MV140, a sublingual vaccine of whole-cell inactivated bacteria, may prevent urinary tract infections (UTIs) in women with recurrent UTIs, according to new trial findings.
The inactivated bacteria in the vaccine are O6:H49 V121 Escherichia coli, capsular type 3 V113 Klebsiella pneumoniae, V125 Enterococcus faecalis, and V127 Proteus vulgaris.
In the double-blind trial (ClinicalTrials.gov number, NCT02543827), investigators randomly assigned 240 women (aged 18-75 years) with at least 3 UTIs per year to 3 or 6 months of treatment with MV140 or placebo. The sublingual route was chosen for delivery of the MV140 vaccine because it has been shown to induce both systemic and mucosal immunity, including in the genitourinary tract.
At 9 months, a median 3 UTI episodes had occurred in the placebo group, compared with 0 in both MV140 groups, María-Fernanda Lorenzo-Gómez, MD, PhD, of the University Hospital of Salamanca, Salamanca, Spain, and colleagues reported in NEJM Evidence. Freedom from UTIs was experienced by a greater proportion of patients in the MV140 group treated for 3 months (56%) and 6 months (58%) compared with the placebo group (25%). The time to first UTI was longer for the intervention groups (275 days) than the placebo group (48 days).
Quality of life improved in the vaccine groups but not in the placebo group. Scores on the 36-Item Short-Form Questionnaire (SF-36) increased as early as 3 months and peaked at 12 months in the MV140 group treated for 3 months (81.9 points) and 6 months (85.8 points), the investigators reported.
A total of 81, 76, and 46 adverse events (AEs) occurred in the placebo group and 3- and 6-month MV140 groups, respectively. The most common AEs were chest infection, candidiasis, and vaginitis.
“In our trial, MV140 demonstrated clinical efficacy and improved [quality of life], with a side effect profile that did not limit treatment acceptance,” Dr Lorenzo-Gómez’s team concluded. The investigators noted that 6 months of MV140 was no more effective than 3 months of treatment. The entire trial lasted 12 months.
“The duration of the treatment effect will need to be established through further research in women with recurrent UTI,” according to the team.
Disclosure: This research was supported by Inmunotek S.L. and Syner-Med. Please see the original reference for a full list of disclosures.
Lorenzo-Gómez M, Foley S, Curtis Nickel J, et al. Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections. NEJM Evidence. Published online January 21, 2022. doi:10.1056/EVIDoa2100018