Vaccine for recurrent UTIs reduces infection rate by 74.8%

Key takeaways:

• MV140, a vaccine for recurrent UTIs, appeared “safe, with almost no side effects” in a real-world trial.
• Data on the vaccine were presented at the American Urological Association annual conference.

A polybacterial sublingual vaccine, which reduced recurrent UTI rates and had few side effects, could be useful in future clinical practice, 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, told Healio that recurrent UTIs (rUTIs) are a “huge problem,” with 10% of women getting a UTI that requires antibiotics every year and one-third of those ending up with rUTIs.

“These patients have to take a lot of antibiotics, sometimes low dose for 3 to 6 months to prevent UTIs,” he said. “With all the side effects, costs, time off work and potentially major problems, such as the problem with worldwide antibiotic resistance ... even though antibiotics work ... they're probably not the best way to deal with rUTIs. The best way would be to prevent them in the first place.”

There are several other preventive strategies, such as increasing intake of water and cranberry, and “some evidence that we can help patients” with the natural products, Nickel said, “but we've always been looking for something that would meet this major unmet need.”

This particular vaccine — a sublingual spray taken daily for 3 months — caught Nickel’s eye several years ago as studies demonstrating its safety and potential efficacy came out.

“This vaccine is a very simple product that uses killed bacteria from four of the main bacterial strains that cause UTIs,” he said.

Nickel presented data from a real-world study on the polybacterial sublingual vaccine MV140 (Inmunotek) at the American Urological Association’s annual conference. The trial included 67 women with a mean age of 55.6 years who had at least three UTIs per year and were given the vaccine for 3 months. The researchers followed participants over 9 months to evaluate the efficacy of the vaccine and then an additional 3 months (total of 15 months).

“Those particular women were very eager to take part in this trial because many of them have had these problems for many years and have been on all sorts of antibiotics and have had difficulties with antibiotics,” Nickel said. “Physicians were very eager to have these patients in our local clinical trial.”

Before vaccination, the participants had almost an average of seven UTIs per year, with the predominant causative bacterial species being Escherichia coli, at 59%, Klebsiella, at 18% and Enterococcus, at 15%.

After completing the vaccine regimen, 40.6% of the participants had no UTIs and there was a 74.8% reduction in UTI rates during the 9-month efficacy period, according to Nickel and colleagues. The total number of overall UTIs and patients reporting them substantially decreased for each 3-month follow-up period. In turn, the percentage of UTI-free participants increased following vaccination.

Additionally, at the 12-month efficacy visit, 82% reported marked or moderate improvement and 59% reported being mostly satisfied, according to the researchers. Nickel said the vaccine is “safe, with almost no side effects.”

“Any side effects like the little tingling goes away very quickly and it’s not something patients complain about — we had to ask about it,” he said.

Nickel said that he and his team will soon present the data to Health Canada and they hope approval in Canada could be forthcoming. For the United States, Nickel said that he expects the FDA would require a U.S.-based randomized placebo-controlled study before approval.

“It was recently approved in Mexico ... Australia, New Zealand and the United Kingdom. It is used on a specialist access program where the physicians have to apply for its use ... based on the patient's history allergy to antibiotics or difficulty with antibiotics,” he said. “That’s how it’s used elsewhere. Canada will be one of the first western countries, if it’s approved, to be able to prescribe this to our patients.”

He added that he is “so happy to be a part of [the vaccine research] because I do believe it is going to be a game changer for women who have rUTIs and for the physicians — primarily the family physicians — who take care of them.”

“I believe that this is the ideal vaccine for family practitioners and general practice because family practitioners are much more cognizant of the use and indications for vaccine than specialists,” Nickel said.