One-year antibody persistence and safety of a 4-dose schedule of menacwy-crm in healthy infants from South Korea

Hoan Jong Lee, Dae Sun Jo, Yun Kyung Kim, Hyunju Lee, Kyung Hyo Kim, Dokyung Lee, Carlo Curina, Marco Costantini, Silvia Barbi, Yan Miao, Michele Pellegrini

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2 Scopus citations


Purpose: Results from a post-marketing study to generate evidence on 1-year antibody persistence and safety following vaccination of infants from South Korea with the quadrivalent meningococcal conjugate vaccine MenACWY-CRM. Materials and Methods: In this phase IV, open-label, multi-center study (NCT02446691), 128 infants received MenACWY-CRM at ages 2, 4, 6, and 12 months. One-year antibody persistence following the full vaccination course was evaluated (primary objective) for the four meningococcal serogroups (Men) by serum bactericidal activity assay using human or rabbit complement (hSBA/rSBA). Immune responses at 1-month post-vaccination and safety were also assessed. Results: The percentage of children with hSBA titers ≥8 ranged between 94% (MenA) and 100% (MenY/W) 1-month post-vaccination, and from 39% (MenA) to 89% (MenY) 1-year post-vaccination. At least 99% and 92% of children had rSBA titers ≥8 and ≥128 against each meningococcal serogroup, 1-month post-vaccination. One-year post-vaccination, the percentage of children with rSBA titers ≥8 and ≥128 ranged from 54% (MenC) to 99% (MenA) and from 30% (MenC) to 98% (MenA). Geometric mean titers declined from 1-month to 1-year post-vaccination, when they varied between 6.8 (MenA) and 53.6 (MenW) by hSBA and between 17.2 (MenC) and 2,269.5 (MenA) by rSBA. At least one solicited and unsolicited adverse event was reported for 79% and 66% of children. Of 36 serious adverse events reported, none were vaccination-related. Conclusion: Antibody persistence (hSBA/rSBA titers ≥8) was determined in 39%-99% of children 1 year after a 4-dose MenACWY-CRM series during infancy, with an acceptable clinical safety profile.

Original languageEnglish
Pages (from-to)94-102
Number of pages9
JournalClinical and Experimental Vaccine Research
Issue number2
StatePublished - Jul 2019

Bibliographical note

Funding Information:
This work was supported by GlaxoSmithKline Biologicals SA, which was the funding source and was involved in all stages of the study conduct and analysis. GlaxoS-mithKline Biologicals SA also took responsibility for all costs associated with the development and publishing of the present manuscript. Hoan-Jong Lee’s, Dae Sun Jo’s and Hyunju Lee’s institutions received grants from the GSK group of companies for the conduct of the study. Dokyung Lee, Carlo Curina, Marco Costantini, Silvia Barbi, Michele Pellegrini, and Yan Miao are employed by the GSK group of companies. Michele Pellegrini also holds shares in the GSK group of companies as part of his employee remuneration. Yun-Kyung Kim, and Kyung-Hyo Kim have nothing to declare.

Publisher Copyright:
© Korean Vaccine Society.


  • Antibody persistence
  • Infants
  • Quadrivalent meningococcal conjugate vaccine
  • Republic of Korea


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