Back to Search Start Over

Phase 2 clinical trial of a vaginal mucosal vaccine for urinary tract infections.

Authors :
Uehling DT
Hopkins WJ
Elkahwaji JE
Schmidt DM
Leverson GE
Source :
The Journal of urology [J Urol] 2003 Sep; Vol. 170 (3), pp. 867-9.
Publication Year :
2003

Abstract

Purpose: Recurrent urinary tract infections (UTIs) in susceptible women remain a common urological condition. With an increasing number of UTIs being caused by antibiotic resistant bacteria there is a need for alternatives to antibiotics. We determined whether multiple doses of a vaginal mucosal vaccine are effective for increasing long-term resistance to recurrent UTIs.<br />Materials and Methods: A total of 54 women were entered into a double-blind, placebo controlled, phase 2 clinical trial using a vaginal vaccine containing 10 heat killed uropathogenic bacteria. Patients were withdrawn from prophylactic antibiotics and randomly assigned to 1 of 3 treatment groups, namely placebo only, primary immunization or primary plus booster immunizations. Subjects received treatments at 0, 1, 2, 6, 10 and 14 weeks. Placebo treated patients received suppositories without bacteria. The primary immunization group received vaccine suppositories, followed by 3 doses of placebo. Patients receiving booster immunizations were given 6 vaccine suppositories. All women were followed for 6 months to determine the time until first recurrence, number of infections and adverse reactions.<br />Results: Women receiving 6 vaccine doses remained free of infections for a significantly longer period than those receiving placebo or primary immunizations. Of patients receiving 6 immunizations 55% did not experience an infection, whereas 89% of placebo treated women had UTIs. No women had significant adverse effects.<br />Conclusions: This study demonstrates that vaginal mucosal vaccine given for a 14-week period increased the time to re-infection in UTI susceptible women. The infrequent, minimal adverse reactions confirm previous observations on the safety of this vaginal mucosal immunization regimen.

Details

Language :
English
ISSN :
0022-5347
Volume :
170
Issue :
3
Database :
MEDLINE
Journal :
The Journal of urology
Publication Type :
Academic Journal
Accession number :
12913718
Full Text :
https://doi.org/10.1097/01.ju.0000075094.54767.6e