Clin Exp Vaccine Res.  2019 Jul;8(2):94-102. 10.7774/cevr.2019.8.2.94.

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

• Lee HJ
• Jo DS
• Kim YK
• Lee H
• Kim KH
• Lee D
• Curina C
• Costantini M
• Barbi S
• Miao Y
• Pellegrini M

• KMID: 2455080
• DOI: http://doi.org/10.7774/cevr.2019.8.2.94

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.

Keyword

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

MeSH Terms

Appointments and Schedules*
Child
Complement System Proteins
Humans
Infant*
Korea*
Republic of Korea
Serogroup
Vaccination
Complement System Proteins

Figure

• 

  Fig. 1 Participant flow chart. M, study month; FAS, full analysis set; hSBA, serum bactericidal assay using human complement; rSBA, serum bactericidal assay using rabbit complement.

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  Fig. 2 (A, B) Immune responses evaluated using hSBA (full analysis set). hSBA, serum bactericidal assay using human complement; GMT, geometric mean titer; A, MenA; C, MenC; W, MenW; Y, MenY. Error bars represent 95% confidence intervals.

• 

  Fig. 3 (A, B) Immune responses evaluated using rSBA (full analysis set). rSBA, serum bactericidal assay using rabbit complement; GMT, geometric mean titer; A, MenA; C, MenC; W, MenW; Y, MenY. Error bars represent 95% confidence intervals.

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