VAGINAL MUCOSAL IMMUNIZATION FOR RECURRENT URINARY-TRACT INFECTION - PHASE-II CLINICAL-TRIAL

Purpose: Decreased local immunity to uropathogenic bacteria may be a f actor predisposing women to recurrent urinary tract infections. Our ph ase I study demonstrated the safety of a multi-strain vaccine administ ered as a vaginal suppository. A phase II study was conducted to deter mine vaccine efficacy. Materials and Methods: A total of 91 women susc eptible to recurrent urinary tract infections was entered into the stu dy and the courses were analyzed in a randomized, double-blind, placeb o controlled trial of vaginal mucosal immunization. Subjects received 3 vaginal suppositories at weekly intervals. Depending on the treatmen t group each suppository contained 1 of 2 vaccine doses or suppository material only. Each patient was followed for 5 months to record infec tion episodes, and obtain urine, vaginal irrigates and serum to measur e immunological responses. Results: Immunogen treated women who were o ff antibiotic prophylaxis throughout the study had a significant delay in interval to reinfection during the first 8 weeks compared to women receiving placebo. Mean interval until reinfection was delayed from 8 .7 weeks for placebo treated to 13 weeks for vaccine treated women. Im munological responses in serum, urine and vaginal fluid were variable. No serious adverse effects were observed. Conclusions: These data dem onstrate that vaginal mucosal immunization can enhance resistance to u rinary tract infections in susceptible patients.