Sublingual vaccination with MV140 prevents recurrent urinary tract infections in women: Preliminary results from a randomized, double-blind, placebo-controlled trial

Introduction: Recurrent urinary tract infections (rUTI) affect 5‐10% of women, resulting in enormously high use of antibiotics contributing to morbidity in individual patients and the massive rise of antimicrobial resistance. MV140 (Uromune®) is a polybacterial sublingual vaccine consisting of whole‐cell inactivated bacteria (E. coli 25%, K. pneumoniae 25%, E. faecalis 25%, and P. vulgaris 25%) that has shown clinical benefit in observational studies of >1000 individuals.1 Confirmation of its clinical efficacy has awaited results from a randomized placebo‐controlled trial (RCT). We present the late‐breaking preliminary results of this RCT, which is presently in the analysis stage. Methods: A phase 3, multicenter, double‐blind, parallel‐group RCT enrolled 240 women aged 18‐75 with rUTI (≥5 uncomplicated UTI during the previous year). They were randomly allocated to receive placebo for six months or MV140 (active) for three or six months, in a 1:1:1 ratio. Primary and major secondary endpoints were number of UTIs and UTI‐free rate in the nine‐month study period following three months of intervention, respectively. Results: The median number of UTI episodes was 3.0 (interquartile range [IQR] 0.5‐6.0] for placebo group compared to 0.0 (IQR 0.0‐1.0] in both groups receiving MV140 (p<0.001). A significant increase (over two‐fold) in the UTI‐free rate was observed (p<0.001) in the treatment groups (55.7% and 58.0% in subjects receiving MV140 for three or six months, respectively) compared to the placebo group (25.0%). Only five subjects reported non‐serious adverse reactions, two in the placebo group and three in the MV140 three‐month group. Conclusions: The preliminary, late‐breaking analysis of this first MV140 RCT shows clinical efficacy and safety in reducing the incidence and preventing recurrence of UTIs. Clinical use of this novel sublingual bacterial vaccine prophylaxis will offer women an effective evidence‐based alternative to antibiotics in the management of rUTI.