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

《Journal of the Formosan Medical Association》 108卷7期 (2009/07) Pp. 539-547

並列摘要

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(superscript TM) 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(superscript TM) 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(superscript TM) 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(superscript TM) ACWY meningococcal vaccine was well tolerated and immunogenic in subjects aged 2-30 years in Taiwan.

並列關鍵字

immune response ； meningococcal vaccines ； Neisseria meningitides ； Taiwan