‘Game changer’ vaccine for recurrent UTIs improves patients’ quality of life

A vaccine for recurrent UTIs significantly reduced UTI episodes and a need for health care resources, reducing “the personal burden” of disease, according to researchers.

J. Curtis Nickel, MD, FRCSC, Emeritus Professor of Urology and Canada Research Chair in Urologic Pain and Inflammation at Queen’s University, presented data on the polybacterial sublingual vaccine MV140 (Inmunotek) at the American Urological Association Annual Conference.

“This vaccine ... is going to be a game changer in patients with recurrent and chronic cystitis symptoms,” he said.

In the 1-year study, patients with recurrent UTIs (rUTIs) were randomly assigned in a 1:1:1 ratio to receive placebo for 6 months or the vaccine for 3 or 6 months. They were followed for 12 months after treatment initiation.

The study showed a significant reduction in UTI episodes among patients in the vaccine groups, with few treatment-related adverse events. Nickel reported that only two patients of about 200 dropped out of the study. Nearly 60% of patients in the 6-month vaccine group and more than 55% in the 3-month vaccine group had no UTI episodes in the next year compared with 25% in the placebo group.

The researchers also observed a significant reduction (75% to 100%) in the need for health care resources among patients in the vaccine groups, as well as a significant reduction in their health care costs. The median number of antibiotic prescriptions was 4.5 [IQR, 1-8.5] for the placebo group, compared with one [IQR, 0-3] in both groups receiving MV140 (P < .001).

“It appears that this ... vaccine that we’ve been working with ... severely decreased the risk of subsequent UTIs; it reduces the severity of overall UTI symptoms, even between active infections; reduces antibiotic use; reduces the patient’s resource utilization — going to the doctor all the time; and improves every single domain of the quality of life of women who suffer from recurrent UTI,” Nickel said.

The manufacturer is seeking approval for the vaccine in Canada, according to Nickel, but he was unsure when it would be submitted for FDA approval.

“[In the] United States, you need two large, randomized placebo-controlled trials before a vaccine goes, so it will be a couple of years,” he said. “That second trial is being planned right now.”

Nickel also noted that anecdotal data from special access programs in Europe showed that some patients have reapplied for special access to the vaccine years after initial vaccination.

“I suspect it’s going to be much like our other vaccines, that once patients start to have recurrent UTIs again, they'll have to be revaccinated,” he said.