Safety and Immunogenicity of a Tetravalent Polysaccharide Vaccine Against Meningococcal Disease

Pei Lan Shao, Luan Yin Chang, Szu Min Hsieh, Shan Chwen Chang, Sung Ching Pan, Chun Yi Lu, Yu Chia Hsieh, Chin Yun Lee, Kurt Dobbelaere, Dominique Boutriau, Haiwen Tang, Hans L. Bock, Li Min Huang*

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

19 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)539-547
Number of pages9
JournalJournal of the Formosan Medical Association
Volume108
Issue number7
DOIs
StatePublished - 07 2009
Externally publishedYes

Keywords

  • Neisseria meningitidis
  • Taiwan
  • immune response
  • meningococcal vaccines

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