Safety and Immunogenicity of a Tetravalent Polysaccharide Vaccine Against Meningococcal Disease

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

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

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Volume 108, Issue 7 , Pages 539-547, July 2009

Safety and Immunogenicity of a Tetravalent Polysaccharide Vaccine Against Meningococcal Disease

Pei-Lan Shao
- Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Luan-Yin Chang
- Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Szu-Min Hsieh
- Department of Internal Medicine, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Shan-Chwen Chang
- Department of Internal Medicine, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Sung-Ching Pan
- Department of Internal Medicine, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Chun-Yi Lu
- Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Yu-Chia Hsieh
- Department of Section of Infection, Department of Medicine, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan
Chin-Yun Lee
- Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
Kurt Dobbelaere
- Department of GlaxoSmithKline Biologicals, Belgium
Dominique Boutriau
- Department of GlaxoSmithKline Biologicals, Belgium
Haiwen Tang
- Department of GlaxoSmithKline Biologicals, Belgium
Hans L. Bock
- Department of GlaxoSmithKline Biologicals, Belgium
Li-Min Huang
- Department of Pediatrics, National Taiwan University Hospital, Taipei Medical University, Taipei, Taiwan
- Correspondence 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.

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).