Recurrent cystitis: the vaccine shows promise


The vaccination is an attractive treatment for recurrent cystitis in women. Some immunoactive agents are proved to be effective and have already included in the treatment guidelines. Hoewever, the first results of vaccination are promising but warrant further clinical investigation to evaluate the clinical benefit.

There has been an increase in the number of antibiotic-resistant bacteria that cause severe urinary tract infections (UTIs). With UTI, infection can ascend from the bladder (cystitis) into the kidneys (pyelonephritis). These infections can further spread into the blood causing sepsis. Kidney damage, hospitalization, and even death are consequences of a severe, untreated UTI infection.

Every second woman will at least experience a symptomatic UTI once in her lifetime, of which, one out of four women will have to fear recurrence within the next 6-12 mo [1,2].

Antimicrobial treatment was the cornerstone of management for decades; however, due to the misuse and overuse of antibiotics, the problem of antimicrobial resistance (AMR) has emerged.

Therefore, we need to change the strategy in treating the recurrent urinary tract infection. We need are new antibiotic agents, the development of alternative and preventive antimicrobial strategies, effective hygiene measures.

A vaccine is an attractive option to prevent or reduce substantially the use of antibiotics. All the experimental and innovative approaches to design vaccines fail because they never enter the phase of a clinical trial.

So, where do we stand in 2018?

We have OM-89 as an immunostimulating compound whose safety and efficacy is well documented. In terms of a potential vaccine, we still do not have one.

In 2017, the outcomes of a randomised, single-blinded, placebo-controlled phase 1b trial were published for a new vaccine termed ExPEC4V [3]. It targets the four most common O-antigens of the lipopolysaccharide of extraintestinal pathogenic E. coli (ExPEC). The single intramuscular injection of this tetravalent bioconjugate vaccine was evaluated for safety, immunogenicity, and clinical efficacy in 188 women with recurrent UTIs who were randomised 1:1 for the treatment with ExPEC4V (n = 93) or placebo (n = 95). The safety profile was good with no vac- cine-related severe or serious adverse events over the follow-up of 9 months. The vaccination was able to mount a robust and durable immune response, which was demonstrated by significantly elevated IgG titres to all four serotypes. These first results are promising but warrant further clinical investigation to evaluate the clinical benefit of ExPEC4V.


  1. Foxman B. Recurring urinary tract infection: incidence and risk factors. Am J Public Health 1990;80:331-3.
  2. Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD. Urinary tract infection: self-reported incidence and associated costs. Ann Epide- miol 2000;10:509-15.
  3. Huttner A, Hatz C, van den Dobbelsteen G, et al. Safety, immunoge- nicity, and preliminary clinical efficacy of a vaccine against extra- intestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, pla- cebo-controlled phase 1b trial. Lancet Infect Dis 2017;17:528-37.