For a few years, the urologic community has been abuzz with news of a preventative UTI vaccine called Uromune (MV140). The vaccine, which has been utilized in 26 countries, is growing in use throughout North America. It was recently approved in Mexico and has been studied closely in Canada as well.(1, 2) The North American research has been spearheaded in Canada by IC researcher and urologist Dr. J. Curtis Nickel. Nickel has combined his interest in this research with his history of research about IC to look at the vaccine’s efficacy for IC patients.

Background of Uromune

Uromune (MV140) is a vaccine self-administered by patients using a spray under their tongue daily for three months. Studies have focused on women who have recurrent UTIs. Recurrent UTIs are defined as three or more UTIs in 12 months or two or more in six months. With UTIs being one of the most common infections in women, 3% of women who have UTIs go on to develop recurrent UTIs. This puts them at a higher risk for depression, anxiety, sexual dysfunction, stress and more.(3)

Currently, the standard treatment for UTIs — both acute and recurrent — is antibiotics. Women experiencing recurrent UTIs are often placed on longer term antibiotics for six months or longer. Such long-term use of antibiotics can lead to serious and even life-threatening side effects plus antibiotic resistance.(3) Finding ways to more effectively treat and prevent UTIs is important.

Uromune, which has been around for about a decade, targets four bacteria commonly responsible for UTIs and has shown positive results in studies.(2) Thus far, 73 studies have examined MV140 with 19 of them specific to recurrent UTI prevention. Of those 19, five met the criteria to be critically reviewed in efficacy of preventing recurrent UTIs for a total of 1,400 women studied. Among those studies, up to 78% of the participants remained UTI free for nine to 24 months post-treatment.(3)

Nickels’ team began with a small group of participants and found Uromune to reduce the incidence of UTIs by 82% for nine months post-vaccination. Patients went from an average of 11.5 UTIs per year collectively to 2.1 UTIs per year. Successful studies have continued globally without any major safety concerns being reported.(3)

Read more of the ICN’s previous coverage about the vaccine.

Uromune and Interstitial Cystitis/Bladder Pain Syndrome

While the results have been promising in treating recurrent UTIs with Uromune, the question remains whether it would help IC/BPS patients. The short answer is yes, for certain phenotypes of ICers. In April, Nickels and his team released preliminary findings looking at this exact question. They started with a small group of 16 women who had both IC and recurrent UTIs.(4)

Overall, the patients did well with Uromune. Since recent research showed women with recurrent UTIs have an imbalance in two types of their bladder mucosa, the researchers postulated it might be helpful for the infection subcategory of IC. The researchers speculate this subcategory has a hypersensitivity to bacteria present in the bladder. As such, removing or improving toleration for such bacteria could improve symptoms for these specific IC patients.(4)

The results of the small study were incredibly promising with none of the patients having a UTI following vaccination. At the end of nine months post-vaccination, six patients remained UTI-free, while all of the patients had at least a reduction in UTIs as compared to the previous year. That’s an 80% reduction in UTIs after using Uromune for three months. Even more promising is that 81.3% of the patients reported a moderate or marked improvement in their IC symptoms after treatment. Eight subjects reported a nearly complete resolution of their long-term bladder pain, urgency and frequency.(4)

For IC/BPS patients with an infection phenotype, the Uromune vaccine could be very effective in preventing recurrent UTIs and vastly improving bladder symptoms. However, Uromune is still in study and trial phases. It is not yet available in Canada or the United States.

A Vaccine Pill Option

A second UTI vaccine option is being developed by researchers at Duke University. This vaccine is also administered under the tongue but is in a dissolvable pill form. The pill activates immune cells that attack UTI-causing bacteria.(5)

So far, this treatment has been tested only in mice, but it is also showing promise. For mice who have a UTI, the vaccine’s efficacy was similar to that of antibiotics without causing the side effects that often come along with antibiotics, including disturbing the gut biome. The researchers postulate that such a vaccine would be able to prevent UTIs as well, but more research and human trials are needed.(5) This vaccine has the potential to treat UTIs without antibiotics, which also reduces the risk of antibiotic resistance.

With two UTI vaccine options on the horizon, IC/BPS patients can only benefit from them. For patients who have a bacterial phenotype of IC, the news is even more promising. But all IC patients can benefit from a reduction in UTIs which are notorious for causing IC flares.

References:

  1. Osborne J. Uromune Vaccine To Prevent UTI Showing Remarkable Success. IC Network. Feb. 19, 2022.
  2. Pharmacy Times. Sublingual Vaccine Shows Efficacy in Preventing Recurrent UTIs, Helping to Eliminate Need for Antibiotics. May 25, 2023.
  3. JC Nickel, et. al. An Effective Sublingual Vaccine, MV140, Safely Reduces Risk of Recurrent Urinary Tract Infection in Women. Pathogens. 2023 Mar; 12(3): 359.
  4. JC Nickel, et. al. PD06-06 Infection Phenotype in Interstitial Cystitis/Bladder Pain Syndrome: Does Bacterial-Induced Mucosal Cellular Immune Imbalance Hypersensitivity Explain Response to MV140 Recurrent UTI Vaccine?. JUrol. 2023 April; 209(4): e150.
  5. Kane M. Tablet-Based Vaccine Prevents Urinary Tract Infections in Mice. Duke Pratt School of Engineering. Nov. 28, 2022.