PURPOSE: Recurrent @entity293 ( @entity293 ) in susceptible @entity1 remain a common urological condition. With an increasing number of @entity293 being caused by antibiotic resistant bacteria there is a need for alternatives to antibiotics. We determined whether multiple doses of a vaginal mucosal vaccine are effective for increasing long-term resistance to recurrent @entity293 . MATERIALS AND METHODS: A total of 54 @entity1 were entered into a double-blind, placebo controlled, phase 2 clinical trial using a vaginal vaccine containing 10 heat killed uropathogenic bacteria. @entity1 were withdrawn from prophylactic antibiotics and randomly assigned to 1 of 3 treatment groups, namely placebo only, primary immunization or primary plus booster immunizations. Subjects received treatments at 0, 1, 2, 6, 10 and 14 weeks. Placebo treated @entity1 received suppositories without bacteria. The primary immunization group received vaccine suppositories, followed by 3 doses of placebo. @entity1 receiving booster immunizations were given 6 vaccine suppositories. All @entity1 were followed for 6 months to determine the time until first recurrence, number of @entity281 and adverse reactions. RESULTS: @entity1 receiving 6 vaccine doses remained free of @entity281 for a significantly longer period than those receiving placebo or primary immunizations. Of @entity1 receiving 6 immunizations 55% did not experience an infection, whereas 89% of placebo treated @entity1 had @entity293 . No @entity1 had significant adverse effects. CONCLUSIONS: This study demonstrates that vaginal mucosal vaccine given for a 14-week period increased the time to re-infection in UTI susceptible @entity1 . The infrequent, minimal adverse reactions confirm previous observations on the safety of this vaginal mucosal immunization regimen.

Phase 2 clinical trial of a vaginal mucosal vaccine for XXXX .

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients', 'Women'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infections'] @entity293 :: ('MESH:D014552', 'Disease') :: ['urinary tract infections', 'UTIs']
@entity293 :: (MESH:D014552,Disease) :: ['urinary tract infections']
