Bexsero: A multicomponent vaccine for prevention of meningococcal disease

Human Vaccines and Immunotherapeutics

Volumn 8, Issue 2, 2012, Pages 164-173

  Gorringe, Andrew R ^a   Pajon, Rolando ^b  

^a PUBLIC HEALTH ENGLAND   (United Kingdom)

^b CHILDREN S HOSPITAL OAKLAND RESEARCH INSTITUTE   (United States)

Author keywords

fHbp; NadA; Neisseria meningitidis; NHBA; PorA; Serogroup B; Vaccine

Indexed keywords

ADHESIN; BEXSERO; COMPLEMENT FACTOR H; FACTOR H BINDING PROTEIN; HEPARIN BINDING PROTEIN; MENINGOCOCCUS VACCINE; NEISSERIAL ADHESIN A; NEISSERIAL HEPARIN BINDING ANTIGEN; PLACEBO; RECOMBINANT VACCINE; UNCLASSIFIED DRUG;

BACTERIAL STRAIN; COST EFFECTIVENESS ANALYSIS; CROSS PROTECTION; DRUG COST; DRUG EFFICACY; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INFECTION PREVENTION; MENINGOCOCCOSIS; NONHUMAN; OUTCOME ASSESSMENT; PUBLIC HEALTH PROBLEM; REVIEW; VACCINATION;

EID: 84858174870     PISSN: None     EISSN: 2164554X     Source Type: Journal    
DOI: None     Document Type: Review

References (67)

1. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine 2009; 27(Suppl 2): B51-63; PMID:19477562; http://dx.doi.org/10. 1016/j.vaccine.2009.04.063
2. Campbell H, Andrews N, Borrow R, Trotter C, Miller E. 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; 17:840-7; PMID: 20219881; http://dx.doi.org/10.1128/CVI.00529-09
3. 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; PMID:4197754; http://dx.doi.org/10. 1093/infdis/126.5.514
4. 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; PMID:15003635; http://dx.doi.org/10.1016/j.vaccine.2003.10.005
5. 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; PMID:6135869; http://dx.doi.org/10. 1016/S0140-6736(83)90340-9
6. Sierra GV, Campa HC, Varcacel NM, Garcia IL, Izquierdo PL, Sotolongo PF, et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann 1991; 14: 195-207, discussion 8-10; PMID:1812432
7. de Moraes JC, Perkins BA, Camargo MC, Hidalgo NT, Barbosa HA, Sacchi CT, et al. Protective efficacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil. Lancet 1992; 340:1074-8; PMID:1357461; http://dx.doi.org/10.1016/0140- 6736(92)93086-3
8. Bjune G, Hoiby EA, Gronnesby JK, Arnesen O, Fredriksen JH, Halstensen A, et al. Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway. Lancet 1991; 338:1093-6; PMID:1682541; http://dx.doi.org/10. 1016/0140-6736(91)91961-S
9. Frasch CE, Borrow R, Donnelly J. Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. Vaccine 2009; 27(Suppl 2): B112-6; PMID:19464093; http://dx.doi.org/10.1016/j.vaccine.2009.04.065
10. Martin SL, Borrow R, van der Ley P, Dawson M, Fox AJ, Cartwright KA. Effect of sequence variation in meningococcal PorA outer membrane protein on the effectiveness of a hexavalent PorA outer membrane vesicle vaccine. Vaccine 2000; 18:2476-81; PMID: 10775781; http://dx.doi.org/10.1016/S0264-410X(00)00047- 5
11. Tappero JW, Lagos R, Ballesteros AM, Plikaytis B, Williams D, Dykes J, et al. Immunogenicity of 2 serogroup B outer-membrane protein meningococcal vaccines: a randomized controlled trial in Chile. JAMA 1999; 281:1520-7; PMID:10227322; http://dx.doi.org/10.1001/jama.281.16.1520
12. O'Hallahan J, Lennon D, Oster P, Lane R, Reid S, Mulholland K, et al. From secondary prevention to primary prevention: a unique strategy that gives hope to a country ravaged by meningococcal disease. Vaccine 2005; 23:2197-201; PMID:15755594; http://dx.doi.org/10.1016/j.vaccine.2005.01.061
13. Galloway Y, Stehr-Green P, McNicholas A, O'Hallahan J. Use of an observational cohort study to estimate the effectiveness of the New Zealand group B meningococcal vaccine in children aged under 5 years. Int J Epidemiol 2009; 38:413-8; PMID:18988650; http://dx.doi.org/10.1093/ije/dyn228
14. Cartwright K, Morris R, Rumke H, Fox A, Borrow R, Begg N, et al. Immunogenicity and reactogenicity in UK infants of a novel meningococcal vesicle vaccine containing multiple class 1 (PorA) outer membrane proteins. Vaccine 1999; 17:2612-9; PMID:10418910; http://dx.doi.org/10.1016/S0264-410X(99)00044-4
15. de Kleijn ED, de Groot R, Lafeber AB, Labadie J, van Limpt CJ, Visser J, et al. Prevention of meningococcal serogroup B infections in children: a protein-based vaccine induces immunologic memory. J Infect Dis 2001; 184:98-102; PMID:11398116; http://dx.doi.org/10.1086/320993
16. de Kleijn E, van Eijndhoven L, Vermont C, Kuipers B, van Dijken H, Rumke H, et al. Serum bactericidal activity and isotype distribution of antibodies in toddlers and schoolchildren after vaccination with RIVM hexavalent PorA vesicle vaccine. Vaccine 2001; 20: 352-8; PMID:11672897; http://dx.doi.org/10.1016/ S0264-410X(01)00371-1
17. Gray SJ, Trotter CL, Ramsay ME, Guiver M, Fox AJ, Borrow R, et al. Epidemiology of meningococcal disease in England and Wales 1993/94 to 2003/04: contribution and experiences of the Meningococcal Reference Unit. J Med Microbiol 2006; 55:887-96; PMID: 16772416; http://dx.doi.org/10.1099/jmm.0. 46288-0
18. Bonvehí P, Boutriau D, Casellas J, Weynants V, Feron C, Poolman J. Three doses of an experimental detoxified L3-derived lipooligosaccharide meningococcal vaccine offer good safety but low immunogenicity in healthy young adults. Clin Vaccine Immunol 2010; 17:1460-6; PMID:20660140; http://dx.doi.org/10.1128/CVI.00129-10
19. Keiser PB, Gibbs BT, Coster TS, Moran EE, Stoddard MB, Labrie JE, 3rd, et al. A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA. Vaccine 2010; 28:6970-6; PMID:20732470; http://dx.doi.org/10.1016/j. vaccine.2010.08.048
20. Keiser PB, Biggs-Cicatelli S, Moran EE, Schmiel DH, Pinto VB, Burden RE, et al. A phase 1 study of a meningococcal native outer membrane vesicle vaccine made from a group B strain with deleted lpxL1 and synX, over-expressed factor H binding protein, two PorAs and stabilized OpcA expression. Vaccine 2011; 29:1413-20; PMID:21199704; http://dx.doi.org/10.1016/j.vaccine.2010.12.039
21. Tettelin H, Saunders NJ, Heidelberg J, Jeffries AC, Nelson KE, Eisen JA, et al. Complete genome sequence of Neisseria meningitidis serogroup B strain MC58. Science 2000; 287:1809-15; PMID:10710307; http://dx.doi.org/10.1126/ science.287.5459.1809
22. Pizza M, Scarlato V, Masignani V, Giuliani MM, Arico B, Comanducci M, et al. Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science 2000; 287:1816-20; PMID:10710308; http://dx.doi.org/10.1126/science.287.5459.1816
23. Giuliani MM, Adu-Bobie J, Comanducci M, Arico B, Savino S, Santini L, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci USA 2006; 103:10834-9; PMID:16825336; http://dx.doi.org/10.1073/pnas.0603940103
24. Serruto D, Spadafina T, Ciucchi L, Lewis LA, Ram S, Tontini M, et al. Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans. Proc Natl Acad Sci USA 2010; 107:3770-5; PMID:20133713; http://dx.doi.org/10.1073/pnas.0915162107
25. Schneider MC, Prosser BE, Caesar JJ, Kugelberg E, Li S, Zhang Q, et al. Neisseria meningitidis recruits factor H using protein mimicry of host carbohydrates. Nature 2009; 458:890-3; PMID:19225461; http://dx.doi.org/10.1038/ nature07769
26. 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
27. 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; PMID:15039331; http://dx.doi.org/10.1128/IAI.72.4.2088-2100. 2004
28. Toneatto D, Ismaili S, Ypma E, Vienken K, Oster P, Dull P. The first use of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) in humans. Hum Vaccin 2011; 7:646-53; PMID: 21904120; http://dx.doi.org/10.4161/ hv.7.6.15482
29. Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, 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:e71-9; PMID:20844462
30. Santolaya ME. O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Muñoz A, et al. Immunogenicity and tolerability of an investigational multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents. Presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands, 2011.
31. Gossger N, Snape M, Finn A, Heath P, Collinson A, Bona G, et al. Immunogenicity of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) administered with or without routine infant vaccinations in different schedules. Presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands, 2011.
32. Prymula RVT, Esposito S, Kohl I, Ypma E, Toneatto D, Kimura A, et al. Catch-Up Vaccination of healthy toddlers with an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) - exploration of a two-dose schedule. Presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands, 2011.
33. Findlow J, Borrow R, Snape MD, Dawson T, Holland A, John TM, 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; 51:1127-37; PMID: 20954968; http://dx.doi.org/10.1086/656741
34. Donnelly J, Medini D, Boccadifuoco G, Biolchi A, Ward J, Frasch C, 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; 107:19490-5; PMID: 20962280; http://dx.doi.org/10.1073/pnas.1013758107
35. Holst J, Feiring B, Fuglesang JE, Hoiby EA, Nokleby H, Aaberge IS, et al. Serum bactericidal activity correlates with the vaccine efficacy of outer membrane vesicle vaccines against Neisseria meningitidis serogroup B disease. Vaccine 2003; 21:734-7; PMID:12531351; http://dx.doi.org/10.1016/S0264-410X(02) 00591-1
36. Jackson C, Lennon D, Wong S, Yan J, Stewart J, Reid S, et al. Antibody persistence following MeNZB vaccination of adults and children and response to a fourth dose in toddlers. Arch Dis Child 2011; 96:744-51; PMID: 21596727; http://dx.doi.org/10.1136/adc.2009.180596
37. Maiden MC, Stuart JM. Carriage of serogroup C meningococci 1 year after meningococcal C conjugate polysaccharide vaccination. Lancet 2002; 359:1829-31; PMID:12044380; http://dx.doi.org/10.1016/S0140-6736(02)08679-8
38. Maiden MC, Ibarz-Pavon AB, Urwin R, Gray SJ, Andrews NJ, Clarke SC, et al. Impact of meningococcal serogroup C conjugate vaccines on carriage and herd immunity. J Infect Dis 2008; 197:737-43; PMID: 18271745; http://dx.doi.org/10. 1086/527401
39. Trotter CL, Maiden MC. Meningococcal vaccines and herd immunity: lessons learned from serogroup C conjugate vaccination programs. Expert Rev Vaccines 2009; 8:851-61; PMID:19538112; http://dx.doi.org/10.1586/erv.09.48
40. Bentley SD, Vernikos GS, Snyder LA, Churcher C, Arrowsmith C, Chillingworth T, et al. Meningococcal genetic variation mechanisms viewed through comparative analysis of serogroup C strain FAM18. PLoS Genet 2007; 3:e23; PMID:17305430; http://dx.doi.org/10.1371/journal.pgen.0030023
41. Comanducci M, Bambini S, Caugant DA, Mora M, Brunelli B, Capecchi B, et al. NadA diversity and carriage in Neisseria meningitidis. Infect Immun 2004; 72:4217-23; PMID:15213166; http://dx.doi.org/10.1128/IAI.72.7.4217-4223.2004
42. Bambini S, Muzzi A, Olcen P, Rappuoli R, Pizza M, Comanducci M. Distribution and genetic variability of three vaccine components in a panel of strains representative of the diversity of serogroup B meningococcus. Vaccine 2009; 27:2794-803; PMID:19428890; http://dx.doi.org/10.1016/j.vaccine.2009.02. 098
43. Pajon R, Beernink PT, Harrison LH, Granoff DM. Frequency of factor H-binding protein modular groups and susceptibility to cross-reactive bactericidal activity in invasive meningococcal isolates. Vaccine 2010; 28: 2122-9; PMID:20044056; http://dx.doi.org/10.1016/ j.vaccine.2009.12.027
44. Lucidarme J, Comanducci M, Findlow J, Gray SJ, Kaczmarski EB, Guiver M, 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; 17:919-29;PMID: 20375242; http://dx.doi.org/10.1128/CVI.00027-10
45. Lucidarme J, Tan L, Exley RM, Findlow J, Borrow R, Tang CM. Characterization of Neisseria meningitidis isolates that do not express the virulence factor and vaccine antigen factor H binding protein. Clin Vaccine Immunol 2011; 18:1002-14; PMID:21508163; http://dx.doi.org/10.1128/CVI.00055-11
46. Christensen H, Hickman M, Edmunds JW. Modelling the cost-effectiveness of new meningococcal vaccines in England. Presented at 17th International Pathogenic Neisseria Conference, Banff, Canada, 2010.
47. Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine 2001; 19: 2688-91; PMID:11257410; http://dx.doi.org/10. 1016/ S0264-410X(00)00554-5
48. Masignani V, Comanducci M, Giuliani MM, Bambini S, Adu-Bobie J, Arico B, et al. Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870. J Exp Med 2003; 197:789-99; PMID: 12642606; http://dx.doi.org/10.1084/jem.20021911
49. Beernink PT, Granoff DM. The modular architecture of meningococcal factor H-binding protein. Microbiology 2009; 155:2873-83; PMID:19574307; http://dx.doi.org/10.1099/mic.0.029876-0
50. 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; PMID:19534597; http://dx.doi.org/10.1086/600141
51. Comanducci M, Bambini S, Brunelli B, Adu-Bobie J, Arico B, Capecchi B, et al. NadA, a novel vaccine candidate of Neisseria meningitidis. J Exp Med 2002; 195:1445-54; PMID:12045242; http://dx.doi.org/10.1084/jem.20020407
52. Capecchi B, Adu-Bobie J, Di Marcello F, Ciucchi L, Masignani V, Taddei A, et al. Neisseria meningitidis NadA is a new invasin which promotes bacterial adhesion to and penetration into human epithelial cells. Mol Microbiol 2005; 55:687-98; PMID:15660996; http://dx.doi.org/10.1111/j.1365-2958.2004.04423.x
53. Serruto D, Spadafina T, Ciucchi L, Lewis LA, Ram S, Tontini M, et al. Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans. Proc Natl Acad Sci USA 2010; 107: 3770-5; PMID:20133713; http://dx.doi.org/10.1073/pnas.0915162107
54. Welsch JA, Moe GR, Rossi R, Adu-Bobie J, Rappuoli R, Granoff DM. Antibody to genome-derived neisserial antigen 2132, a Neisseria meningitidis candidate vaccine, confers protection against bacteremia in the absence of complement-mediated bactericidal activity. J Infect Dis 2003; 188:1730-40; PMID:14639545; http://dx.doi.org/10.1086/379375
55. Vu DM, Wong TT, Granoff DM. Cooperative serum bactericidal activity between human antibodies to meningococcal factor H binding protein and Neisserial heparin binding antigen. Vaccine 2011; 29:1968-73; PMID:21241734; http://dx.doi.org/10.1016/j.vaccine.2010.12.075
56. Giuliani MM, Biolchi A, Serruto D, Ferlicca F, Vienken K, Oster P, et al. Measuring antigen-specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus. Vaccine 2010; 28: 5023-30; PMID:20493284; http://dx.doi.org/10.1016/j.vaccine.2010.05.014
57. Beernink PT, Welsch JA, Harrison LH, Leipus A, Kaplan SL, Granoff DM. Prevalence of factor H-binding protein variants and NadA among meningococcal group B isolates from the United States: implications for the development of a multicomponent group B vaccine. J Infect Dis 2007; 195:1472-9; PMID:17436227; http:// dx.doi.org/10.1086/514821
58. Pajon R, Fergus AM, Koeberling O, Caugant DA, Granoff DM. Meningococcal factor h binding proteins in epidemic strains from Africa: implications for vaccine development. PLoS Negl Trop Dis 2011; 5:e1302; PMID:21909444; http://dx.doi.org/10.1371/journal.pntd.0001302
59. Borrow R, Andrews N, Findlow H, Waight P, Southern J, Crowley-Luke A, et al. Kinetics of antibody persistence following administration of a combination meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine in healthy infants in the United Kingdom primed with a monovalent meningococcal serogroup C vaccine. Clin Vaccine Immunol 2010; 17:154-9; PMID:19906895; http://dx.doi.org/ 10.1128/CVI.00384-09
60. Beeretz I, Snape M, Finn A, Heath P, Collinson A, Bona G, et al. Reactogenicity and safety of multicomponent meningococcal serogroup B vaccine (4CMenB) administered with or without routine infant vaccinations in different schedules. Presented at the 29th European Society for Paediatric Infectious Diseases Conference, June 7-11, 2011, The Hague, The Netherlands, 2011.
61. Prymula R, Esposito S, Kittel C, Kohl I, Toneatto D, Dull P. Prophylactic paracetamol in infants decreases fever following concomitant administration of an investigational meningococcal serogroup b vaccine with routine immunizations. 29th Annual Meeting of the European Society of Paediatric Infectious Diseases-ESPID 2011, The Hague, 2011.
62. Beernink PT, Welsch JA, Bar-Lev M, Koeberling O, Comanducci M, Granoff DM. Fine antigenic specificity and cooperative bactericidal activity of monoclonal antibodies directed at the meningococcal vaccine candidate factor H-binding protein. Infect Immun 2008; 76:4232-40; PMID:18591239; http://dx.doi.org/10.1128/IAI.00367-08
63. Auckland C, Gray S, Borrow R, Andrews N, Goldblatt D, Ramsay M, et al. Clinical and immunologic risk factors for meningococcal C conjugate vaccine failure in the United Kingdom. J Infect Dis 2006; 194:1745-52; PMID:17109348; http://dx.doi.org/10.1086/509619
64. Beernink PT, Shaughnessy J, Braga EM, Liu Q, Rice PA, Ram S, et al. A meningococcal factor H binding protein mutant that eliminates factor H binding enhances protective antibody responses to vaccination. J Immunol 2011; 186:3606-14; PMID:21325619; http://dx.doi.org/10.4049/jimmunol.1003470
65. Beernink PT, Granoff DM. Bactericidal antibody responses induced by meningococcal recombinant chimeric factor H-binding protein vaccines. Infect Immun 2008; 76:2568-75; PMID:18362128; http://dx.doi.org/10.1128/IAI.00033-08
66. Ray TD, Lewis LA, Gulati S, Rice PA, Ram S. Novel blocking human IgG directed against the pentapeptide repeat motifs of Neisseria meningitidis Lip/H.8 and Laz lipoproteins. J Immunol 2011; 186:4881-94; PMID: 21402895; http://dx.doi.org/10.4049/jimmunol.1003623
67. Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. 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; 18:483-6; PMID: 21177912; http://dx.doi.org/10.1128/CVI.00304-10