Safety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): A multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea

Dong Soo Kim, Min Ja Kim, Sung Ho Cha, Hwang Min Kim, Jong Hyun Kim, Kwang Nam Kim, Jin Soo Lee, Jun Yong Choi, Valérie Bosch Castells, Hee Soo Kim, Joon Bang, Philipp Oster

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6 Citations (Scopus)

Abstract

Objectives: To assess the safety and immunogenicity of a meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) in a Korean population. Methods: This was a phase III, blind-observer, controlled study in which participants aged 11-55 years were randomized (2:1 ratio) to a single dose of MenACYW-D or tetanus/diphtheria/acellular pertussis (Tdap) vaccine. Outcomes included rates of seroconversion against all serogroups (≥4-fold increase in antibody titer from pre-vaccination), geometric mean titers (GMTs) at days 0 and 28 based on a serum bactericidal assay using baby rabbit complement, rates of seroprotection (titer ≥1:128) at day 28, and safety. Results: A total of 300 participants were enrolled in the study (200 MenACYW-D and 100 Tdap). Seroconversion rates for serogroups A, C, Y, and W-135 were 77.8%, 88.3%, 74.6%, and 92.4%, respectively, for the MenACYW-D group and 9.3%, 8.1%, 12.2%, and 8.2%, respectively, for the Tdap group. The proportions of participants with pre-vaccination titers ≥1:128 were 57.3%, 12.6%, 51.5%, and 22.2% for serogroups A, C, Y, and W-135, respectively; post-vaccination rates were 98.5%, 89.4%, 96.0%, and 95.0% for the MenACYW-D group. A lower proportion of participants reported solicited reactions with MenACYW-D (46.2%) compared with Tdap (76.8%). Conclusion: A single dose of MenACYW-D was well tolerated and elicited a robust immune response in Korean adolescents and adults.

Original languageEnglish
Pages (from-to)59-64
Number of pages6
JournalInternational Journal of Infectious Diseases
Volume45
DOIs
Publication statusPublished - 2016 Apr 1

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All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

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