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
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Résumé
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 ...
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».