Vaginal Mucosal Vaccine for Recurrent Urinary Tract Infections in Women: Results of a Phase 2 Clinical Trial

No AccessJournal of UrologyAdult urology1 Apr 2007Vaginal Mucosal Vaccine for Recurrent Urinary Tract Infections in Women: Results of a Phase 2 Clinical Trial Walter J. Hopkins, Johny Elkahwaji, Lori M. Beierle, Glen E. Leverson, and David T. Uehling Walter J. HopkinsWalter J. Hopkins Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin , Johny ElkahwajiJohny Elkahwaji University of Nebraska Medical Center, Omaha, Nebraska , Lori M. BeierleLori M. Beierle State of Wisconsin Hospital Preparedness, Madison, Wisconsin , Glen E. LeversonGlen E. Leverson Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin , and David T. UehlingDavid T. Uehling Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin View All Author Informationhttps://doi.org/10.1016/j.juro.2006.11.093AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We assessed the clinical efficacy of vaginal mucosal immunization with a multivalent bacterial vaccine in women with recurrent urinary tract infections. Materials and Methods: A total of 75 patients in a double-blind study were randomly assigned to receive placebo only, primary immunization without boosters, or primary immunization plus boosters using vaginal suppositories containing placebo or vaccine. Vaccine suppositories contained 10 strains of heat-killed uropathogenic bacteria and placebo suppositories had no vaccine organisms. All women were monitored for 6 months to record the number of infections and adverse events. Results: Analysis of data on urinary tract infections caused by any bacteria showed the greatest difference in infection rates between patients in the vaccine plus boosters protocol compared to those receiving placebo only (p = 0.100). When only E. coli urinary tract infections were considered in the analysis, urinary tract infection recurrence rates were significantly less in women given booster immunizations compared to placebo (p = 0.0015). Furthermore, women who received vaccine with boosters and who were sexually active, less than 52 years old, or had not undergone hysterectomy had E. coli urinary tract infections at a much lower rate than women given placebo only (p = 0.0002, 0.002 and 0.003, respectively). No significant adverse events were associated with vaccine treatment. Conclusions: This study demonstrated the efficacy of vaginal mucosal immunization with a multivalent vaccine in reducing recurrence of E. coli urinary tract infections. 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Abstract, Google Scholar © 2007 by American Urological AssociationFiguresReferencesRelatedDetailsCited byDomingos-Pereira S, Derré L, Warpelin-Decrausaz L, Haefliger J, Romero P, Jichlinski P and Nardelli-Haefliger D (2013) Intravaginal and Subcutaneous Immunization Induced Vaccine Specific CD8 T Cells and Tumor Regression in the BladderJournal of Urology, VOL. 191, NO. 3, (814-822), Online publication date: 1-Mar-2014.Beerepoot M, Geerlings S, van Haarst E, van Charante N and ter Riet G (2013) Nonantibiotic Prophylaxis for Recurrent Urinary Tract Infections: A Systematic Review and Meta-Analysis of Randomized Controlled TrialsJournal of Urology, VOL. 190, NO. 6, (1981-1989), Online publication date: 1-Dec-2013. Volume 177Issue 4April 2007Page: 1349-1353 Advertisement Copyright & Permissions© 2007 by American Urological AssociationKeywordsurinary tract infectionsclinical trialvaccinesMetricsAuthor Information Walter J. Hopkins Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin More articles by this author Johny Elkahwaji University of Nebraska Medical Center, Omaha, Nebraska More articles by this author Lori M. Beierle State of Wisconsin Hospital Preparedness, Madison, Wisconsin More articles by this author Glen E. Leverson Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin More articles by this author David T. Uehling Department of Surgery, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin More articles by this author Expand All Advertisement PDF downloadLoading ...