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

J Curtis Nickel; Stephen Foley; Bob Yang; Miguel Casanovas; Raquel Caballero; Carmen María Diez-Rivero; María-Fernanda Lorenzo-Gómez

doi:10.1016/j.euros.2024.03.010

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

Eur Urol Open Sci. 2024 Mar 29:63:96-103. doi: 10.1016/j.euros.2024.03.010. eCollection 2024 May.

Authors

J Curtis Nickel¹, Stephen Foley², Bob Yang², Miguel Casanovas³, Raquel Caballero³, Carmen María Diez-Rivero³, María-Fernanda Lorenzo-Gómez⁴

Affiliations

¹ Queen's University, Kingston, ON, Canada.
² Royal Berkshire Hospital, Reading, UK.
³ Inmunotek S.L., Alcalá de Henares, Madrid, Spain.
⁴ University Hospital of Salamanca, Salamanca, Spain.

Abstract

Background: 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.

Objective: 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.

Design setting and participants: 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.

Intervention: A polybacterial sublingual vaccine, MV140 (four inactivated whole-cell bacteria-Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis), or placebo.

Outcome measurements and statistical analysis: Symptom severity scoring, antibiotic use, safety, and multiple aspects of quality of life (QoL; Short-Form Questionnaire [SF-36]) were assessed.

Results and limitations: 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 < 0.0001), with only social function QoL showing no impact (4.07; 95% CI -4.93, 13.08; p = 0.3744).

Conclusions: Three months of MV140 is associated with a reduction of the personal burden of UTI by reducing overall UTI symptoms and antibiotic use, improving QoL in women with rUTI.

Patient summary: Three months of MV140 vaccine, which has previously been shown to reduce the risk of urinary tract infection safely, is associated with a reduction in the personal burden of disease.

Keywords: Antibiotics; Burden; Cystitis; Prophylaxis; Quality of life; Urinary tract infection; Vaccine; Women.