MV140 sublingual vaccine reduces recurrent urinary tract infection in women

Results from the first North American clinical experience study

Authors

  • J. Curtis Nickel Department of Urology, Queen's University, Kingston, ON
  • Kerri-Lynn Kelly Department of Urology, Queen's University, Kingston
  • Ashley Griffin Department of Urology, Queen's University, Kingston
  • Dean S. Elterman Department of Surgery (Urology), University of Toronto, Toronto
  • Janet Clark-Pereira Department of Urology, Queen's University, Kingston
  • R. Christopher Doiron Department of Urology, Queen's University, Kingston, ON

DOI:

https://doi.org/10.5489/cuaj.8455

Keywords:

urinary tract infection, recurrent urinary track infection, women, vaccine, prevention

Abstract

INTRODUCTION: This is the first North American clinical evidence for MV140, a novel bacterial sublingual vaccine, developed for prevention of recurrent urinary tract infection (UTI) in women.

METHODS: Female subjects with ≥3 documented UTIs/year underwent three-month vaccination treatment, nine-month efficacy period, and optional three-month followup (total 15 months). Primary outcome was no clinically diagnosed UTI following vaccination (UTI-free rate). Secondary outcomes included absolute, mean, and median overall reduction in UTI compared to pre-vaccination, quality of life, global response assessment, patient satisfaction, microbiology, and safety.

RESULTS: Sixty-seven subjects (mean age 56 years, range 18–80) were enrolled; 64 completed the vaccination period and at least one post-vaccination assessment. Prior to vaccination, subjects reported a mean 6.8 UTIs/year. The UTI-free rate for the nine-month efficacy period was 40.6%. Compared to the infection rate in the year prior to vaccination, the reduction was 75.3% for the nine-month efficacy period post-vaccination. At 12-month followup, 80.3% reported that they were moderately/markedly improved; 58.1% were mostly satisfied, pleased, or delighted, while mean quality of life score improved by 1.5 points. Fourteen of the adverse events in nine subjects were potentially related to the vaccine — all mild and resolved by three months. None of the 13 serious adverse events were related to vaccine.

CONCLUSIONS: This first-in-North-America, prospective case series with the sublingual vaccine, MV140, adds further clinical evidence to its safety and effectiveness in reducing recurrent UTIs in women.

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Author Biography

Ashley Griffin, Department of Urology, Queen's University, Kingston

Note that Ashley is away on maternity leave.  Please address any correspondence that must need answering to first author, J. Curtis Nickel, at jcn@queensu.ca

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Published

2023-10-23

How to Cite

Nickel, J. C., Kelly, K.-L., Griffin, A., Elterman, D. S., Clark-Pereira, J., & Doiron, R. C. (2023). MV140 sublingual vaccine reduces recurrent urinary tract infection in women: Results from the first North American clinical experience study. Canadian Urological Association Journal, 18(2), 25–31. https://doi.org/10.5489/cuaj.8455

Issue

Vol. 18 No. 2 (2024): CUAJ February

Section

Original Research

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