“ It’s very exciting… for us, it was almost magical said Bob Yang, who works at the Royal Berkshire NHS Foundation Trust. Addressing Medscape News UKhe explained that the trial, the results of which were presented to the Congress of the European Association of Urology (EAU) in Paris from April 5 to 8, 2024, built on impressive initial results that he and his colleagues had achieved in off-label use in a small number of patients.
Spectacular
“ The results were spectacular said Dr. Yang. “ We had women who came month after month with one infection after another, despite all treatments, often with last-line antibiotics. And [après avoir utilisé le vaccin]they came back saying: “What did you do to us? We no longer have an infection.” »
The MV140 vaccine, called Uromune, was developed by Immunotek SL in Spain. It is composed of whole inactivated bacteria commonly associated with urinary infections: Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcus Faecalis. It is administered by two sprays of a pineapple-flavored suspension under the tongue every day for 3 months.
The vaccine has been used largely off-label in some countries for several years, and its short-term effectiveness has already been confirmed by published trials in which Dr. Yang and colleagues participated. But the researchers wanted to further study whether an initial vaccination protocol could provide safe and effective long-term protection for people with recurrent UTIs.
Long-term results
The 9-year follow-up made it possible to study the long-term safety and effectiveness in 89 patients (72 women and 17 men) aged 18 to 87 years (mean age 56 years) suffering from recurrent urinary infections. These patients were originally treated as part of a course at the Urology Partnership Reading, UK. Forty percent of participants also received repeat doses of the vaccine after 1 or 2 years.
Forty-eight participants (54%) were free of a UTI during the 9-year follow-up period, with the average time free of UTI for the entire cohort being 4.5 years. In terms of safety, Dr. Yang said no adverse effects or other issues have been identified.
Dr. Yang explained to Medscape News UK that one of the main purposes of the presentation at the EAU Congress was to subject the results to initial peer review and feedback. An official and complete publication should then follow by the end of 2024.
Exciting
Jennifer Rohn, professor of renal medicine and director of the Center for Urological Biology at University College London, who was not involved in the research, told Medscape News UK : “ These results are exciting and suggest that preventing UTIs could be a viable strategy in our fight against an infection that affects around 400 million people each year, mainly women, and which antibiotics struggle to control in 30% of these many. case. »
Professor Rohn adds that vaccination is a particularly interesting strategy at a time when bacterial infections are becoming increasingly resistant to antibiotics. “ Although people often think of UTI as a common infection, there are already around a quarter of a million deaths per year linked to antibiotic resistance, and this figure is expected to rise. “, she said.
Also note that reducing the risk of recurrent urinary infections would result in considerable savings.
While recognizing the promising nature of the study, Professor Rohn stressed that it involved a relatively small number of patients who self-reported their symptoms, and she therefore believes that larger studies will be welcome. “ It’s also worth keeping in mind that the study was done on people with relatively simple recurrent UTIs, and more work is needed to understand whether the treatment will be as effective in cases of complicated UTIs. or chronic “, she added.
Next steps
Among efforts by various researchers to study the vaccine’s effectiveness in more complex situations, Yang said he has secured funding to test the Uromune vaccine on patients with spinal injuries, which can be victims of more complex urinary infections. This will initially be a small prospective trial, which will be followed by a large randomized controlled trial.
Prof. Yang also pointed out that although many other bacteria can cause UTIs in addition to the four most common bacteria specifically targeted by the vaccine, these other infections also appeared to be covered by the vaccine.
“ The reason is probably that many of these gram-negative bacteria share an outer layer of lipopolysaccharide… which allows for a broad-spectrum response. ”, as well as other off-target effects on the immune system, he suggested.
For the moment the vaccine is still not approved and Professor Yang stressed that it would be very difficult for general practitioners to use it off-label, so the next steps will be to try to move forward. ahead to obtain regulatory approval in the UK and Europe.
“ Once this treatment is approved, it will be revolutionary for general practitioners “, said Professor Yang. While emphasizing that approval will be a slow process.
There are other vaccines developed against recurrent urinary infections: Solco-Urovac (intravaginal and intramuscular route), Uro-Vaxom (oral route) as well as the Urkavol and Urostim vaccines. “ All of continental Europe is already using lysed polybacterial vaccines against urinary infections such as Solco-Urovac and Uro-Vaxom », according to UroFrance. Studies are also underway with these vaccines.
This article was originally published on Medscape.fr
Funding and links of interest:
Dr. Bob Yang has declared no relationship of interest to the subject.
Jennifer Rohn currently holds a ConvaTec Fundamental Research Fellowship and is Scientific Director (unpaid, with stock options) of AtoCap Ltd, a UCL spin-out company researching new treatments for bladder problems.
