NCT00261248

Vaccine for Recurrent Urinary Tract Infections in Women

Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is determine whether a vaginal mucosal vaccine given to women with a history of recurrent urinary tract infections can reduce the number of infections occurring in a six-month study period, as compared to placebo treatment.

Detailed description

Recurrent urinary tract infections (UTIs) affect approximately 10% of women in the United States. Since antibiotic prophylaxis is not always effective, alternate treatments need to be developed. One such treatment would be immunization with a vaccine containing bacteria known to cause these infections. The objective of the study is to immunize susceptible women with inactivated bacteria contained in a vaginal suppository and to monitor the rates of reinfection compared to a group of women treated with placebo suppositories. Each group of patients will receive a total of six suppositories in the first four-months of the six-month study during which all UTIs and side effects will be recorded. The infection rates between vaccine- and placebo-treated women will be statistically analyzed to determine vaccine efficacy.

Conditions

• Recurrent Urinary Tract Infections in Women

Interventions

Type	Name	Description
BIOLOGICAL	Immunization with inactivated bacteria

Timeline

• Start date: 1996-11-01
• Completion: 2003-12-01
• First posted: 2005-12-02
• Last updated: 2015-10-05

Locations

1 site across 1 country: United States