Journal of the Formosan Medical Association
Volume 108, Issue 7 , Pages 539-547, July 2009

Safety and Immunogenicity of a Tetravalent Polysaccharide Vaccine Against Meningococcal Disease

  • Pei-Lan Shao

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Luan-Yin Chang

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Szu-Min Hsieh

      Affiliations

    • Department of Internal Medicine, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Shan-Chwen Chang

      Affiliations

    • Department of Internal Medicine, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Sung-Ching Pan

      Affiliations

    • Department of Internal Medicine, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Chun-Yi Lu

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Yu-Chia Hsieh

      Affiliations

    • Department of Section of Infection, Department of Medicine, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Chin-Yun Lee

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • ,
  • Kurt Dobbelaere

      Affiliations

    • Department of GlaxoSmithKline Biologicals, Belgium
    • ,
  • Dominique Boutriau

      Affiliations

    • Department of GlaxoSmithKline Biologicals, Belgium
    • ,
  • Haiwen Tang

      Affiliations

    • Department of GlaxoSmithKline Biologicals, Belgium
    • ,
  • Hans L. Bock

      Affiliations

    • Department of GlaxoSmithKline Biologicals, Belgium
    • ,
  • Li-Min Huang

      Affiliations

    • Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
    • Corresponding Author InformationCorrespondence to: Dr Li-Min Huang, Department of Pediatrics, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei 100, Taiwan

Received 19 August 2008; received in revised form 18 September 2008; accepted 31 January 2009.

Article Outline

Background/Purpose

Meningococcal disease, including meningitis and sepsis, usually follows an invasive infection by Neisseria meningitidis, and is a major cause of death and morbidity worldwide. Currently available meningococcal vaccines that consist of pure capsular polysaccharides (serogroups A, C, W-135 and Y) are generally safe and efficacious in adults and children aged >2 years. The purpose of this study was to evaluate the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline Biologicals' Mencevax™ ACWY vaccine in healthy Taiwanese subjects aged 2–30 years.

Methods

This open, single center, Phase III study was conducted in Taiwan. A single dose of the Mencevax™ ACWY vaccine was administered to subjects aged 2–30 years. Immunogenicity and safety of the vaccine were evaluated after vaccination.

Results

The immunogenicity results obtained 1 month after vaccination with Mencevax™ ACWY vaccine indicated that the vaccine elicited a good immune response in vaccinees aged 2–30 years. This was both in terms of functional activity directed against meningococcal polysaccharide (A, C, W-135 and Y) as measured by serum bactericidal assay (>93% activity against all serogroups), and specific IgG concentrations measured by ELISA (>96% seropositivity to all serogroups).

Conclusion

The tetravalent polysaccharide Mencevax™ ACWY meningococcal vaccine was well tolerated and immunogenic in subjects aged 2–30 years in Taiwan.

Key Words:  immune response , meningococcal vaccines , Neisseria meningitidis , Taiwan

No full text is available. To read the body of this article, please view the PDF online.

 

Back to Article Outline

References 

  1. Tikhomirov E , Santamaria M , Esteves K . Meningococcal disease: public health burden and control . World Health Stat Q . 1997;50:170–177
  2. Offit PA , Peter G . The meningococcal vaccine: public policy and individual choices . N Engl J Med . 2003;349:2353–2356
  3. Stephens DS , Greenwood B , Brandtzaeg P . Epidemic meningitis, meningococcaemia, and Neisseria meningitidis . Lancet . 2007;369:2196–2210
  4. Pace D , Pollard AJ . Meningococcal A, C, Y and W-135 polysaccharide-protein conjugate vaccines . Arch Dis Child . 2007;92:909–915
  5. Harrison LH . A multivalent conjugate vaccine for prevention of meningococcal disease in infants . JAMA . 2008;299:217–219
  6. Gold R , Lepow ML , Goldschneider I , et al.   Clinical evaluation of group A and group C meningococcal polysaccharide vaccines in infants . J Clin Invest . 1975;56:1536–1547
  7. Borrow R , Goldblatt D , Andrews N , et al.   Influence of prior meningococcal C polysaccharide vaccination on the response and generation of memory after meningococcal C conjugate vaccination in young children . J Infect Dis . 2001;184:377–380
  8. Soriano-Gabarró M , Toé L , Tiendrebeogo SR , et al.   WHO Trivalent Vaccine Impact Assessment Study Group. Effectiveness of a trivalent serogroup A/C/W-135 meningococcal polysaccharide vaccine in Burkina Faso, 2003 . Vaccine . 2007;25(Suppl 1):A92–A96
  9. Artenstein MS , Gold R , Zimmerly JG , et al.   Prevention of meningococcal disease by group C polysaccharide vaccine . N Engl J Med . 1970;282:417–420
  10. Lepow ML , Beeler J , Randolph M , et al.   Reactogenicity and immunogenicity of a quadrivalent combined meningococcal polysaccharide vaccine in children . J Infect Dis . 1986;154:1033–1036
  11. Reingold AL , Broome CV , Hightower AW , et al.   Agespecific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine . Lancet . 1985;2:114–118
  12. Scheifele DW , Fjornson G , Boraston S . Local adverse effects of meningococcal vaccine . Can Med Assoc J . 1994;150:14–15
  13. De Wals P , Deceuninck G , De Serres G , et al.   Effectiveness of serogroup C meningococcal polysaccharide vaccine: results from a case-control study in Quebec . Clin Infect Dis . 2005;40:1116–1122
  14. Chiou CS , Liao JC , Liao TL , et al.   Molecular epidemiology and emergence of worldwide epidemic clones of Neisseria meningitidis in Taiwan . BMC Infect Dis . 2006;6:25
  15. Jin Zhang X , Shao Z , Zhu Y , et al.   Genetic characteristics of serogroup A meningococci circulating in China, 1956–2005 . Clin Microbiol Infect . 2008;14:555–561
  16. Ni JD , Jin YH , Dai B , et al.   Recent epidemiological changes in meningococcal disease may be due to the displacement of serogroup A by serogroup C in Hefei City, China . Postgrad Med J . 2008;84:87–92
  17. Manchanda V , Gupta S , Bhalla P . Meningococcal disease: history, epidemiology, pathogenesis, clinical manifestations, diagnosis, antimicrobial susceptibility and prevention . Indian J Med Microbiol . 2006;24:7–19
  18. World Health Organization  . Regional Office for the Western Pacific press release. WHO to Help the Philippines Investigate Disease Outbreak . Available at: http://www.wpro.who.int/media_centre/press_releases/news_20050223.htm [Date accessed: June 28, 2008]
  19. Maslanka SE , Gheesling LL , Libutti DE , et al.   Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays . Clin Diagn Lab Immunol . 1997;4:156–167
  20. Goldschneider I , Gotschlich EC , Artenstein MS . Human immunity to the meningococcus. I. The role of humoral antibodies . J Exp Med . 1969;129:1307–1326
  21. 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
  22. Gheesling LL , Carlone GM , Pais LB , et al.   Multicenter comparison of Neisseria meningitidis serogroup C anticapsular polysaccharide antibody levels measured by a standardized enzyme-linked immunosorbent assay . J Clin Microbiol . 1994;32:1475–1482
  23. Peltola H . Meningococcal vaccines. Current status and future possibilities . Drugs . 1998;55:347–366
  24. Amato Neto V , Finger H , Gotschlich EC , et al.   Serologic response to serogroup C meningococcal vaccine in Brazilian pre-school children . Rev Inst Med Trop Sao Paulo . 1974;16:149–153
  25. Lepow ML , Beeler J , Randolph M , et al.   Reactogenicity and immunogenicity of a quadrivalent combined meningococcal polysaccharide vaccine in children . J Infect Dis . 1986;154:1033–1036
  26. Borrow R , Balmer P , Miller E . Meningococcal surrogates of protection—serum bactericidal antibody activity . Vaccine . 2005;23:2222–2227
  27. Cadoz M , Armand J , Arminjon F , et al.   Tetravalent (A, C, Y, W 135) meningococcal vaccine in children: immunogenicity and safety . Vaccine . 1985;3:340–342
  28. Bilukha OO , Rosenstein N . Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP) . MMWR Recomm Rep . 2005;54:1–21
  29. Rosenstein NE , Fischer M , Tappero JW . Meningococcal vaccines . Infect Dis Clin North Am . 2001;15:155–169
  30. World Health Organization  . Group A and C meningococcal vaccines. WHO position paper . WER . 1999;74:297–304
  31. Liu DP , Chr YC , Chang CC , et al.   Prevalence of Nasopharyngeal Meningococcal Carriers Among Newly Enlisted Military Recruits in Taiwan . Available at http://te.cdc.gov.tw/upload/doc/18292_EVOL22N003_54.pdf [Date accessed: September 17, 2007]
  32. Robbins JB , Myerowitz RL , Whisnant JK , et al.   Enteric bacteria cross-reactive with Neisseria meningitidis Groups A and C and Diplococcus pneumoniae Types 1 and 3 . Infect Immun . 1972;6:651–656
  33. Yang CY , Lee YS , Huang LS , et al.   Antigenic diversity of Neisseria meningitidis isolated in Taiwan between 1995 and 2002 . Scand J Infect Dis . 2006;38:273–280
  34. Lu CH , Chang WN , Change HW . Adult bacterial meningitis in Southern Taiwan: epidemiologic trend and prognostic factors . J Neuro Sci . 2000;182:36–44
  35. Meningococcal vaccines: polysaccharide and polysaccharide conjugate vaccines . Wkly Epidemiol Rec . 2002;77:331–339

PII: S0929-6646(09)60371-5

doi:10.1016/S0929-6646(09)60371-5

Journal of the Formosan Medical Association
Volume 108, Issue 7 , Pages 539-547, July 2009

Article Tools