Vaginal mucosal vaccine for recurrent urinary tract infections in women: results of a phase 2 clinical trial

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. The results suggest that the vaccine may provide the most benefit to sexually active women in the 20 to 50-year-old age group.