References
- MacNeil JR, Cohn C. Chapter 8: meningococcal disease. In: VPD surveillance manual. 5th ed. Atlanta (GA): Centers for Disease Control and Prevention; 2011.
- 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;62:1–28.
- Chang Q, Tzeng Y-L, Stephens DS. Meningococcal disease: changes in epidemiology and prevention. Clin Epidemiol. 2012;4:237–245.
- Burrage M, Robinson A, Borrow R, et al. Effect of vaccination with carrier protein on response to meningococcal C conjugate vaccines and value of different immunoassays as predictors of protection. Infect Immun. 2002;70:4946–4954.
- Rosenstein NE, Perkins BA, Stephens DS, et al. Meningococcal disease. N Engl J Med. 2001;344:1378–1388.
- Read RC. Neisseria meningitidis; clones, carriage, and disease. Clin Microbiol Infect. 2014;20:391–395.
- McIntosh ED, Carey V, Toneatto D, et al. Prevention of rare diseases: how revolutionary techniques can help vulnerable individuals-the example of serogroup B meningococcal infection. Ther Adv Vaccines. 2015;3:13–23.
- Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet. 2007;369:2196–2210.
- Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367:397–403.
- Cohn AC, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998–2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010;50:184–191.
- Kirsch EA, Barton RP, Kitchen L, et al. Pathophysiology, treatment and outcome of meningococcemia: a review and recent experience. Pediatr Infect Dis J. 1996;15:967–978; quiz 979.
- Centers for Disease Control and Prevention. Meningococcal disease: technical & clinical information [cited 2015 Jul 13]. Available from: http://www.cdc.gov/meningococcal/clinical-info.html
- Edwards MS, Baker CJ. Complications and sequelae of meningococcal infections in children. J Pediatr. 1981;99:540–545.
- 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;11:774–783.
- Roed C, Omland LH, Skinhoj P, et al. Educational achievement and economic self-sufficiency in adults after childhood bacterial meningitis. JAMA. 2013;309:1714–1721.
- Rouphael NG, Stephens DS. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol. 2012;799:1–20.
- Halperin SA, Bettinger JA, Greenwood B, et al. The changing and dynamic epidemiology of meningococcal disease. Vaccine. 2012;30(suppl 2):B26–B36.
- Anderson AS, Jansen KU, Eiden J. New frontiers in meningococcal vaccines. Expert Rev Vaccines. 2011;10:617–634.
- Baccarini C, Ternouth A, Wieffer H, et al. The changing epidemiology of meningococcal disease in North America 1945–2010. Hum Vaccin Immunother. 2013;9:162–171.
- Centers for Disease Control and Prevention. Surveillance reports: Neisseria meningitidis (1993–2013) [cited 2016 Mar 17]. Available from: http://www.cdc.gov/abcs/reports-findings/surv-reports.html
- MacNeil J Epidemiology of serogroup B meningococcal disease, United States [cited 2015 Mar 27]. Available from: http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2014-10/mening-02-MacNeil.pdf
- Brooks R, Woods CW, Benjamin DK Jr., et al. Increased case-fatality rate associated with outbreaks of Neisseria meningitidis infection, compared with sporadic meningococcal disease, in the United States, 1994–2002. Clin Infect Dis. 2006;43:49–54.
- Weiss D, Antwi M, Del Rosso P, et al. Serogroup C invasive meningococcal disease among men who have sex with men — New York City, 2010–2012. MMWR Morb Mortal Wkly Rep. 2013;61:1033–1052.
- California Department of Public Health. Meningococcal vaccine recommendations for men who have sex with men [cited 2015 Mar 23]. Available from: http://www.cdph.ca.gov/HealthInfo/discond/Documents/MSM_meningococcal_vaccine_health_advisory_April15_2014.pdf
- Chicago Health Alert Network. Meningococcal vaccine recommendations for HIV-positive individuals [cited 2015 Sep]. Available from: https://www.chicagohan.org/mening;jsessionid=26A202153B93BCF32DCEBE782223277B
- Mandal S, Wu HM, MacNeil JR, et al. Prolonged university outbreak of meningococcal disease associated with a serogroup B strain rarely seen in the United States. Clin Infect Dis. 2013;57:344–348.
- Patel M. Serogroup B meningococcal disease in the US. Presented at: IDWeek; 2014 Oct 8–12; Philadelphia, PA.
- Oregon Health Authority. 2015 meningococcal update [cited 2015 Jun 9]. Available from: https://public.health.oregon.gov/DiseasesConditions/DiseasesAZ/MeningococcalDisease/Pages/Meningococcal-Update.aspx
- 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;64:606–607.
- Schaffner W, Baker CJ, Bozof L, et al. Addressing the challenges of serogroup B meningococcal disease outbreaks on campuses: a report by the National Foundation for Infectious Diseases. Bethesda (MD): National Foundation for Infectious Diseases; May 2014.
- Folaranmi T, Rubin L, Martin SW, et al. Use of serogroup B meningococcal vaccines in persons aged ≥10 years at increased risk for serogroup B meningococcal disease: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64:608–612.
- Centers for Disease Control and Prevention. Active bacterial core surveillance (ABCs) report, emerging infections program network, Neisseria meningitidis, 2012 [cited 2016 March 31]. Available from: http://www.cdc.gov/abcs/reports-findings/survreports/mening12.pdf
- Anderson AS, Hao L, Jiang Q, et al. Potential impact of the bivalent rLP2086 vaccine on Neisseria meningitidis carriage and invasive serogroup B disease. Hum Vaccin Immunother. 2013;9:471–479.
- Granoff DM. Review of meningococcal group B vaccines. Clin Infect Dis. 2010;50(Suppl 2):S54–S65.
- Holst J, Martin D, Arnold R, et al. Properties and clinical performance of vaccines containing outer membrane vesicles from Neisseria meningitidis. Vaccine. 2009;27(Suppl 2):B3–B12.
- Cartwright K, Morris R, Rümke H, et al. Immunogenicity and reactogenicity in UK infants of a novel meningococcal vesicle vaccine containing multiple class 1 (PorA) outer membrane proteins. Vaccine. 1999;17:2612–2619.
- Comanducci M, Bambini S, Brunelli B, et al. NadA, a novel vaccine candidate of Neisseria meningitidis. J Exp Med. 2002;195:1445–1454.
- Welsch JA, Moe GR, Rossi R, et al. 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;188:1730–1740.
- 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;107:19490–19495.
- Jacobsson S, Hedberg ST, Mölling P, et al. Prevalence and sequence variations of the genes encoding the five antigens included in the novel 5CVMB vaccine covering group B meningococcal disease. Vaccine. 2009;27:1579–1584.
- Rossi R, Beernink PT, Giuntini S, et al. Susceptibility of meningococcal strains responsible for two serogroup B outbreaks on U.S. university campuses to serum bactericidal activity elicited by the MenB-4C vaccine. Clin Vaccine Immunol. 2015 Dec;22(12):1227–1234.
- Jacobsson S, Thulin S, Mölling P, et al. Sequence constancies and variations in genes encoding three new meningococcal vaccine candidate antigens. Vaccine. 2006;24:2161–2168.
- Wang X, Cohn A, Comanducci M, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. Vaccine. 2011;29:4739–4744.
- Comanducci M, Bambini S, Caugant D, et al. NadA diversity and carriage in Neisseria meningitidis. Infect Immun. 2004;72:4217–4223.
- Fletcher LD, Bernfield L, Barniak V, et al. Vaccine potential of the Neisseria meningitidis 2086 lipoprotein. Infect Immun. 2004;72:2088–2100.
- McNeil LK, Murphy E, Zhao XJ, et al. Detection of LP2086 on the cell surface of Neisseria meningitidis and its accessibility in the presence of serogroup B capsular polysaccharide. Vaccine. 2009;27:3417–3421.
- Masignani V, Comanducci M, Giuliani MM, et al. Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870. J Exp Med. 2003;197:789–799.
- Pajon R, Beernink PT, Harrison LH, et al. Frequency of factor H-binding protein modular groups and susceptibility to cross-reactive bactericidal activity in invasive meningococcal isolates. Vaccine. 2010;28:2122–2129.
- Brehony C, Wilson DJ, Maiden MC. Variation of the factor H-binding protein of Neisseria meningitidis. Microbiology. 2009;155:4155–4169.
- Jiang H-Q, 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;28:6086–6093.
- 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.
- TRUMENBA®. Full prescribing information [package insert]. Collegeville (PA): Pfizer, Inc.; 2014.
- Bexsero. Health Canada [cited 2014 Aug 19]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php
- Bexsero®. Summary of product characteristics. 4CMenB. Basel (Switzerland): Novartis; 2013.
- US Food and Drug Administration (FDA). Approval letter – Bexsero [cited 2015 Jun 8]. Available from: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm431446.htm
- Australian Government Department of Health. Australian public assessment report for multi-component meningococcal B vaccine [cited 2014 Aug 19]. Available from: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf
- Leroy O, Giradie P, Yazdanpanah Y, et al. Hospital-acquired pneumonia: microbiological data and potential adequacy of antimicrobial regimens. Eur Respir J. 2002;20:432–439.
- MacNeil JR, Rubin L, Folaranmi T, et al. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rep. 2015;64:1171–1176.
- Centers for Disease Control and Prevention. Charter of the advisory committee on immunization practices [cited 2015 Nov 24]. Available from: http://www.cdc.gov/vaccines/acip/committee/charter.pdf
- Centers for Disease Control and Prevention. Vaccines for children (VFC) program [cited 2015 Nov 24]. Available from: http://www.cdc.gov/vaccines/programs/vfc/index.html
- Recombivax HB (Hepatitis B Vaccine, recombinant). Full prescribing information [package insert]. White House Station (NJ): Merck & Co., Inc.; 2014.
- Markowitz LE, Dunne EF, Chesson HW, et al. Human papillomavirus vaccination: recommendations of the advisory committee on immunization practices (ACIP). Morb Mortal Wkly Rep. 2014;63:1–30.
- Gardasil (Human Papillomavirus Quadrivalent [types 6, 11, 16, and 18] Vaccine, recombinant). Full prescribing information [package insert]. White House Station (NJ): Merck & Co., Inc.; 2011.
- Madico G, Welsch JA, Lewis LA, et al. The meningococcal vaccine candidate GNA1870 binds the complement regulatory protein factor H and enhances serum resistance. J Immunol. 2006;177:501–510.
- Giuntini S, Reason DC, Granoff DM. Complement-mediated bactericidal activity of anti-factor H binding protein monoclonal antibodies against the meningococcus relies upon blocking factor H binding. Infect Immun. 2011;79:3751–3759.
- Schneider MC, Exley RM, Chan H, et al. Functional significance of factor H binding to Neisseria meningitidis. J Immunol. 2006;176:7566–7575.
- Wright V, Hibberd M, Levin M. Genetic polymorphisms in host response to meningococcal infection: the role of susceptibility and severity genes. Vaccine. 2009;27:B90–B102.
- Murphy E, Andrew L, Lee K-L, 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;200:379–389.
- 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;31:1569–1575.
- 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. 2012;32:364–371.
- 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;12:597–607.
- Richmond PC, Nissen MD, Marshall HS, et al. A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: results of a randomised, controlled, dose-escalation phase 1 trial. Vaccine. 2012;30:6163–6174.
- Marshall HS, Richmond PC, Beeslaar J, et al. Persistence of meningococcal serogroup B–specific responses following vaccination with bivalent rLP2086. Presented at: Meningitis Research Foundation (MRF) Conference; 2015 Nov 4–5; London, UK.
- 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 Jun;35(6):673–682.
- 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;35:548–554.
- Vesikari T, Wysocki J, Beeslaar J, et al. Immunogenicity, safety, and tolerability of bivalent rLP2086 meningococcal group B vaccine administered concomitantly with diphtheria, tetanus, and acellular pertussis and inactivated poliomyelitis vaccines to healthy adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):180–187.
- Vesikari T, Østergaard 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 Jun;5(2):152–160.
- Vesikari T, Senders S, Absalon J, et al. Immunogenicity and safety of bivalent rLP2086, a meningococcal serogroup B vaccine, in adolescents and young adults in 2 pivotal phase 3 trials. Presented at: Meningitis Research Foundation; 2015 Nov 4–5; London, UK.
- 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;34:1465–1471.
- O’Ryan M, Stoddard J, Toneatto D, et al. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014;74:15–30.
- Halperin SA, Baine Y, Domachowske JB, et al. Comparison of the safety and immunogenicity of a novel quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine and a marketed quadrivalent meningococcal ACWY-diphtheria toxoid conjugate vaccine in healthy individuals 10–25 years of age. J Pediatric Infect Dis Soc. 2014;3:33–42.
- Emonts M, Hazelzet JA, de Groot R, et al. Host genetic determinants of Neisseria meningitidis infections. Lancet Infect Dis. 2003;3:565–577.
- Lambris JD, Ricklin D, Geisbrecht BV. Complement evasion by human pathogens. Nat Rev Microbio. 2008;6:132–142.
- Giuntini S, Pajon R, Ram S, et al. Binding of complement factor H to PorB3 and NspA enhances resistance of Neisseria meningitidis to anti-factor H binding protein bactericidal activity. Infect Immun. 2015;83:1536–1545.
- Plotkin SA, Gilbert PB. Nomenclature for immune correlates of protection after vaccination. Clin Infect Dis. 2012;54:1615–1617.
- Frasch CE, Borrow R, Donnelly J. Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. Vaccine. 2009;27(suppl 2):B112–B116.
- Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129:1307–1326.
- Andrews N, Borrow R, Miller E. Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol. 2003;10:780–786.
- Borrow R, Balmer P, Miller E. Meningococcal surrogates of protection–serum bactericidal antibody activity. Vaccine. 2005;23:2222–2227.
- Ramsay M, Kaczmarski E, Rush M, et al. Changing patterns of case ascertainment and trends in meningococcal disease in England and Wales. Commun Dis Rep CDR Rev. 1997;7:R49–R54.
- Ramsay ME, Andrews N, Kaczmarski EB, et al. Efficacy of meningococcal serogroup C conjugate vaccine in teenagers and toddlers in England. Lancet. 2001;357:195–196.
- Borrow R, Carlone GM, Rosenstein N, et al. Neisseria meningitidis group B correlates of protection and assay standardization–international meeting report Emory University, Atlanta, Georgia, United States, 16–17 March 2005. Vaccine. 2006;24:5093–5107.
- Sacchi CT, Whitney AM, Popovic T, et al. Diversity and prevalence of PorA types in Neisseria meningitidis serogroup B in the United States, 1992–1998. J Infect Dis. 2000;182:1169–1176.
- Vipond C, Care R, Feavers IM. History of meningococcal vaccines and their serological correlates of protection. Vaccine. 2012;30(Suppl 2):B10–B17.
- 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.
- Soeters HM, McNamara L, Whaley M, et al. Meningococcal carriage evaluation in response to a serogroup B meningococcal disease outbreak and mass vaccination campaign at a college – Rhode Island, 2015. Presented at: IDWeek; 2015 Oct 7–11; San Diego, CA.
- Centers for Disease Control and Prevention. Infant meningococcal vaccination: Advisory Committee on Immunization Practices (ACIP) recommendations and rationale. MMWR Morb Mortal Wkly Rep. 2013;62:52–54.
- Public Health England. Introduction of MenB immunisation for infants [cited 2016 May 31]. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/437906/150622_MenB_bipartite_letter.pdf