References
- Halperin SA, Bettinger JA, Greenwood B, Harrison LH, Jelfs J, Ladhani SN, et al. The changing and dynamic epidemiology of meningococcal disease. Vaccine. 2012;30:B26–B36. doi:10.1016/j.vaccine.2011.12.032.
- World Health Organization (WHO). Meningococcal vaccines: WHO position paper. Wkly Epidemiol Rec. 2011;86:521–39.
- Panatto D, Amicizia D, Lai PL, Cristina ML, Domnich A, Gasparini R. New versus old meningococcal group B vaccines: how the new ones may benefit infants & toddlers. Indian J Med Res. 2013;138(6):835–46.
- Kaaijk P, van der Ende A, Luytjes W. Routine vaccination against MenB. Considerations for implementation. Hum Vaccin Immunother. 2014;10:310–16. doi:10.4161/hv.26816.
- Mameli C, Galli E, Mantegazza C, Fabiano V, Zuccotti GV. The multicomponent meningococcal serogroup B vaccine (4CMenB): origin, composition, health impact and unknown aspects. Future Microbiol. 2015;10:1579–98. doi:10.2217/fmb.15.91.
- Vernikos G, Medini D. Bexsero® chronicle. Pathog Glob Health. 2014;108:305–16. doi:10.1179/2047773214Y.0000000162.
- Gasparini R, Amicizia D, Lai PL, Panatto D. Neisseria meningitidis: pathogenetic mechanisms to overcome the human immune defences. J Prev Med Hyg. 2012;53:50–5.
- 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. doi:10.1016/S1473-3099(10)70251-6.
- Hill DJ, Griffiths NJ, Borodina E, Virji M. Cellular and molecular biology of Neisseria meningitidis colonization and invasive disease. Clin Sci (Lond). 2010;118:547–64. doi:10.1042/CS20090513.
- Stephens DS, Hoffman LH, McGee ZA. Interaction of Neisseria meningitidis with human nasopharyngeal mucosa: attachment and entry into columnar epithelial cells. J Infect Dis. 1983;148:369–76.10.1093/infdis/148.3.369
- van Deuren M, Brandtzaeg P, van der Meer JW. Update on meningococcal disease with emphasis on pathogenesis and clinical management. Clin Microbiol Rev. 2000;13:144–66.10.1128/CMR.13.1.144-166.2000
- Cohn AC, MacNeil JR, Clark TA, Ortega-Sanchez IR, Briere EZ, Meissner HC, et al. 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. 2013;62:1–28.
- Dwilow R, Fanella S. Invasive meningococcal disease in the 21st century – an update for the clinician 2015. Curr Neurol Neurosci Rep. 2015;15:2. doi:10.1007/s11910-015-0524-6.
- Pace D, Pollard AJ. Meningococcal disease: clinical presentation and sequelae. Vaccine. 2012;30:B3–B9. doi:10.1016/j.vaccine.2011.12.062.
- Stephens DS, Apicella MA. Neisseria meningitidis. In: Bennet E, Dolin R, Blaser M, editors. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. Philadelphia: Elsevier; 2014.
- Sadarangani M, Scheifele DW, Halperin SA, Vaudry W, Le Saux N, Tsang R. Outcomes of invasive meningococcal disease in adults and children in Canada between 2002 and 2011: a prospective cohort study. Clin Infect Dis. 2015;60:e27–e35. doi:10.1093/cid/civ028.
- Andrews SM, Pollard AJ. A vaccine against serogroup B Neisseria meningitidis: dealing with uncertainty. Lancet Infect Dis. 2014;14:426–34. doi:10.1016/S1473-3099(13)70341-4.
- Rosenstein NE, Perkins BA, Stephens DS, Popovic T, Hughes JM. Meningococcal disease. N Engl J Med. 2011;344:1378–88.
- European Centre for Disease Prevention and Control (ECDC). Surveillance of invasive bacterial diseases in Europe 2008/2009. Stockholm: ECDC; 2011. Available from: http://ecdc.europa.eu/en/activities/diseaseprogrammes/vpd/Pages/index.asp.
- Chang Q, Tzeng YL, Stephens DS. Meningococcal disease; changes in epidemiology and prevention. Clin Epidemiol. 2012;4:237–45. doi:10.2147/CLEP.S28410.
- Sridhar S, Greenwood B, Head C, Plotkin SA, Sáfadi MA, Saha S, et al. Global incidence of serogroup B invasive meningococcal disease: a systematic review. Lancet Infect Dis. 2015;15(11):1334–46. doi:10.1016/S1473-3099(15)00217-0.
- Drysdale SB, Pollard AJ. Group B meningococcal vaccine science and policy. J Infect. 2015;71(Suppl 1):S15–20.10.1016/j.jinf.2015.04.021
- European Medicines Agency (EMA). European public assessment report for Menveo; 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/001095/WC500090148.pdf.
- European Medicines Agency (EMA). European public assessment report for Nimenrix; 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002226/WC500127665.pdf.
- Ministry of Health. Italian national plan for immunization prevention (PNPV); 2012–2014. Available from: http://www.salute.gov.it/imgs/C_17_pubblicazioni_1721_allegato.pdf.
- Snape MD, Pollard AJ. The beginning of the end for serogroup B meningococcus? Lancet. 2013;381:785–87.10.1016/S0140-6736(12)62194-1
- Bai X, Borrow R. Genetic shifts of Neisseria meningitidis serogroup B antigens and the quest for a broadly cross-protective vaccine. Expert Rev Vaccines. 2010;9(10):1203–17. doi:10.1586/erv.10.116.
- O’Ryan M, Stoddard J, Toneatto D, Wassil J, Dull PM. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014;74(1):15–30. doi:10.1007/s40265-013-0155-7.
- Holst J, Oster P, Arnold R, Tatley MV, Næss LM, Aaberge IS, 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;9:1241–53. doi: 10.4161/hv.24129.
- Arnold R, Galloway Y, McNicholas A, O’Hallahan J. Effectiveness of a vaccination programme for an epidemic of meningococcal B in New Zealand. Vaccine. 2011;29:7100–6. doi: 10.1016/j.vaccine.2011.06.120.
- Gorringe AR, Pajón R. Bexsero. Hum Vaccin Immunother. 2012;8:174–83. doi: 10.4161/hv.18500.
- 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. doi: 10.1001/jama.2012.85.
- Martin NG, Snape MD. A multicomponent serogroup B meningococcal vaccine is licensed for use in Europe: what do we know, and what are we yet to learn? Expert Rev. Vaccines. 2013;12(8):837–58.10.1586/14760584.2013.814862
- 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):B87–97.10.1016/j.vaccine.2012.01.033
- Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, 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):825–35.10.1016/S0140-6736(12)61961-8
- Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, et al. Persistence of bactericidal antibodies after infant serogroup B meningococcal immunization and booster dose response at 12, 18 or 24 months of age. Pediatr Infect Dis J. 2016;35(4):e113–23. doi: 10.1097/INF.0000000000001056.
- 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;107:19490–5.10.1073/pnas.1013758107
- Bexsero meningococcal group B vaccine for injection in pre-filled syringe. Summary of product characteristics. [cited 2015 Mar 19]. Available from: https://www.medicines.org.uk/emc/medicine/28407/SPC/Bexsero+Meningococcal+Group+B+vaccine+for+injection+in+pre-filled+syringe/#INDICATIONS.
- Tomei S, Biolchi A, Brunelli B, De Angelis G, Moschioni M, Masinagi V, et al. Potential coverage of the BEXSERO® MenB vaccine on non-B meningococci. In: Proceedings of the 19th IPNC 2014. Asheville, North Carolina, USA, 12–17 October 2014, 30 [Poster 30].
- Gorla MCO, Lemos APS, Biolchi A, et al. Impact vaccination with the Novartis meningococcal serogroup B vaccine 4CMenB (BEXSERO®) on non-serogroup B disease burden in Brazil. In: Poster presented at 32nd ESPID 2014 in Dublin, Ireland. 6–10 May 2014, 361
- Medini D, Stella M, Wassil J. MATS: global coverage estimates for 4CMenB, a novel multicomponent meningococcal B vaccine. Vaccine. 2015;33:2629–36.10.1016/j.vaccine.2015.04.015
- Gabutti G. Meningococco B: controllo di due focolai epidemici mediante vaccinazione [Meningococcus B: control of two outbreaks by vaccination]. J Prev Med Hyg. 2014;55:1–3.
- European Medicines Agency (EMA). European public assessment report for Bexsero; 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002333/WC500137857.pdf.
- Italian Society of Hygiene, Preventive Medicine and Public Health. The rationale for ‘immunization schedule for life’. 2nd edition; 2014. Available from: http://sip.it/formazione-aggiornamento/ecco-il-nuovo-calendario-vaccinale-per-la-vita.
- Istituto Superiore di Sanità (ISS). Gruppo di Lavoro del centro nazionale di epidemiologia, sorveglianza e promozione della salute (CINEPS) Dati e evidenze disponibili per l’introduzione della vaccinazione antimeningococco B nei nuovi nati e negli adolescenti [Data and evidences for introduction of antimeningococcus B immunization in newborns and adolescents]; 2014 June. Available from: http://www.epicentro.iss.it/temi/vaccinazioni/pdf/Istruttoria%20MENINGOCOCCO%20B.pdf.
- Novartis meningitis B vaccine Bexsero® receives FDA breakthrough therapy designation in the US (news release). Basel: Novartis; 2014 Apr 7. Available from: www.novartis.com/newsroom/media-releases/en/2014/1774805.shtml.
- Centers for Disease Control and Prevention (CDC). Princeton University meningococcal disease outbreak. Available from: www.cdc.gov/meningococcal/outbreaks/princeton.html.
- National Foundation for Infectious Diseases. Addressing the challenges of serogroup B meningococcal disease outbreaks on campuses: a report by the national foundation for infectious diseases. Available from: www.nfid.org/meningococcal-b.
- Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero® to help protect US adolescents and young adults. Available from: http://www.novartis.com/newsroom/media-releases/en/2014/1793710.shtml.
- Princeton University. Available from: http://web.princeton.edu/sites/emergency/meningitis.html.
- CDC. Advisory committee on immunization practices (ACIP). Summary report, 2015. Atlanta, GA. Available from: http://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2015-06.pdf.
- Haut Conseil de la Santé Publique (HCSP). Avis relatif à l’utilisation du vaccin Bexsero® (Novartis vaccines and diagnostics) [Notice about Bexsero immunization]; 2013. Available from: http://www.hcsp.fr/Explore.cgi/Telecharger?NomFichier=hcspa20131025_vaccmeningocoqueBBexsero.pdf.
- Sächsische Impfkommission; 2013. Recommendations of the Saxon Vaccination Commission to carry out vaccinations in Saxony. Available from: Available from: http://www.gesunde.sachsen.de/download/lua/LUA_HM_Impfempfehlungen_E1.pdf.
- Deutsche Gesellschaft für Kinder und Jugendmedizin (DAKJ). Impfprophylaxe invasiver Erkrankungen mit Meningokokken der Serogruppe B Stellungnahme der Kommission für Infektionskrankheiten und Impffragen [Opinion of the Commission on Infectious Diseases and Immunization on immunization prophylaxis of invasive disease meningococcalserogroup B]; 2013. Available from: http://dakj.de/media/stellungnahmen/infektionskrankheiten-impffragen/2013-meningokokkenB-impfprophylaxe.pdf
- Ständigen Impfkommission (STIKO). Epidemiologisches Bulletin. Stellungnahme der Ständigen Impfkommission (STIKO) am Robert Koch-Institut (RKI) zum Stand der Bewertung des neuen Meningokokken-B-Impfstoffs Bexsero [Opinion of the Standing Committee on Vaccination (STIKO) at Robert Koch Institute (RKI) for prior review of the newMeningococcal B vaccine Bexsero]; 2013. Available from: http://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2013/Ausgaben/49_13.pdf?__blob=publicationFile
- Immunise Australia program; 2014. Available from: http://www.immunise.health.gov.au/
- Doporučení České vakcinologické společnosti pro očkování proti invazivním meningokokovým onemocněním; 2014. Available from: http://www.mzcr.cz/Verejne/dokumenty/doporuceni-ceske-vakcinologicke-spolecnosti-pro-ockovani-proti-invazivnim-mening_8893_1985_5.html
- Public Health Agency of Canada. Advice for the use of the multicomponent meningococcal serogroup B (4CMenB) vaccine; 2014. Available from: http://www.phac-aspc.gc.ca/naci-ccni/mening-4cmenb-eng.php
- Bundesministerium für Gesundheit. Österreichischer Impfplan 2014 [Austrian vaccination plan]; 2014. Available from: http://www.bmg.gv.at/home/Schwerpunkte/Gesundheitsfoerderung_Praevention/Impfen/Oesterreichischer_Impfplan_2014
- Sociedade Portuguesa de Pediatria; 2014. Available from: http://www.spp.pt/noticias/default.asp?IDN=363&op=2&ID=132
- National Immunisation Advisory Committee. National immunization guidelines; 2014. Available from: http://hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter13.pdf
- Instituto de Salud Publica, Ministero da Salud, Gobierno de Chile. Folleto de informacion al professional Bexsero vacuna meningococica recombinante adsorbida multicomponente del serogupo B, suspension inyectable [Information Leaflet on recombinant serogroup B of the multicomponent adsorbed Meningococcal vaccine Bexsero, injectable suspension]. Available from: http://www.ispch.cl.
- Posicionamiento del CAV-AEP sobre Bexsero® (4CMenB) [Position of the CAV-AEP on Bexsero® (4CMenB)]; 2014. Available from: http://vacunasaep.org/profesionales/noticias/posicionamiento-cav-aep-sobre-bexsero
- Országos Epidemiológiai Központ [National Epidemiology Center]; 2014. Available from: http://www.oek.hu/oek.web?to=2238&nid=1195&pid=1&lang=hun
- Dziennik Urzędowy Ministra Zdrowia [Official Journal of the Ministry of Health]. Komunikat głównego inspektora sanitarnego [the main message sanitary inspector]. Available from: http://www.gis.gov.pl/ckfinder/userfiles/files/EP/szczepienia/PSO_2015.pdf
- National Pediatric Society. Clinical recommendation of the greek pediatric society; 2014. Available from: http://vaccines.e-child.gr/sistasis/sistasis-ellinikis-pediatrikis-eterias/
- Republica Oriental Del Uruguay: Ministerio de Salud Publica [Uruguay Republic: Public Health Ministry]. Certificado de registro de Especialidad farmacéutica [Registration of pharmaceutical specialty]. 2014 Oct 2.
- Sociedade Brasileira de Infectologia. Governo Federal licencia uso da vacina meningocócica B. Avaiable from: http://www.infectologia.org.br/posts-910/
- US FDA. FDA approves a second vaccine to prevent serogroup B meningococcal disease. Avaiable from: http://www.fda.gov
- Bettinger JA, Deeks SL, Halperin SA, Tsang R, Scheifele DW. Controlling serogroup B invasive meningococcal disease: the Canadian perspective. Expert Rev Vaccines. 2013;12:505–17. doi: 10.1586/erv.13.30.
- Institut National de Santé Publique du Quebec (INSPQ). Rapport intérimaire de surveillance de la sécurité de la première dose du vaccin contre le méningocoque de sérogroupe B au Saguenay−Lac-Saint-Jean [Interin reportmonitoring the safety of the first dose vaccine against serogroup B meningococcal disease in Saguenay-Lac Saint Jean]; 2014 July. Available from: https://www.inspq.qc.ca/pdf/publications/1885_Vaccin_Menincogoque_SerogroupeB.pdf
- Institut National de Santé Publique du Quebec (INSPQ). Initial dose of a multicomponent serogroup B meningococcal vaccine in the Saguenay–Lac-Saint-Jean region, Québec, Canada: an interim safety surveillance report; 2014 July. Available from: http://www.inspq.qc.ca/pdf/publications/1902_SerogroupB_Meningococcal_Vaccine.pdf
- Institut National de Santé Publique du Quebec (INSPQ). 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 31 décembre 2014 [Epidemiological impactof the vaccination campaign against Meningococcal B in the Saguenay-Lac region Saint-Jean in 2014: report on 31 December 2014]. Available from: https://www.inspq.qc.ca/pdf/publications/1983_Impact_Vaccination_SerogroupeB_Saguenay.pdf
- Nolan T, O’Ryan M, Wassil J, Abitbol V, Dull P. Vaccination with a multicomponent meningococcal B vaccine in prevention of disease in adolescents and young adults. Vaccine. 2015;33(36):4437–45. doi: 10.1016/j.vaccine.2015.06.011.
- Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, 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.28666.
- National Health Service (NHS). Men B vaccine. Available from: http://www.nhs.uk/Conditions/vaccinations/Pages/meningitis-B-vaccine.aspx
- Watson PS, Turner DP. Clinical experience with the meningococcal B vaccine, Bexsero®: prospects for reducing the burden of meningococcal serogroup B disease. Vaccine. 2016 Feb 10;34(7):875–80. doi: 10.1016/j.vaccine.2015.11.057.
- CDC. Morbidity and Mortality Weekly Report (MMWR). Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the advisory committee on immunization practices, 2015. 2015 Oct 23;64(41):1171–6.
- Bhuyan P, Eiden J, Jones TR, York LJ, Ginis J, Jansenet KU, et al. Immunogenicity of human papilloma vaccine coadministered with an investigational bivalent rLP2086 vaccine against meningococcal serogroup B in healthy adolescents. Philadelphia, PA: IDWeek; 2014. Available from: http://ofid.oxfordjournals.org/content/1/suppl_1/S317.2.full?sid=25a2b12f-c211-4ecc-bb47-e6ceba7bb4a2
- Food and Drug Administration. Trumenba US package insert. Washington, DC: Food and Drug Administration; 2014. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM421139.pdf
- Reiner DM, Bhuyan P, Eiden JJ, Ginis J, Harris S, Jansen KU, et al. Immunogenicity, safety, and tolerability of the meningococcal serogroup B bivalent rLP2086 vaccine in adult laboratory workers. Vaccine. 2016;34(6):809–13. doi: 10.1016/j.vaccine.2015.12.016.
- Folaranmi T, Rubin L, Martin SW, Patel M, MacNeil JR. Use of serogroupB meningococcal vaccines in persons aged ≥10 years at increased risk forserogroup B meningococcal disease: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64:608–12.