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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
448
Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
GSK Investigational Site
Lenexa, Kansas, United States
RECRUITINGGSK Investigational Site
Secaucus, New Jersey, United States
RECRUITINGGSK Investigational Site
Rochester, New York, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)
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Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Placebo administered intramuscularly according to a 0, 2 months administration schedule.
GSK Investigational Site
Weatherford, Texas, United States
RECRUITINGGSK Investigational Site
Seattle, Washington, United States
RECRUITINGGSK Investigational Site
Wenatchee, Washington, United States
RECRUITINGGSK Investigational Site
Johannesburg, South Africa
RECRUITINGGSK Investigational Site
Soshanguve, South Africa
RECRUITINGPart 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
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)