{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T20:06:31Z","timestamp":1792181191222,"version":"4.4.0"},"reference-count":31,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T00:00:00Z","timestamp":1748476800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Urinary tract infections (UTIs) are the most common bacterial infections and one of the most common diseases worldwide. These infections induce an enormous financial and economic burden. The most frequent pathogen in UTIs is Escherichia coli (E. coli), which is responsible for over 85% of cases of cystitis and over 60% of recurrent cases. Repeated antibiotic prescriptions increase the risk of bacteria developing resistance, reducing treatment efficacy and limiting long-term therapeutic options. When traditional preventive methods fail to provide protection, other strategies may be necessary. To investigate the effectiveness of vaccination with Uro-Vaxom for the prevention of UTIs based on currently available studies. Methods: Systematic literature search. Results: The available studies focus almost exclusively on the female sex. Uro-Vaxom decreased the recurrence of UTIs, was overall well tolerated, and reduced the need for antibiotic therapies. Conclusions: Uro-Vaxom is a potential effective and well-tolerated option for reducing the recurrence of UTIs in patients prone to frequent infections. Nevertheless, the retrospective nature of several studies, combined with methodological limitations and variability in study design, precluded a reliable quantitative estimation of the treatment effect.<\/jats:p>","DOI":"10.3390\/jcm14113836","type":"journal-article","created":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T09:47:34Z","timestamp":1748512054000},"page":"3836","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and Safety of Uro-Vaxom in Urinary Tract Infection Prevention: A Systematic Literature Review"],"prefix":"10.3390","volume":"14","author":[{"given":"Silvia","family":"Volont\u00e8","sequence":"first","affiliation":[{"name":"Ospedale Sant\u2019Anna, ASST Lariana, 22100 Como, Italy"},{"name":"Faculty of Medicine and Surgery, University of Milano Bicocca, 20126 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9149-1081","authenticated-orcid":false,"given":"Desire\u00e8","family":"De Vicari","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Surgery, University of Milano Bicocca, 20126 Monza, Italy"},{"name":"Gynecology Department, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Cola","sequence":"additional","affiliation":[{"name":"Gynecology Department, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7495-7185","authenticated-orcid":false,"given":"Marta","family":"Barba","sequence":"additional","affiliation":[{"name":"Gynecology Department, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3952-8462","authenticated-orcid":false,"given":"Matteo","family":"Frigerio","sequence":"additional","affiliation":[{"name":"Gynecology Department, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,5,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1016\/j.acuro.2015.04.008","article-title":"Oral vaccine (OM-89) in the recurrent urinary tract infection prophylaxis: A realistic systematic review with meta-analysis","volume":"40","author":"Reis","year":"2016","journal-title":"Actas Urol. Esp."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"542","DOI":"10.1016\/j.eururo.2004.12.009","article-title":"A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections","volume":"47","author":"Bauer","year":"2005","journal-title":"Eur. Urol."},{"key":"ref_3","unstructured":"Grabe, M., Bartoletti, R., Bjerklund-Johansen, T.E., and Guidelines on Urological Infections (2025, April 02). European Association of Urology Website. Available online: http:\/\/uroweb.org\/wp-content\/uploads\/19-Urological-infections_LR2.pdf."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"762","DOI":"10.1016\/j.eursup.2009.07.002","article-title":"Recurrent Urinary Tract Infections: Uro-Vaxom, a New Alternative","volume":"8","author":"Cruz","year":"2009","journal-title":"Eur. Urol. Suppl."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1067\/mda.2003.7","article-title":"Epidemiology of urinary tract infections: Incidence, morbidity, and economic costs","volume":"49","author":"Foxman","year":"2003","journal-title":"Dis. Mon."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Zhou, Y., Zhou, Z., Zheng, L., Gong, Z., Li, Y., Jin, Y., Huang, Y., and Chi, M. (2023). Urinary Tract Infections Caused by Uropathogenic Escherichia coli: Mechanisms of Infection and Treatment Options. Int. J. Mol. Sci., 24.","DOI":"10.3390\/ijms241310537"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1080\/13697137.2018.1551871","article-title":"The etiology and management of recurrent urinary tract infections in postmenopausal women","volume":"22","author":"Jung","year":"2019","journal-title":"Climacteric"},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Schneeberger, C., Geerlings, S.E., Middleton, P., and Crowther, C.A. (2015). Interventions for preventing recurrent urinary tract infection during pregnancy. Cochrane Database Syst. Rev., 2015.","DOI":"10.1002\/14651858.CD009279.pub3"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1016\/j.amjopharm.2011.07.002","article-title":"Urinary tract infections in the elderly population","volume":"9","author":"Matthews","year":"2011","journal-title":"Am. J. Geriatr. Pharmacother."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1586\/14787210.2015.986097","article-title":"The diagnosis, evaluation and treatment of acute and recurrent pediatric urinary tract infections","volume":"13","author":"Becknell","year":"2015","journal-title":"Expert Rev. Anti-Infect. Ther."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1016\/j.jped.2019.10.006","article-title":"Urinary tract infection in pediatrics: An overview","volume":"96","author":"Silva","year":"2020","journal-title":"J. Pediatr. (Rio. J.)"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1159\/000281253","article-title":"Treatment of recurrent urinary tract infections: Efficacy of an orally administered biological response modifier","volume":"41","author":"Frey","year":"1986","journal-title":"Urol. Int."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"279","DOI":"10.33073\/pjm-2011-040","article-title":"Urinary tract infection of Escherichia coli strains of chaperone-usher system","volume":"60","year":"2011","journal-title":"Pol. J. Microbiol."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Schreiber, H.L., Conover, M.S., Chou, W.C., Hibbing, M.E., Manson, A.L., Dodson, K.W., Hannan, T.J., Roberts, P.L., Stapleton, A.E., and Hooton, T.M. (2017). Bacterial virulence phenotypes of Escherichia coli and host susceptibility determine risk for urinary tract infections. Sci. Transl. Med., 9.","DOI":"10.1126\/scitranslmed.aaf1283"},{"key":"ref_15","unstructured":"Ejrn\u00e6s, K. (2011). Bacterial characteristics of importance for recurrent urinary tract infections caused by Escherichia coli. Dan. Med. Bull., 58."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"4002","DOI":"10.1128\/JCM.02086-12","article-title":"Similarity and divergence of phylogenies, antimicrobial susceptibilities, and virulence factor profiles of Escherichia coli isolates causing recurrent urinary tract infections that persist or result from reinfection","volume":"50","author":"Luo","year":"2012","journal-title":"J. Clin. Microbiol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1855","DOI":"10.1128\/AAC.00014-10","article-title":"Persistence of uropathogenic Escherichia coli in the face of multiple antibiotics","volume":"54","author":"Blango","year":"2010","journal-title":"Antimicrob. Agents Chemother."},{"key":"ref_18","unstructured":"World Health Organization (2015). Global Action Plan on Antimicrobial Resistance, World Health Organization. Available online: https:\/\/www.who.int\/publications\/i\/item\/9789241509763."},{"key":"ref_19","first-page":"375","article-title":"Repeated Treatments with Chitosan in Combination with Antibiotics Completely Eradicate Uropathogenic Escherichia coli From Infected Mouse Urinary Bladders","volume":"216","author":"Erman","year":"2017","journal-title":"J. Infect. Dis."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1016\/j.ijantimicag.2011.09.005","article-title":"Antimicrobial prophylaxis in women with recurrent urinary tract infections","volume":"38","author":"Lichtenberger","year":"2011","journal-title":"Int. J. Antimicrob. Agents."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"265.e1","DOI":"10.1016\/j.ajog.2020.05.048","article-title":"D-mannose vs other agents for recurrent urinary tract infection prevention in adult women: A systematic review and meta-analysis","volume":"223","author":"Lenger","year":"2020","journal-title":"Am. J. Obstet. Gynecol."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Lianos, E., Mountrakis, S., and Zampiozis, E. (2005). Effectiveness of Uro-vaxom and vitamin E in delaying recurrences of E. coli LUTS in geriatric patients. Eur. Urol. Suppl., 4.","DOI":"10.1016\/S1569-9056(05)80530-5"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"251","DOI":"10.1016\/S0090-4295(02)01767-3","article-title":"An Escherichia coli-based oral vaccine against urinary tract infections potently activates human dendritic cells","volume":"60","author":"Schmidhammer","year":"2002","journal-title":"Urology"},{"key":"ref_24","first-page":"980","article-title":"Studies on the immunogenicity of an Escherichia coli extract after oral application in mice","volume":"47","author":"Baier","year":"1997","journal-title":"Arzneimittelforschung"},{"key":"ref_25","first-page":"1","article-title":"The immunomodulators Broncho-Vaxom and Uro-Vaxom stimulate the bacterial killing and oxidative metabolism of polymorphonuclear leukocytes by the activation of phosphatidyli-nositol turnover","volume":"4","author":"Nauck","year":"1991","journal-title":"Int. J. Exp. Clin. Chemoter."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1159\/000475363","article-title":"Uro-Vaxom and the management of recurrent urinary tract infection in adults: A randomized multicenter double-blind trial","volume":"26","author":"Magasi","year":"1994","journal-title":"Eur. Urol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"435","DOI":"10.3346\/jkms.2010.25.3.435","article-title":"A prospective multi-center trial of Escherichia coli extract for the prophylactic treatment of patients with chronically recurrent cystitis","volume":"25","author":"Kim","year":"2010","journal-title":"J. Korean Med. Sci."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1111\/j.1464-410X.1990.tb14649.x","article-title":"Immunobiotherapy with Uro-Vaxom in recurrent urinary tract infection. The German Urinary Tract Infection Study Group","volume":"65","author":"Tammen","year":"1990","journal-title":"Br. J. Urol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"917","DOI":"10.1016\/S0022-5347(17)35648-3","article-title":"Oral immunotherapy of recurrent urinary tract infections: A double-blind placebo-controlled multicenter study","volume":"150","author":"Schulman","year":"1993","journal-title":"J. Urol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1159\/000499248","article-title":"A Retrospective Study of Immunotherapy Treatment with Uro-Vaxom (OM-89\u00ae) for Prophylaxis of Recurrent Urinary Tract Infections","volume":"14","author":"Brodie","year":"2020","journal-title":"Curr. Urol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1016\/j.eururo.2024.03.035","article-title":"European Association of Urology Guidelines on Urological Infections: Summary of the 2024 Guidelines","volume":"86","author":"Kranz","year":"2024","journal-title":"Eur. Urol."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/11\/3836\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:43:15Z","timestamp":1760031795000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/11\/3836"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,29]]},"references-count":31,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,6]]}},"alternative-id":["jcm14113836"],"URL":"https:\/\/doi.org\/10.3390\/jcm14113836","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,29]]}}}