‘Game changer’ UTI vaccine stops infection for nine years

Recurring urinary tract infections (UTIs) can be prevented for up to nine years with an oral spray vaccine, a landmark British trial has shown.

Experts said the treatment was a “game changer” for people suffering from continual painful infections, which lead to 150,000 hospitalisations each year, costing the NHS £380 million annually.

Around half of women and 20 per cent of men suffer UTIs, which can be particularly dangerous for older people, causing irregular heartbeat, high blood pressure, and triggering potentially lethal falls.

The death rate for hospital UTIs is four in 100, accounting for around 6,000 deaths a year. It rises to one in 10 for people aged 95 and over as it can often develop into sepsis and make dementia worse.

In a long-running trial, 89 patients were asked to spray the pineapple-flavoured vaccine under their tongue every day for three months, and then followed up for nine years by clinicians at the UK’s Royal Berkshire Hospital.

Nearly half of the participants (48 per cent) remained entirely infection-free during the nine-year follow-up.

The average infection-free period across the cohort was 54.7 months (four and a half years) – 56.7 months for women and 44.3 months, one year less, for men. Forty per cent of the trial participants reported having second doses of the vaccine after one or two years.

‘Vaccine restored quality of life’

Dr Bob Yang, consultant urologist at the Royal Berkshire NHS Foundation Trust, who co-led the research, said: “Before having the vaccine, all our participants suffered from recurrent UTIs, and for many women, these can be difficult to treat.

“Nine years after first receiving this new UTI vaccine, around half of the participants remained infection-free.

“Overall, this vaccine is safe in the long term and our participants reported having fewer UTIs that were less severe. Many of those who did get a UTI told us that simply drinking plenty of water was enough to treat it.

“Many of our participants told us that having the vaccine restored their quality of life.”

At present ongoing and recurrent UTIs are treated with antibiotics, but antibiotic-resistant infections are now on the rise and drugs are becoming less effective.

The vaccine, known as Uromune, was developed by Spain-based pharmaceutical company Immunotek, and contains whole bacteria of the four most common bugs that cause UTIs in men and women –  Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris and Enterococcus Faecalis.

It is licensed in Spain and although it is currently only available off-licence in Britain, experts are hoping it will soon be passed for use on the NHS. New results are expected to be passed to the Medicines and Healthcare Products Regulatory Agency (MHRA).

‘Study results offer hope to those affected’

Mary Garthwaite, chair of the Urology Foundation and a former consultant urological surgeon at James Cook University Hospital, in Middlesbrough, said: “The ability to potentially gain cure or long-term remission, with a non-antibiotic therapy, is a game changer.

“The results of this study, looking at the long-term outcomes for patients treated with Uromune, offer hope to all those affected by this devastating condition which impacts on all aspects of life – from physical and mental health, the ability to work and study, to difficulties with relationships and sex.

“In addition, it offers the benefit of helping to reduce our use of antibiotics, which often leads to a pattern of increasing antimicrobial resistance in the bacteria causing the urine infections in this patient group.

“We hope to see this non-invasive, simple treatment more widely available to recurrent UTI sufferers in the UK in future.”

The research was presented this weekend at the European Association of Urology (EAU) Congress in Paris.

Gernot Bonkat, chairman of the EAU Guidelines on Urological Infections, said: “These findings are promising. Recurrent UTIs are a substantial economic burden and the overuse of antibiotic treatments can lead to antibiotic-resistant infections.

“This follow-up study reveals encouraging data about the long-term safety and effectiveness of the MV140 vaccine.

“While we need to be pragmatic, this vaccine is a potential breakthrough in preventing UTIs and could offer a safe and effective alternative to conventional treatments.”

If the vaccine is approved by the MHRA it would also need to be approved by the National Institute for Health and Care Excellence for cost effectiveness. The NHS calculates that Uromune would cost about £326 per course, compared to about £50 for antibiotics.