Pediatric Infection and Vaccine

The Korean Society of Pediatric Infectious Diseases (대한소아감염학회)
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Meningococcal Disease and Quadrivalent MenACWY-CRM Vaccine (Menveo®)

  • Tsai, Theodore F. (Novartis Vaccines and Diagnostics Inc.)
  • Received : 2012.12.04
  • Accepted : 2012.12.18
  • Published : 2012.12.25
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Abstract

Meningococcal Disease, manifesting as meningitis and septicemia, is a life-threatening bacterial infection that results in significant morbidity and mortality, particularly in childhood. Its epidemic potential and limited opportunities for clinical intervention due to its rapid course present unique public health and clinical challenges. Incidence is highest in infants and young children, with a secondary peak of risk in adolescents. Approximately 10% of cases are fatal and survivors can be left with serious and permanent sequelae including amputations, hearing loss and cognitive impairment. Transmission is only from human-to-human, by infected respiratory tract secretions or saliva and therefore crowding poses a tremendously elevated risk for disease development. Military recruits and university students are at high risk due to the high carriage rate in adolescents, their behavior patterns and close contact. Menveo$^{(R)}$ (Novartis Vaccines and Diagnostics), a novel quadrivalent meningococcal conjugate vaccine directed against meningococcal serogroups A, C, W-135 and Y, has been shown to be immunogenic and well tolerated in all age groups and was recently licensed for use in Korea. Recent cases and deaths among military recruits drew public attention to their elevated risk and the Korean government has recommended vaccination of all new military recruits. Many Korean students seek to attend school, university, or language institutes in countries where routine meningococcal vaccination is required - clinicians should be aware of such requirements to ensure that students are vaccinated prior to arrival in the destination country.

Keywords

References

  1. McIntyre PB, O'Brien KL, Greenwood B, van de Beek D. Effect of vaccines on bacterial meningitis worldwide. Lancet 2012;380:1703-11. https://doi.org/10.1016/S0140-6736(12)61187-8
  2. Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcemia, and Neisseria meningitidis. Lancet 2007;369:2196-210. https://doi.org/10.1016/S0140-6736(07)61016-2
  3. Centers for Disease Control and Prevention. Outbreak of meningococcal disease associated with an elementary school -- Oklahoma, March 2010. MMWR Morb Mortal Wkly Rep 2012;61:217-21.
  4. Krause G, Blackmore C, Wiersma S, Lesneski C, Gauch L, Hopkins RS. Mass vaccination campaign following community outbreak of meningococcal disease. Emerg Infect Dis 2002;8:1398-403. https://doi.org/10.3201/eid0812.040421
  5. Nolan P. The Rhode Island meningitis vaccine experience --mass vaccination campaigns, politics and health policy. Med Health R I 2004;87:65-7.
  6. Thompson MJ, Ninis N, Perera R, Mayon-White R, Phillips C, Bailey L et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet 2006;367:397-403. https://doi.org/10.1016/S0140-6736(06)67932-4
  7. Fitzwater SP, Watt JP, Levine OS, Santosham M. Haemophilus influenzae type b conjugate vaccines: considerations for vaccination schedules and implications for developing countries. Hum Vaccin 2010;6:810-8. https://doi.org/10.4161/hv.6.10.13017
  8. Tan TQ. Pediatric invasive pneumococcal disease in the United States in the era of pneumococcal conjugate vaccines. Clin Microbiol Rev 2012;25:409-19. https://doi.org/10.1128/CMR.00018-12
  9. Yazdankhah SP, Caugant DA. Neisseria meningitidis: an overview of the carriage state. J Med Microbiol 2004; 53:821-32. https://doi.org/10.1099/jmm.0.45529-0
  10. 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. https://doi.org/10.1128/CMR.13.1.144-166.2000
  11. Davila S, Wright VJ, Khor CC, Sim KS, Binder A, Breunis WB, et al. Genome-wide association study identifies variants in the CFH region associated with host susceptibility to meningococcal disease. Nat Genet 2010;42;772-6. https://doi.org/10.1038/ng.640
  12. Owen EP, Leisegang F, Whitelaw A, Simpson J, Baker S, W rzner R, et al. Complement u component C5 and C6 mutation screening indicated in meningococcal disease in South Africa. S Afr Med J 2012;102:525-7. https://doi.org/10.7196/SAMJ.5571
  13. Helminen M, Seitsonen S, Jarva H, Meri S, Jarvela IE. A novel mutation W388X underlying properdin deficiency in a Finnish family. Scand J Immunol 2012;75:445-8. https://doi.org/10.1111/j.1365-3083.2012.02674.x
  14. Ram S, Lewis LA, Rice PA. Infections of people with complement deficiencies and patients who have undergone splenectomy. Clin Microbiol Rev 2010;23:740-80. https://doi.org/10.1128/CMR.00048-09
  15. Hermans PW, Hazelzet JA. Plasminogen activator inhibitor type 1 gene polymorphism and sepsis. Clin Infect Dis 2005;41:S453-8. https://doi.org/10.1086/431996
  16. Bradley DT, Bourke TW, Fairley DJ, Borrow R, Shields MD, Young IS, et al. Genetic susceptibility to invasive meningococcal disease: MBL2 structural polymorphisms revisited in a large case-control study and a systematic review. Int J Immunogenet 2012;39:328-37. https://doi.org/10.1111/j.1744-313X.2012.01095.x
  17. Girard MP, Preziosi MP, Aguado MT, Kieny MP. A review of vaccine research and development: meningococcal disease. Vaccine 2006;24:4692-700. https://doi.org/10.1016/j.vaccine.2006.03.034
  18. Erickson L, De Wals P. Complications and sequelae of meningococcal disease in Quebec, Canada, 1990-1994. Clin Infect Dis 1998;26:1159-64. https://doi.org/10.1086/520303
  19. Viner RM, Booy R, Johnson H, Edmunds JW, Hudson L, Bedford H, et al. Outcomes of invasive meningococcal serogroup B disease in children and adolescents (MOSAIC): a case-control study. Lancet Neurol 2012;11:774-83. https://doi.org/10.1016/S1474-4422(12)70180-1
  20. van de Beek D, Brouwer MC, Thwaites GE, Tunkel AR. Advances in treatment of bacterial meningitis. Lancet 2012;380:1693-702. https://doi.org/10.1016/S0140-6736(12)61186-6
  21. Dalton T, Cegielski P, Akksilp S, Asencios L, Campos Caoili J, Cho SN, et al. Prevalence of and risk factors for resistance to second-line drugs in people with multidrug-resistant tuberculosis in eight countries: a prospective cohort study. Lancet 2012;380:1406-17. https://doi.org/10.1016/S0140-6736(12)60734-X
  22. World Health Organization. Meningococcal vaccines: WHO position paper, November 2011. Wkly Epidemiol Rec 2011;86:521-39.
  23. Agrawal S, Nadel S. Acute bacterial meningitis in infants and children. epidemiology and management. Paediatr Drugs 2011;13:385-400. https://doi.org/10.2165/11593340-000000000-00000
  24. Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 1969;129:1307-26. https://doi.org/10.1084/jem.129.6.1307
  25. Harrison LH, Pass MA, Mendelsohn AB, Egri M, Rosenstein NE, Bustamante A, et al. Invasive meningococcal disease in adolescents and young adults. JAMA 2001; 286:694-9. https://doi.org/10.1001/jama.286.6.694
  26. 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 Suppl 2:B26-36. https://doi.org/10.1016/j.vaccine.2011.12.032
  27. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine 2009;27 Suppl 2:B51-63. https://doi.org/10.1016/j.vaccine.2009.04.063
  28. du Plessis M, Moodley C, Mothibeli KM, Fali A, Klugman KP, von Gottberg A, et al. Population snapshot of invasive serogroup B meningococci in South Africa from 2005 to 2008. J Clin Microbiol 2012;50:2577-84. https://doi.org/10.1128/JCM.00401-12
  29. Pollard AJ. Global epidemiology of meningococcal disease and vaccine efficacy. Pediatr Infect Dis J 2004;23:S274-9.
  30. Broker M, Jacobsson S, Kuusi M, Pace D, Simoes MJ, Skoczynska A, et al. Meningococcal serogroup Y emergence in Europe: Update 2011. Hum Vaccin Immunother 2012;8 [Epub ahead of print].
  31. Vyse A, Wolter JM, Chen J, Ng T, Soriano-Gabarro M. Meningococcal disease in Asia: an under-recognized public health burden. Epidemiol Infect 2011;139:967-85. https://doi.org/10.1017/S0950268811000574
  32. Kilic A, Urwin R, Li H, Saracli MA, Stratton CW, Tang YW. Clonal Spread of Serogroup W135 Meningococcal Disease in Turkey. J Clin Microbiol 2006;44:222-4. https://doi.org/10.1128/JCM.44.1.222-224.2006
  33. Kriz P, Wieffer H, Holl K, Rosenlund M, Budhia S, Vyse A. Changing epidemiology of meningococcal disease in Europe from the mid-20th to the early 21st century. Expert Rev Vaccines 2011;10:1477-86. https://doi.org/10.1586/erv.11.117
  34. Cho HK, Lee H, Kang JH, Kim KN, Kim DS, Kim YK et al. The causative organisms of bacterial meningitis in Korean children in 1996-2005. J Korean Med Sci 2010;25:895-9. https://doi.org/10.3346/jkms.2010.25.6.895
  35. Kim SA, Kim DW, Dong BQ, Kim JS, Anh DD, Kilgore PE. An expanded age range for meningococcal meningitis: molecular diagnostic evidence from population-based surveillance in Asia. BMC Infect Dis 2012;12:310. https://doi.org/10.1186/1471-2334-12-310
  36. Lee SO, Ryu SH, Park SJ, Ryu J, Woo JH, Kim YS. Meningococcal disease in the republic of Korea army: incidence and serogroups determined by PCR. J Korean Med Sci 2003;18:163-6. https://doi.org/10.3346/jkms.2003.18.2.163
  37. Park HS, Lee DH, Seo PW, Kim SH, Choi TY, Kim JH. Carrier rate, serogroup and vaccination effect of Neisseria meningitidis on army trainees in Korea. Chungbuk Med J 1995;5:45-57.
  38. Holers VM. The spectrum of complement alternative pathway-mediated diseases. Immunol Rev 2008;223: 300-16. https://doi.org/10.1111/j.1600-065X.2008.00641.x
  39. Zuber J, Fakhouri F, Roumenina LT, Loirat C, Fremeaux-Bacchi V. Use of eculizumab for atypical haemolytic uraemic syndrome and C3 glomerulopathies. Nat Rev Nephrol 2012;8:643-57. https://doi.org/10.1038/nrneph.2012.214
  40. Bekondi C, Bernede C, Passone N, Minssart P, Kamalo C, Mbolidi D, et al. Primary and opportunistic pathogens associated with meningitis in adults in Bangui, Central African Republic, in relation to human immunodeficiency virus serostatus. Int J Infect Dis 2006;10:387-95. https://doi.org/10.1016/j.ijid.2005.07.004
  41. Bruce MG, Rosenstein NE, Capparella JM, Shutt KA, Perkins BA, Collins M. Risk factors for meningococcal disease in college students. JAMA 2001;286:688-93. https://doi.org/10.1001/jama.286.6.688
  42. Brundage JF, Ryan MA, Feighner BH, Erdtmann FJ. Meningococcal disease among United States military service members in relation to routine uses of vaccines with different serogroup-specific components, 1964-1998. Clin Infect Dis 2002;35:1376-81. https://doi.org/10.1086/344273
  43. MacLennan J, Kafatos G, Neal K, Andrews N, Cameron JC, Roberts R, et al. Social behavior and meningococcal carriage in British teenagers. Emerg Infect Dis 2006;12: 950-7. https://doi.org/10.3201/eid1206.051297
  44. Dull PM, McIntosh ED. Meningococcal vaccine development - from glycoconjugates against MenACWY to proteins against MenB - potential for broad protection against meningococcal disease. Vaccine 2012;30 Suppl 2:B18-25.
  45. Lee LH, Blake MS. Effect of increased CRM197 carrier protein dose on meningococcal C bactericidal antibody response. Clin Vaccine Immunol 2012;19:551-6. https://doi.org/10.1128/CVI.05438-11
  46. 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; 10:780-6.
  47. Campbell H, Andrews N, Borrow R, Trotter C, Miller E. Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales: effectiveness, validation of serological correlates of protection, and modeling predictions of the duration of herd immunity. Clin Vaccine Immunol 2010;17:840-7. https://doi.org/10.1128/CVI.00529-09
  48. De Wals P, Deceuninck G, Lefebvre B, Boulianne N, De Serres G. Effectiveness of serogroup C meningococcal conjugate vaccine: a 7-year follow-up in Quebec, Canada. Pediatr Infect Dis J 2011;30:566-9. https://doi.org/10.1097/INF.0b013e31820e8638
  49. Macneil JR, Cohn AC, Zell ER, Schmink S, Miller E, Clark T, et al. Early estimate of the effectiveness of quadrivalent meningococcal conjugate vaccine. Pediatr Infect Dis J 2011;30:451-5. https://doi.org/10.1097/INF.0b013e31820a8b3c
  50. Novak RT, Kambou JL, Diomande FV, Tarbangdo TF, Ouedraogo-Traore R, Sangare L, et al. Serogroup A meningococcal conjugate accination in Burkina Faso: analysis of national surveillance data. Lancet Infect Dis 2012;12:757-64. https://doi.org/10.1016/S1473-3099(12)70168-8
  51. Centers for Disease Control and Prevention. Licensure of a meningococcal conjugate vaccine (Menveo) and guidance for use - Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep 2010;59:273.
  52. Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, et al. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J 2012;31:64-71. https://doi.org/10.1097/INF.0b013e31823dce5c
  53. Klein NP, Shepard J, Bedell L, Odrljin T, Dull P. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers. Vaccine 2012;30:3929-36. https://doi.org/10.1016/j.vaccine.2012.03.080
  54. Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine 2010;28:657-63. https://doi.org/10.1016/j.vaccine.2009.10.104
  55. Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, et al. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine 2010;28:7865-72. https://doi.org/10.1016/j.vaccine.2010.09.092
  56. Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, et al. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis 2009;49:e1-10. https://doi.org/10.1086/599376
  57. Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J 2009;28:86-91. https://doi.org/10.1097/INF.0b013e31818a0237
  58. Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol 2009;16:1810-5. https://doi.org/10.1128/CVI.00207-09
  59. Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine ($Menveo^{(R)}$) or $Menactra^{(R)$ among healthy adolescents. Hum Vaccin 2010;6:881-7. https://doi.org/10.4161/hv.6.11.12849
  60. Jackson LA, Baxter R, Gill CJ, Odrljin T, Dull P. Persistence of bactericidal antibodies and boosting after vaccination with $Menveo^{(R)}$ in adolescents enrolled in phase II and III clinical studies. Presented at 49th annual meeting of IDSA, 2011.
  61. Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2012 Oct 30. [Epub ahead of print].
  62. Gasparini R, Conversano M, Bona G, Gabutti G, Anemona A, Dull PM, et al. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol 2010;17:537-44. https://doi.org/10.1128/CVI.00436-09
  63. Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, et al. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine 2010;28:3171-9. https://doi.org/10.1016/j.vaccine.2010.02.045
  64. Pina ML, Bassily E, Machmer A, Hou V, Reinhart A. Safety and immunogenicity of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine in infants and toddlers: three multicenter phase 3 studies. Pediatr Infect Dis J 2012;31:1173-83. https://doi.org/10.1097/INF.0b013e318268dfe4
  65. Lee HJ, Chung MH, Kim WJ, Hong YJ, Choi KM, Lee J, et al. Safety and immunogenicity of MenACWYCRM vaccine administered to Korean adolescents and adults. Presented at 19th WONCA Asia Pacific Regional Conference, 2012.
  66. NATO Standardization Agency. National military strategies for vaccination of NATO forces. AMedP-23:2008.
  67. Ministry of Hajj, Kingdon of Saudi Arabia. Saudi Ministry of Health Requirements. http://www.hajinformation.com/main/p3001.htm. Accessed 18th Nov 2012.
  68. Korean Educational Development Institute. http://cesi.kedi.re.kr accessed 11th May 2012.
  69. The National Meningitis Association. Discover the NMA's Work State by State. http://www.nmaus.org/awareness accessed 18th Dec 2012.
  70. Higher Education in Korea. http://www.academyinfo.go.kr accessed 11th May 2012.