Meningococcal serogroup B vaccine in Italy: state-of-art, organizational aspects and perspectives
PDF
HTML

Keywords

Meningococcal serogroup B vaccine
meningococcal diseases
regional immunization schedules

Abstract

Neisseria meningitidis causes severe invasive meningococcal diseases (IMDs) in humans including meningitis and septicemia, responsible for serious clinical conditions and leading to life-long disabilities and death. Serogroup B dominates IMDs burden in Italy, accounting for over 60% of total cases. On January 2013 the European Medicine Agency (EMA) licensed the first serogroup B meningococcal (Men B) vaccine in Europe. A number of European countries and Regions have introduced the new Men B vaccine in their immunization schedule, including Italy. In this paper we present the state of art, related critical issues and future perspectives of Men B vaccine introduction in Italy, in the context of the most recent available epidemiological data. In particular, we systematically assess the ongoing processes in the 8 Italian regions and one autonomous province that have already introduced Men B vaccine. With the new National Vaccine Prevention Plan including active Men B vaccine offer about to be adopted, it is of fundamental importance to gather further evidence on Men B vaccine clinical effectiveness, duration of protection and cost-effectiveness. Italian regions are called to organize and manage Men B immunization programs. Careful consideration will need to be devoted on timing, doses, and co-administration with other vaccines but also to economic assessments and strengthened communication to the general public. Our data will help to plan, implement and evaluate Men B immunization programmes in other Italian and international settings.

https://doi.org/10.15167/2421-4248/jpmh2015.56.3.484
PDF
HTML

References

World Health Organization , author. Weekly epidemiological record. Meningococcal vaccines position paper. Available: http://www.who.int/wer/en/ Accessed: May 2015.

Brigham KS, Sandora TJ. Neisseria meningitidis: epidemiology, treatment and prevention in adolescents. Current Opinion in Pediatrics 2009;21(4):437-443. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00008480-200908000-00004 PubMed PMID: 19421058. doi: 10.1097/MOP.0b013e32832c9668. [Google Scholar]

Stein-Zamir C, Shoob H, Sokolov I, Kunbar A, Abramson N, Zimmerman D. The clinical features and long-term sequelae of invasive meningococcal disease in children.. Pediatr Infect Dis J 2014;33(7):777-779. Available from: https://www.nlm.nih.gov/medlineplus/learningdisorders.html PubMed PMID: 24622347. doi: 10.1097/INF.0000000000000282. [Google Scholar]

Harrison OB, Brueggemann AB, Caugant DA, van der Ende, (Arie) , Frosch M, Gray S, et al. Molecular typing methods for outbreak detection and surveillance of invasive disease caused by Neisseria meningitidis, Haemophilus influenzae and Streptococcus pneumoniae, a review. Microbiology 2011 May;157(Pt 8):2181-2195. Available from: http://europepmc.org/abstract/MED/21622526 PubMed PMID: 21622526. doi: 10.1099/mic.0.050518-0. [Google Scholar]

Bishai DM, Champion C, Steele ME, et al. Product development partnerships hit their stride: lessons from developing a meningitis vaccine for Africa. Health Affairs (Project Hope 2011;30(6):1058-1064. Available from: http://content.healthaffairs.org/cgi/doi/10.1377/hlthaff.2011.0295 doi: 10.1377/hlthaff.2011.0295. [Google Scholar]

Xie O, Pollard AJ, Mueller JE, Norheim G. Emergence of serogroup X meningococcal disease in Africa: need for a vaccine.. Vaccine 2013;31(27):2852-2861. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0264410X13004751 PubMed PMID: 23623866. doi: 10.1016/j.vaccine.2013.04.036. [Google Scholar]

World Health Organization , author. Weekly epidemiological record. 2015. Available: http://www.who.int/wer/en/ Accessed: May 2015.

European Centre for Disease Prevention and Control , author . Surveillance of invasive bacterial diseases in Europe, 2012. Stockholm: ECDC; 2015. [Google Scholar]

Jafri RZ, Ali A, Messonnier NE, Tevi-Benissan C, Durrheim D, Eskola J, et al. Global epidemiology of invasive meningococcal disease. Popul Health Metr 2013;11(1):17. Available from: http://pophealthmetrics.biomedcentral.com/articles/10.1186/1478-7954-11-17 PubMed PMID: 24016339. doi: 10.1186/1478-7954-11-17. [Google Scholar]

Organization WH. Meningococcal meningitis. Available: Http://www.who.int/mediacentre/factsheets/fs141/en. Accessed: 2015. [Google Scholar]

European Centre for Disease Prevention and Control , author . European Centre for Disease Prevention and Control , author. Annual epidemiological report 2014 – Vaccine-preventable diseases – invasive bacterial diseases. Stockholm: ECDC; 2015. [Google Scholar]

Racloz VN, Luiz SJD. The elusive meningococcal meningitis serogroup: a systematic review of serogroup B epidemiology. BMC Infect Dis 2010;10(1):175. Available from: http://bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-10-175 PubMed PMID: 20565757. doi: 10.1186/1471-2334-10-175. [Google Scholar]

Food and Drug Administration (FDA) , author. First vaccine approved by FDA to prevent serogroup B Meningococcal disease. 2014

Giuliani MM, Adu-Bobie J, Comanducci M, Aricò B, Savino S, Santini L, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A 2006 Jul;103(29):10834-10839. Available from: http://www.pnas.org/cgi/pmidlookup?view=long&pmid=16825336 PubMed PMID: 16825336. doi: 10.1073/pnas.0603940103. [Google Scholar]

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):837-858. Available from: https://www.nlm.nih.gov/medlineplus/meningococcalinfections.html PubMed PMID: 23984957. doi: 10.1586/14760584.2013.814862. [Google Scholar]

Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine 2001;19(17-19):2688-2691. Available from: https://www.nlm.nih.gov/medlineplus/immunization.html PubMed PMID: 11257410. doi: 10.1016/S0264-410X(00)00554-5. [Google Scholar]

Kelly DF, Rappuoli R. Reverse vaccinology and vaccines for serogroup B Neisseria meningitidis.. Adv Exp Med Biol 2005;568:217-223. Available from: http://www.diseaseinfosearch.org/result/5121 PubMed PMID: 16107075. doi: 10.1007/0-387-25342-4_15. [Google Scholar]

Pizza M, Scarlato V, Masignani V, et al. Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science (New York, NY 2000;287(5459):1816-1820. Available from: http://www.sciencemag.org/cgi/doi/10.1126/science.287.5459.1816 doi: 10.1126/science.287.5459.1816. [Google Scholar]

Shea MW. The Long Road to an Effective Vaccine for Meningococcus Group B (MenB).. Ann Med Surg (Lond) 2013;2(2):53-56. Available from: http://europepmc.org/abstract/MED/25628885 PubMed PMID: 25628885. doi: 10.1016/S2049-0801(13)70037-2. [Google Scholar]

Agency EM. Bexsero: Authorization details. Available: http: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333human_med_001614.jsp&mid=WC0b01ac058001d124. Accessed; 2013. [Google Scholar]

Food and Drug Administration (FDA) , author. TRUMENBA. Available: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm421020.htm Accessed: June 2015.

Gossger N, Snape MD, Yu L, Finn A, Bona G, Esposito S, 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 Feb;307(6):573-582. Available from: http://ClinicalTrials.gov/search/term=22318278%20%5BPUBMED-IDS%5D PubMed PMID: 22318278. doi: 10.1001/jama.2012.85. [Google Scholar]

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. Available from: http://europepmc.org/abstract/MED/25424809 PubMed PMID: 25424809. doi: 10.4161/hv.28666. [Google Scholar]

Santolaya ME, O'Ryan ML, Valenzuela MT, Prado V, Vergara R, Muñoz A, 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. Available from: http://ClinicalTrials.gov/search/term=22260988%20%5BPUBMED-IDS%5D PubMed PMID: 22260988. doi: 10.1016/S0140-6736(11)61713-3. [Google Scholar]

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):825-835. Available from: http://ClinicalTrials.gov/search/term=23324563%20%5BPUBMED-IDS%5D PubMed PMID: 23324563. doi: 10.1016/S0140-6736(12)61961-8. [Google Scholar]

JCVI position statement on use of Bexsero® meningococcal B vaccine in the UK. 21st March 2014. Available: https://www.gov.uk/government/publications/meningococcal-b-vaccine-jcvi-position-statement Accessed: May 2015.

Haut Conseil de la Santé Publique. Vaccination contre les infec- tions invasives à méningocoque B. Place du vaccin Bexsero®. Available: http://www.hcsp.fr/explore.cgi/avisrapportsdomaine?clefr=386 Accessed: May 2015.

German Standing Committee on Vaccination (STIKO). Statement on the new meningococcal serogroup B vaccine, Bexsero ®. Robert Koch Institute. 9 diciembre 2013. Available: http://www.rki.de/EN/Content/Prevention/VaccinationrecommandationsSTIKO_ statement_Men_SgB.html Accessed: May 2015.

Disease Prevention and Control , author. Meningococcal Serogroup B Vaccine and Outbreaks. Available: http: www.cdc.gov/meningococcal/outbreaks/vaccine-serogroupb.html. Accessed; 2014. [Google Scholar]

Meningococcal B Pilot Project Task Group , author; National Advisory Committee on Immunization (2014) , author; Public Health Agency in Canada , author. The recommended use of the multicomponent meningo- coccal B (4CMenB) vaccine in Canada: common guidance statement. 2014. Available: http://www.phac-aspc.gc.ca/naci-ccni/mening-4cmenb-exec-resum-eng.php Accessed: May 2015.

Istituto Superiore di Sanità (ISS). Dati di sorveglianza delle malattie batteriche invasive aggiornati al 23 marzo 2015.

Istituto Superiore di Sanità (ISS). Rapporti della sorveglianza delle malattie batteriche invasive dell'Istituto Superiore di Sanità. Available: http://www.iss.it/mabi/index.php?lang=1&id=5&tipo=16 Accessed: June 2015.

Istituto Superiore di Sanità (ISS). Vaccinazione anti-meningococco B: dati ed evidenze disponibili per l'introduzione in nuovi nati e adolescenti. 2015.

Piano Nazionale Prevenzione Vaccinale (PNPV) 2012-2014. Ministero della Salute.

Bonanni P, Azzari C, Castiglia P, et al. The 2014 lifetime immunization schedule approved by the Italian scientific societies. Epidemiologia e Prevenzione 2014;38(6 Suppl 2):131-146. Available from: http://www.epiprev.it/materiali/2014/EP2014_I6S2_131.pdf PubMed PMID: 25759359. [Google Scholar]

Provinciale D. Il calendario vaccinale per l'Alto Adige. Bolzano: 2013. [Google Scholar]

Bollettino Ufficiale della Regione Autonoma Trentino-Alto Adige. 2013;21. [Google Scholar]

Deliberazione giunta regionale. Commissione Regionale Vaccini. Modifica Calendario Regionale per la vita 2012 - DGR 241/2013. Approvazione nuovo Calendario Vaccinale per la vita 2014. Deliberazione n. 958 del 20-05-2014. Regione Puglia.

Deliberazione giunta regionale. Calendario vaccinale della Regione Toscana e direttive in materia di vaccinazioni. Aggiornamento al 2014. Delibera N 823 del 06-10-2014. Regione Toscana.

Calendario vaccinale della Regione Toscana e direttive in materia di vaccinazioni. Aggiornamento al 2014.

Regionale DG. Approvazione del documento tecnico-scientifico dal titolo "Programma di campagna vaccinale per la prevenzione primaria della malattia invasiva da meningococco di gruppo B". Regione. Basilicata: . [Google Scholar]

Gazzetta Ufficiale della Regione Siciliana. Parte I. Palermo 30 gennaio 2015.

Assessorato Regionale della Salute. "Calendario Vaccinale per la Vita" Modifica ed integrazione

del Calendario Vaccinale Regionale. Regione Sicilia.

Bollettino Ufficiale Regione Liguria: Parte II 21.01.2015. Aggiornamento Piano Regionale Prevenzione Vaccinale.

Bollettino Ufficiale Regione Veneto: n. 89 del 12 settembre 2014.

Offerta vaccinale per l'infanzia ed adolescenza della Regione Friuli Venezia Giulia

Deliberazione Giunta Regionale. Offerta vaccinale regionale: Vaccinazioni raccomandate per i gruppi a rischio. delibera n. 2535 del 18 dicembre 2014. Regione Fruli Venezia Giulia.

n DCA . Oggetto: P.O. 2013-2015. Programma 11 - Sanità pubblica. Az. 11.2.1 e 11.2.2 "Miglioramento. Calabria: 2015. [Google Scholar]

Bonanni P, Ferro A, Guerra R, Iannazzo S, Odone A, Pompa MG, et al. Vaccine coverage in Italy and assessment of the 2012-2014 National Immunization Prevention Plan.. Epidemiol Prev 2015;39(4 Suppl 1):146-158. Available from: http://www.epiprev.it/materiali/2015/EP2015_I4S1_146.pdf PubMed PMID: 26499433. [Google Scholar]

Odone A, Ferrari A, Spagnoli F, Visciarelli S, Shefer A, Pasquarella C, et al. Effectiveness of interventions that apply new media to improve vaccine uptake and vaccine coverage. Hum Vaccin Immunother 2014 Nov;11(1):72-82. Available from: http://europepmc.org/abstract/MED/25483518 PubMed PMID: 25483518. doi: 10.4161/hv.34313. [Google Scholar]

Studi Investimenti Sociali (CENSIS). La prevenzione della meningite da meningococco B: La vaccinazione contro il Meningococco B secondo i genitori italiani. Sintesi dei risultati. Roma, aprile: Centro Nazionale; 2015. [Google Scholar]

Odone A, Fara GM, Giammaco G, Blangiardi F, Signorelli C. The future of immunization policies in Italy and in the European Union: The Declaration of Erice. Human Vaccines & Immunotherapeutics 2015;11(5):1268-1271. Available from: http://www.tandfonline.com/doi/full/10.1080/21645515.2015.1019980 doi: 10.1080/21645515.2015.1019980. [Google Scholar]

Signorelli C. Vaccines: building on scientific excellence and dispelling false myths. Epidemiol Prev 2015;39(4). Available from: http://www.ncbi.nlm.nih.gov/pubmed/25874805 PubMed PMID: 25874805. doi: 10.1371/journal.pone.0123383. [Google Scholar]

Centre for Disease Prevention and Control (2005). Prevention and Control of Meningococcal Disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm Accessed: June 2015.

Tirani M, Meregaglia M, Melegaro A. Health and economic outcomes of introducing the new MenB vaccine (Bexsero) into the Italian routine infant immunisation programme.. PLoS One 2015 Apr;10(4). Available from: http://www.ncbi.nlm.nih.gov/pubmed/25874805 PubMed PMID: 25874805. doi: 10.1371/journal.pone.0123383. [Google Scholar]

Ferro A, Odone A, Siddu A, Colucci M, Anello P, Longone M, et al. Monitoring the web to support vaccine coverage: results of two years of the portal VaccinarSì.. Epidemiol Prev 2015;39(4 Suppl 1):88-93. Available from: http://www.epiprev.it/materiali/2015/EP2015_I4S1_088.pdf PubMed PMID: 26499422. [Google Scholar]

Odone A, Chiesa V, Ciorba V, Cella P, Pasquarella C, Signorelli C. Influenza and immunization: a quantitative study of media coverage in the season of the «Fluad case».. Epidemiol Prev 2015;39(4 Suppl 1):139-145. Available from: http://www.epiprev.it/materiali/2015/EP2015_I4S1_139.pdf PubMed PMID: 26499432. [Google Scholar]

Signorelli C, Odone A, Pezzetti F, Spagnoli F, Visciarelli S, Ferrari A, et al. [Human Papillomavirus infection and vaccination: knowledge and attitudes of Italian general practitioners].. Epidemiol Prev 2014;38(6 Suppl 2):88-92. Available from: http://www.epiprev.it/materiali/2014/EP2014_I6S2_088.pdf PubMed PMID: 25759351. [Google Scholar]

Signorelli C, Odone A, Conversano M, et al. Deaths after Fluad flu vaccine and the epidemic of panic in Italy. BMJ 2015;350. [Google Scholar]