The capsular group B meningococcal vaccine, 4CMenB: Clinical experience and potential efficacy

Expert Opinion on Biological Therapy

Volumn 15, Issue 1, 2015, Pages 131-142

  Rollier, Christine S ^a   Dold, Christina ^a   Marsay, Leanne ^a   Sadarangani, Manish ^a   Pollard, Andrew J ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Capsular group B meningococcus; Four component meningococcal group B vaccine; Meningococcal disease; Outer membrane vesicles; Recombinant proteins; Vaccine

Indexed keywords

MENINGOCOCCUS VACCINE; PARACETAMOL; 4CMENB VACCINE; BACTERIAL ANTIGEN; CAPSULAR POLYSACCHARIDE, MENINGOCOCCAL GROUP B;

ARTICLE; AUSTRALIA; BACTERICIDAL ACTIVITY; CANADA; CAPSULAR GROUP B MENINGOCOCCAL DISEASE; DRUG ANALYSIS; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; EUROPEAN UNION; HUMAN; IMMUNOGENICITY; IN VITRO STUDY; MENINGOCOCCOSIS; NEW ZEALAND; PEER REVIEW; PERSONAL EXPERIENCE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); ANTIBODY PRODUCTION; BACTERIAL CAPSULE; CLINICAL PRACTICE; IMMUNOLOGY; INFANT; MENINGITIS, MENINGOCOCCAL; PRACTICE GUIDELINE; SEPSIS; STATISTICS AND NUMERICAL DATA; UNITED KINGDOM;

BACTERIA (MICROORGANISMS); NEISSERIA MENINGITIDIS;

ANTIBODY FORMATION; ANTIGENS, BACTERIAL; BACTERIAL CAPSULES; CANADA; EUROPEAN UNION; GREAT BRITAIN; HUMANS; INFANT; MENINGITIS, MENINGOCOCCAL; MENINGOCOCCAL VACCINES; NEW ZEALAND; PHYSICIAN'S PRACTICE PATTERNS; PRACTICE GUIDELINES AS TOPIC; SEPSIS;

EID: 84917729487     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2015.983897     Document Type: Article

References (59)

1. Nadel S. Prospects for eradication of meningococcal disease. Arch Dis Child 2012;97(11):993-8
2. Martin NG, Sadarangani M, Pollard AJ, Goldacre MJ. Hospital admission rates for meningitis and septicaemia caused by Haemophilus influenzae, Neisseria meningitidis, and Streptococcus pneumoniae in children in England over five decades: a population-based observational study. Lancet Infect Dis 2014;14(5):397-405
3. Goldacre MJ, Roberts SE, Yeates D. Case fatality rates for meningococcal disease in an English population, 1963- 98: database study. BMJ 2003;327(7415):596-7
4. Andrews SM, Pollard AJ. A vaccine against serogroup B Neisseria meningitidis: dealing with uncertainty. Lancet Infect Dis 2014;14(5):426-34
5. Halperin SA, Bettinger JA, Greenwood B, et al. The changing and dynamic epidemiology of meningococcal disease. Vaccine 2012;30(Suppl 2):B26-36
6. Finne J, Leinonen M, Makela PH. Antigenic similarities between brain components and bacteria causing meningitis: implications for vaccine development and pathogenesis. Lancet 1983;2:355-7
7. Sadarangani M, Pollard AJ. Serogroup B meningococcal vaccines-an unfinished story. Lancet Infect Dis 2010;10(2):112-24
8. Vaccination SeSS. 2014. Available from: http://www.msss. gouv.qc.ca/sujets/santepub/vaccination/index.php?accueil-en
9. Department of Health. JCVI position statement on use of Bexsero meningococcal B vaccine in the UK. 2014
10. Centers for Disease Control and Prevention. Active bacterial core surveillance report - emerging infections programm network: Neisseria meningitidis. 2012. Available from: http://wwwcdcgov/abcs/report-findins/survreports/mening12pdf
11. Mandal S, Wu HM, MacNeil JR, et al. Prolonged university outbreak of meningococcal disease associated with a serogroup B strain rarely seen in the United States. Clin Infect Dis 2013;57(3):344-8
12. Ladhani SN, Lucidarme J, Newbold LS, et al. Invasive meningococcal capsular group Y disease, England and Wales, 2007-2009. Emerg Infect Dis 2012;18(1):63-70
13. Christensen H, May M, Bowen L, et al. Meningococcal carriage by age: a systematic review and meta-analysis. Lancet Infect Dis 2010;10(12):853-61
14. Howitz M, Lambertsen L, Simonsen JB, et al. Morbidity, mortality and spatial distribution of meningococcal disease, 1974-2007. Epidemiol Infect 2009;137(11):1631-40
15. Christensen H, Hickman M, Edmunds WJ, Trotter CL. Introducing vaccination against serogroup B meningococcal disease: an economic and mathematical modelling study of potential impact. Vaccine 2013;31(23):2638-46
16. JCVI statement on the use of meningococcal C vaccines in the routine childhood immunisation programme. 2012. Available from: http://webarchivenationalarchivesgovuk/20130107105354/, http://wwwdhgovuk/prod-consum-dh/groups/dh-digitalassets/@dh/@ab/documents/digitalasset/dh-132443pdf
17. Christensen H, Trotter CL, Hickman M, Edmunds WJ. Re-evaluating cost effectiveness of universal meningitis vaccination (Bexsero) in England: modelling study. Bmj 2014;349:g5725
18. Pouwels KB, Hak E, van der Ende A, et al. Cost-effectiveness of vaccination against meningococcal B among Dutch infants: crucial impact of changes in incidence. Hum Vaccin Immunother 2013;9(5):1129-38
19. Novartis. A Phase 2b, randomized, controlled, observer-blind, multi-center study assessing the effectiveness, immunogenicity and safety of novartis meningococcal ABCWY vaccine administered to healthy adolescents in the U.S. NCT02140762 2014. Available from: http://clinicaltrialsgov
20. Richmond PC, Marshall HS, Nissen MD, et al. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, singleblind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2012;12(8):597-607
21. Wong SH, Lennon DR, Jackson CM, et al. Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine. Pediatr Infect Dis J 2009;28(5):385-90
22. Gossger N, Snape MD, Yu LM, et al. 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(6):573-82
23. Oster P, et al. MeNZB: a safe and highly immunogenic taylor-made vaccine against the New Zealand Neisseria meningitidis serogroup B disease epidemic strain. Vaccine 2005;23:2191-6
24. Wong S, Lennon D, Jackson C, et al. New zealand epidemic strain meningococcal B outer membrane vesicle vaccine in children aged 16-24 months. Pediatr Infect Dis J 2007;26(4):345-50
25. Vesikari T, Esposito S, Prymula R, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet 2013;381(9869):825-35
26. Findlow J, Borrow R, Snape MD, et al. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis 2010;51(10):1127-37
27. Snape MD, Dawson T, Oster P, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J 2010;29(11):e71-9
28. Prymula R, Esposito S, Vincenzo Zuccotti G, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I): efects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB. Hum Vaccin Immunother 2014;10:7
29. Santolaya ME, O'Ryan ML, Valenzuela MT, et al. 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(9816):617-24
30. Moreira ED Jr, Palefsky JM, Giuliano AR, et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Hum Vaccin 2011;7(7):768-75
31. Kimura A, Toneatto D, Kleinschmidt A, et al. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol 2011;18(3):483-6
32. Nokleby H, Aavitsland P, O'Hallahan J, et al. Safety review: two outer membrane vesicle (OMV) vaccines against systemic Neisseria meningitidis serogroup B disease. Vaccine 2007;25(16):3080-4
33. Mills EJ, Montori VM, Ross CP, et al. Systematically reviewing qualitative studies complements survey design: an exploratory study of barriers to paediatric immunisations. J Clin Epidemiol 2005;58(11):1101-8
34. McQuaid F, Snape MD, John TM, et al. Persistence of bactericidal antibodies to 5 years of age following immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J 2014;33(7):760-6
35. Holst J, Oster P, Arnold R, et al. Vaccines against meningococcal serogroup B disease containing outer membrane vesicles (OMV): lessons from past programs and implications for the future. Hum Vaccin Immunother 2013;9(6):1241-53
36. Findlow J, Taylor S, Aase A, et al. Comparison and correlation of neisseria meningitidis serogroup B immunologic assay results and human antibody responses following three doses of the Norwegian meningococcal outer membrane vesicle vaccine MenBvac. Infect Immun 2006;74(8):4557-65
37. Giuliani MM, Biolchi A, Serruto D, et al. Measuring antigen-specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus. Vaccine 2010;28:5023-30
38. Donnelly J, Medini D, Boccadifuoco G, et al. Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines. Proc Natl Acad Sci USA 2010;107(45):19490-5
39. Vogel U, Taha MK, Vazquez JA, et al. Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis 2013;13(5):416-25
40. Frosi G, Biolchi A, Lo Sapio M, et al. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine 2013;31(43):4968-74
41. Tzanakaki G, Hong E, Kesanopoulos K, et al. Diversity of greek meningococcal serogroup B isolates and estimated coverage of the 4CMenB meningococcal vaccine. BMC Microbiol 2014;14(1):111
42. Bettinger JA, Scheifele DW, Halperin SA, et al. Diversity of Canadian meningococcal serogroup B isolates and estimated coverage by an investigational meningococcal serogroup B vaccine (4CMenB). Vaccine 2013;32(1):124-30
43. Snape MD, Philip J, John TM, et al. Bactericidal antibody persistence 2 years after immunization with 2 investigational serogroup B meningococcal vaccines at 6, 8 and 12 months and immunogenicity of preschool booster doses: a follow-on study to a randomized clinical trial. Pediatr Infect Dis J 2013;32(10):1116-21
44. Santolaya ME, O'Ryan M, Valenzuela MT, et al. Persistence of antibodies in adolescents 18-24 months after immunization with one, two, or three doses of 4CMenB meningococcal serogroup B vaccine. Hum Vaccin Immunother 2013;9(11):2304-10
45. Campbell H, Andrews N, Borrow R, et al. Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales: effectiveness, validation of serological correlates of protection, and modeling predictions of the duration of herd immunity. Clin Vaccine Immunol 2010;17(5):840-7
46. Snape MD, Saroey P, John TM, et al. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. CMAJ 2013;185(15):E715-24
47. Pajon R, Beernink PT, Harrison LH, Granoff DM. Frequency of factor Hbinding protein modular groups and susceptibility to cross-reactive bactericidal activity in invasive meningococcal isolates. Vaccine 2010;28(9):2122-9
48. Masignani V, Comanducci M, Giuliani MM, et al. Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870. J Exp Med 2003;197(6):789-99
49. Lucidarme J, Comanducci M, Findlow J, 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. Clin Vaccine Immunol 2010;17(6):919-29
50. Jacobsson S, Hedberg ST, Molling P, et al. Prevalence and sequence variations of the genes encoding the five antigens included in the novel 5CVMB vaccine covering group B meningococcal disease. Vaccine 2009;27(10):1579-84
51. Trotter CL, Maiden MC. Meningococcal vaccines and herd immunity: lessons learned from serogroup C conjugate vaccination programs. Expert Rev Vaccines 2009;8(7):851-61
52. Read RC, Baxter D, Chadwick DR, et al. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observerblind, phase 3 randomised clinical trial. Lancet 2014, August 18. In press
53. Hong E, Giuliani MM, Deghmane AE, et al. Could the multicomponent meningococcal serogroup B vaccine (4CMenB) control Neisseria meningitidis capsular group X outbreaks in Africa? Vaccine 2013;31(7):1113-16
54. Toneatto D, Ismaili S, Ypma E, et al. The first use of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) in humans. Hum Vaccin 2011;7(6):646-53
55. Abad R, Luca O, Fabio R, et al. Strain coverage of meningococcal multicomponent (4CMenB) vaccine in Spain. 18th International Pathogenic Neisseria Conference; Wurzburg, Germany; 2012
56. Nissen M, Tozer S, Whiley D, et al. Use of the meningococcal antigen typing system (MATS) to assess the Australian meningococcal strain coverage with a multicomponent serogroup B vaccine. 18th International Pathogenic Neisseria Conference; Wurzburg, Germany; 2012
57. Lemos AP, Gorla MC, Brandileone MC, et al. MATS based coverage prediction for the 4CMenB Vaccine on Neisseria meningitidis B (MenB) Brazilian invasive strains. 18th Internation Pathogenic Neisseria Conference; Wurzburg, Germany; 2012
58. Claus H, Kriz P, Musilek M, et al. Strain coverage of a multi-component meningococcus B vaccine in the Czech Republic and in Germany. 18th International Pathogenic Neisseria Conference; Wurzburg, Germany; 2012
59. Kim E, Paulos S, Carlone G, et al. Meningococcal antigen typing system (MATS) based coverage prediction for the 4CMenB vaccine in United States. 18th International Pathogenic Neisseria Conference; Wurzburg, Germany; 2012