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Vaccine for Recurrent Urinary Tract Infections in Women

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ClinicalTrials.gov Identifier: NCT00261248
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infections in Women Biological: Immunization with inactivated bacteria Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections
Study Start Date : November 1996
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Rate of re-infection over the study

Secondary Outcome Measures :
  1. Infection-free status at completion of study


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Three or more urinary tract infections in the previous year

Exclusion Criteria:

  • Neurogenic bladder
  • Interstitial cystitis
  • Urinary diversion
  • Kidney stones
  • Indwelling catheter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261248


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Investigators
Principal Investigator: David T Uehling, M.D. University of Wisconsin, Madison

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00261248     History of Changes
Other Study ID Numbers: 1996-295
DK-30808
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: September 2003

Keywords provided by University of Wisconsin, Madison:
Phase 2
Vaccine
Urinary Tract Infection
Vaginal Mucosal

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs