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

Research output: Contribution to journalArticle

Abstract

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
Volume8
Issue number2
DOIs
Publication statusPublished - 2019 Jul

Keywords

  • Antibody persistence
  • Infants
  • MenACWY-CRM
  • Quadrivalent meningococcal conjugate vaccine
  • Republic of Korea

ASJC Scopus subject areas

  • Immunology and Allergy
  • Pharmacology
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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  • Cite this

    Lee, H. J., Jo, D. S., Kim, Y. K., Lee, H., Kim, K. H., Lee, D., Curina, C., Costantini, M., Barbi, S., Miao, Y., & Pellegrini, M. (2019). One-year antibody persistence and safety of a 4-dose schedule of menacwy-crm in healthy infants from South Korea. Clinical and Experimental Vaccine Research, 8(2), 94-102. https://doi.org/10.7774/cevr.2019.8.2.94