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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

ConditionUrinary Tract Infections
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

has practiced adequate contraception for 1 month prior to study intervention administration, and

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Candidate UTI vaccine low dose formulation 1

    Combination product

    Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

  • Candidate UTI vaccine low dose formulation 2

    Combination product

    Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

  • Candidate UTI vaccine medium dose formulation 1

    Combination product

    Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

  • Candidate UTI vaccine medium dose formulation 2

    Combination product

    Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

  • Candidate UTI vaccine high dose formulation 1

    Combination product

    Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

  • Candidate UTI vaccine high dose formulation 2

    Combination product

    Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

  • Candidate UTI vaccine HTD formulation 2

    Combination product

    Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

  • Placebo

    Combination product

    Placebo administered intramuscularly according to a 0, 2 months administration schedule.

Treatment groups

448 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1 Group A1/A2Experimental treatment 2 interventions
Group B: Part 1 Group B1/B2Experimental treatment 2 interventions
Group C: Part 1 Group C1/C2Experimental treatment 2 interventions
Group D: Part 1 Group D1/D2Experimental treatment 2 interventions
Group E: Part 1 Group E1/E2Experimental treatment 2 interventions
Group F: Part 1 Group F1/F2Experimental treatment 2 interventions
Group G: Part 2 Group 1Experimental treatment 1 intervention
Group H: Part 2 Group 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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
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)
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

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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