Pregnant or lactating female participant.
Female participant planning to become pregnant or planning to discontinue contraceptive precautions before 1 month after completion of the study intervention administration series.
History of chronic alcohol consumption and/or drug abuse, based on investigator judgment.
Persons under guardianship or trusteeship.
Persons deprived of liberty.
Any study personnel or their immediate dependents, family, or household members.

What this trial measures

  • Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)

    Solicited administration site events include pain, redness and swelling at administration site.

  • Part 1 and 2: Number of participants reporting solicited administration site AEsDuring the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)

    Solicited administration site events include pain, redness and swelling at administration site.

  • Part 1 and 2: Number of participants reporting solicited systemic AEsDuring the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)

    Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature greater than or equal to (\>=) 38.0°C and preferred location for measuring temperature is the axilla.

  • Part 1 and 2: Number of participants reporting solicited systemic AEsDuring the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)

    Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature \>=38.0°C and preferred location for measuring temperature is the axilla.

  • Part 1 and 2: Number of participants reporting unsolicited AEsDuring the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)

    An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

  • Part 1 and 2: Number of participants reporting unsolicited AEsDuring the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)

    An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

  • Part 1 and 2: Number of participants reporting any immediate unsolicited AEsDuring the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)

    An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

  • Part 1 and 2: Number of participants reporting any immediate unsolicited AEsDuring the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)

    An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

  • Part 1 and 2: Number of participants reporting serious adverse events (SAEs)From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

    An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.

  • Part 1 and 2: Number of participants reporting potential immune-mediated diseases (pIMDs) leading to study withdrawalFrom Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

    pIMDs are a subset of Adverse Events of Special Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

  • Part 1 and 2: Number of participants reporting medically-attended adverse events (MAAEs) leading to study withdrawalFrom Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

    An MAAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider.

  • Part 1 and 2: Number of participants reporting AEs leading to study withdrawalFrom Day 1 (Dose 1 administration) until Day 426 (end of follow-up)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

  • Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline valueAt 7 days post-Dose 1 (Day 8) compared with baseline (pre-Dose 1, Day 1)
  • Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline valueAt 7 days post-Dose 2 (Day 68) compared with Day 61 (pre-Dose 2)
  • Part 2: Incidence rate (IR) of the first occurrence of a urine culture confirmed UTI due to E. coli in the investigational group compared to the IR in placebo groupFrom 14 days (Day 75) up to 12 months (Day 426) post-Dose 2