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

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
GlaxoSmithKline
Study ID
NCT06702449
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Urinary Tract Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 19, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
448 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Part 1 Group A1/A2
    Participants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61.
  • Experimental: Part 1 Group B1/B2
    Participants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61.
  • Experimental: Part 1 Group C1/C2
    Participants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61.
  • Experimental: Part 1 Group D1/D2
    Participants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61.
  • Experimental: Part 1 Group E1/E2
    Participants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61.
  • Experimental: Part 1 Group F1/F2
    Participants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61.
  • Experimental: Part 2 Group 1
    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.
  • Placebo Comparator: Part 2 Group 2
    Participants receive placebo on Day 1 and Day 61.

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) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLenexaKansas66219
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Carlos A Fierro (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSecaucusNew Jersey07094
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Guarang Brahmbhatt (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteRochesterNew York14609
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Matthew G Davis (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWeatherfordTexas76086
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Stephen Stamatis (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSeattleWashington98104
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Ashley Fuller (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWenatcheeWashington98801
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Anton Grasch (PRINCIPAL_INVESTIGATOR)

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