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Research Paper

Optimization and qualification of an assay that demonstrates that a FimH vaccine induces functional antibody responses in women with histories of urinary tract infections

ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon &
Pages 283-292 | Received 27 Feb 2020, Accepted 12 May 2020, Published online: 23 Jul 2020

References

  • IMS Health. National disease and therapeutic index, ims health, Plymouth Meeting. Plymouth Meeting (PA): IMS Health; 2014.
  • Urologist UTI Survey. Sequoia Sciences, Inc. and HRA research. 2010.
  • Trevino SE, Babcock HM, Henderson JP, Lane MA, Beekmann SE, Polgreen PM, Marschall J. Perceptions and behaviours of infectious diseases physicians when managing urinary tract infections due to MDR organisms. J Antimicrob Chemother. 2015;70:3397–400. doi:10.1093/jac/dkv271.
  • Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the fight against multidrug-resistant bacteria? A review of U.S. Food and drug administration-approved antibiotics, 2010-2015. Ann Intern Med. 2016;165:363–72. doi:10.7326/M16-0291.
  • Norrby SR, Nord CE, Finch R. Lack of development of new antimicrobial drugs: a potential serious threat to public health. Lancet Infect Dis. 2005;5:115–19. doi:10.1016/S1473-3099(05)70086-4.
  • Payne DJ, Gwynn MN, Holmes DJ, Pompliano DL. Drugs for bad bugs: confronting the challenges of antibacterial discovery. Nat Rev Drug Discov. 2007;6:29–40. doi:10.1038/nrd2201.
  • Rappuoli R, Bloom DE, Black S. Deploy vaccines to fight superbugs. Nature. 2017;552:165–67. doi:10.1038/d41586-017-08323-0.
  • Abbott A. Vaccines promoted as key to stamping out drug-resistant microbes. Nature. 2017. doi:10.1038/nature.2017.22324.
  • Wright KJ, Seed PC, Hultgren SJ. Development of intracellular bacterial communities of uropathogenic Escherichia coli depends on type 1 pili. Cell Microbiol. 2007;9:2230–41. doi:10.1111/j.1462-5822.2007.00952.x.
  • Martinez JJ, Mulvey MA, Schilling JD, Pinkner JS, Hultgren SJ. Type 1 pilus-mediated bacterial invasion of bladder epithelial cells. Embo J. 2000;19:2803–12.
  • Langermann S, Palaszynski S, Barnhart M, Auguste G, Pinkner JS, Burlein J. Prevention of mucosal Escherichia coli infection by FimH-adhesin-based systemic vaccination. Science. 1997;276:607–11. doi:10.1126/science.276.5312.607.
  • Langermann S, Mollby R, Burlein JE, Palaszynski SR, Auguste CG, DeFusco A, Strouse R, Schenerman M, Hultgren S, Pinkner J, et al. Vaccination with fimH adhesin protects cynomolgus monkeys from colonization and infection by uropathogenic Escherichia coli. J Infect Dis. 2000;181:774–78. doi:10.1086/315258.
  • Meiland R, Geerlings SE, Langermann S, Brouwer EC, Coenjaerts FE, Hoepelman AI. FimCH antiserum inhibits the adherence of Escherichia coli to cells collected by voided urine specimens of diabetic women. J Urol. 2004;171:1589–93. doi:10.1097/01.ju.0000118402.01034.fb.
  • Thankavel K, Madison B, Ikeda T, Malaviya R, Shah AH, Arumugam PM, Abraham SN. Localization of a domain in the FimH adhesin of Escherichia coli type 1 fimbriae capable of receptor recognition and use of a domain-specific antibody to confer protection against experimental urinary tract infection. J Clin Invest. 1997;100:1123–36. doi:10.1172/JCI119623.
  • Poggio TV, La Torre JL, Scodeller EA. Intranasal immunization with a recombinant truncated FimH adhesin adjuvanted with CpG oligodeoxynucleotides protects mice against uropathogenic Escherichia coli challenge. Can J Microbiol. 2006;52:1093–102. doi:10.1139/w06-065.
  • O’Brien VP, Hannan TJ, Yu L, Livny J, Roberson EDO, Schwartz DJ, Souza S, Mendelsohn CL, Colonna M, Lewis AL, et al. A mucosal imprint left by prior Escherichia coli bladder infection sensitizes to recurrent disease. Nature Microbiol. 2016;2:16196. doi:10.1038/nmicrobiol.2016.196.
  • Wurpel DJ, Beatson SA, Totsika M, Petty NK, Schembri MA. Chaperone-usher fimbriae of Escherichia coli. PLoS One. 2013;8:30. doi:10.1371/journal.pone.0052835.
  • Korea CG, Badouraly R, Prevost MC, Ghigo JM, Beloin C. Escherichia coli K-12 possesses multiple cryptic but functional chaperone-usher fimbriae with distinct surface specificities. Environ Microbiol. 2010;12:1957–77. doi:10.1111/j.1462-2920.2010.02202.x.
  • Rossez Y, Holmes A, Lodberg-Pedersen H, Birse L, Marshall J, Willats WG, Toth IK, Holden NJ. Escherichia coli Common Pilus (ECP) targets arabinosyl residues in plant cell walls to mediate adhesion to fresh produce plants. J Biol Chem. 2014;289:34349–65. doi:10.1074/jbc.M114.587717.
  • Wurpel DJ, Totsika M, Allsopp LP, Hartley-Tassell LE, Day CJ, Peters KM, Sarkar S, Ulett GC, Yang J, Tiralongo J, et al. F9 fimbriae of uropathogenic Escherichia coli are expressed at low temperature and recognise Galβ1-3GlcNAc-containing glycans. PLoS One. 2014;9. doi:10.1371/journal.pone.0093177.
  • Larsonneur F, Martin FA, Mallet A, Martinez-Gil M, Semetey V, Ghigo JM, Beloin C. Functional analysis of E scherichia coli Yad fimbriae reveals their potential role in environmental persistence. Environ Microbiol. 2016;18:5228–48. doi:10.1111/1462-2920.13559.
  • Eldridge G, Martin SM Compositions of vaccines and adjuvants and methods for the treatment of urinary tract infections. US Patent 9,017,698, ed. St. Louis (MO): Sequoia Sciences, Inc.; 2015.
  • Bioanalytical Method Validation Guidance for Industry. 2018. U.S. Department of health and human services food and drug administration center for drug evaluation and research (CDER). Silver Spring (MD): Center for Veterinary Medicine (CfVMC).
  • Huttner A, Hatz C, van den Dobbelsteen G, Abbanat D, Hornacek A, Frolich R, Dreyer AM, Martin P, Davies T, Fae K, et al. Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial. Lancet Infect Dis. 2017;17:528–37. doi:10.1016/S1473-3099(17)30108-1.
  • Frenck RW Jr., Ervin J, Chu L, Abbanat D, Spiessens B, Go O, Haazen W, van den Dobbelsteen G, Poolman J, Thoelen S, et al. Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): Aphase 2 randomised controlled trial. Lancet Infect Dis. 2019;19:631–40. doi:10.1016/S1473-3099(18)30803-X.
  • Janssen Research & Development LLC. A study of three different doses of VAC52416 (ExPEC10V) in adults aged 60 to 85 years in stable health. [accessed 2020 Apr 3]. Clinicaltrials.gov Accession NCT03819049
  • Abbanat D, Davies TA, Amsler K, He W, Fae K, Janssen S, Poolman JT, van den Dobbelsteen GPJM. Development and qualification of an opsonophagocytic killing assay to assess immunogenicity of a bioconjugated Escherichia coli vaccine. Clin Vaccinei Immunol. 2017;24:e00123–17. doi:10.1128/CVI.00123-17.
  • Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17:1055–65. doi:10.1128/CVI.00131-10.
  • Krah DL, Amin RD, Nalin DR, Provost PJ. A simple antigen-reduction assay for the measurement of neutralizing antibodies to hepatitis A virus. J Infect Dis. 1991;163:634–37. doi:10.1093/infdis/163.3.634.
  • Greene SE, Hibbing ME, Janetka J, Chen SL, Hultgren SJ. Human urine decreases function and expression of type 1 pili in uropathogenic Escherichia coli. MBio. 2015;6:00820–15. doi:10.1128/mBio.00820-15.