Vaccine for Recurrent Urinary Tract Infections in Women
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Urology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | November 1996 |
| End Date: | December 2003 |
Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections
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.
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.
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.
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.
Inclusion Criteria:
- Three or more urinary tract infections in the previous year
Exclusion Criteria:
- Neurogenic bladder
- Interstitial cystitis
- Urinary diversion
- Kidney stones
- Indwelling catheter
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
Click here to add this to my saved trials
