Trial Outcomes & Findings for Uromune in Treating Recurrent Urinary Tract Infections in Women (NCT NCT04096820)

NCT ID: NCT04096820

Last Updated: 2024-05-30

Results Overview

Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-05-30

Participant Flow

Participant milestones

Measure	Open Label Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Overall Study STARTED	67
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Open Label Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Overall Study Did not return for intervention	2
Overall Study Death	1

Baseline Characteristics

Uromune in Treating Recurrent Urinary Tract Infections in Women

Baseline characteristics by cohort

Measure	Open Label n=64 Participants Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: intention to treat participants received at least one dose of vaccine and had first 3-month follow-up.

Participant considered complete responder if no UTI requiring antibiotics reported in the 9 month efficacy period following completion of 3 month vaccine therapy.

Outcome measures

Measure	Open Label n=64 Participants Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Complete Responder	26 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Modified intention to treat included all participants who received at least one dose of vaccine and had first 3-month follow-up visit

The number of UTI in individual participants requiring antibiotics in the 9 month efficacy period following completion of vaccine therapy will be compared to the number of UTIs requiring antibiotics before therapy is initiated.

Outcome measures

Measure	Open Label n=64 Participants Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Number of UTI in the Efficacy Period	0.14 Number of UTI/month Interval 0.0 to 20.0

Adverse Events

Open Label

Serious events: 13 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	Open Label n=65 participants at risk Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Pregnancy, puerperium and perinatal conditions Pregancy	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mastectomy	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Gastrointestinal disorders Colitis	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Endocrine disorders Throidectomy	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Surgical and medical procedures Knee replacement	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Gastrointestinal disorders Upper GI bleed	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Gastrointestinal disorders rectal prolapse	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Injury, poisoning and procedural complications hip fracture	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Injury, poisoning and procedural complications radial bone fracture	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Injury, poisoning and procedural complications Accidental overdose of pain medication	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Injury, poisoning and procedural complications rib fracture	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Immune system disorders antibiotic related anaphylaxis	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Cardiac disorders Myocardial infarction	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.

Other adverse events

Measure	Open Label n=65 participants at risk Uromune will be taken by the participant for 90 days. Uromune: 2 sprays of vaccine under the tongue for 90 days. Liquid is to held under tongue for 2 minutes without swallowing.
Gastrointestinal disorders Gastrointestinal events	6.2% 4/65 • Number of events 4 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
Skin and subcutaneous tissue disorders rash	9.2% 6/65 • Number of events 9 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.
General disorders fatigue	1.5% 1/65 • Number of events 1 • 15 months One patient died (unrelated myocardial infarction) before the first assessment so was not included in the modified intention to treat analysis.

Additional Information

Heather McFarlane, Administrative Assistant

Queen's University/Kingston General Health Research Institute

Phone: 613-549-6666

Email: heather.mcfarlane@kingstonhsc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place