The M140 vaccine against recurrent UTIs now being studied in Canada

A vaccine that is sprayed under the tongue for the prevention of recurrent urinary tract infections (UTIs) may be coming to Canada.The M140 vaccine is already used in Europe, but recent clinical trials and other studies underway in Canada should nudge it closer to approval.“I understand the company is doing safety, stability and durability studies as part of their submission to Health Canada. If the application is submitted early next year, I expect it may be available late next year or 2026,” said urologist Dr. J. Curtis Nickel, who has conducted several l studies of the vaccine. He is a professor emeritus of medicine at Queen’s University in Kingston, Ont.Oral and vaginalHe stated that Europeans also have access to other vaccines including oral and vaginal forms. “They have been around more than two decades,” he told the Canadian Healthcare Network. Indeed, the European Association of Urology guidelines recommend consideration of UTI vaccines. These vaccines are not presently approved or available in North America.M140 was developed about 15 years ago by Spain-based Immunoteck and is a polyvalent sublingual vaccine developed for UTI prevention. It consists of four inactivated whole-cell bacteria—Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis. Earlier studies reported that among women who had suffered recurrent UTIs and who were treated with M140 had UTI-free rates of 32% to 90%.M140 is available in 26 countries where it is either approved for use, or via special access programs, according to a study in the Canadian Urology Association Journal, published earlier this year by Dr. Nickel and colleagues. The study was the first North American clinical experience study of the vaccine.That safety-effectiveness prospective case series included 67 women who experienced three or more documented UTIs per year. They underwent three-month vaccination treatment, nine-month efficacy period and optional three-month followup for a total of 15 months; 64 completed the study.At study entry, and before vaccination, subjects reported a mean 6.8 UTIs per year. The study found that the UTI-free rate for the nine-month efficacy period was 40.6%. When this was compared to the infection rate in the year prior to vaccination with M140, “The reduction was 75.3% for the nine-month efficacy period post-vaccination,” the study said.At 12-month followup, 80.3% reported they moderate improvement compared to 58.1% who reported they were mostly satisfied. Quality of life (QOL) scores improved by a mean of 1.5 points.In practice, it would be used “daily, under the tongue for three months,” said Dr. Nickel. A commentary by urologist Dr. Duane Hickling in the same journal stated the study brings, “further hope for a potential breakthrough in preventing recurrent UTIs in women.” Dr. Hickling is an assistant professor of surgery at the University of Ottawa.He noted that while close to 40% of women were UTI-free and UTI recurrences were reduced by 75% during the study period, this is less than what was shown in a previous study of 240 women in Spain and the U.K.'New possibilities'But these results, “are more likely representative of and applicable to our real-world practice.” A possible reason for the difference is that the patients had a higher average number of UTIs per year than the other study.“As we await further studies in vulnerable patient populations and regulatory approvals, the MV140 sublingual vaccine presents itself as a promising therapeutic option, heralding new possibilities in combating recurrent UTIs,” he wrote.A followup study, also by Dr. Nickel’s team, was a randomized controlled trial investigating the impact of personal burden of disease reported on outcomes for a total of 150 women with recurrent UTIs.That study concluded that MV140 taken for three months, “significantly reduces the personal burden of UTI disease by safely decreasing the risk of subsequent UTIs, reducing severity of overall UTI symptoms.” It also reduced antibiotic use and demonstrated improvements in QOL.Recurrent UTIs in women are a major healthcare issue. They affect about 150 million people worldwide annually making them one of the most common bacterial infections. The severity of symptoms can range from a frequent sense of urgency to painful urination and abdominal pain, to critical kidney infections if not treated. UTIs are commonly treated with antibiotics. However, growing antibiotic resistance is complicating treatment because some UTIs have become less responsive to conventional therapies.More than half of all women will have at least one UTI in their lifetime, and despite treatment with antibiotics, 20% to 30% of these women suffer a recurrence within three to four months of the initial infection.

The M140 vaccine against recurrent UTIs now being studied in Canada

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