2002-05-28 16:48:30 -0400 (Reuters Health)
By Emma Hitt, PhD
ORLANDO, Florida (Reuters Health) - An experimental vaccine, administered as a suppository inserted into the vagina, may be safe and effective in warding off urinary tract infections (UTIs) in women who suffer them repeatedly, a study suggests.
According to Dr. Johny E. Elkahwaji of the University of Wisconsin-Madison and colleagues, about half of all women will get a UTI at some point in their lifetime.
Antibiotics are useful in preventing and treating UTIs, but a vaccine could prevent the overuse of antibiotics, which can cause resistant, hard-to-treat strains of bacteria to develop.
Speaking here Saturday at the annual meeting of the American Urological Association, Elkahwaji presented data on a vaccine containing 10 different types of heat-killed bacteria that frequently cause UTIs.
Elkahwaji told Reuters Health that the vaccine was previously tested in Switzerland about 10 years ago in an injection form. "But its use was discontinued because of the side effects," he said.
To test the suppository form of the vaccine, researchers assigned 54 women to one of three treatment groups. One group received six inactive placebo treatments. Another group received six active treatments, one at the beginning of the study and then one at weeks 1, 2, 6, 10 and 14. The third group received three active and three placebo treatments over a similar time frame.
All the women were followed for 5 months to record side effects and to see whether their UTIs returned.
The researchers found that 45% of patients in the group receiving six immunizations experienced a repeat infection whereas 89% of placebo-treated women developed UTIs.
"No women had significant adverse effects," they report. A few patients experienced "brief vaginal irritation within one day of immunization or bad transient diarrhea."
The investigators conclude, "The lack of significant adverse effects in over 100 women confirms the safety of the vaccine itself and the immunization method."
According to Elkahwaji, this is the only vaginal vaccine currently being
tested for recurrent UTI. "We have FDA approval to continue the commercialization
of this vaccine, and we plan to start a multicenter phase III clinical
trial," he said.
Copyright © 2002 Reuters Limited