Vaginal mucosal immunization for recurrent urinary tract infection: phase II clinical

Many women remain susceptible to ascending urinary tract infections (UTIs) despite the absence of a demonstrable ana-tomic abnormality [1]. Repeated treatment with antibiotics is often necessary for these women but may lead to adverse re-actions and infection with antibiotic-resistant organisms [2]. On the basis of concepts of mucosal immunity in the genitourinary tract [3±5], we have been working to develop an effective mu-cosally applied vaginal immunogen to help prevent ascending UTIs. After a trial in nonhuman primates, we carried out and reported two previous clinical trials in susceptible women [6±8]. We are now reporting on a clinical trial to extend the time period of protection through use of the same multivalent vagi-nal immunogen and through immunogen boosts given at 4-week intervals. Materials and Method