Bibliographic record
Abstract
Introduction: Recurrent urinary tract infection (rUTI) in women is associated with widespread morbidity, massive antibiotic use, increasing antibiotic resistance, significant costs and is believed to be implicated in the etiology of infection phenotype of bladder pain syndrome (BPS).This is the first North American real-world, clinical experience evaluation of MV140, a novel bacterial sublingual vaccine developed for prevention of rUTI.Methods: Female participants with ≥3 documented UTI/year (≥3 one culture proven) underwent a three-month vaccination treatment period, nine-month efficacy period, and subsequent three-month followup (total 15 months).Primary outcome was no clinically diagnosed UTI (defined as symptoms requiring antibiotic therapy) following vaccination.Secondary outcomes included reduction in UTI compared to pre-vaccination, quality of life (QoL), global response assessment (GRA), microbiology, and safety.A sub-study evaluated subjects with rUTI and concurrent BPS.Results: Sixty-seven subjects (mean age 55.6 years, range 18-80), including 16 with BPS, were enrolled; 64 completed the three-month vaccination period and at least one post-vaccination assessment.Prior to vaccination, subjects reported 6.8±4.6 UTI/year.The UTI-free rate for the nine-month post-vaccination efficacy period was 40.6%.Compared to the UTI rate in the year prior to vaccination (0.56 UTI/subject/month), the reduction in UTI rate was 74.8% for the nine-month efficacy period (0.14 UTI/subject/month) post-vaccination.The total number of UTI and the number of patients reporting UTI decreased substantially for each three-month followup period, while the percentage of UTI-free subjects increased following vaccination.At the 12-month 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.In the BPS sub-study, 6/16 subjects were UTI-free, while all 16 subjects had a reduction (overall 80%) in UTI compared to the year pre-vaccination (0.5 to 0.1 UTI/ subject/month).At 12 months, 13 subjects (81.3%) reported moderate or marked improvement, with eight reporting significant or almost complete resolution of their specific long-term bladder discomfort/pain and bothersome urinary frequency or urgency.In the entire group, 11 adverse events in nine subjects were potentially related to the vaccine; all were mild and resolved by three months.None of the 13 serious adverse events were related to the 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, including those with IC/BPS, completely UTI-free (and offering amelioration of BPS symptoms for those with BPS).
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.495 | 0.219 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".