Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults

Hoan Jong Lee, Moon Hyun Chung, Woo Joo Kim, Young Jin Hong, Kyong Min Choi, Jina Lee, Chi Eun Oh, Jo Anne Welsch, Kyung Hyo Kim, Ki Bae Hong, Alemnew F. Dagnew, Hans Bock, Peter M. Dull, Tatjana Odrljin

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Objectives: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults (quadrivalent polysaccharide-CRM197 conjugate vaccine containing meningococcal serogroups A, C, W, and Y). Methods: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific to serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. Results: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (. n=. 297) or a saline placebo (. n=. 153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. Conclusions: Findings of this first study on a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination.

Original languageEnglish
Pages (from-to)204-210
Number of pages7
JournalInternational Journal of Infectious Diseases
Volume28
DOIs
Publication statusPublished - 2014 Nov 1

Keywords

  • Conjugate vaccines
  • Korea
  • Neisseria meningitidis
  • Quadrivalent meningococcal vaccine

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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