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Vaccine for Recurrent Urinary Tract Infections in Women

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261248
Enrollment
75
Registered
2005-12-02
Start date
1996-11-30
Completion date
2003-12-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Urinary Tract Infections in Women

Keywords

Phase 2, Vaccine, Urinary Tract Infection, Vaginal Mucosal

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.

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.

Interventions

BIOLOGICALImmunization with inactivated bacteria

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Three or more urinary tract infections in the previous year

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Rate of re-infection over the study

Secondary

MeasureTime frame
Infection-free status at completion of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026