Session: MP34: Infections/Inflammation/Cystic Disease of the Genitourinary Tract: Kidney & Bladder I
MP34-07: MV140 sublingual vaccine reduces risk of recurrent urinary tract infection (rUTI) in North American women: Results from the first North American clinical experience study
Introduction: Recurrent UTI in women is associated with widespread morbidity, massive antibiotic use, increasing antibiotic resistance, and significant costs. This is the first North American real-world, clinical experience evaluation of MV140, a novel bacterial sublingual vaccine for prevention of rUTI. Methods: Females with = 3 UTI/yr underwent 3-month (mo) vaccination treatment, 9-mo efficacy and subsequent 3-mo follow-up (total 15-mo) periods. Primary outcome was no clinically diagnosed UTI (symptoms requiring antibiotics) following vaccination. Secondary outcomes included reduction in UTI compared to pre-vaccination, quality of life (QoL), global response assessment (GRA), microbiology and safety. Results: 67 subjects (mean age 55.6 yr; range 18-80) were enrolled; 64 completed 3-mo vaccination period and at least one post-vaccination assessment. Prior to vaccination, subjects reported 6.8±4.6 UTI/yr with E. coli (59%), Klebsiella (18%) and Enterococcus (15%) being the predominant causative bacterial species. The UTI free rate for the 9-mo post-vaccination efficacy period was 40.6%. Compared to the UTI rate in the year prior to vaccination (0.56 UTI/subject/mo), the reduction in UTI rate was 74.8% for the 9-mo efficacy period (0.14 UTI/subject/mo) post-vaccination. Total number of UTI and patients reporting UTI decreased substantially for each 3-mo follow-up period while the percentage of UTI free subjects increased following vaccination (Table). The predominant bacterial strains post-vaccination remained E. coli (60%), Klebsiella (14%) and Enterococcus (11%). At the 12-mo efficacy visit, 82% reported (GRA) that they were moderately/markedly improved; 59% were mostly satisfied, pleased or delighted while mean SF-12 improved by 1.5 points on QoL assessment. 11 adverse events (A/Es) in 9 subjects were potentially related to vaccine; all mild and resolved by 3 mo. None of the 13 Serious AEs were related to vaccine. Conclusions: This first Health Canada-approved North American experience with the sublingual vaccine, MV140, demonstrates its safety and potential effectiveness in real world clinical practice in reducing UTI risk and rendering a significant number of women suffering from rUTI completely UTI-free. SOURCE OF Funding: Inmunotek supplied MV140 vaccine
