Table of Contents Author Guidelines Submit a Manuscript
Journal of Immunology Research
Volume 2015, Article ID 353461, 9 pages
http://dx.doi.org/10.1155/2015/353461
Review Article

Meningococcal Antigen Typing System Development and Application to the Evaluation of Effectiveness of Meningococcal B Vaccine and Possible Use for Other Purposes

1Department of Health Sciences, University of Genoa, Via Pastore 1, 16132 Genoa, Italy
2Novartis Vaccines, Via Fiorentina 1, 53100 Siena, Italy

Received 24 November 2014; Revised 16 January 2015; Accepted 17 February 2015

Academic Editor: Saul N. Faust

Copyright © 2015 Alexander Domnich et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. R. Z. Jafri, A. Ali, N. E. Messonnier et al., “Global epidemiology of invasive meningococcal disease,” Population Health Metrics, vol. 11, no. 1, article 17, 2013. View at Publisher · View at Google Scholar · View at Scopus
  2. D. Panatto, D. Amicizia, P. L. Lai, M. L. Cristina, A. Domnich, and R. Gasparini, “New versus old meningococcal Group B vaccines: how the new ones may benefit infants & toddlers,” Indian Journal of Medical Research, vol. 138, pp. 835–846, 2013. View at Google Scholar · View at Scopus
  3. World Health Organization (WHO), “Meningococcal vaccines: WHO position paper, November 2011,” Weekly Epidemiological Record, vol. 86, no. 47, pp. 521–539, 2011. View at Google Scholar
  4. R. Rappuoli, “Reverse vaccinology, a genome-based approach to vaccine development,” Vaccine, vol. 19, no. 17-19, pp. 2688–2691, 2001. View at Publisher · View at Google Scholar · View at Scopus
  5. U. Vogel, M.-K. Taha, J. A. Vazquez et al., “Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment,” The Lancet Infectious Diseases, vol. 13, no. 5, pp. 416–425, 2013. View at Publisher · View at Google Scholar · View at Scopus
  6. M. M. Giuliani, J. Adu-Bobie, M. Comanducci et al., “A universal vaccine for serogroup B meningococcus,” Proceedings of the National Academy of Sciences of the United States of America, vol. 103, no. 29, pp. 10834–10839, 2006. View at Publisher · View at Google Scholar · View at Scopus
  7. World Health Organization (WHO), Correlates of Vaccine-Induced Protection: Methods and Implications, World Health Organization (WHO), Geneva, Switzerland, 2013.
  8. S. A. Plotkin and P. B. Gilbert, “Nomenclature for immune correlates of protection after vaccination,” Clinical Infectious Diseases, vol. 54, no. 11, pp. 1615–1617, 2012. View at Publisher · View at Google Scholar · View at Scopus
  9. A. C. Conn, J. R. MacNeil, L. H. Harrison et al., “Changes in neisseria meningitidis disease epidemiology in the united states, 1998–2007: implications for prevention of meningococcal disease,” Clinical Infectious Diseases, vol. 50, no. 2, pp. 184–191, 2010. View at Publisher · View at Google Scholar · View at Scopus
  10. European Centre for Disease Prevention and Control (ECDC), Surveillance of Invasive Bacterial Diseases in Europe, 2011, European Centre for Disease Prevention and Control, Stockholm, Sweden, 2013.
  11. L. Qin, P. B. Gilbert, L. Corey, M. J. McElrath, and S. G. Self, “A framework for assessing immunological correlates of protection in vaccine trials,” Journal of Infectious Diseases, vol. 196, no. 9, pp. 1304–1312, 2007. View at Publisher · View at Google Scholar · View at Scopus
  12. C. E. Frasch, R. Borrow, and J. Donnelly, “Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease,” Vaccine, vol. 27, supplement 2, pp. B112–B116, 2009. View at Publisher · View at Google Scholar · View at Scopus
  13. R. Borrow, G. M. Carlone, N. Rosenstein et al., “Neisseria meningitidis group B correlates of protection and assay standardization—international meeting report Emory University, Atlanta, Georgia, United States, 16-17 March 2005,” Vaccine, vol. 24, no. 24, pp. 5093–5107, 2006. View at Publisher · View at Google Scholar · View at Scopus
  14. J. Donnelly, D. Medinia, G. Boccadifuoco et al., “Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines,” Proceedings of the National Academy of Sciences of the United States of America, vol. 107, no. 45, pp. 19490–19495, 2010. View at Publisher · View at Google Scholar · View at Scopus
  15. G. Boccadifuoco, B. Brunelli, M. G. Pizza, and M. M. Giuliani, “A combined approach to assess the potential coverage of a multicomponent protein-based vaccine,” Journal of Preventive Medicine and Hygiene, vol. 53, no. 2, pp. 56–60, 2012. View at Google Scholar · View at Scopus
  16. J. Lucidarme, M. Comanducci, J. Findlow et al., “Characterization of fHbp, nhba (gna2132), nadA, porA, and sequence type in group B meningococcal case isolates collected in England and Wales during January 2008 and potential coverage of an investigational group B meningococcal vaccine,” Clinical and Vaccine Immunology, vol. 17, no. 6, pp. 919–929, 2010. View at Publisher · View at Google Scholar · View at Scopus
  17. V. Masignani, M. Comanducci, M. M. Giuliani et al., “Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870,” Journal of Experimental Medicine, vol. 197, no. 6, pp. 789–799, 2003. View at Publisher · View at Google Scholar · View at Scopus
  18. S. Bambini, A. Muzzi, P. Olcen, R. Rappuoli, M. Pizza, and M. Comanducci, “Distribution and genetic variability of three vaccine components in a panel of strains representative of the diversity of serogroup B meningococcus,” Vaccine, vol. 27, no. 21, pp. 2794–2803, 2009. View at Publisher · View at Google Scholar · View at Scopus
  19. D. M. Vu, R. Pajon, D. C. Reason, and D. M. Granoff, “A broadly cross-reactive monoclonal antibody against an epitope on the N-terminus of meningococcal fHbp,” Scientific Reports, vol. 2, article 341, 2012. View at Publisher · View at Google Scholar · View at Scopus
  20. P. T. Beemink and D. M. Granoff, “The modular architecture of meningococcal factor H-binding protein,” Microbiology, vol. 155, no. 9, pp. 2873–2883, 2009. View at Publisher · View at Google Scholar · View at Scopus
  21. M. C. J. Maiden, J. A. Bygraves, E. Feil et al., “Multilocus sequence typing: a portable approach to the identification of clones within populations of pathogenic microorganisms,” Proceedings of the National Academy of Sciences of the United States of America, vol. 95, no. 6, pp. 3140–3145, 1998. View at Publisher · View at Google Scholar · View at Scopus
  22. D. M. Aanensen and B. G. Spratt, “The multilocus sequence typing network: mlst.net,” Nucleic Acids Research, vol. 33, supplement 2, pp. W728–W733, 2005. View at Publisher · View at Google Scholar · View at Scopus
  23. U. Vogel, P. Stefanelli, J. Vazquez, M.-K. Taha, H. Claus, and J. Donnelly, “The use of vaccine antigen characterization, for example by MATS, to guide the introduction of meningococcus B vaccines,” Vaccine, vol. 30, no. 2, pp. B73–B77, 2012. View at Publisher · View at Google Scholar · View at Scopus
  24. R. Gasparini, D. Amicizia, A. Domnich, P. L. Lai, and D. Panatto, “Neisseria meningitidis B vaccines: recent advances and possible immunization policies,” Expert Review of Vaccines, vol. 13, no. 3, pp. 345–364, 2014. View at Publisher · View at Google Scholar · View at Scopus
  25. S. L. Harris, D. Zhu, E. Murphy et al., “Preclinical evidence for the potential of a bivalent fHBP vaccine to prevent Neisseria meningitidis serogroup C disease,” Human Vaccines, vol. 7, supplement 1, pp. 68–74, 2011. View at Publisher · View at Google Scholar · View at Scopus
  26. B. D. Plikaytis, M. Stella, G. Boccadifuoco et al., “Interlaboratory standardization of the sandwich enzyme-linked immunosorbent assay designed for MATS, a rapid, reproducible method for estimating the strain coverage of investigational vaccines,” Clinical and Vaccine Immunology, vol. 19, no. 10, pp. 1609–1617, 2012. View at Publisher · View at Google Scholar · View at Scopus
  27. J. A. Welsch, S. Ram, O. Koeberling, and D. M. Granoff, “Complement-dependent synergistic bactericidal activity of antibodies against factor H-binding protein, a sparsely distributed meningococcal vaccine antigen,” The Journal of Infectious Diseases, vol. 197, no. 7, pp. 1053–1061, 2008. View at Publisher · View at Google Scholar · View at Scopus
  28. V. E. Weynants, C. M. Feron, K. K. Goraj et al., “Additive and synergistic bactericidal activity of antibodies directed against minor outer membrane proteins of Neisseria meningitidis,” Infection and Immunity, vol. 75, no. 11, pp. 5434–5442, 2007. View at Publisher · View at Google Scholar · View at Scopus
  29. B. Brunelli, E. Del Tordello, E. Palumbo et al., “Influence of sequence variability on bactericidal activity sera induced by Factor H binding protein variant 1.1,” Vaccine, vol. 29, no. 5, pp. 1072–1081, 2011. View at Publisher · View at Google Scholar · View at Scopus
  30. G. Frosi, A. Biolchi, M. L. Sapio et al., “Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage,” Vaccine, vol. 31, no. 43, pp. 4968–4974, 2013. View at Publisher · View at Google Scholar · View at Scopus
  31. L. D. Fletcher, L. Bernfield, V. Barniak et al., “Vaccine potential of the Neisseria meningitidis 2086 lipoprotein,” Infection and Immunity, vol. 72, no. 4, pp. 2088–2100, 2004. View at Publisher · View at Google Scholar · View at Scopus
  32. J. A. Bettinger, D. W. Scheifele, S. A. Halperin et al., “Diversity of Canadian meningococcal serogroup B isolates and estimated coverage by an investigational meningococcal serogroup B vaccine (4CMenB),” Vaccine, vol. 32, no. 1, pp. 124–130, 2013. View at Publisher · View at Google Scholar · View at Scopus
  33. G. Tzanakaki, E. Hong, K. Kesanopoulos et al., “Diversity of greek meningococcal serogroup B isolates and estimated coverage of the 4CMenB meningococcal vaccine,” BMC Microbiology, vol. 14, no. 1, article 111, 2014. View at Publisher · View at Google Scholar · View at Scopus
  34. S. Budroni, A. Kleinschmidt, E. Ypma, P. Boucher, and D. Medini, “Pooled hSBA titers predict seroresponse rates of infants vaccinated with 4CMenB,” in Proceedings of the 19th International Pathogenic Neisseria Conference (IPNC '14), Asheville, NC, USA, October 2014.
  35. E. Hong, M. M. Giuliani, A.-E. Deghmane et al., “Could the multicomponent meningococcal serogroup B vaccine (4CMenB) control Neisseria meningitidis capsular group X outbreaks in Africa?” Vaccine, vol. 31, no. 7, pp. 1113–1116, 2013. View at Publisher · View at Google Scholar · View at Scopus
  36. H. Christensen, M. May, L. Bowen, M. Hickman, and C. L. Trotter, “Meningococcal carriage by age: a systematic review and meta-analysis,” The Lancet Infectious Diseases, vol. 10, no. 12, pp. 853–861, 2010. View at Publisher · View at Google Scholar · View at Scopus
  37. H. Claus, M. S. Jördens, P. Kriz et al., “Capsule null locus meningococci: typing of antigens used in an investigational multicomponent meningococcus serogroup B vaccine,” Vaccine, vol. 30, no. 2, pp. 155–160, 2012. View at Publisher · View at Google Scholar · View at Scopus
  38. R. Gasparini, M. Comanducci, D. Amicizia et al., “Molecular and serological diversity of Neisseria meningitidis carrier strains isolated from Italian students aged 14 to 22 years,” Journal of Clinical Microbiology, vol. 52, no. 6, pp. 1901–1910, 2014. View at Publisher · View at Google Scholar · View at Scopus
  39. European Medicines Agency (EMA), “Bexsero: summary of product characteristics,” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002333/WC500137881.pdf.
  40. B. van de Waterbeemd, G. Zomer, J. van den Ijssel et al., “Cysteine depletion causes oxidative stress and triggers outer membrane vesicle release by Neisseria meningitidis; implications for vaccine development,” PLoS ONE, vol. 8, no. 1, Article ID e54314, 2013. View at Publisher · View at Google Scholar · View at Scopus
  41. E. Rosenqvist, E. A. Hoiby, E. Wedege, B. Kusecek, and M. Achtman, “The 5C protein of Neisseria meningitidis is highly immunogenic in humans and induces bactericidal antibodies,” The Journal of Infectious Diseases, vol. 167, no. 5, pp. 1065–1073, 1993. View at Publisher · View at Google Scholar · View at Scopus
  42. N. Cadieux, M. Plante, C. R. Rioux, J. Hamel, B. R. Brodeur, and D. Martin, “Bactericidal and cross-protective activities of a monoclonal antibody directed against Neisseria meningitidis NspA outer membrane protein,” Infection and Immunity, vol. 67, no. 9, pp. 4955–4959, 1999. View at Google Scholar · View at Scopus
  43. M. M. Giuliani, A. Biolchi, D. Serruto et al., “Measuring antigen-specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus,” Vaccine, vol. 28, no. 31, pp. 5023–5030, 2010. View at Publisher · View at Google Scholar · View at Scopus
  44. D. M. Vu, T. T. Wong, and D. M. Granoff, “Cooperative serum bactericidal activity between human antibodies to meningococcal factor H binding protein and Neisserial heparin binding antigen,” Vaccine, vol. 29, no. 10, pp. 1968–1973, 2011. View at Publisher · View at Google Scholar · View at Scopus
  45. M. M. E. Metruccio, E. Pigozzi, D. Roncarati et al., “A novel phase variation mechanism in the meningococcus driven by a ligand-responsive repressor and differential spacing of distal promoter elements,” PLoS Pathogens, vol. 5, no. 12, Article ID e1000710, 2009. View at Publisher · View at Google Scholar · View at Scopus
  46. D. J. Litt, S. Savino, A. Beddek et al., “Putative vaccine antigens from Neisseria meningitidis recognized by serum antibodies of young children convalescing after meningococcal disease,” The Journal of Infectious Diseases, vol. 190, no. 8, pp. 1488–1497, 2004. View at Publisher · View at Google Scholar · View at Scopus
  47. L. Fagnocchi, A. Biolchi, F. Ferlicca et al., “Transcriptional regulation of the nada gene in neisseria meningitidis impacts the prediction of coverage of a multicomponent meningococcal serogroup b vaccine,” Infection and Immunity, vol. 81, no. 2, pp. 560–569, 2013. View at Publisher · View at Google Scholar · View at Scopus
  48. European Medicines Agency (EMA), Bexsero Authorization Details, European Medicines Agency, London, UK, 2013, http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp&mid=WC0b01ac058001d124.
  49. Australian Technical Advisory Group on Immunisation (ATAGI), “Advice for immunisation providers regarding the use of Bexsero,” http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi-advice-bexsero.
  50. Health Canada, Bexsero Summary Basis of Decision, Health Canada, 2014, http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php.
  51. C. Donati and R. Rappuoli, “Reverse vaccinology in the 21st century: improvements over the original design,” Annals of the New York Academy of Sciences, vol. 1285, no. 1, pp. 115–132, 2013. View at Publisher · View at Google Scholar · View at Scopus
  52. S. Capri, M. A. Veneziano, and C. de Waure, “Valutazione economica di Bexsero,” Quaderni dell'Italian Journal of Public Health, vol. 2, no. 13, pp. 68–79, 2013. View at Google Scholar
  53. H. A. T. Tu, S. L. Deeks, S. K. Morris et al., “Economic evaluation of meningococcal serogroup B childhood vaccination in Ontario, Canada,” Vaccine, vol. 32, no. 42, pp. 5436–5446, 2014. View at Publisher · View at Google Scholar