Reducing Recurrent Urinary Tract Infections in Women with MV140 Impacts Personal Burden of Disease: Secondary Analyses of a Randomized Placebo-controlled Efficacy Study

• Published in: European urology open science (Online) 2024-05, Vol.63, p.96-103
• Main Authors: Curtis Nickel, J., Foley, Stephen, Yang, Bob, Casanovas, Miguel, Caballero, Raquel, Diez-Rivero, Carmen María, Lorenzo-Gómez, María-Fernanda
• Format: Article
• Language: English
• Subjects: Antibiotics; Burden; Cystitis; Prophylaxis; Quality of life; Urinary tract infection; Vaccine; Women
• ISSN: 2666-1683; 2666-1683
• DOI: 10.1016/j.euros.2024.03.010

A secondary analysis of a randomized placebo-controlled trial of MV140 vaccine demonstrating a reduction of recurrent urinary tract infection (UTI) in women showed an associated reduction in the personal burden of disease with a reduction of UTI symptoms and antibiotics, and improvement in quality of life. Recurrent urinary tract infection (rUTI) remains a major health burden for women. A randomized, double-blind, placebo-controlled trial (RCT; NCT02543827) reported that female patients with rUTI receiving a sublingual vaccine, MV140, had a reduction in rUTI and increase in UTI-free rate compared with placebo. To determine the impact of MV140 on the personal burden of disease in women with rUTI using secondary endpoint data from the pivotal RCT evaluating MV140. In the primary RCT, female patients with rUTI enrolled in Spain and UK (from October 2015 to April 2019) were randomized to placebo (6 mo) or MV140 (3 or 6 mo), and followed for 12 mo. Individuals analyzed in this secondary analysis included those in the placebo and 3-mo (recommended dose) groups. A polybacterial sublingual vaccine, MV140 (four inactivated whole-cell bacteria—Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis), or placebo. Symptom severity scoring, antibiotic use, safety, and multiple aspects of quality of life (QoL; Short-Form Questionnaire [SF-36]) were assessed. Compared with the placebo group (n = 76), the 3-mo vaccinated group (n = 74) experienced fewer overall UTI symptoms (mean symptom score 102.2 ± 222.9 vs 194.2 ± 178.8; p = 0.0002), fewer days on antibiotics (12.4 ± 17.7 vs 28.7 ± 25.2; p = 0.0001), and improved total, general, and physical SF-36 QoL improvement (differences in means for total SF-36 score 15.7; 95% confidence interval [CI] 8.80, 22.64; p