Urinary Tract InfectionsPhase 1/2NCT06702449
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
A Phase 1/2 study testing Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine low dose formulation 2 and Candidate UTI vaccine medium dose formulation 1 in people with Urinary Tract Infections, run by GlaxoSmithKline at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine low dose formulation 2 and Candidate UTI vaccine medium dose formulation 1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 19 Nov 2024to 31 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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 the last 12 months prior to study vaccine administration.
Who cannot join
- Medical conditions:
- 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.
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- 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.
- Additional exclusionary medical conditions only for participants in Part 1 of the study (SLI):
- Any clinically significant hematologic and/or biochemical laboratory abnormality at Screening Visit.
- Additional exclusionary medical conditions only for participants in Part 2 of the study (PoP):
- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Lenexa, Kansas, 66219
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rochester, New York, 14609
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seattle, Washington, 98104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Secaucus, New Jersey, 07094
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Weatherford, Texas, 76086
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Wenatchee, Washington, 98801
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Africa2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Johannesburg, 2113
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Soshanguve, 0152
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine low dose formulation 2, Candidate UTI vaccine medium dose formulation 1, Candidate UTI vaccine medium dose formulation 2, Candidate UTI vaccine high dose formulation 1
- Keywords
- Urinary Tract infection (UTI), UTI vaccine, E. coli, Safety, Immunogenicity, Efficacy
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidate UTI vaccine low dose formulation 1Combination product
Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine low dose formulation 2Combination product
Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine medium dose formulation 1Combination product
Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine medium dose formulation 2Combination product
Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine high dose formulation 1Combination product
Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine high dose formulation 2Combination product
Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine HTD formulation 2Combination product
Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
PlaceboCombination product
Placebo administered intramuscularly according to a 0, 2 months administration schedule.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Group A1/A2 | Experimental | Participants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine low dose formulation 1; Combination Product: Placebo |
| Part 1 Group B1/B2 | Experimental | Participants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine low dose formulation 2; Combination Product: Placebo |
| Part 1 Group C1/C2 | Experimental | Participants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine medium dose formulation 1; Combination Product: Placebo |
| Part 1 Group D1/D2 | Experimental | Participants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine medium dose formulation 2; Combination Product: Placebo |
| Part 1 Group E1/E2 | Experimental | Participants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine high dose formulation 1; Combination Product: Placebo |
| Part 1 Group F1/F2 | Experimental | Participants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine high dose formulation 2; Combination Product: Placebo |
| Part 2 Group 1 | Experimental | Participants receive the candidate UTI vaccine highest tolerated dose (HTD) formulation 2, tested in Part 1 of the study, on Day 1 and Day 61. Receives: Combination Product: Candidate UTI vaccine HTD formulation 2 |
| Part 2 Group 2 | Placebo comparator | Participants receive placebo on Day 1 and Day 61. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)
Solicited administration site events include pain, redness and swelling at administration site.
Measured: 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
Solicited administration site events include pain, redness and swelling at administration site.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting any immediate unsolicited AEs
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.
Measured: During the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting any immediate unsolicited AEs
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.
Measured: During the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting serious adverse events (SAEs)
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.
Measured: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting potential immune-mediated diseases (pIMDs) leading to study withdrawal
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.
Measured: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting medically-attended adverse events (MAAEs) leading to study withdrawal
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.
Measured: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting AEs leading to study withdrawal
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.
Measured: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value
Measured: At 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 value
Measured: At 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 group
Measured: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Secondary outcomes (3)
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Measured: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Part 2: 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 group
Measured: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Measured: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start19 Nov 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702449
- Sponsor's protocol ID
- 219685
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06702449
- Acronym / sponsor ID
- 219685
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary Tract infection (UTI), UTI vaccine, E. coli, Safety, Immunogenicity, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 Group A1/A2 | Experimental | Combination Product: Candidate UTI vaccine low dose formulation 1, Combination Product: PlaceboParticipants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61. |
| Part 1 Group B1/B2 | Experimental | Combination Product: Candidate UTI vaccine low dose formulation 2, Combination Product: PlaceboParticipants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61. |
| Part 1 Group C1/C2 | Experimental | Combination Product: Candidate UTI vaccine medium dose formulation 1, Combination Product: PlaceboParticipants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61. |
| Part 1 Group D1/D2 | Experimental | Combination Product: Candidate UTI vaccine medium dose formulation 2, Combination Product: PlaceboParticipants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61. |
| Part 1 Group E1/E2 | Experimental | Combination Product: Candidate UTI vaccine high dose formulation 1, Combination Product: PlaceboParticipants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61. |
| Part 1 Group F1/F2 | Experimental | Combination Product: Candidate UTI vaccine high dose formulation 2, Combination Product: PlaceboParticipants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61. |
| Part 2 Group 1 | Experimental | Combination Product: Candidate UTI vaccine HTD formulation 2Participants receive the candidate UTI vaccine highest tolerated dose (HTD) formulation 2, tested in Part 1 of the study, on Day 1 and Day 61. |
| Part 2 Group 2 | Placebo comparator | Combination Product: PlaceboParticipants receive placebo on Day 1 and Day 61. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
- Blood sample for simultaneous follicle stimulating hormone (FSH) and estradiol levels may be collected.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candidate UTI vaccine low dose formulation 1Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group A1/A2 |
| Candidate UTI vaccine low dose formulation 2Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group B1/B2 |
| Candidate UTI vaccine medium dose formulation 1Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group C1/C2 |
| Candidate UTI vaccine medium dose formulation 2Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group D1/D2 |
| Candidate UTI vaccine high dose formulation 1Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group E1/E2 |
| Candidate UTI vaccine high dose formulation 2Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group F1/F2 |
| Candidate UTI vaccine HTD formulation 2Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 2 Group 1 |
| PlaceboPlacebo administered intramuscularly according to a 0, 2 months administration schedule. | Combination product | Part 1 Group A1/A2, Part 1 Group B1/B2, Part 1 Group C1/C2, Part 1 Group D1/D2, Part 1 Group E1/E2, Part 1 Group F1/F2, Part 2 Group 2 |
Primary outcome
Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)
Time frame: 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 AEs
Time frame: During 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 AEs
Time frame: During 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 AEs
Time frame: During 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 AEs
Time frame: During 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 AEs
Time frame: During 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 AEs
Time frame: During 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 AEs
Time frame: During 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)
Time frame: 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 withdrawal
Time frame: From 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 withdrawal
Time frame: From 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 withdrawal
Time frame: From 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 value
Time frame: At 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 value
Time frame: At 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 group
Time frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
3 secondary outcomes
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Time frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Part 2: 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 group
Time frame: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Time frame: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine low dose formulation 2 and Candidate UTI vaccine medium dose formulation 1 in people with Urinary Tract Infections, run by GlaxoSmithKline at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs) (time frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.