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Impact of whole-cell bacterial immunoprophylaxis in the management of recurrent urinary tract infections in the frail elderly
Institution:1. Department of Surgery, University of Salamanca, Spain;2. Renal Urological Multidisciplinary Research Group (GRUMUR for its acronym in Spanish) of the Biosanitary Research Institute of Salamanca (IBSAL for its acronym in Spanish), Spain;3. Urology Service of the University Hospital of Salamanca, Salamanca, Spain;4. Urology Section of the Department of Surgery, University of La Laguna, Tenerife, Spain;5. Urology Service of the University Hospital of Avila, Avila, Spain;6. Inmunotek S.L., Alcalá de Henares, Madrid, Spain;7. Division of Urology, Department of Urology, School of Medicine, Universidad del Valle, Cali, Colombia;8. Research Office Confederación Americana de Urología, USA
Abstract:PurposeThis study aimed to determine the effectiveness of whole-cell bacterial immunotherapy, i.e. MV140 and autovaccines, in reducing the number of urinary tract infections (UTIs) in frail elderly patients with recurrent UTI (RUTI).MethodA prospective cohort observational study was performed including 200 frail elderly subjects suffering RUTI, both females and males, between 2016 and 2018. The effectiveness of autovaccines and the polybacterial formulation MV140 (Uromune®), consisting of whole-cell heat-inactivated Escherichia coli 25%, Klebsiella pneumoniae 25%, Proteus vulgaris 25% and Enterococcus faecalis 25% were evaluated. Subjects initiated a 3-month sublingually daily course with MV140 or autovaccine, either first treatment or a new course if they had been previously vaccinated prior to inclusion in the study. Number of UTIs and quality of life (QoL, SF-36 score) were measured in the different study groups.ResultsThe mean age for participants was 82.67 (SD, 7.12) for female and 80.23 (SD, 11.12) for male subjects. In all groups, 12 months following bacterial immunotherapy, the number of UTIs significantly decreased compared to before the treatment with autovaccine or MV140: the rate of reduction ranged between 7- and 40-fold. An increase in QoL scoring was also observed in any study group. When comparing medical interventions, MV140 conferred significantly higher benefit than autovaccines. For previously vaccinated individuals, a new 3-month course with MV140 or autovaccines provided further clinical improvement.ConclusionsMV140 and autovaccines emerge as valuable immunoprophylaxis for the management of RUTI in the frail elderly, contributing to an improvement in patient’s quality of life. Herein, MV140 has shown to confer a higher effectiveness compared to autovaccines, regardless sex or course of treatment.
Keywords:Bacterial immunoprophylaxis  MV140  Autovaccines  Recurrent urinary infections  Frail elderly  GMP"}  {"#name":"keyword"  "$":{"id":"k0035"}  "$$":[{"#name":"text"  "_":"Good Manufacturing Practices  QoL"}  {"#name":"keyword"  "$":{"id":"k0045"}  "$$":[{"#name":"text"  "_":"Quality of life  RUTI"}  {"#name":"keyword"  "$":{"id":"k0055"}  "$$":[{"#name":"text"  "_":"Recurrent UTI  UTIs"}  {"#name":"keyword"  "$":{"id":"k0065"}  "$$":[{"#name":"text"  "_":"Urinary tract infections
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