Vaccine for Recurrent Urinary Tract Infections in Women

Recurrent Urinary Tract Infections in Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261248
• Other study ID #: 1996-295
• Secondary ID: DK-30808
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2005
• Last updated: October 1, 2015
• Start date: November 1996
• Est. completion date: December 2003

Study information

• Verified date: September 2003
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Three or more urinary tract infections in the previous year

Exclusion Criteria:

• Neurogenic bladder

• Interstitial cystitis

• Urinary diversion

• Kidney stones

• Indwelling catheter

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Recurrent Urinary Tract Infections in Women
• Urinary Tract Infections

Intervention

Biological:
• Immunization with inactivated bacteria

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Uehling DT, Hopkins WJ, Beierle LM, Kryger JV, Heisey DM. Vaginal mucosal immunization for recurrent urinary tract infection: extended phase II clinical trial. J Infect Dis. 2001 Mar 1;183 Suppl 1:S81-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of re-infection over the study
Secondary	Infection-free status at completion of study