מתוך medicontext.co.il
CHICAGO (Reuters Health) – In women with recurrent urinary tract infections (RUTIs), use of an investigational vaginal vaccine was tied to longer infection-free periods than was placebo use, according to phase II study findings presented here on Monday at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Dr. Walter J. Hopkins and colleagues, from the University of Wisconsin Medical School in Madison, tested the efficacy of the vaccine in 54 women with RUTIs. The vaccine consisted of a vaginal suppository containing 10 types of heat-inactivated, uropathogenic bacteria.
Eighteen women received 3 weekly primary immunization doses of the vaccine, followed by 3 monthly booster doses. Another 18 received primary immunization only and a third group of 18 received placebo for all six doses.
Among the women who received primary and booster doses, half stayed UTI-free for 6 months after the start of the study, compared with only 20% of women who received placebo. In addition, in vaccine-treated women who developed infections, the onset of infection was delayed compared with placebo-treated women.
The benefits of the vaccine began to decline about 2 months after the women received their last dose, Dr. Hopkins said, so subsequent studies will include longer booster periods. An open-label, year-long study is planned, along with a multicenter randomized, placebo-controlled trial.
The Cincinnati-based company Protein Express has received a license from the US Food and Drug Administration to manufacture the vaccine for the upcoming trials. Dr. Hopkins believes the vaccine could reach the market in 3 to 5 years.
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