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Special Focus Research Paper

A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults

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Pages 888-895 | Published online: 01 Jul 2012

References

  • Christensen H, May M, Bowen L, Hickman M, Trotter CL. Meningococcal carriage by age: a systematic review and meta-analysis. Lancet Infect Dis 2010; 10:853 - 61; http://dx.doi.org/10.1016/S1473-3099(10)70251-6; PMID: 21075057
  • Thompson MJ, Ninis N, Perera R, Mayon-White R, Phillips C, Bailey L, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet 2006; 367:397 - 403; http://dx.doi.org/10.1016/S0140-6736(06)67932-4; PMID: 16458763
  • Bilukha OO, Rosenstein N, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC). Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2005; 54:RR-7 1 - 21; PMID: 15917737
  • Edmond K, Clark A, Korczak VS, Sanderson C, Griffiths UK, Rudan I. Global and regional risk of disabling sequelae from bacterial meningitis: a systematic review and meta-analysis. Lancet Infect Dis 2010; 10:317 - 28; http://dx.doi.org/10.1016/S1473-3099(10)70048-7; PMID: 20417414
  • Girard MP, Preziosi MP, Aguado MT, Kieny MP. A review of vaccine research and development: meningococcal disease. Vaccine 2006; 24:4692 - 700; http://dx.doi.org/10.1016/j.vaccine.2006.03.034; PMID: 16621189
  • Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine 2009; 27:Suppl 2 B51 - 63; http://dx.doi.org/10.1016/j.vaccine.2009.04.063; PMID: 19477562
  • Zollinger WD, Boslego J. Immunologic Methods for Diagnosis of Infections by Gram-Negative Cocci. In: Rose NR, ed. Manual of clinical laboratory immunology. Washington, DC: ASM Press, 1997:473-83.
  • Pace D, Pollard AJ, Messonier NE. Quadrivalent meningococcal conjugate vaccines. Vaccine 2009; 27:Suppl 2 B30 - 41; http://dx.doi.org/10.1016/j.vaccine.2009.05.003; PMID: 19477560
  • Trotter CL, Ramsay ME, Kaczmarski EB. Meningococcal serogroup C conjugate vaccination in England and Wales: coverage and initial impact of the campaign. Commun Dis Public Health 2002; 5:220 - 5; PMID: 12434692
  • United Kingdom Health Protection Agency. Meningococcal Reference Unit: Isolates of Neisseria menengitidis; England and Wales, by serogroup & calendar year, 1998-2010*. 2010: http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1234859712887. Accessed February 2012.
  • de Greeff SC, de Melker HE, Spanjaard L, Schouls LM, van Derende A. Protection from routine vaccination at the age of 14 months with meningococcal serogroup C conjugate vaccine in the Netherlands. Pediatr Infect Dis J 2006; 25:79 - 80; http://dx.doi.org/10.1097/01.inf.0000195594.41449.c6; PMID: 16395110
  • Slinko VG, Sweeny A. Reduction in invasive meningococcal disease in Queensland: a success for immunisation. Commun Dis Intell 2007; 31:227 - 32; PMID: 17725000
  • Australian Meningococcal Surveillance Programme. Annual report of the Australian Meningococcal Surveillance Programme, 2009. Commun Dis Intell 2010; 34:291 - 302; PMID: 21090184
  • van Driel JJ, Bekker V, Spanjaard L, van der Ende A, Kuijpers TW. Epidemiologic and microbiologic characteristics of recurrent bacterial and fungal meningitis in the Netherlands, 1988-2005. Clin Infect Dis 2008; 47:e42 - 51; http://dx.doi.org/10.1086/590251; PMID: 18643757
  • Bruge J, Bouveret-Le Cam N, Danve B, Rougon G, Schulz D. Clinical evaluation of a group B meningococcal N-propionylated polysaccharide conjugate vaccine in adult, male volunteers. Vaccine 2004; 22:1087 - 96; http://dx.doi.org/10.1016/j.vaccine.2003.10.005; PMID: 15003635
  • Wyle FA, Artenstein MS, Brandt BL, Tramont EC, Kasper DL, Altieri PL, et al. Immunologic response of man to group B meningococcal polysaccharide vaccines. J Infect Dis 1972; 126:514 - 21; http://dx.doi.org/10.1093/infdis/126.5.514; PMID: 4197754
  • Jelfs J, Munro R, Wedege E, Caugant DA. Sequence variation in the porA gene of a clone of Neisseria meningitidis during epidemic spread. Clin Diagn Lab Immunol 2000; 7:390 - 5; PMID: 10799451
  • Martin DR, Ruijne N, McCallum L, O’Hallahan J, Oster P. The VR2 epitope on the PorA P1.7-2,4 protein is the major target for the immune response elicited by the strain-specific group B meningococcal vaccine MeNZB. Clin Vaccine Immunol 2006; 13:486 - 91; http://dx.doi.org/10.1128/CVI.13.4.486-491.2006; PMID: 16603616
  • Tondella ML, Popovic T, Rosenstein NE, Lake DB, Carlone GM, Mayer LW, et al, The Active Bacterial Core Surveillance Team. Distribution of Neisseria meningitidis serogroup B serosubtypes and serotypes circulating in the United States. J Clin Microbiol 2000; 38:3323 - 8; PMID: 10970378
  • Madico G, Welsch JA, Lewis LA, McNaughton A, Perlman DH, Costello CE, et al. The meningococcal vaccine candidate GNA1870 binds the complement regulatory protein factor H and enhances serum resistance. J Immunol 2006; 177:501 - 10; PMID: 16785547
  • Schneider MC, Exley RM, Chan H, Feavers I, Kang YH, Sim RB, et al. Functional significance of factor H binding to Neisseria meningitidis. J Immunol 2006; 176:7566 - 75; PMID: 16751403
  • Murphy E, Andrew L, Lee KL, Dilts DA, Nunez L, Fink PS, et al. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis 2009; 200:379 - 89; http://dx.doi.org/10.1086/600141; PMID: 19534597
  • Jiang HQ, Hoiseth SK, Harris SL, McNeil LK, Zhu D, Tan C, et al. Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease. Vaccine 2010; 28:6086 - 93; http://dx.doi.org/10.1016/j.vaccine.2010.06.083; PMID: 20619376
  • Fletcher LD, Bernfield L, Barniak V, Farley JE, Howell A, Knauf M, et al. Vaccine potential of the Neisseria meningitidis 2086 lipoprotein. Infect Immun 2004; 72:2088 - 100; http://dx.doi.org/10.1128/IAI.72.4.2088-2100.2004; PMID: 15039331
  • Borrow R, Carlone GM, Rosenstein N, Blake M, Feavers I, Martin D, 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 2006; 24:5093 - 107; http://dx.doi.org/10.1016/j.vaccine.2006.03.091; PMID: 16838413
  • Marshall H, Nissen MD, Richmond P, Lambert SB, Roberton D, Gruber W, et al. A Randomized, Plaebo-Controlled, Double-Blind, Phase 1 Trial of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults. Rotterdam, The Netherlands: Presented at the Sixteenth International Pathogenic Conference, 2008.
  • Marshall H, Richmond P, Nissen MD, Jiang Q, Anderson A, Jansen KU, et al. Phase 1 Randomized Controlled Clinical Trial of Safety and Immunogenicity of a Meningococcal B Bivalent Vaccine in Healthy Toddlers. The Hague, The Neatherlands: Presented at the Twenty-ninth Annual Meeting of the European Society for Paediatric Infectious Diseases, 2011.
  • Richmond P, Marshall H, Nissen M, Jiang Q, Jansen KU, Garces-Sanchez M, et al. Phase 2 Randomised Controlled Trial of Safety and Immunogenicity of a Meningococcal B Bivalent Vaccine (rLP2086) in Healthy Adolescents. The Hague, The Netherlands: Presented at the Twenty-ninth Annual Meeting of the European Society for Paediatric Infectious Diseases, 2011.
  • Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, et al, European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA 2012; 307:573 - 82; http://dx.doi.org/10.1001/jama.2012.85; PMID: 22318278
  • Santolaya ME, O’Ryan ML, Valenzuela MT, Prado V, Vergara R, Muñoz A, et al, V72P10 Meningococcal B Adolescent Vaccine Study group. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet 2012; 379:617 - 24; http://dx.doi.org/10.1016/S0140-6736(11)61713-3; PMID: 22260988
  • Ala’aldeen DA, Flint M, Oldfield NJ, Omer SA, McNeil LK, Jiang Q, et al. Human antibody responses to the meningococcal factor H binding protein (LP2086) during invasive disease, colonization and carriage. Vaccine 2010; 28:7667 - 75; http://dx.doi.org/10.1016/j.vaccine.2010.09.038; PMID: 20875489

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