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
Bibliographic record
Abstract
You have accessJournal of UrologyCME1 Apr 2023MP34-07 MV140 SUBLINGUAL VACCINE REDUCES RISK OF RECURRENT URINARY TRACT INFECTION (RUTI) IN NORTH AMERICAN WOMEN: RESULTS FROM THE FIRST NORTH AMERICAN CLINICAL EXPERIENCE STUDY J. Curtis Nickel, Dean Elterman, Kerri-Lynn Kelly, Ashley Griffin, and R. Christopher Doiron J. Curtis NickelJ. Curtis Nickel More articles by this author , Dean EltermanDean Elterman More articles by this author , Kerri-Lynn KellyKerri-Lynn Kelly More articles by this author , Ashley GriffinAshley Griffin More articles by this author , and R. Christopher DoironR. Christopher Doiron More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003268.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: 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 1). 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 © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e461 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.Metrics Author Information J. Curtis Nickel More articles by this author Dean Elterman More articles by this author Kerri-Lynn Kelly More articles by this author Ashley Griffin More articles by this author R. Christopher Doiron More articles by this author Expand All Advertisement PDF downloadLoading ...
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".