Evaluation of MV140 in older adults

Evaluation of the sublingual vaccination MV140 in the prevention of recurrent urinary tract infections in the older adult Australian population - a multi-centre, double-blinded, randomised controlled trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000258651

Enrollment

150

Registered

2023-03-10

Start date

2023-04-03

Completion date

2023-07-03

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Australian population has a large proportion of older adults, and it is known that people of age greater than 65-years-old have a six-fold increased risk of acquiring recurrent urinary tract infections. Recurrent urinary tract infections cause significant burden to quality of life and result in a large number of presentations to general practitioners and hospitals for treatment. They are a significant cost to patients and the healthcare system. Whilst prophylactic use of antibiotics has been shown to be effective in the prevention of recurrent urinary tract infections, due to growing concern regarding antibiotic resistance, alternative treatments are being sought. MV140 is a form of bacterial vaccine, which means it uses de-activated strains of bacteria to improve your immune system’s response to infection. MV140 includes strains from 4 of the most common types of urinary tract infection bacteria (enteroccocus faecalis, escherichia coli, klebsiella pneumoniae, and proteus vulgaris). MV140 is not designed to treat such infections once patients have them, but is designed to help your immune system prevent them from developing in the first instance. Our goal is to determine whether MV140 is effective at preventing recurrent urinary tract infections in people aged greater than 65-years of age.

Interventions

Intervention arm: MV140 - Dose: 2 puffs (100uL) daily - Mode of administration: Sublingual - Duration: 3 months Compliance will be ensure by participant return of the empty product packaging to the clinical trials pharmacy following the 3-month treatment duration.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

• People aged greater than or equal to 65-years of any gender • Recurrent UTI (defined as 3 or more UTIs within the last 12 months) • Competence to consent to participate in trial and comply with study requirements

Exclusion criteria

• History of bladder tumours • Diagnosed bladder fistula disease • Currently receiving immunotherapy for another condition • Any immunological disease requiring active treatment • Known intolerance/allergy to MV140 or ingredients it contains • Known bladder stones • Long-term urinary catheter dependence (IDC/SPC) • Unable to provide informed consent or meet study requirements

Outcome results