A study on the safety, and immunogenicity of a UTI vaccine in adults 18 through 64 years of age and clinical efficacy in females 18 through 64 years of age

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

27 Aug 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519319-32-00

ClinicalTrials.gov

NCT06702449

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Prophylaxis, Safety

• To assess the reactogenicity and safety profile of the candidate UTI vaccine.
• To assess the efficacy of the candidate UTI vaccine in preventing new cases of UTI due to E. coli compared to placebo

Secondary objectives 2

1. To assess the efficacy of the candidate UTI vaccine in reducing the total number of occurrences of UTI due to E. coli compared to placebo.
2. To assess the efficacy of 1 dose of the candidate UTI vaccine in preventing new cases of UTI due to E. coli and in reducing the total number of occurrences of UTI due to E. coli compared to placebo.

Conditions and MedDRA coding

Urinary Tract Infections

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. • 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.
2. 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.
3. 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. • 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 criteria 3

1. 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. • 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.
2. 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.
3. 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. • 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. For participants in both parts of the study (Part 1 [SLI] and Part 2 [PoP]), occurrence of: • solicited administration site and systemic AEs during the 7 days post-Dose 1 and post-Dose 2, • any unsolicited AEs during the 30 days post-Dose 1 and post Dose 2, • any immediate unsolicited AEs in the 60 minutes post-Dose 1 and post-Dose 2. • SAEs, pIMDs, MAAEs, and AEs leading to study withdrawal until Day 426 (i.e., end of follow-up).
2. For participants in the Part 1 of the study (SLI): • Occurrence of hematological and biochemical laboratory abnormalities, and changes from the baseline values, at 7 days after the day of Dose 1 and Dose 2 compared to pre-dose values (i.e., on Day 8 and Day 68, compared to Day 1# and Day 61, respectively).
3. For participants in the Part 2 of the study (PoP): • First occurrence of a urine culture confirmed UTI due to E. coli from 14 days (Day 75) up to 12 months (Day 426) post-Dose 2.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 9

Locations

2 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 100 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications