Meningococcal Group B Vaccine For The Prevention Of Invasive Meningococcal Disease Caused By Neisseria meningitidis Serogroup B

References

• Jafri RZ, Ali A, Messonnier NE, et al. Global epidemiology of invasive meningococcal disease. Popul Health Metr. 2013;11(1):17. doi:10.1186/1478-7954-11-1724016339
   PubMed Web of Science ®Google Scholar
• Martinón-Torres F, Salas A, Rivero-Calle I, et al. Life-threatening infections in children in Europe (the EUCLIDS Project): a prospective cohort study. Lancet Child Adolesc Health. 2018;2(6):404–414. doi:10.1016/S2352-4642(18)30113-530169282
   PubMedGoogle Scholar
• Rivero-Calle I, Vilanova-Trillo L, Pardo-Seco J, et al. The burden of pediatric invasive meningococcal disease in Spain (2008–2013). Pediatr Infect Dis J. 2016;35(4):407–413. doi:10.1097/INF.000000000000104826974748
   PubMed Web of Science ®Google Scholar
• Vetter V, Baxter R, Denizer G, et al. Routinely vaccinating adolescents against meningococcus: targeting transmission & disease. Expert Rev Vaccines. 2016;15(5):641–658. doi:10.1586/14760584.2016.113062826651380
   PubMed Web of Science ®Google Scholar
• Soriano-Gabarro M, Wolter J, Hogea C, Vyse A. Carriage of Neisseria meningitidis in Europe: a review of studies undertaken in the region. Expert Rev Anti Infect Ther. 2011;9(9):761–774. doi:10.1586/eri.11.8921905785
   PubMed Web of Science ®Google Scholar
• 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(12):853–861. doi:10.1016/S1473-3099(10)70251-621075057
   PubMed Web of Science ®Google Scholar
• Martinon-Torres F. Deciphering the burden of meningococcal disease: conventional and under-recognized elements. J Adolesc Health. 2016;59(2 Suppl):S12–S20. doi:10.1016/j.jadohealth.2016.03.04127449145
   PubMed Web of Science ®Google Scholar
• Pace D, Pollard AJ. Meningococcal disease: clinical presentation and sequelae. Vaccine. 2012;30 Suppl 2:B3–B9. doi:10.1016/j.vaccine.2011.12.06222607896
   PubMed Web of Science ®Google Scholar
• Serra LC, York LJ, Gamil A, Balmer P, Webber C. A Review of meningococcal disease and vaccination recommendations for travelers. Infect Dis Ther. 2018;7(2):219–234. doi:10.1007/s40121-018-0196-z29550909
   PubMed Web of Science ®Google Scholar
• Grupo de trabajo MenCC 2012. Ministerio de Sanidad SSeI. Revisión del programa de vacunación frente a enfermedad meningocócica por serogrupo C: Ponencia de Programa y Registro de Vacunaciones. Madrid: Ministerio de Sanidad, Servicios Sociales e Igualidad; 2013.
   Google Scholar
• Pelton SI. The global evolution of meningococcal epidemiology following the introduction of meningococcal vaccines. J Adolesc Health. 2016;59 2 Suppl:S3–S11. doi:10.1016/j.jadohealth.2016.04.01227449148
   PubMed Web of Science ®Google Scholar
• Sridhar S, Greenwood B, Head C, et al. Global incidence of serogroup B invasive meningococcal disease: a systematic review. Lancet Infect Dis. 2015;15(11):1334–1346. doi:10.1016/S1473-3099(15)00217-026453240
   PubMed Web of Science ®Google Scholar
• McNamara LA, Shumate AM, Johnsen P, et al. First use of a serogroup B meningococcal vaccine in the US in response to a university outbreak. Pediatrics. 2015;135(5):798–804. doi:10.1542/peds.2014-401525917990
   PubMed Web of Science ®Google Scholar
• Soeters HM, McNamara LA, Whaley M, et al. Serogroup B meningococcal disease outbreak and carriage evaluation at a college – Rhode Island, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(22):606–607.26068563
   PubMed Web of Science ®Google Scholar
• Schildkamp RL, Lodder MC, Bijlmer HA, Dankert J, Scholten RJ. Clinical manifestations and course of meningococcal disease in 562 patients. Scand J Infect Dis. 1996;28(1):47–51. doi:10.3109/003655496090271499122633
   PubMed Web of Science ®Google Scholar
• Ruth A, McCracken CE, Fortenberry JD, Hall M, Simon HK, Hebbar KB. Pediatric severe sepsis: current trends and outcomes from the Pediatric Health Information Systems database. Pediatr Crit Care Med. 2014;15(9):828–838. doi:10.1097/PCC.000000000000025425226500
   PubMed Web of Science ®Google Scholar
• Rivero Calle I, Rodriguez-Tenreiro Sanchez C, Martinon-Torres F. [Meningococcal vaccines. Global epidemiological situation and strategies for prevention by vaccination]. Enferm Infecc Microbiol Clin. 2015;33(4):257–267. doi:10.1016/j.eimc.2015.03.00125795150
   PubMed Web of Science ®Google Scholar
• Finne J, Leinonen M, Makela PH. Antigenic similarities between brain components and bacteria causing meningitis: implications for vaccine development and pathogenesis. Lancet. 1983;2(8346):355–357. doi:10.1016/s0140-6736(83)90340-96135869
   PubMed Web of Science ®Google Scholar
• Hayrinen J, Jennings H, Raff HV, et al. Antibodies to polysialic acid and its N-propyl derivative- binding properties and interaction with human embryonal brain glycopeptides. J Infect Dis. 1995;171:1481–1490. doi:10.1093/infdis/171.6.14817769282
   PubMed Web of Science ®Google Scholar
• Montero-Martin M, Inwald DP, Carrol ED, Martinon-Torres F. Prognostic markers of meningococcal disease in children: recent advances and future challenges. Expert Rev Anti Infect Ther. 2014;12(11):1357–1369. doi:10.1586/14787210.2014.96607925301230
   PubMed Web of Science ®Google Scholar
• Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014;5(1):4–11. doi:10.4161/viru.2737224335434
   PubMed Web of Science ®Google Scholar
• Martinon-Torres F, Png E, Khor CC, et al. Natural resistance to Meningococcal Disease related to CFH loci: meta-analysis of genome-wide association studies. Sci Rep. 2016;6:35842. doi:10.1038/srep3584227805046
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/S1473-3099(14)70027-124631222
   PubMed Web of Science ®Google Scholar
• Wang NY, Pollard AJ. The next chapter for group B meningococcal vaccines. Crit Rev Microbiol. 2018;44(1):95–111. doi:10.1080/1040841X.2017.132927628557577
   PubMed Web of Science ®Google Scholar
• 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 U S A. 2010;107(45):19490–19495. doi:10.1073/pnas.101375810720962280
   PubMed Web of Science ®Google Scholar
• Toneatto D, Pizza M, Masignani V, Rappuoli R. Emerging experience with meningococcal serogroup B protein vaccines. Expert Rev Vaccines. 2017;16(5):433–451. doi:10.1080/14760584.2017.130882828375029
   PubMed Web of Science ®Google Scholar
• Europeans Medicines Agency. European public assessment report - Bexsero product information. 2018 Available from: https://www.ema.europa.eu/documents/product-information/bexsero-epar-product-information_en.pdf. Accessed 114, 2019.
   Google Scholar
• 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):1127–1137. doi:10.1086/65674120954968
   PubMed Web of Science ®Google Scholar
• 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. Can Med J Assoc. 2013;185(15):715–724. doi:10.1503/cmaj.130257
   PubMed Web of Science ®Google Scholar
• 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. J Am Med Assoc. 2012;307(6):573–582. doi:10.1001/jama.2012.85
   PubMed Web of Science ®Google Scholar
• Nissen MD, Marshall HS, Richmond PC, et al. A randomized, controlled, phase 1/2 trial of a Neisseria meningitidis serogroup B bivalent rLP2086 vaccine in healthy children and adolescents. Pediatr Infect Dis J. 2013;32(4):364–371. doi:10.1097/INF.0b013e31827b0d2423114369
   PubMed Web of Science ®Google Scholar
• Marshall HS, Richmond PC, Nissen MD, et al. A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine. 2013;31(12):1569–1575. doi:10.1016/j.vaccine.2013.01.02123352429
   PubMed Web of Science ®Google Scholar
• Vesikari T, Ostergaard L, Diez-Domingo J, et al. Meningococcal serogroup B bivalent rLP2086 vaccine elicits broad and robust serum bactericidal responses in healthy adolescents. J Pediatric Infect Dis Soc. 2016;5(2):152–160. doi:10.1093/jpids/piv03926407272
   PubMed Web of Science ®Google Scholar
• Giuliani MM, Biolchi A, Serruto D, et al. Measuring antigen-specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus. Vaccine. 2010;28(31):5023–5030. doi:10.1016/j.vaccine.2010.05.01420493284
   PubMed Web of Science ®Google Scholar
• Perrett KP, McVernon J, Richmond PC, et al. Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study. Vaccine. 2015;33(39):5217–5224. doi:10.1016/j.vaccine.2015.06.10326232542
   PubMed Web of Science ®Google Scholar
• 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 observer-blind, phase 3 randomised clinical trial. Lancet. 2014;384(9960):2123–2131. doi:10.1016/S0140-6736(14)60842-425145775
   PubMed Web of Science ®Google Scholar
• 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):617–624. doi:10.1016/S0140-6736(11)61713-322260988
   PubMed Web of Science ®Google Scholar
• Safadi P. MA, Martinon-Torres F, Weckx LY, et al. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine. 2017;35(16):2052–2059. doi:10.1016/j.vaccine.2017.03.00228318767
   PubMed Web of Science ®Google Scholar
• Harris SL, Donald RG, Hawkins JC, et al. Neisseria meningitidis Serogroup B Vaccine, Bivalent rLP2086, Induces Broad Serum Bactericidal Activity Against Diverse Invasive Disease Strains Including Outbreak Strains. Pediatr Infect Dis J. 2017;36(2):216–223. doi:10.1097/INF.000000000000139927846061
   PubMed Web of Science ®Google Scholar
• Martinon-Torres F, Safadi MAP, Martinez AC, et al. Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: immunogenicity and safety results from a randomised open-label phase 3b trial. Vaccine. 2017;35(28):3548–3557. doi:10.1016/j.vaccine.2017.05.02328533054
   PubMed Web of Science ®Google Scholar
• Kuhdari P, Stefanati A, Lupi S, Valente N, Gabutti G. Meningococcal B vaccination: real-world experience and future perspectives. Pathog Glob Health. 2016;110(4–5):148–156. doi:10.1080/20477724.2016.119507227309042
   PubMed Web of Science ®Google Scholar
• Bianchi A, Fantoni S, Prugnola A. Meningococcal B vaccine and the vision of a meningitis free world. J Prev Med Hyg. 2015;56:e140–e143.26788735
   PubMedGoogle Scholar
• 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):1113–1116. doi:10.1016/j.vaccine.2012.12.02223261039
   PubMed Web of Science ®Google Scholar
• Gloria MCO, Lemos APS, Biolchi A. Impact vaccination with the Novartis meningococcal serogroup B vaccine 4CMenB (BEXSERO®) on non-serogroup B disease burden in Brazil. 32nd European Society for Pediatric Infectious Diseases; 2014; Dublin, Ireland.
   Google Scholar
• Vogel U, Stefanelli P, Vazquez J, Taha MK, Claus H, Donnelly J. The use of vaccine antigen characterization, for example by MATS, to guide the introduction of meningococcus B vaccines. Vaccine. 2012;30 Suppl 2:B73–B77. doi:10.1016/j.vaccine.2011.12.06122607902
   PubMed Web of Science ®Google Scholar
• Parikh SR, Newbold L, Slater S, et al. Meningococcal serogroup B strain coverage of the multicomponent 4CMenB vaccine with corresponding regional distribution and clinical characteristics in England, Wales, and Northern Ireland, 2007–08 and 2014–15: a qualitative and quantitative assessment. Lancet Infect Dis. 2017;17(7):754–762. doi:10.1016/S1473-3099(17)30170-628366725
   PubMed Web of Science ®Google Scholar
• Carter NJ. Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero((R))): a review of its use in primary and booster vaccination. BioDrugs. 2013;27(3):263–274. doi:10.1007/s40259-013-0029-223575646
   PubMed Web of Science ®Google Scholar
• Giuliani MM, Adu-Bobie J, Comanducci M, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A. 2006;103(29):10834–10839. doi:10.1073/pnas.060394010316825336
   PubMed Web of Science ®Google Scholar
• Tettelin H, Saunders NJ, Heidelberg J, et al. Complete genome sequence of Neisseria meningitidis serogroup B strain MC58. Science. 2000;287(5459):1809–1815. doi:10.1126/science.287.5459.180910710307
   PubMed Web of Science ®Google Scholar
• Rappuoli R, Bottomley MJ, D’Oro U, Finco O, De Gregorio E. Reverse vaccinology 2.0: human immunology instructs vaccine antigen design. J Exp Med. 2016;213(4):469–481. doi:10.1084/jem.2015196027022144
   PubMed Web of Science ®Google Scholar
• Seib KL, Zhao X, Rappuoli R. Developing vaccines in the era of genomics: a decade of reverse vaccinology. Clin Microbiol Infect. 2012;18 Suppl 5:109–116. doi:10.1111/j.1469-0691.2012.03939.x22882709
   PubMed Web of Science ®Google Scholar
• Serruto D, Bottomley MJ, Ram S, Giuliani MM, Rappuoli R. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: immunological, functional and structural characterization of the antigens. Vaccine. 2012;30 Suppl 2:B87–B97. doi:10.1016/j.vaccine.2012.01.03322607904
   PubMed Web of Science ®Google Scholar
• Pizza M, Scarlato V, Masignani V, et al. Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science. 2000;287:1816–1820. doi:10.1126/science.287.5459.181610710308
   PubMed Web of Science ®Google Scholar
• 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):789–799. doi:10.1084/jem.2002191112642606
   PubMed Web of Science ®Google Scholar
• Capecchi B, Adu-Bobie J, Di Marcello F, et al. Neisseria meningitidis NadA is a new invasin which promotes bacterial adhesion to and penetration into human epithelial cells. Mol Microbiol. 2005;55(3):687–698. doi:10.1111/j.1365-2958.2004.04423.x15660996
   PubMed Web of Science ®Google Scholar
• Giuliani M, Bartolini E, Galli B, et al. Human protective response induced by meningococcus B vaccine is mediated by the synergy of multiple bactericidal epitopes. Sci Rep. 2018;8(1):3700. doi:10.1038/s41598-018-22057-729487324
   PubMed Web of Science ®Google Scholar
• 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(10):1968–1973. doi:10.1016/j.vaccine.2010.12.07521241734
   PubMed Web of Science ®Google Scholar
• McNeil LK, Zagursky RJ, Lin SL, et al. Role of factor H binding protein in Neisseria meningitidis virulence and its potential as a vaccine candidate to broadly protect against meningococcal disease. Microbiol Mol Biol Rev. 2013;77(2):234–252. doi:10.1128/MMBR.00056-1223699256
   PubMed Web of Science ®Google Scholar
• Zlotnick GW, Jones TR, Liberator P, et al. The discovery and development of a novel vaccine to protect against Neisseria meningitidis Serogroup B Disease. Hum Vaccin Immunother. 2015;11(1):5–13. doi:10.4161/hv.3429325483509
   PubMed Web of Science ®Google Scholar
• McNeil LK, Donald RGK, Gribenko A, et al. Predicting the Susceptibility of Meningococcal Serogroup B Isolates to Bactericidal Antibodies Elicited by Bivalent rLP2086, a Novel Prophylactic Vaccine. mBio. 2018;9(2):e00036–e00018. doi:10.1128/mBio.00036-1829535195
   PubMed Web of Science ®Google Scholar
• Murphy E, Andrew L, Lee KL, 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(3):379–389. doi:10.1086/60014119534597
   PubMed Web of Science ®Google Scholar
• Luo Y, Friese OV, Runnels HA, et al. The dual role of lipids of the lipoproteins in trumenba, a self-adjuvanting vaccine against meningococcal meningitis B disease. AAPS J. 2016;18(6):1562–1575. doi:10.1208/s12248-016-9979-x27604766
   PubMed Web of Science ®Google Scholar
• Rosenstein NE, Perkins BA, Stephens DS, Popovic T, Hughes JM. Meningococcal disease. N Engl J Med. 2001;344(18):1378–1388. doi:10.1056/NEJM20010503344180711333996
   PubMed Web of Science ®Google Scholar
• Gandhi A, Balmer P, York LJ. Characteristics of a new meningococcal serogroup B vaccine, bivalent rLP2086 (MenB-FHbp; Trumenba(R)). Postgrad Med. 2016;128(6):548–556. doi:10.1080/00325481.2016.120323827467048
   PubMed Web of Science ®Google Scholar
• Bjune G, Høiby EA, Grønnesby JK, et al. Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway. Lancet. 1991;338(8775):1093–1096. doi:10.1016/0140-6736(91)91961-s1682541
   PubMed Web of Science ®Google Scholar
• Sierra GV, Campa HC, Varcacel NM, et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann. 1991;14(2):195–207; discussion 208–110.
   Google Scholar
• van Alphen L, van den Dobbelsteen G. Meningococcal B vaccine development and evaluation of efficacy. Hum Vaccines. 2014;4(2):158–161. doi:10.4161/hv.4.2.4871
   Web of Science ®Google Scholar
• Beernink PT, Shaughnessy J, Pajon R, Braga EM, Ram S, Granoff DM. The effect of human factor H on immunogenicity of meningococcal native outer membrane vesicle vaccines with over-expressed factor H binding protein. PLoS Pathog. 2012;8(5):e1002688. doi:10.1371/journal.ppat.100268822589720
   PubMed Web of Science ®Google Scholar
• 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(3):483–486. doi:10.1128/CVI.00304-1021177912
   PubMed Web of Science ®Google Scholar
• 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 Vaccines. 2014;7(6):646–653. doi:10.4161/hv.7.6.15482
   Web of Science ®Google Scholar
• 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):825–835. doi:10.1016/S0140-6736(12)61961-823324563
   PubMed Web of Science ®Google Scholar
• 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, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012;12(8):597–607. doi:10.1016/S1473-3099(12)70087-722569484
   PubMed Web of Science ®Google Scholar
• Van den Bruel A, Thompson MJ, Haj-Hassan T, et al. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011;342:d3082. doi:10.1136/bmj.d308221653621
   PubMed Web of Science ®Google Scholar
• Block SL, Szenborn L, Daly W, et al. A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: results of a phase 2 randomized, controlled trial. Vaccine. 2015;33(21):2500–2510. doi:10.1016/j.vaccine.2015.03.00125795256
   PubMed Web of Science ®Google Scholar
• Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–1326. doi:10.1084/jem.129.6.13074977280
   PubMed Web of Science ®Google Scholar
• Martinon-Torres F, Nolan T, Toneatto D, Banzhoff A. Persistence of the immune response after 4CMenB vaccination, and the response to an additional booster dose in infants, children, adolescents, and young adults. Hum Vaccin Immunother. 2019;1–12. doi:10.1080/21645515.2019.1627159
   PubMed Web of Science ®Google Scholar
• Flacco ME, Manzoli L, Rosso A, et al. Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis. Lancet Infect Dis. 2018;18(4):461–472. doi:10.1016/S1473-3099(18)30048-329371070
   PubMed Web of Science ®Google Scholar
• Martinon-Torres F, Carmona Martinez A, Simko R, et al. Antibody persistence and booster responses 24–36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018;76(3):258–269. doi:10.1016/j.jinf.2017.12.00529253560
   PubMed Web of Science ®Google Scholar
• Nolan T, Santolaya ME, de Looze F, et al. Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. Vaccine. 2019;37(9):1209–1218. doi:10.1016/j.vaccine.2018.12.05930691980
   PubMed Web of Science ®Google Scholar
• Singer M, Deutschman CS, Seymour CW, et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315(8):801–810. doi:10.1001/jama.2016.028726903338
   PubMed Web of Science ®Google Scholar
• Schlapbach LJ, Straney L, Alexander J, et al. Mortality related to invasive infections, sepsis, and septic shock in critically ill children in Australia and New Zealand, 2002–13: a multicentre retrospective cohort study. Lancet Infect Dis. 2015;15(1):46–54. doi:10.1016/S1473-3099(14)71003-525471555
   PubMed Web of Science ®Google Scholar
• Muse D, Christensen S, Bhuyan P, et al. A Phase 2, Randomized, Active-controlled, Observer-blinded Study to Assess the Immunogenicity, Tolerability and Safety of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered With Tetanus, Diphtheria and Acellular Pertussis Vaccine and Serogroup A, C, Y and W-135 Meningococcal Conjugate Vaccine in Healthy US Adolescents. Pediatr Infect Dis J. 2016;35(6):673–682. doi:10.1097/INF.000000000000112426974889
   PubMed Web of Science ®Google Scholar
• Senders S, Bhuyan P, Jiang Q, et al. Immunogenicity, tolerability and safety in adolescents of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with quadrivalent human papilloma virus vaccine. Pediatr Infect Dis J. 2016;35(5):548–554. doi:10.1097/INF.000000000000107226835974
   PubMed Web of Science ®Google Scholar
• Marshall HS, Richmond PC, Beeslaar J, et al. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2017;17(1):58–67. doi:10.1016/S1473-3099(16)30314-027745812
   PubMed Web of Science ®Google Scholar
• Lujan E, Partridge E, Giuntini S, Ram S, Granoff DM. Breadth and duration of meningococcal serum bactericidal activity in health care workers and microbiologists immunized with the MenB-FHbp vaccine. Clin Vaccine Immunol. 2017;24:8. doi:10.1128/CVI.00121-17
   Google Scholar
• Martinón-Torres F, Bernatowska E, Shcherbina A, et al. Meningococcal B vaccine immunogenicity in children with defects in complement and splenic function. Pediatrics. 2018;141(6):e20174250. doi:10.1542/peds.2017-4250
   Web of Science ®Google Scholar
• Hernando Real S, Vega Castano S, Pajares Garcia R. Meningococcemia in vaccinated patient under treatment with eculizumab. Enferm Infecc Microbiol Clin. 2017;35(3):200–201. doi:10.1016/j.eimc.2016.02.01526994815
   PubMed Web of Science ®Google Scholar
• McNamara LA, Topaz N, Wang X, Hariri S, Fox L, MacNeil JR. High risk for invasive meningococcal disease among patients receiving eculizumab (Soliris) despite receipt of meningococcal vaccine. Am J Transplant. 2017;17(9):2481–2484. doi:10.1111/ajt.2017.17.issue-9
   Web of Science ®Google Scholar
• Parikh SR, Lucidarme J, Bingham C, et al. Meningococcal B vaccine failure with a penicillin-resistant strain in a young adult on long-term eculizumab. Pediatrics. 2017;140:3. doi:10.1542/peds.2017-0685
   Web of Science ®Google Scholar
• Tozer SJ, Whiley DM, Smith HV The use of the Meningococcal Antigen Typing System (MATS) to assess Australian epidemiology and meningococcal strain coverage with multicomponent serogroup B vaccine. Paper presented at: 27th International Congress of Pediatrics; 8 24–27, 2013; Melbourne, Australia.
   Google Scholar
• Harris SL, Tan C, Andrew L, et al. The bivalent factor H binding protein meningococcal serogroup B vaccine elicits bactericidal antibodies against representative non-serogroup B meningococci. Vaccine. 2018;36(45):6867–6874. doi:10.1016/j.vaccine.2018.05.08130269916
   PubMed Web of Science ®Google Scholar
• Petousis-Harris H, Paynter J, Morgan J, et al. Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study. Lancet. 2017;390(10102):1603–1610. doi:10.1016/S0140-6736(17)31449-628705462
   PubMed Web of Science ®Google Scholar
• Seib KL. Gonorrhoea vaccines: a step in the right direction. Lancet. 2017;390(10102):1567–1569. doi:10.1016/S0140-6736(17)31605-728705461
   PubMed Web of Science ®Google Scholar
• Semchenko EA, Tan A, Borrow R, Seib KL. The serogroup B meningococcal vaccine Bexsero elicits antibodies to Neisseria gonorrhoeae. Clin Infect Dis. 2018.
   Web of Science ®Google Scholar
• Rajam G, Stella M, Kim E, et al. Meningococcal antigen typing system (MATS)-based neisseria meningitidis serogroup B coverage prediction for the MenB-4C vaccine in the United States. mSphere. 2017;2(6). doi:10.1128/mSphere.00261-17
   PubMed Web of Science ®Google Scholar
• Plikaytis BD, Stella M, Boccadifuoco G, 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. Clin Vaccine Immunol. 2012;19(10):1609–1617. doi:10.1128/CVI.00202-1222875603
   PubMed Web of Science ®Google Scholar
• Vernikos G, Medini D. Bexsero(R) chronicle. Pathog Glob Health. 2014;108(7):305–316. doi:10.1179/2047773214Y.000000016225417906
   PubMed Web of Science ®Google Scholar
• Medini D, Stella M, Mats: WJ. Global coverage estimates for 4CMenB, a novel multicomponent meningococcal B vaccine. Vaccine. 2015;33(23):2629–2636. doi:10.1016/j.vaccine.2015.04.01525882169
   PubMed Web of Science ®Google Scholar
• Jiang HQ, Hoiseth SK, Harris SL, 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(37):6086–6093. doi:10.1016/j.vaccine.2010.06.08320619376
   PubMed Web of Science ®Google Scholar
• Prymula R, Esposito S, Zuccotti GV, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I). Hum Vaccin Immunother. 2014;10(7):1993–2004. doi:10.4161/hv.2866625424809
   PubMed Web of Science ®Google Scholar
• Parikh SR, Andrews NJ, Beebeejaun K, et al. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study. Lancet. 2016;388(10061):2775–2782. doi:10.1016/S0140-6736(16)31921-328100432
   PubMed Web of Science ®Google Scholar
• De Wals P, Deceuninck G, Lefebvre B, et al. Impact of an Immunization Campaign to Control an Increased Incidence of Serogroup B Meningococcal Disease in One Region of Quebec, Canada. Clin Infect Dis. 2017;64(9):1263–1267. doi:10.1093/cid/cix15428207068
   PubMed Web of Science ®Google Scholar
• De Serres G, Billard MN, Gariepy MC, et al. Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec, Canada. Vaccine. 2018;36(52):8039–8046. doi:10.1016/j.vaccine.2018.10.09530467063
   PubMed Web of Science ®Google Scholar
• Bryan P, Seabroke S, Wong J, et al. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. Lancet Child Adolesc Health. 2018;2(6):395–403. doi:10.1016/S2352-4642(18)30103-230169281
   PubMedGoogle Scholar
• De Serres G, Billard MN, Gariepy MC, Rouleau I, Toth E, Landry M. Rapport final de surveillance de la sécurité de la vaccination des jeunes de 20 ans et moins contre le méningocoque de sérogroupe B au Saguenay–Lac-Saint-Jean. Quebec (Canada): Institut National de Santé Publique du Québec; 2016.
   Google Scholar
• Jones R. Costs of pediatric assessment. Br J Healthcare Manage. 2013;17(2):57–63. doi:10.12968/bjhc.2011.17.2.57
   Google Scholar
• Marshall HS, Chen G, Clarke M, Ratcliffe J. Adolescent, parent and societal preferences and willingness to pay for meningococcal B vaccine: A Discrete Choice Experiment. Vaccine. 2016;34(5):671–677. doi:10.1016/j.vaccine.2015.11.07526740249
   PubMed Web of Science ®Google Scholar
• Ostergaard L, Lucksinger GH, Absalon J, et al. A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults. Vaccine. 2016;34(12):1465–1471. doi:10.1016/j.vaccine.2016.01.04426845739
   PubMed Web of Science ®Google Scholar
• Vesikari T, Ostergaard L, Beeslaar J, et al. Persistence and 4-year boosting of the bactericidal response elicited by two- and three-dose schedules of MenB-FHbp: A phase 3 extension study in adolescents. Vaccine. 2019;37(12):1710–1719. doi:10.1016/j.vaccine.2018.11.07330770221
   PubMed Web of Science ®Google Scholar
• Marshall HS, Richmond PC, Nissen MD, et al. Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers aged 18–36 months: a phase 1 randomized-controlled clinical trial. Pediatr Infect Dis J. 2012;31(10):1061–1068. doi:10.1097/INF.0b013e31826327e422718089
   PubMed Web of Science ®Google Scholar
• Ahluwalla J. Trumenba pediatric safety and utilization review for the pediatric advisory committee (PAC). 2018 Available from: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM599285.pdf. Accessed 222, 2019.
   Google Scholar
• Fiorito TM, Baird GL, Alexander-Scott N, et al. Adverse events following vaccination with bivalent rLP2086 (Trumenba(R)): an observational, longitudinal study during a college outbreak and a systematic review. Pediatr Infect Dis J. 2018;37(1):e13–e19. doi:10.1097/INF.000000000000174228834957
   PubMed Web of Science ®Google Scholar
• Balmer P, Burman C, Serra L, York LJ. Impact of meningococcal vaccination on carriage and disease transmission: a review of the literature. Hum Vaccin Immunother. 2018;14(5):1118–1130. doi:10.1080/21645515.2018.145457029565712
   PubMed Web of Science ®Google Scholar
• McNamara LA, Thomas JD, MacNeil J, et al. Meningococcal carriage following a vaccination campaign with MenB-4C and MenB-FHbp in response to a university serogroup B meningococcal disease outbreak-Oregon, 2015–2016. J Infect Dis. 2017;216(9):1130–1140. doi:10.1093/infdis/jix44628968661
   PubMed Web of Science ®Google Scholar
• Delbos V, Lemee L, Benichou J, et al. Impact of MenBvac, an outer membrane vesicle (OMV) vaccine, on the meningococcal carriage. Vaccine. 2013;31(40):4416–4420. doi:10.1016/j.vaccine.2013.06.08023856330
   PubMed Web of Science ®Google Scholar
• Soeters HM, Whaley M, Alexander-Scott N, et al. Meningococcal carriage evaluation in response to a serogroup B meningococcal disease outbreak and mass vaccination campaign at a college-Rhode Island, 2015–2016. Clin Infect Dis. 2017;64(8):1115–1122. doi:10.1093/cid/cix09128158417
   PubMed Web of Science ®Google Scholar
• University of Adelaide. South Australian meningococcal B vaccine herd immunity study (B Part of It). clinicaltrialsgov. 2017 Available from: https://clinicaltrials.gov/ct2/show/record/NCT3089086. NLM identifier: NCT3089086 Accessed 917, 2019.
   Google Scholar
• University of Adelaide. A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis in adolescents in South Australia. Australian New Zealand Clinical Trials Registry. 2017 Available from: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371948. Accessed 917, 2019.
   Google Scholar
• Mcmillan M, Walters L, Koehler A, et al. Impact of 4cmenb vaccine on meningococcal carriage density in adolescents. 37th Annual Meeting of the European Society for Paediatric Infectious Diseases; 5 6–11, 2019; Ljubljana, Slovenia.
   Google Scholar
• University of Oxford. Evaluating the effect of immunisation with group B meningococcal vaccines on meningococcal carriage. EU Clinical Trials Register. 2018 Available from: www.clinicaltrialsregister.eu. Accessed 917, 2019.
   Google Scholar
• World Health Organization. WHO vaccine-preventable diseases: monitoring system. 2018 global summary. 2018 Available from: http://apps.who.int/immunization_monitoring/globalsummary. Accessed 228, 2019.
   Google Scholar
• European Medicines Agency. Bexsero authorization details and assessment history. 2018 Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/bexsero#authorisation-details-section. Accessed 129, 2019.
   Google Scholar
• Public Health England. Introduction of MenB vaccination for infants. 2015 Available from: https://www.gov.uk/government/publications/menb-vaccination-introduction-from-1-september-2015. Accessed 129, 2019.
   Google Scholar
• Cohn AC, MacNeil JR, Clark TA, et al. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013;62(Rr–2):1–28.
   PubMed Web of Science ®Google Scholar
• Institut national de santé publique. Impact épidémiologique de la campagne de vaccination contre le méningocoque de sérogroupe B dans la région du Saguenay-Lac-Saint-Jean, en 2014: rapport au 30 Juin 2018. Quebec (Canada): Institut national de santé publique; 2018.
   Google Scholar
• Grupo de trabajo MenB Ponencia de Programa y Registro de Vacunaciones. Vacuna frente a enfermedad meningocócica invasora por serogrupo B y su posible utilización en salud pública, Junio de 2013. Madrid: Ministerio de Sanidad, Servicios Sociales e Igualidad; 2015.
   Google Scholar
• Moreno-Pérez D, Álvarez García FJ, Arístegui Fernández J, et al. Vaccination against meningococcal B disease. public statement of the advisory committee on vaccines of the Spanish Association of Paediatrics (CAV-AEP). An Pediatr. 2015;82(3):198.e191–198.e199. doi:10.1016/j.anpede.2014.09.004
   Google Scholar
• Martinon-Torres F, Trilla A. Meningococcal disease: can we predict the unpredictable? Med Clin. 2019.
   Web of Science ®Google Scholar
• Pearson GA, Ward-Platt M, Kelly D. How children die: classifying child deaths. Arch Dis Child. 2011;96(10):922–926. doi:10.1136/adc.2009.17708920656738
   PubMed Web of Science ®Google Scholar
• Vila Perez D, Jordan I, Esteban E, et al. Prognostic factors in pediatric sepsis study, from the Spanish Society of Pediatric Intensive Care. Pediatr Infect Dis J. 2014;33(2):152–157. doi:10.1097/01.inf.0000435502.36996.7224413407
   PubMed Web of Science ®Google Scholar
• Sumpter R, Brunklaus A, McWilliam R, Dorris L. Health-related quality-of-life and behavioural outcome in survivors of childhood meningitis. Brain Inj. 2011;25(13–14):1288–1295. doi:10.3109/02699052.2011.61309021961570
   PubMed Web of Science ®Google Scholar
• Delany I, Rappuoli R, Seib KL. Vaccines, reverse vaccinology, and bacterial pathogenesis. Cold Spring Harb Perspect Med. 2013;3(5):a012476. doi:10.1101/cshperspect.a01551123637311
   PubMed Web of Science ®Google Scholar
• Vacca I, Del Tordello E, Gasperini G, et al. Neisserial heparin binding antigen (NHBA) contributes to the adhesion of neisseria meningitidis to human epithelial cells. PLoS One. 2016;11(10):e0162878. doi:10.1371/journal.pone.016287827780200
   PubMed Web of Science ®Google Scholar
• Serruto D, Spadafina T, Ciucchi L, et al. Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans. Proc Natl Acad Sci U S A. 2010;107(8):3770–3775. doi:10.1073/pnas.091516210720133713
   PubMed Web of Science ®Google Scholar
• Viner RM, Booy R, Johnson H, et al. Outcomes of invasive meningococcal serogroup B disease in children and adolescents (MOSAIC): a case-control study. Lancet Neurol. 2012;11(9):774–783. doi:10.1016/S1474-4422(12)70180-122863608
   PubMed Web of Science ®Google Scholar
• Comanducci M, Bambini S, Brunelli B, et al. NadA, a Novel Vaccine Candidate ofNeisseria meningitidis. J Exp Med. 2002;195(11):1445–1454. doi:10.1084/jem.2002040712045242
   PubMed Web of Science ®Google Scholar
• Bambini S, Piet J, Muzzi A, et al. An analysis of the sequence variability of meningococcal fHbp, NadA and NHBA over a 50-year period in the Netherlands. PLoS One. 2013;8(5):e65043. doi:10.1371/journal.pone.006504323717687
   PubMed Web of Science ®Google Scholar
• Granoff DM. Review of meningococcal group B vaccines. Clin Infect Dis. 2010;50 Suppl 2:S54–S65. doi:10.1086/64896620144017
   PubMed Web of Science ®Google Scholar
• Costa I, Pajon R, Granoff DM. Human factor H (FH) impairs protective meningococcal anti-FHbp antibody responses and the antibodies enhance FH binding. MBio. 2014;5(5):e01625–e01614. doi:10.1128/mBio.01625-1425161192
   PubMed Web of Science ®Google Scholar
• Foltyn Zadura A, Zipfel PF, Bokarewa MI, et al. Factor H autoantibodies and deletion of Complement Factor H-Related protein-1 in rheumatic diseases in comparison to atypical hemolytic uremic syndrome. Arthritis Res Ther. 2012;14(4):R185. doi:10.1186/ar401622894814
   PubMed Web of Science ®Google Scholar
• Partridge E, Lujan E, Giuntini S, Vu DM, Granoff DM. The role of anti-NHba antibody in bactericidal activity elicited by the meningococcal serogroup B vaccine, MenB-4C. Vaccine. 2017;35(33):4236–4244. doi:10.1016/j.vaccine.2017.06.02028651840
   PubMed Web of Science ®Google Scholar
• 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(6):1002–1014. doi:10.1128/CVI.00055-1121508163
   PubMedGoogle Scholar
• Rappuoli R, Pizza M, Masignani V, Vadivelu K. Meningococcal B vaccine (4CMenB): the journey from research to real world experience. Expert Rev Vaccines. 2018;17(12):1111–1121. doi:10.1080/14760584.2018.154763730457407
   PubMed Web of Science ®Google Scholar
• Grupo de Trabajo de “uso de 4CMenB en situaciones especiales”. Recomendaciones de utilización de la vacuna frente a enfermedad meningocócica por serogrupo B. Madrid: Ministerio de Sanidad, Servicios Sociales e Igualidad; 2015.
   Google Scholar
• Fisher EA, Poissant T, Luedtke P, Leman R, Young C, Cieslak P. Evaluation of mass vaccination clinics in response to a serogroup B meningococcal disease outbreak at a large, public university-Oregon, 2015. J Adolesc Health. 2018;63(2):151–156. doi:10.1016/j.jadohealth.2018.03.01830149923
   PubMed Web of Science ®Google Scholar
• Abad R, Orlando L, Rigat F, Boccadifuoco G, Comanducci M, Muzzi A. Strain coverage of a meningococcal multicomponent (4CMenB) vaccine in Spain. 18th International Pathogenic Neisseria Converence; 9 9–14, 2012; Wurzburg, Germany.
   Google Scholar